Case Study 5
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Week5BelmontStudy_belmont_report_vol_2.pdf
Appendix Volume II
The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects
of Research The National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research
This Appendix contains (in two volumes) the full text of the papers that were prepared to assist the Commission in its consideration of the basic ethical principles that should
underlie the conduct of research involving human subjects.
DHEW Publication No. (OS) 78-0014
For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402
TABLE OF CONTENTS
APPENDIX TO BELMONT REPORT
Volumes I and II
Volume II
I. PRELIMINARY PAPERS PREPARED FOR THE COMMISSION BY ROBERT J. LEVINE, M.D.
1. The Boundaries Between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine
The Role of Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects
Consent in Various Research Settings
Appropriate Guidelines for the Selection of Human Subjects for Participation in Biomedical and Behavioral Research
2.
3. The Nature and Definition of Informed
4.
II. BASIC ETHICAL PRINCIPLES RELATING TO RESEARCH INVOLVING HUMAN SUBJECTS
5. Ethical Principles and Their Validity . . . . . . . Kurt Baier, D. Phil.
6. Differences . . . . . . . . . . . . . . . . . . . Tom Beauchamp, Ph.D.
7. The Identification of Ethical Principles . . . . . . James Childress, B.D., Ph.D.
8. Basic Ethical Principles in the Conduct of Biomedical and Behavioral Research Involving Human Subjects. . . . . . . . . . . . . H. Tristram Engelhardt,
Distributive Justice and Morally Relevant
Jr., Ph.D., M.D.
9. Medical Ethics and the Architecture of Clinical Research . . . . . . . . . . . . . . . . Alvan R. Feinstein, M.D.
Jeffrey L. Lichtenstein,
10. How to Identify Ethical Principles . . . . . . . . Alasdair MacIntyre, M.A.
M.D.
Belmont Appendix 2
11. Some Ethical Issues in Research Involving Human Subjects. . . . . . . . . . . . . . . . . . . LeRoy Walters, B.D.,
Ph.D.
Volume II
III. BOUNDARIES BETWEEN RESEARCH AND PRACTICE
12. Protection of the Rights and Interests of Human Subjects in the Areas of Pro- gram Evaluation, Social Experimenta- tion, Social Indicators, Survey Re- search, Secondary Analysis of Research Data, and Statistical Analysis of Data From Administrative Records . . . . . . . . . . . . . Donald T. Campbell, Ph.D.
Joe Shelby Cecil, Ph.D.
13. Response to Commission Duties as Detailed
On the Usefulness of Intent for Distinguishing
in P.L. 93-348, Sec. 202(a)(1)(B)(i). . . . . . . . Donald Gallant, M.D.
14. Between Research and Practice, and Its Replace- ment by Social Contingency. . . . . . . . . . . . . Israel Goldiamond, Ph.D.
Especially in Mental Health . . . . . . . . . . . . Perry London, Ph.D. 15. Boundaries Between Research and Therapy,
Gerald Klerman, M.D.
16. Legal Implications of the Boundaries Between Biomedical Research Involving Human Subjects and the Accepted or Routine Practice of Medicine. . . . . . . . . . . . John Robertson, J.D.
17. The Boundaries Between Biomedical Re- search Involving Human Subjects and the Accepted or Routine Practice of Medicine, with Particular Emphasis on Innovation in the Practice of Surgery . . . . . . . . David Sabiston, M.D.
18. What Problems are Raised When the Current DHEW Regulation on Protection of Human Subjects is Applied to Social Science Research? . . . . . . . . . . . . . . . . . . . . . Richard A. Tropp
Belmont Appendix 3
IV. RISK/BENEFIT CRITERIA
19. Some Perspectives on the Role of Assess- ment of Risk/Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects . . . . . . . . Bernard Barber, Ph.D.
Conduct of Psychological Research . . . . . . . . Gregory Kimble, Ph.D.
ment of Risk-Benefit Criteria in Connection with Research Involving Human Subjects. . . . . . Maurice Natanson, Ph.D.
Analysis in Clinical Pharmacology . . . . . . . . Lawrence C. Raisz, M.D.
20. The Role of Risk/Benefit Analysis in the
21. A Philosophical Perspective on the Assess-
22. Essay on Some Problems of Risk-Benefit
V. INFORMED CONSENT
23.
24. Some Complexities and Uncertainties
Nature and Definition of Informed Consent in Research Involving Deception . . . . . Diana Baumrind, Ph.D.
Regarding the Ethicality of Deception in Research with Human Subjects . . . . . . . . . Leonard Berkowitz, Ph.D.
25. Selected Issues in Informed Consent and Confidentiality with Special Reference to Behavioral/Social Science Research/ Inquiry . . . . . . . . . . . . . . . . . . . . . Albert Reiss, Jr., Ph.D.
Philosophical Foundations and Pol icy Implications. . . . . . . . . . . . . . . . . . . Robert Veatch. Ph.D.
26. Three Theories of Informed Consent:
III
BOUNDARIES BETWEEN RESEARCH AND PRACTICE
12
PROTECTION OF THE RIGHTS AND INTERESTS
OF HUMAN SUBJECTS IN THE AREAS OF PROGRAM EVALUATION,
SOCIAL EXPERIMENTATION, SOCIAL INDICATORS,
SURVEY RESEARCH, SECONDARY ANALYSIS OF
RESEARCH DATA, AND STATISTICAL ANALYSIS OF DATA
FROM ADMINISTRATIVE RECORDS
Donald T. Campbell, Ph.D.
and
Joe Shelby Cecil, Ph.D.
Protection of the Rights and Interests of Human Subjects in the Areas of Program Evaluation, Social Experimentation, Social Indicators,
Survey Research, Secondary Analysis of Research Data, and Statistical Analysis of Data From Administrative Records
Donald T. Campbell and Joe Shelby Cecil
Northwestern University
An important task facing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is the establishment of standards for the burgeoning new areas of program evaluation, social in- dicators, and related activities (to be collectively designated "program evaluation" in this manuscript unless greater specificity is needed). All of these activities are "research" (usually behavioral research) in the sense of Public Law 93-348; thus they fall within the scope of the commission's assignments. As Institutional Review Boards become increasingly involved in approving such research, they could benefit from guidelines prepared by the NCPHSBBR for this novel set of problems.
While the participants in such research clearly have rights and interests which may be violated, the nature of these threats is somewhat unique. Rarely will risk to physical health be involved. Indeed, the experimental group par- ticipants often receive an apparent boon which the control group participants may well feel they equally deserve, so that control group rights may often be the greater problem. The more frequent danger in program evaluation is the risk that the research data will be misused since sensitive information is often collected. Such data may be subpoenaed by prosecutors searching for evidence of crimes, or become a source of malicious gossip or blackmail. Federally funded program evaluations frequently require auditing, verifica- tion, and reanalysis. These activities may preclude a promise of complete confidentiality to the respondents and increase the risk that the informa- tion they provide will be used improperly. However, if respondents are fully informed of these risks, the quality of the research data may be diminished. From these few examples it is apparent that these areas of social research present a different set of problems from those encountered in medical and laboratory research.
This problem area has already received attention from several national organizations. For instance, the Social Science Research Council's Committee on Social Experimentation considered these issues at length over a four-year period, producing a short chapter on "Human Values and Social Experimentation" (Riecken, Boruch, et al., 1974, pp. 245-269). The contemporaneous National Academy of Science - National Research Council "Committee on Federal Agency Evaluation Research" addressed these issues in its report entitled Protecting Individual Privacy in Evaluation Research (Rivlin, et al., 1975). (One of the present authors participated in both of these committees.) The Privacy Protec- tion Study Commission, established by the Privacy Act of 1974, has extensively considered the problem of maintaining confidentiality of research information (Notice of Hearing and Draft Recommendations: Research and Statistics, January 6, 1977). The Social Science Research Council has a longstanding committee
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and special staff devoted to Social Indicators, and is establishing a new committee on program evaluation. The Brookings Panel on Social Experimenta- tion recently published a series of papers on this topic (Rivlin and Timpane, 1975). Special committees with this concern exist in many professional organ- izations. This recent activity provides the National Commission with a unique opportunity to integrate these diverse findings into a general code protecting the rights of subjects participating in these new areas of research.
Background Comments:
Lake the others who have agreed to write background papers for the Commission, the present writers have volunteered to do so because of strong concerns on this matter. In these areas of research, two widely cherished valued are in potential conflict. The subject's right of privacy may conflict with the researcher's need to gather sensitive information necessary for mean- ingful program evaluation. We wish to make explicit our manner of resolving this conflict. In agreement with the dominant mood in Washington, we recognize the right to privacy of individuals participating in these areas of research. This paper includes several suggestions which would result in increased pro- tection for the privacy of research participants. However, our greater fear is that Congress and the administration will needlessly preclude important program evaluation and access to research information through ill-considered efforts to protect individual privacy. For example, special procedures of file linkage permit inexpensive and highly relevant program evaluation. Although these procedures require the retrieval of administrative records, they may be employed without jeopardizing the privacy of program participants. (The case for such procedures will be presented in the context of specific recommenda- tions.) We urge that special caution be exercised to avoid creating rules that unnecessarily restrict these procedures.
Before providing our recommendations we wish to set the scope of this report by defining some of the major terms that will be employed:
Program Evaluation: Assembly of evidence bearing on the effectiveness and side effects of ameliorative programs, social innovations, etc. These programs have usually been initiated by governments.
Social Indicators: Statistical summaries, often in time-series form, bearing on the well-being of the nation or smaller social units. Social indicators may be viewed in contrast to more common economic indicators. Many social indicators are generated from statistical summaries of adminis- trative records. Others, such as indicators based on the Census, are produced by institutionalized survey procedures. Increasing attention is being given to "subjective" social indicators, in which representative samples of the public report on their "happiness" or satisfaction with various aspects of their lives in public opinion surveys.
Social Experimentation: This will be narrowly defined, as it was in the SSRC volume (Riecken, et al., 1974), to refer to an experimental form of policy research and/or program evaluation, experiments carried out in social (as op- posed to laboratory) settings evaluating governmental or other social inter- ventions. (This definition excludes experiments in public settings to test social science theories, an important form of social experimentation that the National Commission is attending to through other background papers.)
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Respondents: Participants, interviewees, anthropological "informants," the persons whose responses are recorded, the "subjects" of research, etc. Many social scientists prefer the terms "respondent" or "participant" to the term "subject," since the term "subject" has been associated with an exploi- tative attitude neglecting the rights and interests of the research cooperator.
Statistical Data: The Privacy Act of 1974 uses this term to refer to information collected originally for research rather than administrative purposes. This usage will be avoided here in favor of research data-
Statistical Analysis, Statistical Product, and Statistic: These terms refer to summary indices no longer containing individually identifiable data that may be based on either research data or administrative records. Means, standard deviations, correlation coefficients, t ratios, F ratios, probabil- ity levels, etc., exemplify statistical products. Frequency counts and per- centages usually qualify as statistical products precluding individual identi- fication, but not if the identities of individuals can be deduced through as- sociation of research data with public records.
Administrative Records: Refer to data collected originally for bureau- cratic purposes rather than research purposes. School grades, achievement test scores, earnings subject to withholding tax, unemployment insurance pay- ments, days hospitalized, incidence of serum hepatitis, auto insurance claims, all represent administrative records that can be of great value in program evaluation if they are used in ways safeguarding individual privacy.
Record , File , Data Bank : These are terms used for collections of data on individuals, either administrative or research data.
Reanalysis and Data Analysis by Outsiders: Refer to the use of research data or administrative records for purposes other than were originally under- stood by the respondents, and by persons other than the regular custodians of the data.
File Merging: Refers to combining individual data from two files contain- ing data about the same respondents, so that one or both of the files, or a third file, ends up containing individually identified data originating in another file. Unified data banks involve file merging.
File Linkage: Refers to linking data from two or more files so that File statistical products are generated involving data from both files.
merging is the most complete form of file linkage, and where permissible, the most statistically efficient. are restricted forms of file linkage that do not involve file merger, and where no individually identified data are transferred from any file to any other (e.g., the "mutually insulated" file linkage to be discussed below).
Recommendations:
1. Review and Review Boards
It is important to note, however, that there
Let us start with a concrete recommendation:
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la. Evaluation research, social indicator research, social survey research, secondary analysis of research data, and statistical analysis of data from administrative records, are to conform to rights of subjects legislation (in particular, PL93-348) and to the guidelines and regulations developed to implement these laws by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This coverage includes all such research regard- less of auspices or funding: private, unfunded, university- related, profit and nonprofit research groups, research by govemmental employees, etc.
There is general agreement that these areas of research are and should be covered by PL93-348 and other rights-of-subjects legislation. 99% of such research already is conforming to such standards in the sense of not violating the rights-of-subjects specified. publicized cases of violations in these areas. is the monstrous bureaucratic burden of requiring this vast area of low-risk research to go through formal institutional review processes. pendices that present sponse to this problem, we are suggesting a process of conditional clearance by affidavit. This procedure provides an expeditious means of reviewing certain low-risk research areas. Sample verification, such as is done for income tax reports, and the threat of subsequent prosecution for actions in violation of the clearance affidavit should discourage abuses. The suggested procedure will be superior to the kind of mass-produced perfunctory clearance that institutional Review Boards would tend to employ in these areas. affidavit clearance requires a revision of PL93-348, or other laws, we recom- mend such revisions be enacted.
Probably
There are essentially no The problem raised by PL93-348
(See the two Ap- reactions to an earlier draft of this report.) In re-
If
lb. Rights of Subjects Clearance Procedures: Conditional Clearance by Affidvait and Full Review by Institutional Review Boards. Before soliciting funding or initiating a research activity in the low-risk areas of evaluation research, social experimentation, social indicator research, social survey research, secondary analysis of research data, or statistical analysis of data from administrative records, the Principal Investigator(s) should file with the Institutional Review Board concerned with protecting the rights of the participants in the planned study, a full research proposal and a "clearance affidavit," constituting a detailed affimation that the rights of the participants and subjects are not jeopardized in any of the ways specified by the National Comission for the Protection of Human Subjects of Biomedical and Behavioral Research in implementing PL93-348. the Review Board and the request of the Principal Investigator, this affidavit may constitute a conditional rights-of-subiects clearance, permitting funding requests and research to proceed forthwith, unless or until the Principal Investigator, the Institutional Review Board, or the funding source, requests delay for a full review by the Insti- tutional Review Board. The Institutional Review Board may conduct such a full review at any time during a research proceeding under conditional affidavit clearance, and may order the cessation of research found to be violating rights-of-subjects regulations.
We envisage this conditional clearance by affidavit, for these low- risk areas of research, being implemented through a long, detailed question-
At the discretion of
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naire that the Principal Investigator(s) would fill out, sign, and have notar- ized. and guidelines that the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research is now developing, including regulations such as those suggested below. be kept on file by the Review Board for the length of the research project and the subsequent period of project liability for participant injury. designated low-risk areas, the funding and/or research process could proceed as soon as the proposal and clearance affidavit were filed, if the Principal Investigator(s) had affirmed it as lacking in participant jeopardies and did not wish a Board review. The Board would have the right to examine these on a spot-check, sample, or systematic basis, and to request at any point the cessation of activity (funding applications, data collection, data analysis, etc.) until a Board clearance had been achieved. For these low-risk areas such a delayed decision to hold full review or a veto of the research would be rare, lations that a principal investigator would opt for conditional affidavit clear- ance rather than requesting a full Board review. to have a staff or Board member examine each affidavit for combinations of features that might indicate possible risks. technique for quality control, perhaps a Board should give full review to a random one-tenth of conditional affidavit clearances.
The contents of the questionnaire would be based on the rules, issues,
These affidavits and research proposals would
For these
and it would be upon such an estimate and understanding of the regu-
Certainly a Board would want
Since sampling is an efficient
From the investigator's point of view, affidavit clearance prolongs the project's vulnerability to a negative Review Board decision and may in- crease its liability to legal damage claims brought against it by participants. The relative advantage of prior Board clearance may easily be overestimated however. Even for projects they have approved, Review Boards will want the right to determine that the project is restricting itself to the approved activities, and will use that right if it receives complaints.
Consideration should be given to the effects of including program evalua- tion, etc., on the constitution of Review Boards. This raises a number of problems that were not fully presented in the initial draft of this paper and thus have not received comments. One recommendation is obvious:
1c. Rights-of-Subjects Review Boards should be available to handle program evaluation, etc., on research done by independent investigators, profit and nonprofit research organizations, governmental agencies, etc., as well as for research conducted through universities.
Note that while the Statistical Policy Division of the Office of Management and Budget reviews questionnaire forms for governmental and govern- ment contract research, and may consider respondents' rights in the process, this does not necessarily provide the equivalent of Institutional Review Board clearance.
The proper location of these Review Boards becomes a problem. It would
This role for Review Boards be desirable for them to be locally available to the research participants so that complaints can easily be placed and heard. becomes particularly important in monitoring the conditional affidavit clear- ance procedure.
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To date, Institutional Review Boards have been set up in the institutions doing the research. ities and hospitals, the participants in such research have had easy access to
Since most of this research has been conducted in univers-
the Board. However, a program evaluation may be conducted by a more distant institution. Thus local institutions (such as public schools) whose members are frequent subjects of evaluation research may wish to set up their own Rights-of-Subjects Review Boards.
Local Review Boards seem impractical for broad public opinion surveys. While city, county, and state boards are conceivable, and should be given juris- diction if they request it (local jurisdictions that require licensing of opin- ion survey interviewers could insist on approval by Review Boards), it would be unreasonable to require local Review Boards for national surveys interviewing only a few people in any one local jurisdiction. Board is necessary.
For these, a national Review
Enforcement of the review requirement will be most effective when tied to funding. This suggests that each major source of funding, government and pri- vate, set up review boards. While some commercial and private political opin- ion research may avoid review, this may be the practical limit of the enforce- ment power. Opinion survey interviewing merges into investigative interviewing by journalists, detective work, credit investigation, neighborly curiosity, and intelligence activities more generally. It is in these areas that Rights-of- Subjects are in the most jeopardy (persons interviewed about as well as persons interviewed) yet we are unlikely to see such "research" activities subject to Rights-of-Subjects scrutiny.
1d. Where there are several Institutional Review Board ap- propriate, one review is sufficient if the Review Board most directly responsible for the well-being of the respondents does the review or formally concurs in the review.
Research by a university team on hospital patients would provide one example. In such a case, the hospital has the primary responsiblity for the well-being of the participants. required data from high school students to be collected through the and if the school district had a Review Board, it would be the one with the primary responsibility for protecting respondent rights.
sential for the participants to know the extent of their rights and where to complain if they feel their rights are in jeopardy. Fully informed research participants will be necessary to monitoring the conduct of research approved under the conditional clearance procedure:
If a community drug abuse abatement agency schools,
To adequately protect research participants' rights, it would seem es-
le. Research participants should each be given a printed statement informing them that the research is being conducted in conformity with Congressional legislation on the rights-of-subjects, the extent of their rights under this legislation, and providing the address and telephone number of the Review Board to whom complaints should be directed.
In the case of a national Review Board, this might include a Toll- Free 800 area code number. be implemented with a statement in writing that could be left with the respon- dent.
This recommendation is one of several that could
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Does the inclusion of program evaluation, survey research, €etc., have any special implications for the selection of Review Board members? A recommenda- tion characteristic of these areas of research would be that Review Boards contain members of the groups from which participants are being drawn, or, in the case of children, parents of such participants. out of experience with ghetto neighborhood boycotts of survey research. It is probably generally true that on these research topics potential participants are more competent to judge when their own interests are threatened than in the case of medical research. nical knowledge would be necessary to make an informed judgment. concur in the desirability of having such persons on Boards, along with sub- stantial proportions of nonresearchers, we have been unable to develop a recom- mendation that would insure such representation and still be feasible. difficult to develop a method that would insure representation of the interests of the members of the community while limiting the intrusion of narrow politi- cal issues into the review process. given veto power, this would in effect recognize class or category rights, which is recommended against in section 7.
2.
Such suggestions arise
A brief training program could supply what tech- While we
It is
If such community representatives were
The Borderline Between Administrative Reports on Social Service Delivery and Program Evaluation
There is a problem of borderlines between a social work department de- livering its regular services and a similar department testing out new pro- cedures or giving a special evlauation to its standard method of operation. Similarly, there is a borderline between the regular instructional activities in a school and the comparative evaluation of alternative practices. parallels exist to the troublesome problem the Commission faces with regard to medical practice: When does the doctor's exploration of alternative thera- pies with his patient become research? While the Commission should take some cognizance of the borderlines for program evaluation, these problems seem less serious than those in medical research, and it is probably wise to employ a narrow definition of program evaluation to minimize the coverage. cautions and dissentions on this, as related to specific recommendations to follow, see the Appendix A, reactions to points 5-8.)
Social service programs, employment offices, adult education programs,
Thus
(For
schools, police departments, administrative agencies of all kinds, have in the past had wide latitude in varying their modes of operation. unwise to add regulations curtailing this freedom, or adding to the bureau- cratic difficulties of initiating change. distinguish between variations in the services and variations in the infor- mation collection activities:
It would seem
Thus it might be necessary to
2a. Changes in mode of operation of a service agency that are within the legal or customary latitude for change enjoyed by the agency will not be interpreted as research under the purview of the Commission and related statutes, except with regard to any novel data collection activities initiated for the purpose of evaluating the change as a program alternutive capable of being adopted by other
There is an ambiguous borderline between information collected for use
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similar units.
in an annual report of an operating agency and that collected for a program evaluation done by an in-house staff. annual reports or even special-topic operational analyses done to monitor regular operations:
Clearly it would be unwise to include
2b. Data collection and analysis done by an institution for opera- tional monitoring of its own operations (as opposed to evaluating pro- gram alternatives as policy items capable of being disseminated to other units) will not be regarded as research for the purposes of this Commission and the related laws.
These proposed regulations have obvious ambiguities, but rather than sug- gest specific refinements, it seem better to wait, allowing operating agencies to define their activities as they choose unti1 specific problems emerge. must remember that there are Rights-of-Participants issues in every social in- stitution and profession, public and private, whether doing research or not, and this Commission must avoid taking on this whole responsibility.
We
Expressed purpose in the funding of programs may provide guidelines:
Where funds are specifically designated for evaluation of 2c. program effectiveness, construction of social indicators, statistical analyses of administrative data, etc., the activities undertaken with these funds me ''research" that should receive clearance as to protec- tion of rights-of-participants in research from an Institutional Review Board.
This proposed regulation does not cover the treatment involved (although 2d below does) but merely the data collection introduced for the evaluation. Such an emphasis contrasts with medical therapies, where the dangers of the treatment are usually the major concern of an Institutional Review Board.
Consider a borderline case like "Title I" programs of compensatory educa- tion in public schools. schools meeting specified poverty criteria are eligible to receive funds to spend on a variety of special remedial activities of their own devising or choosing, but limited to children designated as educationally deficient. While a great diversity of innovative and traditional remedial activities are involv- ed, these are still within the range of standard operating procedures, and the program is funded as a nationwide activity, not a pilot program. where Congress and the Office of Education fund scientific evaluations of the effectiveness of a sample of Title I programs, employing new data collection activities, opinion surveys of parents, students, and school personnel, spec- ifically administered achievement tests, etc., these latter are judged "research" for present purposes.
In this massive national program, all districts and
However,
There are, however, instances in which the treatment as well as the informational research procedures should be reviewed.
2d. Where the enabling legislation specifies a trial or experimental pilot program or demonstration project as well as an evaluation budget; where the research contract or grant funding covers funds for treatment development and treatment delivery as well as
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for evaluative information collection, Institutional Review Boards should review the treatment as well as the informational research activities of the project.
Usually the contract RFP'S (Requests for Proposals) and grant applica- tions will provide adequate grounds for determining this. lustrations have involved governmental programs, privately supported programs also come within the scope of the recommendations.
3. Informed Consent - General
While the il-
The blanket inclusion of "behavioral research" in PL93-348 may make par- ticularly marked changes in extending the concept of informed consent from laboratory research into areas such as program evaluation and survey research. These effects may be so marked as to result in considerable apposition from the research community. However, the principle is so obviously fair that we recommend the endorsement of this extension.
3a. Individually identifiable participants in social research, surveys, program evaluation, etc., must be informed:
3a-1. that research is being conducted; 3a-2. of the procedures they will be experiencing; 3a-3. of the risks and benefits reasonably to be expected; 3a-4. of the purpose of the research; 3a-5. of the anticipated uses of the information; 3a-6. of the names, addresses, and telephone numbers of the
3a-7. of the names, addresses, and telephone numbers of the
3a-8. that they are free to ask questions and may refuse to
3a-9. that they may later withdraw from the research, and
researchers;
sponsors of the research;
participate; and,
the consequences of such withdrawal (cancellation of income subsidies, etc.).
3b. The exact wording of these statements must be approved by the Rights- of- Subjects Review Board. modifications of the elements of the informed consent agree- ment when:
3b-1. 3b-2.
The Board may approve
the risk to a subject is minimal; rigid adherence to the specified elements of the informed
consent agreement undermines important objectives of the research; and
objectives would be less advantageous to the parti- cipants in the research.
3b-3. any reasonable alternative means for attaining these
The elements of this informed consent agreement are similar to the cur- rent HEW informed consent regulation used predominantly in biomedical and clinical psychological research. (For a discussion of the problems raised when the current HEW regulations are extended to social research, see the position paper written for the National Commission by Richard A. Tropp.)
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However, certain elements have been added to accommodate special problems that arise in the context of surveys, program evaluation, etc.
Informed consent must be obtained only from "individually identifiable participants" in social research. row definition of "subject at risk" as the term is used in the current HEW regulations. For example, restriction of the informed consent requirements to "participants" in the research will not require the researcher to obtain the consent of nonparticipants who might be affected by the treatment, such as landlords in a housing allowance experiment. Restriction of the require- ment to "individually identifiable" participants would exempt anonymous obser- vational studies, etc., in which no jeopardy to the rights of the individual participants exists. at risk" may be inadequate, such as in research based on hearsay information concerning identifiable individuals. In such rare situations, as in instances of anonymous participants and nonparticipants who may be affected by the re- search, the broad representation of interests on the Rights-of-Subjects Board should insure that the rights of those whose consent is not required will be respected.
This limitation results in a fairly nar-
In rare instances this narrow definition of "subjects
Even with this narrow definition of "subjects at risk," major changes in the conduct of social research would result. Social researchers will be ex- plicitly required to obtain some kind of informed consent of participants. Opinion surveys would be required to identify the sponsors and purposes of the survey, as well as the research firm conducting the survey. (Note that the requirements of information regarding the sponsor's identity (3a-7) and the purpose of the research (3a-4) in the previous draft failed to receive the endorsement of the majority of commentators. Appendix A, Recommendation 24.)
In keeping with the recommendations of Section 5 below, the statements of the purpose of the research (3a-4) may stop short of telling the participants of experimental treatments that they are not receiving. Even so, such infor- mation may influence the degree of cooperation by participants, and, even more likely, modify the responses given. It is this latter effect that will most disturb the social research profession. However, data collected under these conditions can be almost as useful as present surveys. differences under common contexts that are most informative. Present surveys do not provide "absolute" opinions, but rather opinions conditioned by a heterogenous set of respondents' surmises and suspicions on the very issues that this recommendation would make explicit. Of course, the more explicit nature of this information may result in greater attention by respondents to these issues, and researchers should anticipate the resulting biases.
It is comparative
In major experiments such as the New Jersey Negative Income Tax Experiments, participants are asked to sign a written consent form. formality is usually missing from survey research, even in panel studies where repeated interviews are envisioned. This recommendation anticipates that in most instances, the written consent of the participant must be obtained. In situations such as in telephone surveys, where it would be difficult or awkward to obtain written consent, some other means of obtaining consents will be per- mitted. individual was properly informed and consented to participation in the research, and therefore may wish to require a signed consent form for their own protection.
Such
However, researchers must always bear the burden of showing that the
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It has been suggested (see Appendix A, page 8 ,)that separate consents be solicited for the experimental treatment and information collection compon- ents of social research. Such separation can improve the control and estima- tion of attrition bias (Riecken, et al., 1974, 58-59). For the most part, in program evaluation, social indicators research, etc., and for control groups in experiments, only informational consent forms will be required.
Recommendation 3b permits the Rights-of-Subjects Review Board to modify the elements of the informed consent requirements when the risks to the sub- jects are minor and information regarding one or more of the elements of inform- ed consent would undermine some important research objective. mendation is similar to the modification clause in the HEW regulations, and permits the flexability to accommodate a wide range of social research settings. In certain extreme instances, such assessment of the impact of Title 1 funding, consent of the participants in the research (consent by the parents of the school children) may be waived by the Rights-of-Subjects Review Board. a waiver would be appropriate when an institution rather than an individual is the focus of the study. can be obtained from an institution representing the interests of the parti- cipants (such as a school board or local governmental body).
This recom-
Such
In such a situation a similar informed consent
Some issues of informed consent in social research are left open by this recommendation. special or institutionalized participants (children, prisoners, mental patients). These topics are discussed in other papers submitted to the National Commission.
These proposals on informed consent have not been reviewed in their present
It does not address the problems of gaining consent from
form by our cooperating readers, and should be regarded with more caution than the better-tested sections of this paper. Moreover, insofar as the content of these recommendations was covered (Appendix A, Recommendation 24) no favorable consensus was found.
4. Rights and Interests of Respondents in Informational Surveys
A major part of social and behavioral research involves soliciting information from and about respondents by interviews and questionnaires. Respondents certainly have interests and risks with regard to information about themselves that they have provided. Their interests should also be recognized in determining the proper uses of any information that they have provided if it is used in ways identifying them as the source. They also have rights over information that others have provided in which they may have been identified. (It will be argued below that they have no rights that are jeopardized in transfers and uses of such data in which their identification as a source or target is precluded.)
The Rights-of-Subjects in survey research, polling, and interviewing have received relatively little attention compared to the attention these issues have received in other areas of research and record systems. this overview coverage. its purview, a special paper centering on the opinion survey industry is called for.
While will touch on these problems, it is necessarily limited in its
If the National ommission agrees that these problems fall within
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The data solicited by interview and questionnaire for program evaluation, and social indicator development (or for descriptive surveys serving social science or journalistic purposes) often involves information about illegal acts. In addition to indicating obvious criminal behavior, information about income and income sources may indicate violation of tax or welfare laws. sensitive information that could result in personal embarrassment or discom- forts to the respondent may be solicited.
Other
The procedures of survey sampling make the identity of the respondent known to the interviewer in door-to-door and telephone surveys. for checking on the honesty and accuracy of interviews through reinterviewing a portion of the respondents require recording this identity, as do research procedures involving reinterviews of the same respondents (e.g., pretests and posttests) or linking respondents to program treatments and other information sources.
Procedures
Subpoena and Government Audit. The Mercer County prosecutor requested information about the participants in the New Jersey Negative Income Tax Experiment (Watts & Rees, 1973) as a part of a broad search for cases of wel- fare cheating. information creates a real jeopardy to participants in much social research. The decenial census and the interim sample surveys conducted by the Bureau of the Census are made exempt from such subpoena by acts of Congress. enabling legislation in drug abuse research has empowered the Secretary of HEW to give such immunity to specific research projects. Negative Income Tax Experiment and most program evaluation research lacks such protection. rather than release confidential information, while in other cases, confidential information has been released (Carroll & Knerr, 1976).
The power of governmental agencies to legally subpoena such
Certain
But the New Jersey
In some cases, researchers have gone to jail or risked going
In the Mercer County case, the project and the prosecutor settled out-of- court. money received from the project, but no information on income or anything else that respondents had provided the project. that this is also the dividing line that any statutes providing privileged communication protection for research data should follow. government and of research agencies must be subject to freedom of information requirements. purpose of providing research information, however, should be privileged com- munications. If law enforcement groups want this information, they can ask it of the respondents themselves. Nejelski & Peyser (1975) recommend a broader protection, including protection of information about the researcher's actions. However, all agree that such a statute should cover the information in all its data processing stages, rather than just in the interviewer-interviewee com- munication. Such legislation seems unlikely, and the National Commission on safeguarding research participants' rights will have to set standards that assume subpoena jeopardy.
The project gave the prosecutor names of recipients and amounts of
The present writers believe
The actions of
The communiations of cooperating respondents made for the
Required audits of federally sponsored social experiments may result in similar threats to the confidentiality of identifiable information. General Accounting Office, pursuant to a request from a Senate Committee con- sidering preliminary analyses from the New Jersey Experiment, sought to audit and verify interviews. The project staff gave these auditors full access to the computer data from interviews with individual identifiers deleted, and the
The
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GAO produced its own parallel analyses of income guarantee effects. The staff also permitted GAO access to a sample of individually identified files to audit the accuracy of the transfer from individual files to the record systems used in the analysis which may have been in violation of the project's promise of confidentiality. audit without requiring GAO auditors to reinterview the respondents. During 1975 a similar issue has been raised between the GAO and the Housing Allowance Experiment operated by HUD through The Urban Institute, Rand Corporation, and Abt and Associates.
Such access was sufficient to meet the purpose of the
Since, in ordinary public opinion polls, verification by sample reinter- view is a standard procedure for checking interviewer honesty and competence, it would seem a desirable feature of government auditing of program evaluation data. making process, it seems essential that audit, recount, reanalyses, and other verification processes be possible. ify sample surveys by selecting and interviewing independent samples of the same size drawn according to the same rules. But since this will rarely be feasible, it seems undesirable to preclude verification contacts with the original interviewees. It also seems undesirable to violate pledges of con- fidentiality to the respondents. Perhaps slight changes in those pledges so as to mention the rare possibility of verification interviews to check inter- viewer honesty would suffice without reducing respondent cooperation on sen- sitive material. If, despite these precautions, the information is so sensi- tive that the threat of recontact would substantially impair participation in the research, other less intrusive means of establishing response validity should be considered (Boruch & Cecil, 1977).
Because such data are assembled as a part of a governmental decision-
Theoretically it might be possible to ver-
The possibility of subpoena and of release of names to auditors for re- search verification interact crucially with informed consent. The Institutional Review Board should examine the specific wordings of the explanation of research purpose and pledges of confidentiality made to respondents. ings might eventually be prepared. type of information being requested and degree of cooperation promised by local prosecutors and police.
Recommended word- The risks involved will depend upon the
4a. Where the material solicited involves no obvious jeopardy to respondents, a vague, general promise of confidentiality is accept- able. E.g., "These interviews will be summarized in group statistics so that no one will learn of your individual answers. will be kept confidential. be contacted later to verify the fact that I actually conducted this interview and have conducted it completely and honestly."
All interviews There is a remote chance that you will
4b. Where full and honest answers to the question could jeo- pardize a respondent's interests in the case of a subpoena, the re- spondent should be so informed. E.g., "These interviews are being made to provide average statistical evidence in which individual answers will not be identified or identifiable. We will do every- thing in our power to keep your answer completely confidential.
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Only if so ordered by Court and Judge would we turn over individu- ally identified interviews to any other group or government agency. We believe that this is very unlikely to happen, because of the assurance of cooperation we have received from ."
4c. Where the researcher has made the data invulnerable to subpoena, as by not himself having the key linking names to code members, this being stored beyond reach of subpoena or in some agency like the census bureau immune from subpoena, or where the researcher has used other procedural or statistical techniques that insure the anonymity of the sensitive information, the warning of possible subpoena may be omitted from the background statement to the respondent.
The devices are discussed more fully elsewhere (see Boruch & Cecil, 1977, and Campbell, Boruch, Schwartz, & Steinberg, 1977, for a review of this lit- erature). While they have not been tested in the courts, they are probably sure enough, and the dangers of subpoena remote enough, so that omitting men- tion of the subpoena possibility creates no real jeopardy. In general, as shown in the Appendix (reactions to recommendations 9, 10, and 11) our volunteer panel were favorable to these recommendations, although vigorous comments were generated. A strong minority found 4b not protective enough.
Subpoena is probably a rarer threat than accidental release of individual information in the form of gossip. be considered. data processers have access to the data in an individually identified form. From the COFAER Report (Rivlin, et al., 1975) come these three recommendations that the present authors also endorse.
Blackmail, though a rare event, should also Thus respondents' rights are involved in the degree to which the
4d. Sensitive information should not be collected unless it is clearly necessary to the evaluation and is to be used.
of the evaluation, the anonymity of the respondent should be pre- served from the beginning by not collecting identifying information at all.
4e. Where it is feasible and does not undermine the validity
4f. Identifying information, such as name and address or Social Security number, should be removed from the individual records at the earliest possible stage of analysis and replaced by a code number. The key linking this code number to the identifying infor- mation should be stored in a safe place and access to it severely limited. This key should be destroyed as soon as it is no longer needed.
Even with individual identifiers removed, individual data should probably not be stored on time-sharing computer systems, as this makes possible a repeated accessing of the data, utilizing variables that are a matter of public record, so as to break the code for some specific individuals.
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5. Rights and Interests of Participants in Social Experiments with Regard to Treatment Variables.
5a. All participants in an experimental program should be informed in advance of all features of the treatment and measurement process that they will be experiencing that would subject them to any obvious risk or jeopardy and that would be likely to influence their decision to participate in the program or their conduct as participants in the program. provided with copies of the statements made to potential participants when seeking their consent.
All experts would probably concur in this recommendation, even though
Institutional Review Boards should be
there will be many settings in which living up to it will produce less valid data than if participants were not informed of certain aspects of the treat- ment variable, or kept in ignorance of the fact that an experiment was going on. There is a further degree of informed consent, however, that methodolo- gists would recommend against. the other groups in the experiment are getting, in particular, informing the control group of the desirable treatments the experimental groups are getting. The social experimentation committee of the Social Science Council discussed this issue at length, and ended up approving this position, since the interests of the control group are not jeopardized and since more complete disclosure would have potentially destructive effects on the conduct of the research. For example, in the New Jersey Negative Income Tax Experiment, the control group members were not informed about the maintenance payments of up to $1000 or $2000 per year to the experimental group members. of the control group were lost from the experiment in spite of the $15.00 per interview four times a year, while only 7% were lost from the best-paying ex- perimental group. Envy and resentment, coming from awareness of relative de- privation of the control group would almost certainly have added to this dif- ferential drop-out rate.
This is the informing of each group of what
As it was, some 26%
There are cases, to be sure, in which keeping a control group untreat- ed and in ignorance of the availability of the treatment being offered the experimental group represents major deprivation of rights and harm to well- being. The recently publicized experiment on syphilis treatments started in the 1930's in the South is a case in point. When started, the informed con- sent of the participants should have been secured, but the available "cures" were so ineffective that the use of a control group restricted to traditional treatments was probably not unethical. However, once penicillin became avail- able, the dramatic (even if only quasi-experimental) evidence of its effective- ness and its plentiful availability, made it immoral to withhold it from the experimental group. While a parallel situation is extremely unlikely in the realm of program evaluation, the possibility should be kept in mind.
To return to a discussion of informed consent with regard to experimental treatments, in the New Jersey Experiment, it was recognized as essential that the recipients of the income supports understand clearly that it was for three years only. (This has been the source of such serious criticisms about the validity of the experiment for purposes of extrapolating to the impact of a permanent national program, that in later experiments small groups are getting guarantees of up to 20 years.) Were the experiment to be redone again today, the recipients should be warned that information about the payments made by
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the project to them would be released to government officials if requested.
It should also be remembered that many boons are and should be adopted on the basis of a consensus of expert judgment and popular demand. a consensus is present, quasi-experimental designs not involving equally needy control groups may have to be used (Riecken, et al., 1974, Chapter IV). the treatment is in short supply, by making quantitatively explicit the degree of need and assigning to treatment on this basis, an especially powerful quasi- experimental design is made possible (Riecken, loc. cit.).
If such
If
5b. Where there is already expert consensus on the value and feasibility of a treatment and where there are adequate supplies of the treatment available, needy control groups should not be deprived of the treatment.
It should be noted that pilot programs, experimental programs, and demon- stration programs do not come under this exclusion. Such testings of potential policies should be done so as to optimally learn of the social costs and bene- fits of the program, and this will usually require random assignment of par- ticipants to experimental and control conditions. If there is expert consensus on the costs, benefits, feasibility, etc., then the program could just as well be adopted as national policy at once; if controls cannot ethically be deprived of the treatment, then usually the pilot program is not worth doing. However, if no one is to get the experimental boon unless others equally needy are left without it, then the drawing of lots, random assignment, is a traditional equit- able method of assigning the boon. not being deprived in relation to the general population, but only in relation to the temporary experimental recipients. hold in the syphilis study.)
6.
In such circumstances, the controls are
(This condition definitely did not
Reanalysis of Research Data and Statistical Analysis of Administrative Records.
Here is an area in which some current interpretations of subjects' rights Let us begin by proposing an exclus- are needlessly hampering useful science.
ionary rule.
6a. The reuse of research data for reanalysis or for novel analyses, and the statistical analysis of administrative records, jeopardize no individual rights as long as no individually identi- fiable data are transferred out of the file of original custody into another file. For uses and reuses meeting this requirement, the informed consent of the respondents is not required.
There are horror stories about Institutional Review Boards requiring each original subjects' permission for the statistical reanalysis of 20-year old intelligence test data even though names and other identifying information had been deleted from the data. requirement. school records (Russell Sage Foundation, 1970) suggests parental approval of each research use of a child's Certainly this should be changed to read "for each research use involving the release of individually identified records."
Certainly this seems a totally unnecessary The Russell Sage Foundation's guidelines for the maintenance of
record.
The most recent draft recommendations to the Privacy Protection Study
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Commission suggest that greater access to records for research purposes be per- mitted so long as the information is any individual (Notice of Hearings and Draft Recommendations: Research and Statistics, January 6, 1977).
not used to make a determination about
As an example of the practice recommended in 6a, data of the New Jersey Negative Income Tax Experiment are now available to social scientists through the Institute for Research on Poverty, University of Wisconsin. From the data have been deleted names, addresses (but not cities), Social Security numbers, names of the family doctor, and a few other specifics that might lead to identification.
6b. Individually identified data (research or administrative) may be released to new users for statistical analysis only with per- mission of the individual described by and originally generating the data.
While this rule is consistent with the spirit of the Privacy Act of 1974, the draft recommendations of the Privacy Protection Study Commission suggests that the Privacy Act be amended to permit greater access to identifiable research information without the consent of the individual participants. the act is so amended, we would urge that this proposed rule then be rewritten to permit much greater access to research information.
If
6c. Release of research or administrative data to new users for statistical analysis when done without the express permission of each respondent must be done so as to adequately safeguard all individual identities.
Procedures for achieving this have been described elsewhere (see Boruch & Cecil, 1977, and Campbell, Boruch, Schwartz, & Steinberg, 1977, for reviews). Usually this would include deletion of the participant's name, address, Social Security number, specific birth date (but not year), specific birth place (but not geographical region). Where some of the research variables are pub- licly available and can be associated with identifiable individuals (such as lists and descriptions of members of a school or a professional association), it may also be necessary to delete this information or use crude report cate- gories for the variables that are in these accessible lists. Even where multiple tables of frequencies or percentages are presented, rather than individual-level data, detective work may make possible the uncovery of in- dividual identified information. randomized rounding may be required in such cases.
Restrictions on minimal cell frequency and
6d. The original custodians of research or administrative data may generate and release to others statistical products in which individual information is not identifiable, including statistical products not anticipated by the individuals initially generating the data.
It is anticipated that in the future the requirements of respondent confidentiality and of hard-headed meaningful program evaluation will be resolved by increasing the data-analysis capabilities of administrative record files. Through the "Mutually Insulated File Linkage" (Campbell, Baruch, Schwartz, & Steinberg, 1977), the records of two files can be
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statistically linked without exchanging any individually identified data, thus conforming to this rule. be able to do standard statistical analyses as well as internal data retrieval for individuals. For many ameliorative programs, government records on sub- sequent earnings and unemployment compensation would provide accurate and in- expensive measures of effects. While these procedures would have their own problems, almost certainly they would avoid the differential attrition rate found for the interviews in the New Jersey study. Accordingly, it would be in the government's interest to increase the internal data retrieval and statistical analysis capacities of private health insurance, auto insurance, educational testing agencies, hospitals, schools, etc., so that these data could be used in program evaluation and social indicator generation in ways precluding identifying individual data.
But this procedure requires that the custodial file
For many psychological studies in college settings, it would be desir-
This could be done either able to statistically correlate laboratory performance and general intel- ligence or grade point average from school records. with individual permission, or through mutually insulated file linkage, in which regular registrar staff members were paid to work overtime to retrieve the relevant data on specified lists of persons, transform these to means and standard deviations by lists, and then return only these summary statistics by list.
While it is beyond the scope of the National Commission, it should be noted that privacy legislation curtailing the use of Social Security numbers as all-purpose individual identifiers hinders the uses just described. Greater protection of individual privacy can be achieved by prohibiting unified data banks. No abuse of privacy has resulted from the limited use of social security numbers in research. The prohibition of the use of social security numbers for research purposes is a needless and harmful precaution.
7. Future Controversial Issues.
The above sections have hastily sketched some of the major areas of concern that are "timely," in the sense that they are in tune with the con- cerns of Congress in setting up the Commission, and also represent to a con- siderable degree an emerging consensus among the quantitative social scientists engaged in program evaluation and social indicator development. (Section 3, Informed Consent, as it affects opinion surveys may have gone beyond this consensus.)
This present consensus, however, may be seen as but the current form of a growing shift in public consciousness about the rights-of-subjects as a part of an increasingly equalitarian participatory democracy. It may help the Commission to consider what the parallel set of demands 10 years hence might also contain. The following three topics are included for this purpose.
Respondents' Interests in the Topics on Which Data are Collected. A recent trend in criticism of research on social problems, including evaluation research, goes under the name "blaming the victim" (Ryan, 1971; Caplan & Nelson, 1973). There is a recurrent option in program evaluation and social indicator research as to whether evidence of a social problem is indexed as an attribute of the individual or as an attribute of the social setting and the social institutions present. When the data are indexed as individual attributes
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(ability, morale, personality, employment status) this predisposes the analysis to end up "blaming the victims" of social system malfunction for their lot in life. Many times there are options in the wordings of questions that can make big differences in the social causation implied even while collecting very near- ly the same data. Standards could be developed requiring that articulate spokes- men of the program recipient population be asked to check on the research instru- ments in this regard. Or more specific recommendations could be developed, such as recommending the social setting attributional format wherever the option existed. Shifts of this kind might be of practical value as well. ghetto settings, opinion surveys meet with mass boycott, greatly hampering the evaluation of new alternatives in social welfare services delivery. In most such instances, the program evaluation purposes would be served just as well by substituting "is this service effective" questions for the "are you sick" questions. on the quality of welfare services delivered rather than a source of evidence about his own inadequacies. This shift, plus one on rights to the results be- low, will almost certainly increase the cooperation received, and turn the in- formational survey into a useful vehicle for communicating neighborhood com- plaints to government. We have not developed a recommendation in this area, and the reactions of our panel of readers of the earlier draft (See the Appendix, points 21 and 22) shows that no consensus exists to support such a recommendation.
Note that the "blaming the victim" theme is only one illustration of such
In many urban
The conceptual shift is to turn the welfare recipient into an expert
respondents' interests. The more general class is discussed in the next section.
Class or Category, Privacy, Interests, and Rights. This paper and the National Commissions' activities as a whole have assumed that the rights-of- subjects are individual rights. Jeopardy to the rights of a class or category to which the subject belongs have not been considered. Most discuss ions of rights-of-subjects join us on this. Class rights are a Pandora's box that, if given recognition, would totally preclude most social science research. The present writers recommend that we continue to refrain from recognizing such rights in research ethics but that we make this decision self-consciously, with some recognition of the issues we are neglecting.
Some examples: The American Council on Education from anonymous surveys of college students prepared a profile of the activist campus radical who had been involved in destruction of property and disruption of speeches, etc. No radical respondent was thereby jeopardized for the past acts confessed to, since the data were genuinely anonymous in their initial collection by mailed ballot. But the interests of current and future radicals are jeopardized. For example, college admissions offices seeking to exclude such students, could do so on an actuarial basis by asking applicants the profile questions about back- grounds, interests, activities, and values, and excluding those applicants who fit the profile with a large proportion of the predisposing signs. a case, the proper protection may be to increase the legal accountability of college admissions procedures by prohibiting the use of anything but academic competence criteria. Rules seeking to preclude such class or category jeopardy in research seem to us unacceptable in their likely coverage.
In such
The statistical analyses by the Bureau of Internal Revenue might show that M.D.'s of certain types have twice the income of other professionals. This jeopardizes the interests of these M.D.'s by increasing the frequency with which they are approached by fund raisers, confidence men, and burglars,
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and by the invidiously focused zeal of internal revenue agents. and category social statistics seem to us absolutely essential for the govern- ance of a democracy in which past governmental decisions are a major determin- ant of income inequities even in the free market sector of the economy.
Yet such class
Black leaders are justifiably disturbed about social statistics reporting on invidious black-white comparisons in achievement test scores and crime rates. Perhaps even data on income and rental costs could be regarded as prejudicial. Yet these data seem essential background evidence on which to base governmental action seeking to remove the traditional environmental disadvantages blacks live under. The Civil Rights movement has had to reverse itself on this within the last 25 years. For example, in 1950 those working on reducing the de facto segregation in the Chicago schools had as their goal color-blind assignment of children to school districts and setting of school district boundaries. time open or disguised records indicated the race of every child and teacher. Within ten years, the Chicago school system was stonewalling those pushing for more integration by asserting that they had no way of telling which teachers and Pupils were black. To achieve real integration, racial identification had to be made known and counted by categories. integration would be impossible without it.
At that
Affirmative action and school
At the present time, the no doubt environmentally produced black-white difference in school achievement tests has been so redundantly documented and is so regularly misinterpreted as evidence of an innate racial inferiority, that one of us has called for a cessation on all such research unless ac- companied by thorough measurement of the black-white differential in oppor- tunities to learn the specific items the tests employ (Campbell & Frey, 1970). Considering the problem of class or category rights as a whole, however, we are reluctant to see any such appeal made a compulsory rule.
Respondent Rights to Data Produced. the future that the participants in research, the interviewees in public opin- ion surveys, etc., are co-producers of the research product, and should be co- owners of that product with an equal right to know the results and to use that information in political arguments and in other ways. rule that all respondents to an informational survey should be provided with the statistical results produced. these results placed in the nearest public library to each respondent.
It will increasingly be argued in
This could lead to the
Such a rule could be implemented by having
Another way of arriving at such a proposal is to recognize that where such surveys are a part of governmental decision-making, the voting booth rather than the animal laboratory becomes the relevant model. get to know and use the results of elections they have voted in, so too they should know the results of surveys and interviews they have participated in. This equalitarian emphasis is supported by an analysis that sees researchers as a potentially self-serving elite who may exploit the cooperative efforts of the respondents by producing products that may be used to harm the interests of the respondents. not usually be meaningful and useful to the respondents, for most social science surveys they would be.
Just as voters
While in medical and physical research, the results might
The present writers would be happy to have this adopted right now as standard operating procedure for all public opinion polls as well as evaluation research, including private polls now never published. Along with this would
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go full information prior to the questioning as to who was paying for each question and how the information would be used. the descriptive value of opinion surveys, in that answers would be more con- sciously given so as to produce politically desired statistical results. However, we believe the trends in political conscience are such that in 10 or 20 years we will have to live with these limitations. received a bare majority of endorsements in our volunteer panel, as reported in the Appendix under Recommendation 24.)
Summary
These rules would decrease
(This proposal
This background paper for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research asserts that research in program evaluation, social experimentation, social indicator research, survey research, secondary analysis of research data and statistical analysis of data from administrative records are and should be covered by PL93-348 and other rights-of-subjects legislation.
Because this vastly increases the burden on existing Review Boards, and because actual cases of abuse of subjects' rights are essentially nonexistent in this area, a procedure of conditional clearance affidavit is suggested that, at the discretion of the Review Board, might substitute for full review in most cases. will be needed.
Greater numbers and new types of Rights-of-Subjects Review Boards
Most jeopardies to rights-of-subjects in these areas will come from the information about them that is collected. In the boundary between research and practice, it is recommended that shifts in administrative policy that are normally within an administrator's discretion not be regarded as research, but that novel data collection procedures designed to evaluate such changes be classified as research and subject to Review Board scrutiny.
Extending the right of informed consent into these areas, especially survey research and other information gathering activities, will require major procedural changes that will seem to threaten the validity of results. This extension is nonetheless recommended. Informing respondents of the risks of verificational interviews and of subpoena of information is recommended where these risks exist.
It is recommended that reanalysis of research data and statistical analyses of administrative records be permitted without respondent permission where no individually identifiable data are transmitted out of the original file of custody.
In future decades, issues of class rights, of respondents' interest in question form to avoid blaming the victim, and of respondents' co-ownership of the research results will have to be faced. While the Commission's atten- tion is called to these areas, no formal recommendations are offered.
References
Boruch, R. F., & Cecil, J. S. Methods for assuring confidentiality of social research data. (In press, Rose Monograph Series, New York: Cambridge University Press, 1977)
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Campbell, D. T., Boruch, R. F., Schwartz, R. D., & Steinberg, J. Confidentiality-preserving modes of access to files and to inter- file exchange for useful statistical analysis. 1(2), 1977, pp. 269-300.
Campbell, D. T., & Frey, P. W., fade-out of gains from compensatory education. In J. Hellmuth (Ed.). Compensatory education: A national debate, Vol. 3, Disadvantaged child. N.Y.: Brunner/Mazel, 1970, 455-463.
Evaluation Quarterly
The implications of learning theory for the
Caplan, N., & Nelson, S. D. On being useful: The nature and consequences of psychological research on social problems. American Psychologist, 1973, 199-211.
Carroll, J. D., & Knerr, C. R. Law and the regulation of social science research: Confidentiality as a case study. Presented at the Symposium on Ethical Issues in Social Science Research, Department of Sociology, University of Minnesota, April 9, 1976.
Nejelski, P., & Peyser, H. A researcher's shield statute: Guarding against the compulsory disclosure of research data. In Appendix B, (86 pp.), in Rivlin, et al., 1975, (NRC-NAS).
Notice of hearings and draft recommendations. Research and Statistics. Hearings of the Privacy Protection Study Commission, Washington, D.C.: January 6, 1977.
Riecken, H. W., Boruch, R. F., Campbell, D. T., Caplan, N., Glennan, T. K., Pratt, J., Rees, A., & Williams, W. Social experimentation: A method for planning and evaluating social intervention. New York: Academic Press, 1974.
privacy threaten research? British Association for the Advancement of Science, London, June 1974.
Rivlin, A., et al. Protecting individual privacy in evaluation research. Final Report of the National Research Council Committee on Federal Agency Evaluation Research, Washington, D.C.: National Research Council, National Academy of Sciences, 1975.
mentation. Washington, D.C.: Brookings Institution, 1975.
dissemination of pupil records. New York: Russell Sage Foundation, 1970.
Ritchie-Calder, Lord, Chairman. Does research threaten privacy or does
Rivlin, A. M., & Timpane, P. M.
Russell Sage Foundation. Guidelines for the collection, maintenance and
Ryan, W. Blaming the victim. New York: Pantheon, 1971.
Tropp, Richard A. Extending the HEW guidelines to social science research. Paper prepared for the symposium: "Ethical Issues in Social Science Research." Department of Sociology, Paul Davidson Reynolds, Symposium Coordinator, University of Minnesota, 1976.
Watts, H. W., & Rees, A. (Ed.). Final report of the New Jersey Graduated work incentive experiment. Vol. I. An overview of the labor supply results and of central labor-supply results (700 pp.). Vol. II. Studies relating to the validity and generalizability of the results (250 pp.). Vol. III. Response with respect to expenditure, health, and social behavior and technical notes (300 pp.). Madison, Wisc.: Institute for Research on Poverty, University of Wisconsin, 1973, (Duplicated.)
Ethical and legal issues of social experi-
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References (Cont'd.)
HEW Regulations. "Protection of Human Subjects" (Federal Register, Vol. 39, No. 105, Pt. 2 (1974) pp. 18914-18920.)
Title II of the National Research Service Award Act of 1974 (PL93-348). * * * *
Two appendices to this report are available upon request.
Appendix A (23 pp) provides a summary of the reactions to the 25 recommendations contained in the 3 Jan 76 Draft of this report.
Appendix B (74 pp) provides the full details of the written comments, the names and addresses of those reacting to the 3 Jan 76 Draft, and a list of the lists from which came the 400 names of those asked to comment.
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13
RESPONSE TO COMMISSION DUTIES AS DETAILED IN
P.L. 93-348, SEC. 202(a)(1)(B)(i)
Donald Gallant, M.D.
Response to Commission Duties as Detailed in PL 93-348,
Sec. 202 (a)(1)(B)(i)
Don M. Gallant, M.D. Professor of Psychiatry
Tulane University School of Medicine
Before considering the boundaries between research and therapy in
the field of mental health, I should first state that the original charge
to the National Commission for the Protection of Human Subjects of Bio-
medical and Behavioral Research (NCPHSBBR) in Public Law 93-348, Section
202 (a) (1)(B)(i) totally ignored the reality that the present "accepted
and routine practice of medicine" is frequently less than adequate in
many sections of the United States. Thus, "accepted and routine prac-
tice" of medicine by some physicians includes techniques that have not
been scientifically proved in a valid manner and could, therefore, be
considered research.
of medicine" deviates from the "intelligent" practice of medicine to
such an extent that the ignorant physician is actually conducting re-
search without the realization that he is utilizing unproved techniques
in the treatment of his patient. Excellent examples of this situation
are detailed in an article, "The Prescribed Environment," by Dr. Harry
Dowling that was published in the Saturday Review of April 3, 1971 (pages
58 through 60). Practices in surgery such as the use of prophylactic an-
tibiotics for inguinal hernia operations are still standard practice in
a number of communities; yet this treatment approach is not based on any
scientifically valid observations or statistically significant experimental
In many cases, the "accepted and routine practice
13-1
results, thus placing this "standard practice" in the area of research.
This same article refers to a survey of the use of antibiotics in 76
community hospitals in which a review of 85,000 patients' charts showed
that only 54 percent of the patients were receiving antibiotics based
upon justifiable reasons. Thus, the use of the term "accepted and rou-
tine practice of medicine" in PL 93-348 is somewhat misleading and makes
it impossible to separate definitions of research from intelligent inno-
vative medical practice or from ignorant medical practice which frequent-
ly is "accepted and routine practice of medicine."
"accepted and routine practice" were allowed to prevail, the eventual
accomplishment would be the least common denominator or a relatively
uniform standard of mediocre medical practice. Perhaps more appropri-
ate terminology might have been, "the boundaries between biomedical or
behavioral research involving human subjects and the competent practice
of medicine based upon scientifically valid experimentation."
If this concept of
To reinforce this viewpoint and attempt to show that this is not
merely a difference in semantics, it should be pointed out that "blood-
letting" was still included in the "accepted and routine practice of
medicine" in the early Nineteenth Century. This procedure was still
being utilized at that time despite the fact that it was based upon no
scientifically valid experiments with controlled observations more than
50 years after Lind had demonstrated the value of controlled experimen-
tation. At present, the same lack of scientifically valid data applies
to classical psychoanalysis, encounter group therapy, marathon group
therapy, etc. Another example may be seen in surgical practice. Until
13-2
recent years, it was the standard practice in this country to use radical
mastectomy for the treatment of breast cancer.
the book, Medical Experimentation, by Charles Fried (pages 48 and 49),
radical mastectomy does not result in a higher incidence of therapeutic
success than simple mastectomy. The use of radical mastectomy in this
country was not based upon scientifically valid experimentation but was
considered to be part of the "accepted and routine practice of medicine."
In research conducted by teams of doctors in Great Britain and Denmark,
it was concluded that radical mastectomy was not more successful than
simple mastectomy concerning recurrence rate or mortality rate. The
use of the term, "accepted and routine practice of medicine," bears the
connotation of competent and best available techniques.
above examples demonstrate the inadequacies of certain "accepted and
routine practices of medicine."
However, as detailed in
However, the
Definitions
This section will define the "competent practice of medicine" and
"research." The definition of "accepted and routine practice of medi-
cine" should be based upon the requirement that the therapeutic tech-
nique should have been shown to have been more successful in a statis-
tically significant manner than any type of inert (placebo) therapy ap-
proach and the benefits of the treatment technique outweigh the risks.
This definition. of the "competent practice of medicine" enables us to
more clearly differentiate research from the practice of medicine.
intent of all legislation should be to improve the welfare of the
13-3
The
community. Thus, the framers of this particular piece of legislation are
obligated to upgrade the practice of medicine if they intend to delineate
research from the "competent practice of medicine." Present routine or
accepted practices of medicine that are not based upon scientifically
proved observations should be allowed to continue temporarily, but reg-
ulations must be established to require the evaluation of such techniques
which have never been shown to be significantly superior to an inactive
or inert type of treatment approach,
Biomedical or behavioral research involving human subjects should be
defined as well-designed and critical investigations of therapeutic tech-
niques with unknown efficacy and/or risks or an attempt to find the eti-
ology of a disease having for its aim the discovery of new facts associ-
ated with the "accepted and routine practice of medicine" with the ulti-
mate goal of providing beneficial effects for human subjects.
A Proposed Method for Delineating "Research" from the "Competent Practice
of Medicine" Based Upon Scientifically Proved Experiments
In his paperf Dr. R. Levine raised some important questions about
specific problems relating to the boundaries between research and the
practice of medicine. Any question of boundaries could be reviewed by
a local Extraordinary Treatment Committee (ETC) which would consist of
legal advisors and physicians not associated with the clinic or institu-
tion. This type of Extraordinary Treatment Committee has been detailed
in the Wyatt v. Stickney case, 1972. The first level of the review would
13-4
be a local treatment review committee; the next level should be consti-
tuted of regional appeal boards; the highest appeal authority would be
a national board with the same approximate composition as the local ones
but involving persons of national stature, to evolve review standards
and clarify the questions.
lines for these independent Extraordinary Treatment Committees (ETC)
should be assigned to your commission (NCPHSBBR). It is my own personal
recommendation that, in addition to the scientists and legal consultants
etc., an expert in statistics be assigned to each of these committees.
(At present, we are making the same recommendation in regard to the In-
stitutional Review Boards.) Such a committee may be more appropriate
for review of the problem under consideration than the Professional
Standards Review Committees (PSRO).
Responsibility for establishing the guide-
In those treatment procedures which are not based upon scientifical-
ly significant observations, it is particularly essential that full in-
formed consent be obtained from the patient.
informed consent should be:
The basic elements of this
1) An explanation of the procedures to be followed, including an
identification of those which are not based upon scientifically
valid observations or statistically significant results and
thus are experimental;
A description of the attendant discomforts and risks;
A description of the benefits which may be expected;
2)
3)
4) A disclosure of appropriate and available alternative proce-
dures that would
5) An offer to answer any inquiries concerning the procedures;
be advantageous for the patient;
13-5
6) An instruction to the patient that he is free to withdraw his
consent and discontinue the treatment at any time;
7) The physician has the continuing responsibility to inform the
patient about any significant new information arising from
other sources which might affect the patient's choice to con-
tinue the treatment;
In cases where a patient is mentally incompetent or too young
to comprehend, informed consent must be obtained from one who
is legally authorized to consent in behalf of the proposed sub-
ject.
to state.) However, where the subject is a child who has reached
the age of some discretion such as adolescence or if the patient
is otherwise mentally competent: the physician should obtain the
patient’s consent in addition to that of the person legally au-
thorized to consent on his behalf.
8)
(Of course, this type of permission varies from state
Since behavioral therapy, psychotherapy, psychoanalysis, and other
types of verbal and physical techniques (as well as pharmacologic medica-
tions) may have important consequences for the patient's life, the patient
should definitely have the opportunity to obtain adequate information
about the proposed treatment technique and then make his or her own judge-
ments whether or not to undergo treatment with a therapeutic technique
that has not been scientifically proved to be statistically significant in
relation to an inert technique.
this principle with regard to electroconvulsive therapy, aversive condi-
tioning, and psychosurgery.
The Wyatt case has already established
The same principles should be applied to other
13-6
types of treatment. The real problem arises with the non-medical per-
son who does not require licensure in his locality to utilize behavioral
or verbal techniques with patients.
be subject to the authority of the Extraordinary Treatment Committee;
this important gap and potentially dangerous situation must be corrected
by the NCPHSBBR.
This type of individual would not
In addition to having the opportunity to review and reject a treat-
ment program which has not been based upon scientifically valid observa-
tions, the patient should also have the opportunity to receive a new medi-
cation or innovative treatment approach if previously available scientif-
ically valid techniques have failed.
ney-General of the State of Louisiana (Opinion:74-1675, 1974), it is re-
cognized that "patients who are committed to state mental hospital s have
a constitutional right to receive such individual treatment as would give
each of them a 'realistic' opportunity to be cured or to improve." An
Extraordinary Treatment Committee (ETC) should be available to give appro-
val to a physician who wants to increase the dosage of medication for a
"drug-refractory" schizophrenic patient above the maximal dosages recom-
mended by the FDA.
innovative, intelligent physician who understands how to apply a variety
of pharmacologic techniques or behavioral techniques for the welfare and
benefit of the patient. New behavioral therapy approaches or innovative
types of group encounter techniques practiced by either physicians or lay"
therapists would have to be reviewed by the same ETC. Thus, the ETC would
require several full-time administrative staff members as well as rotating
part-time professional members, since many of the present techniques that
In an opinion rendered by the Attor-
A readily available ETC would be essential for the
13-7
are utilized in psychotherapy and behavioral therapy (as well as in other
fields of medical practice) lack scientific validity.
difficult to find competent professional people in the field of medicine
who would be willing to serve on a full-time basis on the ETC.
It would be too
It should be noted that the literature contains a number of valid
scientific observations concerning psychotherapy and behavioral therapy.
One such article by Sloane et al. (American Journal of Psychiatry 132:
373-377, 1975) reviewed a controlled evaluation of 94 patients with an-
xiety neurosis or personality disorder who had been randomly assigned
for 4 months to a waiting list, behavioral therapy, or psychoanalytically
oriented therapy.
nificantly more than those on the waiting list at the end of 4 months.
However, one year and two years after the initial assessment, all groups
including the waiting list group were found to be equally and significant-
ly improved. Thus, the Extraordinary Treatment Committee as well as the
Institutional Review Board will have difficult problems in evaluating the
acceptable duration of treatment time as well as specific treatment tech-
nique. Theoretically, all treatment techniques, including behavioral ap-
proaches such as individual therapy, group therapy, encounter therapy,
etc. should be based on valid, controlled research data which show the
therapy to be significantly superior to non-specific treatment approaches.
There is no doubt that this requirement would cause a heavy administra-
tive burden on a local as well as national basis, but this approach should
eventually result in maintaining a competent standard for the practice of
medicine, and the requirement would help to differentiate more clearly
The two treatment groups improved equally well and sig-
13-8
between research and the competent practice of medicine, as compared
to the subjective attempt to understand the physician's "intent" when
he uses a scientifically unproved technique to treat his patient.
If one were to accept the legislative assignment to the committee
as detailed in Section 202 (a)(1)(B)(i), there would be no other choice
than to accept Dr. R. Levine's differentiation between research and the
"accepted and routine practice of medicine," which relies mainly upon
intent.
the physician's mind accurately and separate the innovative practitioner
of medicine from the researcher.
Treatment Committee would be of help to the innovative physician while
halting the incompetent physician from continuing an "accepted or rou-
tine practice" that has no scientific validity or therapeutic efficacy.
A specific recent example of the problems in this area can be seen in
the use of propanolol (Inderal) in the United States. Propanolol was
approved for use by the FDA for certain types of cardiac conditions but
had not been approved for use in hypertension. However, hundreds of
United States physicians being familiar with the European literature
describing the efficacy of propanolol in patients who presented high
blood pressure, were utilizing propanolol for their patients with high
blood pressure.
be of definite help to some patients with hypertension or high blood
pressure, and it also is of help to patients who have familial tremor.
However, the use of propanolol was not an "accepted and routine prac-
tice of medicine;" thus the inference in PL 93-348 would have been that
propanolol was being used in a research approach, but this medical
From this point of view, it would then be impossible to "read"
A readily accessible Extraordinary
When propanolol is used in a sensible manner, it can
13-9
technique would not have been defined as research by Dr. Levine, who
recognized that the "intent" was based upon scientifically valid data
from Europe and that the physician was not experimenting with the pa-
tient but was using propanolol as a therapeutic tool.
sible Extraordinary Treatment Committee (ETC) would have given the prac-
ticing physician permission to use propanolol as a therapeutic agent and
would not have required the physician to submit a research protocol to
the IRB to prove the therapeutic efficacy of the agent which had already
been accomplished in Europe. Therefore, the ETC should have individuals
who are experts in the various medical research specialities available
for ad hoc consultation.
are underlined because these requirements would be absolutely essential
if new therapeutic techniques are to be made available to patients with-
out undue delay.
A readily acces-
The words "available" and "readily accessible"
However, there is no doubt that a need also exists for this same
Extraordinary Treatment Committee to eliminate those ineffective medical
practices or effectual psychotherapeutic techniques still considered to
be "accepted and routine practices of medicine" in some communities.
Despite all of the available well-designed research studies that show
the significant efficacy of antipsychotic compounds in schizophrenia,
there are still some psychiatrists who use only psychotherapy in treat-
ing those schizophrenic patients, while keeping these patients institu-
tionalized for long durations of time at great financial costs to the
families.
uated by the Extraordinary Treatment Committee.
is to adequately protect the human subject (patient or research patient
This type of current medical practice would have to be eval-
If this new legislation
13-10
or volunteer) in biomedical and behavioral research, Section 202 (a)(1)
(B)(i) should be written as follows: "shall consider ... (i) The boun-
daries between biomedical or behavioral research involving human subjects
and the competent practice of medicine based upon scientifically valid
experimentation." As stated previously, those current medical treatment
techniques that have not been validated by controlled scientific obser-
vations may be allowed to be continued on a temporary basis. However,
governmental support of statistical evaluations and comparisons of the
presently unproved techniques now utilized as "accepted and routine prac-
tice of medicine" should be immediately initiated.
would fulfill its obligations to upgrade the standard of medical practice
as well as to protect the human subject in biomedical and behavioral re-
search.
Thus, the government
Additional Examples for Caution in the Development and Interpretation of
Guidelines
Since research in the field of psychopharmacology is much more ex-
tensive and more reliable than in the area of behavioral therapy or psycho-
therapy, I should like to refer to some problems of psychopharmacology
(which is only another therapeutic tool in the treatment of mental ill-
ness) that the committee should be aware of in preparing its recommenda-
tions to the President, the Congress, and the Secretary.
antipsychotic medications for schizophrenic patients, there are at least
six major drug variables which determine the differences in dosage that
patients require.
In the use of
In fact, these same drug dosage variables apply to
13-11
all oral medications ingested by all of us.
1) Each of us may react differently to a drug if the setting or
environment is changed.
2) Each one of us has a unique interpersonal reaction to the per-
son administering the drug which may affect our reaction to the
medication.
3) The absorption rate of the drug may vary according to whether
it is dispensed in capsule or tablet form.
Each one of us absorbs at a different rate from the gastroin-
testinal tract.
Each one of us metabolizes or "burns up" the drug at different
rates as it passes through the liver.
The end-organ for which the drug is intended (in the case of
schizophrenia, the brain) requires a different blood concentra-
tion in each individual.
4)
5)
6)
Considering these six major variables that affect the response to drugs
or medications, one can easily understnad why one patient might require
5 times the dosage of Dilantin to stop his epileptic seizures as another
patient, and some schizophrenics may require four or five-fold increases
in maximal dosages of medication in order to show a therapeutic response.
Thus, when the FDA approves a maximal recommended dosage, which is then
printed in the Physician's Desk Reference, this current "accepted" stan-
dard guideline may hinder the competent physician who is knowledgeable
in the area of pharmacodynamics, which considers the above major varia-
bles in drug metabolism. In the Wyatt case which has accomplished much
13-12
good, we also see a hinderance of the intelligent physician when we come
to the court guidelines which utilize the Physician's Desk Reference for
maximal dosage. A physician at one of the state hospitals in Alabama
had to write to the judge responsible for the case as follows:
alternative to the constraints placed on adequate treatment of an individ-
ual using the FDA level requires a combination of several different drugs
up to the prescribed levels in order to achieve the appropriate psychia-
tric treatment effects for the patient, The latter alternative, while
somewhat effective, does raise a question as to the appropriateness of
combining medications to achieve an effect of a single medication with a
dosage that exceeds the FDA levels, Individual patients have different
levels of tolerance to medications which makes almost every administra-
tion and dosage level an individualized one." Thus, this physician had
been placed in a position of using what we call polypharmacy which is
usually bad medical practice; this type of polypharmacy had been inad-
vertently caused by the guidelines set by the court. Thus, in getting
guidelines to decrease the mistakes of the incompetent physician, the
court unfortunately also hindered the knowledgeable physician from using
this knowledge for the welfare of the patient.
the court offered helpful guidelines for aversive conditioning which was
designed to alter aggressive behavior. The court made the final recommen-
dations that:
... no patient shall be subjected to any aversive conditioning or systematic attempts to alter his behavior by means of painful or noxious stimuli except under the following conditions: a) a pro- gram of aversive conditioning recommended by a Qualified Mental Health Professional trained and experienced in the use of aversive conditioning. This recommendation shall be made in writing with detailed clinical justification and explanation of which alterna- tives and treatments were considered and why they were rejected ...
"... the
However, in the same case
13-13
b) any program with aversive therapy proposed for the benefit of institution patients shall have been reviewed and approved by that institution's Human Rights Committee before its use and shall be recommended by Qualified Mental Health Profession for an individ- ual patient ... c) the patient has given his expressed and informed consent in writing to the administration of aversive conditioning ... d) no aversive conditioning shall be imposed on any patient without the prior approval of the Extraordinary Treatment Commit- tee, formed in accordance with this paragraph, whose parent res- ponsibility it is to determine, after appropriate inquiry and in- terview with the patient, whether the patient's consent to such therapy is, in fact, knowing, intelligent, and voluntary and whether the proposed treatment is in the best interest of the pa- tient. The Extraordinary Treatment Committee shall consist of five members to be nominated by the Human Rights Committee of the hospital and appointed by Court. The members shall be so se- lected that the committee will be competent to deal with the medi- cal, psychological, psychiatric, legal, social and ethical issues involved in such treatment methods; to this end, at least one mem- ber shall be a neurologist or specialist in internal medicine; at least one member shall be an attorney acting as the patient advo- cate and licensed to practice law in this state. No member shall be an officer, employee or agent of the Department of Mental Health; nor may any member be otherwise involved in the proposed treatment.
The court order goes on to state that "no patient shall be subjected to
an aversive conditioning program which attempts to extinguish or alter
socially appropriate behavior to develop new behavior patterns for the
sole or primary purpose of institutional convenience." Thus, easy
availability and accessibility of the ETC for the evaluation of the
aversive conditioning technique would be of essential help in protecting
the subject.
observations in other medical reports and not upon scientifically valid,
controlled studies, it would then be the responsibility of the ETC to
require that a controlled trial of the specific aversion technique be
conducted, with the protocol approved by the local Institutional Review
Board, before the technique is utilized as a standard or routine treat-
ment procedure.
If the aversive technique were based only upon empirical
13-14
Further Explanation of the Recommendation to Change the Wording in Sec-
tion 202 (a)(1)(B)(i)
I have previously suggested that the consideration for the NCPHSBBR
should have been "the boundaries between biomedical or behavioral research
involving human subjects and the competent practice of medicine based upon
scientifically valid experimentation." The change in the wording has been
recommended because it helps to differentiate clearly between research and
what should be "the competent practice of medicine" rather than the "accep-
ted and routine practice of medicine" which confuses the entire assignment
given to the NCPHSBBR.
from the practice of medicine and defines the major difference. In addi-
tion, this wording may be utilized as a guideline that not only protects
the research patient against the incompetent physician but may also be
used to help develop and maintain competent treatment methods for patients;
it may further serve to help the patient understand his particular role in
relation to the physician who is treating him. There is a thin line in
many cases between the use of therapeutic technique or drug for treatment
and for institutional advantage. Again, the availability of the ETC will
help to decide individual cases, using the guidelines as state above. Re-
search is an exploration of a new technique or medication that has not yet
been shown to have significant therapeutic efficacy as compared to a cur-
rently available medical practice or to an inert substance, and the risks
of this technique or medication are relatively unknown.
the "competent practice of medicine" should be based upon scientifically
valid observations that have been detailed in the medical literature.
Using this change in wording delineates research
On the other hand,
13-15
It should be remembered, however, that a physician is not bound to
use one specific therapeutic method or drug for a particular disease.
The physician has the opportunity and the responsibility to select from
among all generally accepted modes of therapy as long as there is a
scientific, logical basis for the determination. Moreover, the physi-
cian cannot guarantee a cure, but only the exercise of his skill, exper-
ience, and best judgement for the particular patient. It would be un-
fortunate if rules to insure rights and benefits became impediments to
personal care and individualized therapy. However, accountability is
needed and is proper within the contexts of both research and medical
practice by even the most conscientious physicians. At the same time,
too many detailed constrictions based on inadequate scientific evidence
would tend to move most therapeutic techniques or approaches toward the
average or the mediocre or toward the "accepted and routine practice of
medicine" which is not always acceptable at the present time.
Proposed Guidelines for the "Competent and Routine Practice of Medicine"
"Competent and accepted routine practice of medicine" should utilize
medical techniques which have been validated by scientific experimentation.
In addition, the proper and accepted routine practice of medicine should
include the following information before initiating treatment: 1) diag-
nosis , symptom profile, and etiology of the disease; 2) course and his-
tory of the disease; 3) treatment of choice; 4) anticipated beneficial
effects and side effects of the treatment technique; 5) alternative
treatment techniques available for the disease; 6) the physician should
13-16
should be knowledgeable about the scientific research results concerning
the treatment techniques that he is applying to the patient and should
fully inform the patient about the important aspects concerning the side
effects as well as beneficial effects of the treatment technique; 7) the
physician should have some concept of the duration of treatment and this
aspect should also be explained to the patient; and 8) the patient should
be informed about what alternative treatments are available, if any, if
the present treatment technique fails or progresses too slowly.
Concluding Remarks
Biomedical or behavioral research involving human subjects has been
defined as well-designed and critical investigations of a therapeutic
technique with unknown efficacy and risks or an attempt to find the eti-
ology of a disease having for its aim, the discovery of new facts or the
revision of the present techniques associated with the "accepted and rou-
tine practice of medicine" with the ultimate goal of providing beneficial
effects for human subjects. The latter part of the sentence in Section
202(a)(1)(B)(i) which is worded, "the accepted and routine practice of
medicine" has been changed in this paper to read, "the competent prac-
tice of medicine that has been validated by scientifically valid experi-
mentation." Human research shall not include those studies which exclu-
sively utilize tissue or fluids or other products after their removal or
withdrawal from a non-pregnant human being. In this manner, an attempt
has been made to delineate more clearly the proper practice of medicine
from the proper conduct of research. The author considers "the accepted
13-17
and routine practice of medicine” in this country as well as in many other
countries to be unacceptable in certain situations, and there are many
physicians whose performance does not always meet reasonable criteria
of quality.
be using a treatment modality which has been shown in scientific experi-
ments to have been more efficacious for the specific disease than compar-
atively inert treatment techniques or substances.
sician should have a reasonable expectation that the treatment imposed
on patients who have a questionable understanding of informed consent
(thus, their legally authorized representative signs consent) will pro-
duce changes that the patient would seek if he were more rational. Any
question of the efficacy of the treatment technique or treatment goals
should be reviewed by the Extraordinary Treatment Committee (ETC). In
those psychiatric emergencies concerned with patients presenting acutely
suicidal or homicidal behavior, treatment may be immediately instituted
on admission of the patient to the hospital, but any question of the
efficacy of the treatment technique or treatment goals should be reviewed
by the Extraordinary Treatment Committee within a reasonable period of
time after treatment has been initiated. It should be emphasized that
the undue delay of treatment may be harmful for the long-term as well as
short-term prognosis of the patient. Therefore, if the Extraordinary
Treatment Committee system is to function for the welfare of the patient,
several of the key members of the ETC will have to be full-time admini-
strative staff members who are not employees of the institution or clinic
where the patient is undergoing treatment. Extraordinary Treatment Com-
mittees should be available for out-patient community facilities as well
The physician in charge of treatment of the patient should
In addition, the phy-
13-18
as for institutions.
questions as to its safety or efficacy, evidence from the published sci-
entific literature and from the clinical experience of qualified experts
should receive substantially greater weight than what is considered to
be the "accepted and routine practice of medicine" which frequently is
below the standard that we expect in this country. If the question is
related to drug use, then the evidence from the scientific literature
and clinical experience of qualified experts should receive substan-
tially greater weight than the statements printed in the package in-
sert and Physicians Desk Reference (PDR).
If any treatment technique should lead to serious
I have referred to Dr. R. Levine's July 14, 1975 paper several times
and would like to state that I would agree with him on most of the major
points that he raises in his manuscript if the "accepted and routine prac-
tice of medicine" were adequate.
be valid if "routine and standard practice of medicine" were deemed to
be adequate.
should be based upon scientifically validated experimentation or on em-
pirical knowledge that the presently used mode of treatment is the best
available technique for the specific disease at this time.
there is no doubt that one can differentiate the intent of the profes-
sional researcher from the practicing physician.
ion that there are many exceptions to this observation and that in many
cases it would be impossible to differentiate the innovative and intelli-
gent physician who is using a standard medication with a slightly differ-
ent approach for the benefit of the patient from the researcher who is
attempting to gain new knowledge from the use of the same medication.
His conceptual models on page 5 would
However, the proper and competent practice of medicine
In many cases,
However, it is my opin-
13-19
Similarly, in some situations it may be very difficult to differentitate
the intent of the incompetent physician who is using "a standard type of
treatment" in an inappropriate manner from the incompetent research per-
son who is performing an ill-designed project in an uninformed patient.
These are some of the reasons why I reworded Section 202 in my attempt
to delineate research from what should be the "competent" practice of
medicine.
some physicians may "proceed with pure practice intent" with an inno-
vative therapeutic approach after other treatment modalities have failed.
However, according to the definition in this manuscript and according
to the present regulations, these intelligent, innovative approaches
are still considered to be research. Thus, I once again must re-empha-
size the essential need for an Extraordinary Treatment Committee easily
accessible for a rapid evaluation of this type of innovative treatment
approach, thus eliminating a great deal of bureaucratic paper work
for this particular type of practicing physician. Otherwise, under pre-
sent regulations, he would be forced not only to write out a detailed
research protocol but to have it evaluated by an Institutional Review
Board which may only meet once monthly. This delay of treatment could
be disastrous for the patient. Thus, the patient would be the main
individual to suffer under the present system when he has the good
fortune to be treated by an intelligent, innovative physician.
I strongly agree with Dr. Levine's statement on page 14 that
It has been previously mentioned in this paper that there are many
people practicing behavioral therapy, psychotherapy, marital counselling,
encounter therapy, etc. who do not require licensure by the state in
which they reside, have not received adequate training, and are not
13-20
subject to any legal controls. This situation is ridiculous and must
be addressed by the NCPHSBBR since these individuals are frequently
utilizing treatment techniques that are not scientifically grounded
and are not based upon any scientifically valid experimentation. Thus,
these individuals are actually performing behavioral research with hu-
man subjects without any restrictions or controls or guidelines. The
requirement that such individuals be evaluated by an Extraordinary Treat-
ment Committee may prove to be of great benefit to a major part of the
patient population which is now being treated by these individuals.
There is no doubt that the patient population treated by these unproved
techniques and unqualified personnel are within the subject population
that the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research has to report about to the President,
the Congress, and the Secretary.
It is apparent that the cost of treatment for mental health will
increase even more if the Extraordinary Treatment Committees are to be
effective committees with full-time administrative staff and not just
rubber stamp committees. However, the possible elimination of ineffec-
tive and expensive treatments such as psychosurgery and psychoanalysis
for schizophrenic patients (See P.R.A.: Treatment of Schizophrenia:
A Comparative Study of Five Treatment Methods, Science House, New York,
1968) may partially or completely compensate for the additional costs.
Although it is recognized that it would be impossible for the Extra-
ordinary Treatment Committees to review or even be aware of all treat-
ment and research problems, the very existence of these committees would
serve as a deterent for the negligent therapist or researcher and would
13-21
foster a more cautious, thoughtful attitude in all who are involved in
research or treatment.
13-22
14
ON THE USEFULNESS OF INTENT FOR DISTINGUISHING BETWEEN RESEARCH AND
PRACTICE, AND ITS REPLACEMENT BY SOCIAL CONTINGENCY:
IMPLICATIONS FOR STANDARD AND INNOVATIVE PROCEDURES,
COERCION AND INFORMED CONSENT, AND FIDUCIARY
AND CONTRACTUAL RELATIONS
Israel Goldiamond, Ph.D.
Advances in biomedical and behavioral research have aroused public
concern in at least two areas.
advances and the human means necessary to produce them.
discussion centers on the latter, specifically as it relates to human
experimental subjects undergoing experimentation and human patients under-
going treatment.
outcomes, which can contribute to advances.
has been established to consider the protection of subjects, rather than
patients, or than both.
These are the social implications of the
The present
In both cases, there is professional manipulation of
Nevertheless, a commission
If there are distinctions between the two areas, as is implied by the
Commission's mandate, then there are at least three reasons to make them
explicit.
tion by the Commission is to be defined.
tend to curtail expansion into one area of controls properly directed at
the other. In legislative terms, in the absence of clear distinctions,
rulings directed specifically at, say, experimentation, may come to be
extended to treatment, and rulings which specifically exclude treatment
may come to exclude experimentation. Third, if meaningful distinction
is not possible, there may be repercussions far beyond these, given the
present social climate.
the present scrutiny of the means for such abuse, which adhere to
experimentation.
then the same means for abuse. are also inherent in treatment.
whatever social winds sweep at experimentation will also sweep at treatment.
Indeed, Senate hearings (Hearings before the Subcommittee on Health, 1973)
on S. 974, training in "implications of advances in biomedical research and
technology;" on S.J. Res. 71, evaluation of implications of such advances;
and S. 878, "provision of restrictions on funds for experimental use" are
First, such distinction is necessary if the scope of delibera-
Second, such distinction will
Reports of abuse of human subjects have occasioned
If treatment is indistinguishable from experimentation,
Accordingly,
14-1
published under the title Quality of Health Care -- Human Experimentation
1973.
ing of research, the routine and accepted practice of medicine is becoming
routinely less accepted on its own, as suggested by the rising cost of
malpractice insurance and the increasing scrutiny represented by books such
as The End of Medicine (Carlson, 1973).
In addition to not being immune from incorporation into the question-
That the distinction between practice and research is not self-evident
derives in part from the fact that research is often performed in the context
of treatment:
subject in a biomedical or behavioral experiment.
research upon which advances in treatment often depend can be conducted only
under such circumstances.
it seems to be generally accepted by reviewers that treatment is often
indistinguishable from experimentation.
the physician tries out a new drug or a new technique... he is experi-
menting in his effort to relieve or cure the individual involved" (1970,
p.83) but this is extended to "every medical procedure, no matter how
simple or accepted," by Ladimer.
applied in a new context each time" (1963, p. 190). F. Moore expands this
into several experiments in the course of one treatment episode:
surgical operation is an experiment in bacteriology," he states, and is
simultaneously an experiment "in the pharmacology of anesthetic drugs ...
in the conformity to anatomical norms, and often in the biology of malignant
tumors" (1975, p. 15). Levine's overview is indeed apt: "Even a super-
ficial exploration ... will reveal the impossibility of describing mutually
exclusive subsets (one called research and one called practice)"
(1975a, p. 1).
the person who is a patient may at the same time be a
Indeed, much of the
Even when practice and research are separated,
Thus, Beecher states that "whenever
Treatment "is an experiment since it is
"Every
14-2
In both cases, manipulations derive from systematic approaches; the
intervention procedures used and the results obtained are recorded; these
are evaluated in terms of baselines, basal measures, or other norms; the
interventions are subject to change depending on their outcomes.
similarities exist. Given the social importance of distinguishing the two
subsets, and given the overlap between observable behaviors, the use of
a subjective unobservable to distinguish the two is understandable.
history of psychology is replete with the introduction of such terms to
distinguish between processes which it is important to separate, but
which the verbal-observational system in use does not permit.
noted, the history of psychology also reports correctives.)
the "taxonomic" function is assigned to intent .
between procedures described, they are classified as treatment where there
is "therapeutic intent," and as experimentation when the professional's
"motive is indirect benefit to society, not benefit to the patient"
(Blumgart, 1969, p. 252).
thereby; conversely, if the professional "believes (even if only on the
basis of advertising) that [the treatment] will do the patient good, then
he is acting as a physician," presumably even if it does him no good (Edsall,
1969, p. 466). The general opinion is summarized by Levine:
physician proceeds in his interaction with a patient to bring what he con-
siders to be the best available techniques and technology to bear on the
problems of that patient with the intent of doing the most possible good
for that patient, this may be considered the pure practice of medicine."
(1975a p. 6). He reports a second system of classification, namely, group
acceptance or approval , presumably of a particular procedure as treatment.
The two systems can conflict, as when a physician uses a new drug with the
intent to doing the most possible good for the patient, while this drug
Other
The
(As will be
In this case,
Thus, regardless of overlap
And this holds even if the patient benefits
"If a
14-3
has not yet been approved for "safe use" in such cases by a procedure-
accrediting group -- here, the Food and Drug Administration (1975a, p. 11).
Intent would then be overridden.
defined by efforts deriving from an intent to distinguish between classes
of patients for whom a treatment should be approved or disapproved, since
the intent is to provide generally useful information.
restricted to the use of the procedure, when approved, with the intent of
doing the most possible good for a particular patient.
In such situations, research would be
Treatment would be
Undoubtedly, there are differences in intent when research or treat-
ment is undertaken, and subjects and patients do have different expectations.
While these differences may be along the lines noted, it would seem that
intent is a rather slender reed upon which to build public policy,
especially where issues as important as those noted rest upon this platform.
That intent is used in its subjective sense is made clear by Levine's
quotations from the dictionary, e.g., "the state of mind or mental
attitude with which an act is done" (1975b, p. 2a).
of how one ascertains intent or, more properly, ascertains individuals'
"state of mind or mental attitude" in the performance of their acts, or in their
"concentra[tion] on some end or purpose" (ibid).
intent through consensus by experts is no more valid than such assignment
by a single person and, ever since Freud, at least, we have learned to
question even self-assignment of intent, no matter how sincerely or
tenaciously held.
The question arises
The definition of someone's
Subjective terms such as intent, expectation, desire, motive cluster
around a common core close to the subjective dictionary definition noted.
They may be used in several ways, among which are the following.
jective : The terms are used with reference to this common cluster.
cally, research and treatment are distinguished by differences in intent and
(1) Sub -
Specifi-
14-4
expectations (Ladimer, 1963, p. 192).
difficulty noted, with its attendant problems for social policy.
cator :
stated relations between explicit sets of procedures, called indicators .
The indicators do not define the subjective processes, which are independent
of them.
(professional pays subject) and treatment (patient pays professional) stem
from differences in intent; they may indicate the existence of such differences
but do not define them (Levine, 1975b, p. 8a).
be readily defined, the validational difficulty of the referent remains,
as do the social consequences noted.
originally subjective meaning may be used as a metaphor or simply as a con-
venient label for clearly stated relations between explicit sets of procedures,
which define the terms.
stipulated procedures, and treatment intent by yet others.
no other properties.
definition.
exclusion of the area of concern.
importance attached to subjective distinctions may be considered as repre-
senting important differences in social and personal consequences which are
contingent on the behaviors which are occasioned by the systems discussed.
Specifically, if differences in intent are consistently used to separate
research and treatment, this may derive from important differences in the
social and personal consequences contingent on behavior in the two institu-
tions.
This usage imposes the validational
(2) Indi -
The subjective terms may be considered as indicated by clearly
Specifically, the different monetary exchanges in research
Although the indicators may
(3) Operational : Terms with an
Specifically, research intent is defined by certain
The terms have
This is the most familiar form of the operational
It couples clarity and ready validation with what is often the
(4) Operant contingency : The social
Overlap between many of the behaviors in the systems necessitates the
introduction of a classification system other than behavior. This can be
14-5
intent which, unfortunately, leads to validational problems, since it is
unobservable. However, the alternative classification system can also be
the operant (as opposed to operational, cf., J. Moore, 1975) contingency,
which does not define terms simply by the behaviors, but also by their
relation to the consequences differently contingent on them in the two
settings. These, too, are observable and can be validated. They fulfill
the same logical necessity to which subjective intent is addressed, and
may serve the same social functions. The system of analysis, however,
is not as familiar as the others, nor has it been used as extensively in
discussions of social issues. Accordingly, it can not be referred to as
readily, nor stated as simply. The simplest statement, of course, is
intent. However, the complexities and difficulties encountered when one
tries to apply it meaningfully to matters of social policy suggest that
the verbal simplicity provides little help in systematizing the issues to
which it is addressed.
definitions of consent (i.e., did the person really understand?) and the
coercion which jeopardizes its legal acceptance,
This drawback is also encountered in subjective
This discussion is addressed to the problem of making explicit the
social and personal contingencies to which terms such as intent, coercion,
and consent are addressed, in the context of distinguishing research from
treatment and, therefore, of distinguishing human subjects of biomedical
and behavioral research from human patients of biomedical and behavioral
treatment.
different types of contractual relations involved, as well as some
assumptions on which these are based.
In the process, I shall note ancillary issues such as the
The discussion will open with a brief exposition of the analytic
system, its commonalities with cognate systems in the social sciences and
in law.
differential treatments, for the clues it contributes to this discussion.
I shall examine a legal use of intent as a taxonomic device to apply
14-6
I. SOCIAL CONTINGENCIES AND LEGAL INTENT
The opening discussion of operant contingencies will be confined to
that which is necessary for the later presentation.
The "three-term" formulation of an operant contingency requires that
at least the following elements be specified:
(2) consequences are contingent (3) on behavior (cf. Skinner, 1969, p. 7).
The term contingency refers to the fact that unless the behaviors occur,
the consequences will not. follow.
behavior is required (if the consequence is to occur) or is a requirement
(for its occurrence).
behavior occurrence:
of no behavior may be required, among others.
said to occasion the behavior or provide the opportunity for it.
in order of appearance, the contingency is described as (1) occasion,
(2) behavior, (3) consequence.
(1) the occasions upon which
Another way of stating this is that the
The consequence, however, need not follow every
a fixed or variable number of responses, or a period
The event in (1) may be
Presented
Where, given the occasion-behavior-consequence contingency, the
behavior increases in likelihood when the appropriate occasion occurs, a
reinforcement contingency is defined.
behavior-increasing consequence is the presentation of an event.
negative reinforcement, the behavior-increasing consequence is the post-
ponement (avoidance) or elimination of an event (escape).
behavior-consequence relations, and the behavior decreases in likelihood,
a punishment contingency is defined. Punishment can involve postponement
or elimination of an event (typically, one whose presentation is positively
reinforcing), or it can involve presentation of an event (typically the
events whose withdrawal is negatively reinforcing).
In positive reinforcement, the
In
Given occasion-
It will be noted that whether the contingency is defined as reinforce-
ment or as punishment depends on whether or not behavior was increased or
14-7
attenuated, respectively, and not upon the intent of the wielder.
who intends to stop a child's annoying behavior or to prevent its recurrence,
and behaves in a manner judged by self and others to be punitive, will be
defined as having instituted a reinforcement contingency -- if there was
an ensuing increase in behavior. If the behavior did indeed cease, this
outcome might then reinforce the parent's punitive behavior on those
occasions when the child misbehaves.
obtaining relief.
A parent
Being punitive is the requirement for
One last point will be made. Whether or not presentation of a conse-
quence will affect behavior will depend on antecedent conditions which must
be specified. Whether food can reinforce behavior depends on the organism's
degree of deprivation, upon the cultural definition of that food as permiss-
ible or forbidden, among others. Further, events may acquire reinforcing or
punitive properties through their relation to other events.
behavior required for reinforcement is an extended sequence of interactions
with the environment, each component link in that chain may be considered
as an occasion-behavior-consequence link.
reinforcing property from its progressive relation to that consequence for
which the whole sequence is required.
Where the
This consequence derives its
The formulations may be used to analyze social relations, and the pro-
cedures developed may be used to change them.
in extended interaction with another or with a system, the behaviors of each
may be viewed as occasions and consequences which bracket the behaviors of the other.
Each consequence may derive its reinforcing properties from its relation to
a consequence at the end of the chain-requirement, or for other reasons.
When one person is engaged
The relation can be considered in terms of gains for each. The
advantage can be considered positive, e.g., obtaining something valued, or
negative, e.g., obtaining relief from distress. The relationship can be
14-8
described in terms borrowed from the market-place:
involved, with one person's behavior providing the other with something
valued, and the other providing something valued in return.
usage (before its corruption by psychotherapists), transactional analysis
referred to such relationships, often involving extended verbal intercourse.
The descriptive metaphor may be a barter system, with exchange theory being
the model.
decision requires at least two well-defined sets of behavior, which inter-
sect with at least two states of the environment.
thereby defined, with the entry in each being the consequence of that
behavior under the particular environmental occasion.
must be considered, in accord with some decision rule, and the analysis
often consists of ascertaining which decision rule rationalizes the empirical
data obtained, that is, which provides the best fit.
where the states of the environment, present or future, are unknown, there
is risk attached to either behavior, since the consequence may or may not
be a gain, depending on state of the environment.
considers the consequences which are contingent on behavior, but in contrast
to the decision model presented, in which either of two consequences is
contingent on behavior (depending on the occasion), in cost-benefit analysis,
at least two consequences are often both attached to the same behavior.
there are transactions
In its original
Decision theory may be viewed as a related development. A
A 2 x 2 matrix is
All four consequences
It will be noted that
Cost-benefit analysis also
Each of these models covers overlapping terrain, and also considers
variables not considered by the others.
the languages they use and the concepts they relate these to, as well as
differences in variables considered derive from the different requirements
of the academic disciplines, e.g., transactional analysis in anthropology,
exchange analysis in sociology, decision theory in economics, and operant
contingency analysis in the conditioning laboratory, from whose requirements
Differences in metaphors, that is,
14-9
much of the terminology and procedures derive.
and metaphors have tended to restrict communication between models.
a model has been applied to a discipline other than its origin, it has often
led to bursts of progress (e.g., decision theory applied to perception and
clinical decisions), since it contributes procedures which are new to the
adopting discipline.
participants have expectations, they make decisions, they hope or intend
to optimize net gain, what makes the adoption useful is the procedures for
analysis it provides. I shall consider the relevance of such procedural
analysis for analysis of legal intent.
Differences in terminology
Where
Although the language has often been subjective, e.g.,
It would be surprising if the legal system, faced with decisions which
have social consequences, had not come up with similar procedures.
power over life, liberty, and property is involved, the consequences of
definitions in terms which are open to a variety of interpretations in
practice, and in terms which are quite specific and limited, can be markedly
different.
of witches executed in Renaissance Europe on the Continent (500,000 estimated
executions) and in England (less than 200) to differences in the stringency
of the definitions of witchcraft applied by the different legal systems,
and to the different consequences of conviction to the accusing system.
Intent, as noted, is a difficult term to define.
use in mens rea , or criminal intent, specifically with regard to intent to
commit murder.
Where
For example, Currie (1968) attributes differences in the number
I shall consider its legal
Wexler, a legal scholar, notes that "the law is ripe for contingency
analysis" (1975, p. 174) and that such analysis "can help to clarify the
definitional and evidentiary aspects of hazy and imprecise legal concepts"
(p. 175). He also notes that previous attempts "to purge the
penal law of the concept of mens rea ('criminal intent') ran head-on into
14-10
numerous obstacles and objections" (p. 175). However, as was discussed,
there is a difference between the operational definitions associated with
classical behaviorism and the operant contingency definitions associated
with radical behaviorism (Skinner, 1974).
Two types of contingencies will be noted which are related to the
statement that someone "did willfully and knowingly intend" to commit
murder and then carried out his intent. The first contingency to be dis-
cussed defines the intent which distinguishes first degree murder. The
second defines the social consequences contingent on differentiation of
murder by intent and other types of killing.
1. Intent defined. Three things are involved here: motive, opportunity,
and means.
Motive is defined by the consequences of the act. A victim is found
If it turns out that dead in Trenton with a bullet hole through his head.
a nephew is bequeathed $50 million as a result, the nephew is considered
as having a motive.
vailing consequence (motive) in that society.
The French maxim, "Cherchez la femme" suggests a pre-
Opportunity. This is where the alibi enters. If the nephew was in San
Francisco at the time, he may not be as likely a suspect as if he had been
in Trenton, in the neighborhood of the crime, at the time.
be a suspect.
He will then
Means. The nephew has recently purchased a carbine, has practiced,
and the murder bullet was .30 caliber; the nephew reports that the rifle
had been stolen the week before.
The nephew is the prime target, and the state will make every effort
to demonstrate that the means was probable behavior.
despite his strenuous denials, a jury of his peers may find him guilty of
murder with intent, that is,
He may be indicted and,
first degree murder.
14-11
It will be noted that the three-way operant contingency discussed
earlier is considered to be present:
Intent is thereby defined.
opportunity, consequence, behavior.
2. Social necessity. If the uncle is killed in what appears to be a
traffic accident, and the driver had no motive, the law will treat this
differently. If, in addition, the driver had exceeded the speed-limit,
the law will treat this yet differently.
fleeing the scene of a robbery he had committed, this will be considered
the equivalent of first degree murder.
are operationally the same:
He is just as dead in each case, including the murder case.
not bring him back, yet it treats the killings differently.
If, in addition, the driver was
To the immediate family, the results
they have lost a beloved member of the family.
The law will
On (a) the occasions of the offenses cited (b) the consequences for
society (c) of classifying the offenses in actionable categories must be
considered in accord with a particular social policy. Inspection of the
offenses, classes established, and social consequences suggests what the
pol icy may be. With regard to the intent-to-kill contingency discussed,
societies apparently abound with people whose elimination would be useful
to other people.
by theft and other felonious behaviors.
which yield to them are prevalent.
to social control.
hood of these behaviors by threatening its most drastic punishment, and
applies the general term "first degree" killing.
La Place's maxim on the improbable, accidents allow themselves the luxury
of occurring. No legal sanctions can prevent them from occurring, so the
law will not apply its deterrent.
inferred from the discussion, namely, that severity of consequence be
Societies also abound with earnings which may be obtained
Both the temptations and behaviors
In addition, the behaviors are amenable
Accordingly, the law intervenes to decrease the likeli-
However, to paraphrase
A component of social policy may be
14-12
directly proportional to its efficacy in decreasing the likelihood of the
offense.
should be. Another component of social policy may be inferred from the
The more effective the punishment on behavior, the more severe it
different punishments attached to killing when the speed limit was exceeded
or when a felony was committed. Both speeding and felonies may be amenable
to control by social deterrents, but the offenses differ in a variety of ways,
including prevalence, and the likelihood of general damage to the social
fabric.
talionis (e.g., a life for a life), whereby the severity of the legal con-
sequence is governed by the general severity of the offense.
of killing might be treated similarly.
The presence of yet a different component is suggested by lex
Here, all types
No pretense is made that the discussion is exhaustive; the writer is a
legal layman.
legal resolution, although often couched in subjective terms such as intent
(coercion and consent will be considered later), is amenable to contingency
analysis and possibly was formulated in accord.
various social disciplines have almost independently developed forms of
contingency analysis and there is no reason to assume that this is not the
case for law. It is of interest that decision theory, a system of complex
contingency analyses, employs, as does the law, subjective metaphors to
label its components, e.g., a decision is made, a strategy is followed,
it may be governed by its expectations.
for explicit procedures and explicit formal (mathematical) relations between
procedures and data.
and their relations , and not the subjective designations given them , nor, for
that matter the dictionary definitions of the designations.
Nevertheless, the two contingencies presented suggest that
It was noted earlier that
The terms, however, are names
The bases for classification are the observables
Nor should it be assumed that the contingencies presented are those
which actually occur.
workings of each system can indicate what contingencies are actually operating
Only a careful fine-grain analysis of the actual
14-13
in that system, as opposed to those which "should be," as defined ethically
or as stipulated by its empowering group or by its own members. The con-
tingencies presented are purely heuristic, and serve to suggest some necessary
considerations for social definition.
Contingencies of classification of social activity .
Assuming that contingencies are employed in classification (if human
behavior is under consideration, since it is sensitive to influence by con-
sequences, such contingency analysis is suggested), the discussion suggests
that at least two social contingencies are required. One is the particular
contingency which defines the class to be treated.
governs the specification of a classificatory scheme, whereby the first
contingency is distinguished from others in the scheme.
The other contingency
A variety of classificatory schemes can be proposed, each of which
can be stated as a contingency.
of one rather than the other should be made explicit. A parallel is found in
decision theory where, for the same sets of contingencies, different decision
criteria or decision goals, are offered (e.g., minimax, maximin, Neyman-
Pearson criteria) which set different types of outcomes as acceptable, and
thereby require different policies, or strategies of choices.
The social policy which affects the choice
Decision theory may be employed normatively, that is, to suggest
strategies which accord with the policy, e.g., if average losses are to be
kept below a certain level (minimax), a specified strategy should be followed.
Decision theory may also be employed descriptively. For the actual
choices and their consequences, the question may be raised as to which
decision criterion best rationalizes the data, that is, which best fits the
data. This postdiction may then be validated by prediction of experimental
or other research outcomes.
to assume that the choices were governed by rational intent.
It should be noted that it is not necessary
Animals have
14-14
been excellent subjects for decision research.
rationalizes the data is the one which makes the most sense to the analyst,
not the "decision maker".
The decision criterion which
Finally, a discrepancy between socially normative criteria and descrip-
tively inferred criteria may be used to orient programs of change.
Gray (1975) concludes, "relatively little consideration has been given to
mechanisms or procedures that might help assure that the ideals are
achieved" (p. 245).
committees only because consequences such as protection of the institution and
a continued flow of research funds are contingent on such behavior. Further,
the very review procedures chosen may be those whose conseqeunces are simply
to " appear to meet the official goal " (1975, p. 46, original emphasis).
Indeed, as
He notes that an institution may set up peer review
Decision theory specifies its requirements, procedures, and outcomes
in explicit terms which are related mathematically and are often so defined.
Obviously, all of these can not be met -- what quantity do we assign a human
right or an iatrogenic dysfunction (even if a jury does)?
may be worthwhile to specify those classes of observations and relations which
the theory requires, and consider them explicitly, for policy formulation.
Nevertheless, it
Contingency analysis, as used in decision theory and in operant behavior
analysis, would appear to be useful in consideration of social issues and
policy. We shall now consider such definitions of treatment and research.
II. TREATMENT AND RESEARCH
The first two terms of the three-term contingency which specifically
define treatment and research will be considered together since (a) the
occasions and (b) the consequences (which will then be contingent on behavior)
are defined in terms of each other in a manner to be noted. The third element,
(c) the behaviors then required, will be considered separately.
different contingencies for patients and subjects and for their corresponding
The
14-15
professionals will be noted in a separate section which will also consider
the means-ends differences often assumed to distinguish patients from subjects.
Discussion of the social contingencies and policy which specify a
particular classificatory scheme will be dispersed throughout and accordingly
will not be restricted to a separate section.
Occasions and consequences in the social definitions of treatment and
research .
There are interesting parallels between the occasion-consequences
relations of the treatment and research systems.
lines other than patients and subjects.
These parallels are along
In the various treatment systems, the events which occasion treatment
are individuals (collectives may be considered as such) who present functioning
which is less than adequate or which poses problems, and the consequences
which maintain treatment are progress toward, and it is hoped, production
of functioning which is more adequate than before, for the same individuals.
The individual units can be humans who are designated as patients going
through a clinical system, as students through an educational system, as
trainees through a training system, and so on.
through clinical or training systems.
electrical appliances going through their repair systems.
in functioning may be designated in terms such as correction, enhancement,
innovation, limitation, repair, restoration, and treatment, among others.
The units can be animals going
The units can also be automobiles or
The transmutations
In the various research systems, the events which occasion research
are somewhat systematized and organized statements or related problems, and
the consequences which maintain research are progress toward and, it is hoped,
better organized statements.
include, among other things, changes in consistency, parsimony, coverage
and, for those empirical systems we call scientific, validation by prediction
or control.
The criteria used to evaluate the organization
The transmutations along these lines may, like treatment,
14-16
be designated as correction, enhancement (extension), innovation, limitation,
repair, restoration, and treatment, among others.
The changes attributed to the two systems may be described as the
positive reinforcers of functioning, healthy, or educated individuals in the
treatment systems and of better-systematized statements or new knowledge
in the research systems.
be described as the negative reinforcers of relief from distress or ignorance.
Although these consequences whether viewed "constructionally" or "patho-
logically" (Goldiamond, 1974) are not always produced by the social
institutions (n.b., school ineffectiveness), they are considered to be
contingent upon their proper functioning, and the consequences (no matter
how variable) therefore maintain social support of the institutions.
support can be financial, as in research, or partly financial and partly also
in the granting of virtual state monopoly, as in the school systems and
medical licensing systems.
The changes attributed to the two systems may also
The
This cursory analysis suggests that in the clinical treatment enter-
prise and in the biomedical-behavioral research enterprise, the patient and
the systematic formulation ("Nature") are analogous. The human patient and
the human research subject are not analogous in considerations of the two
enterprises as enterprises.
Behaviors in the contingencies defining treatment and research .
Whereas the differences between occasion-consequences in treatment,
and occasions-consequences, in research seem clear, there is considerable
confusion in the literature on differences between the third terms of the
contingency, namely, behavior. As was noted in the introduction, "every
medical procedure, no matter how simple or accepted" is considered to be
"an experiment since it is applied in a new context each time" (Ladimer,
1963, p. 190). Since the outcome is never certain, "all or nearly all therapy is
14-17
experimental" in this sense (Beecher, 1970, p. 94; cf. Freund, 1969, p. viii).
Where there is uncertainty of outcome, the effort must be considered
as a trial or as an attempt whose Outcome is to be related to the trial
to produce a type of knowledge or inference which is never certain,
is fallible, and is therefore subject to change.
certainty of the a priori knowledge which derives from faith, the classical
distinction between the a posteriori knowledge derived from experience and that
derived from faith is evident.
expérience , defined in my Larousse Petit dictionnaire (1936) as "n.f. Essai ,
épreuve .
tinguished from knowledge gained through faith.
" Particul . Essais , opérations pour demontrer ou vérifier une chose ."
Same term catches
as experience and experiment.
v. tr. Eprouver par des expériences ."
English.
15 (Revised Standard Version, 1952, "By this you shall be tested") opens
"Now y schal take experyment of ou", but in the 1388 edition, it is "NOW
y schal take experience of ou."
When one contrasts the
Indeed, the French word for experiment is
Connaissance acquise par la pratique , par l'observation " as dis-
Its specific meaning is
The
the common tentative quality of what English separates
Indeed, to experiment is given by " expérimenter ,
The terms were not always separated in
The OED reports that in 1382, Wyclif's translation of Genesis xiii,
Indeed, if this close linkage makes experiments of all experiences
(both are derived from L. experiri . to try) then not only does all medical
treatment become biomedical experimentation, as we are told, but all sensory
experience and knowledge gained thereby becomes experimental.
this is what Moore was leading up to when he noted that every surgical
operation is an experiment in bacteriology, .. [in] pharmacology, ... [in]
anatom[y], [in] biology" (F. Moore, 1975, 15), for shortly thereafter he
speaks of "this basic experimental nature of clinical medicine and, indeed ,
of all human intercourse " (p. 16, emphasis added).
Possibly,
Since teaching "is applied
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in a new context each time," as is serving customers, and conversing, these,
too, become experimentation with human beings.
A simple test which distinguishes scientific experimentation from the
practices of clinical medicine, routine or innovative, of teaching etc.,
would be to apply the principle of concordance, in the form of a simple
question: Would a group such as the National Science Foundation give research
grants in bacteriology, pharmacology, anatomy, and biology for "every
surgical operation", for every classroom session, and so on?
tinction between the scientific usage of experimental and the lay (and pro-
fessional usage by writers in the field we are discussing) usage of the term,
and the distinction between experimentation and treatment are not clear to
any investigator or practitioner who submits a research proposal, they will
be clear after review.
If the dis-
What defines research varies with the discipline, the research strategy,
the review agency or journal, and no definition will therefore be offered here.
The peer review committees of the various granting agencies and the editorial
reviewers of scientific journals and agendas of scientific meetings offer
sufficient definition.
such review, its designation as a research project might depend on an affirmative
answer to the concordance question, which in this case is put hypothetically,
and only to define the behavior.
Whether or not a particular project is proposed for
Whether activity qualifies as acceptable treatment might similarly be
defined by peer review, in this case weighted toward post-hoc review.
scientific review is to be used as an example, "track-records" of each
practitioner might serve evaluative functions, just as department heads file
publications of faculty for consideration of tenure and promotion, and just
as grant review committees require such listings and evaluation of quality.
If
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Where committees are institutional, its members are subject to the
same contingencies which govern the person under review.
preferable.
who are outside the specialty and are therefore personally impartial misses
the point.
trol.
more important to build in independent contingencies since the special interest
groups being regulated are the ones which possess the special knowledge
needed to regulate. Indeed, the history of governmental regulatory agencies
shows that they wind up being run by the groups they are supposed to regulate.
It should not be assumed that research and treatment will be exceptions.
Even where the contingencies governing regulator and regulated are separated,
there can be "deferred bribes", that is, hiring by the regulated once the
term of the regulator is up.
Independence is
To assert that the public is best protected by having reviewers
The critical issue is to ensure independence of contingency con-
In areas where specialized knowledge is required it becomes all the
The existence of yet a different type of public protection is implied
by statements such as "doctors (or other professionals) always stick together."
Where the implied consequence of a coverup of a person or agency is protection
of a profession or other specialty group, the argument that only such specialists
have the evaluative skills may be beside the point.
is to have a review group comprising members of other specialty groups.
However, this solution of professional impartiality may also miss the point,
which is to ensure independence of contingency control.
The solution in practice
For research in the context of treatment, if the research is to be
meaningful it should meet the concordance criterion mentioned. If the
treatment is to be considered acceptable, it should meet the criteria for
treatment. Stated otherwise, clinical research should meet both criteria.
The concordance solution may also apply to a practitioner who, having
provided acceptable treatment for some time, would now like to go over the
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records for their possible contributions to science or general treatment.
It should be noted that research grants are made for historical and archival
analysis, and the research concordance principle would apply to the procedures
for analysis, the records available, and so on.
(students, etc) and types of treatments selected allow comparisons and
facilitate research, the use of intent as a taxonomic device poses a pro-
blem, since it may be inferred that choices for treatment were governed
by the "intent of developing new knowledge" (Levine, 1975a, p. 6), that is,
of research. The procedures are, after all, in concordance with research.
If the treatment provided was concordant with treatment, it also meets this
test.
ment, as evident by professional specializations in both patients and
treatments; economic and other selection criteria ("I can't treat that
type") abound.
of patient is, after all, what diagnosis is about.
patient-treatment interactions are treatment-concordant, the fact that they
are also research-concordant may be the concern of the research review
committee.
If types of patients
Selection of patients and treatments is also concordant with treat-
Using a particular type of procedure for a particular type
And if the particular
In all events, now that treatment is coming under public scrutiny,
treatment systems might profitably examine the procedures developed by
cognate systems governed by similar contingencies, namely, scientific
research systems whose major funding has come from the same public sources
that will be increasingly tapped for treatment, with the same requirements
for accountability.
Effects on innovation and the accepted practice of medicine
The fact that innovative treatments or treatments in new contexts
are defined as experimental (cf. Beecher, 1970; Freund, 1969; Ladimer, 1963;
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McDermott, 1975; F.D. Moore, 1975) is of concern to lexicographers and will
not be pursued further here. New procedures and new conditions can be con-
cordant with treatment and, when so used, Freund sees "no quarrel" (1969,
p. 317). Our concern will be with the testing of innovative treatments,
which may fit the research contingency noted, although review committees
tend to regard such proposals as "demonstration proposals" rather than
"research proposals".
"the routine and accepted practice of medicine", henceforth to be abbreviated
raapo medicine, we shall also discuss raapo medicine when implications of
innovation apply here as well.
treated separately.
Since innovation may be defined as a departure from
Research and treatment contexts will be
If innovations are not to be accepted until it is demonstrated that the
gains are worth the "risks", an issue that immediately arises is our satis-
faction with raapo treatment. Are the gains worth the "risks" here? And
how do they compare with innovation? Or do we apply a grandfather clause
to raapo treatment? The issue, Robbins notes, "not only applies to procedures
that are developmental or experimental but also to many procedures that
are considered established and about which questions of risk are no longer
raised" (1975, p. 4).
trials may be standards of "safety and efficiency beyond those that can be
offered for the best of medical practice" (1975, p. 96).
raapo medicine, he cites the case of Benjamin Rush, who is considered to be
one of the fathers of American medicine.
remained at his post in Philadelphia, ministering to the stricken, instead of
joining most of his colleagues in their escape to the country:
And Eisenberg notes that the requirements for therapeutic
With regard to
During the plague of 1793, he
"Messianic in his zeal for purging and blood-letting,
therapeutic maneuvers based on contemporary author -
ity , he went from home to plague-ridden home,
causing more carnage than the disease itself. Good
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intention ... provided no substitute for knowledge then,
nor ... now" (1975, p. 96; emphasis added).
And Beecher notes that "a number of examples come to mind to suggest the
need for healthy skepticism as to how readily established a standard may be,"
(1970, p. 92).
In discussing private and public good and harm, over short and long
run, Barber suggests that "a rough functional calculus" be applied which
"shows some definite net advantage all around" (1967, p. 100).
proposing has some elements of a decision approach.
criterion is to be applied to a 2 x 2 matrix, whose columns are private and
public and whose rows are short and long run, with specific consequences in
the cells.
formal decision theory to the assessment of innovative approaches, since
these are, after all, social decisions.
What he is
Some optimization
I am proposing that we begin considering the application of
The decision criterion to be applied must be specified. Claude
Bernard's implied criterion of no "ill to one's neighbor" is moderated by
Beecher's "shades of gray" (quoted in Barber, p. 98).
would be applied to a matrix whose columns are types of treatment and whose
rows may be that which the treatments are to be applied to.
different diagnoses, or different assumed stages of an illness.
research, for example, chemotherapy and radiation might be applied to cases
where the probability of metastasis was >.2 and .2, and all four empirically
obtained effects (entries in the cells of the matrix) might help obtain
comparative "expected values" (a decision criterion) of these two (or more)
treatments for these probabilities. Similar matrices might be applied for
other probability levels.
entries, nor are the possibilities exhausted.
The decision criterion
These may be
In cancer
No ready prescription is offered for the row
Outcomes need not be restricted to gains and losses, or benefits
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and damages.
which equally control self-damage (physical constraints and occasional slaps
upon head-banging by an autistic child), may have different effects on what
new behaviors may be taught (none in raapo constraint, and progress toward
developmental norms in behavior modification), and protection of civil
liberties and right to treatment might also be considered (Goldiamond, 1975b).
A matrix was offered to rationalize the tendency to overdiagnose and undertreat
found in some psychiatric hospitals (Goldiamond, 1974).
Elsewhere (Goldiamond, 1974) I have noted that two treatments
What is being proposed is that the evaluation of benefits and damages
of an innovative procedure never be assessed purely in terms such as how
much damage are we willing to tolerate for how much benefit, that is, in
terms of effects of the procedure alone, but that comparison with the benefits
and damages of raapo treatment be the routine strategy.
theory minimally requires a 2 x 2 matrix, and a decision is not defined in
terms of weighing alternative outcomes of simply one course of action.
Ordinarily, it would seem that a control group provides such a possibility,
but I am suggesting that raapo treatment be that control, or one of two
controls.
treatment, raapo treatment, placebo.
Formal decision
This might give a 3 x 2 matrix, with the columns being innovative
Where the "expected outcome" data are available for raapo treatment,
such data would be useful in comparing projections from innovative treatment
as results are obtained.
historical analysis might supply cell entries which would be useful in
establishing "expected values" of the treatments for different conditions.
It should be noted that it is possible to construct such matrices only to
the extent that the requirements of decision analysis (implicitly or
explicitly) entered into data collection procedures.
data even approximating this requirement for raapo treatment, one might
Where several types of treatment had been used, a
Where there are no
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question the bases for having accepted or continuing to accept this treatment
as standard, and question whether it should be used as a standard against
which innovation is to be measured.
The use of raapo treatment as a standard for defining innovation (that
which deviates from raapo treatment) is carried to a logical conclusion when
Levine extends this definition of innovation to the social sciences, namely,
as that "which differs in any way from customary medical (or other professional)
practice" (1975a, p. 24). The innovations would thus require all sorts of
protections not provided in raapo social discipline.
parallel to the investigator-doctor role confusion is a criminologist-law-
enforcement officer.
confinement) is raapo prison treatment, as indeed is the case (In one prison
in Illinois a cubicle within a cube within a cube is standard), and suppose
a warden-penologist wishes to see if such treatment is necessary ( a general
statement) and for half the prisoners so consigned, converts the cubicle to
a larger room, provides options, and so on. He records differences between
the two situations.
all the other safeguards for this deviation from "customary [penal] practice",
when they were not required for the standard procedures? A decision matrix
might prove quite useful (procedures x assumed severity of offense) in
convincing the outside world to adopt the change, or to whom to apply it.
All of the foregoing may be summarized by a common expression, when
One example given of a
But suppose some highly undesirable hole (solitary
Would we require the imposition of informed consent and
innovative treatments are assessed, comparative raapo treatments should be
"up for grabs."
clarified as innovations progress.
By this process, raapo treatments might gradually be
This maxim should not hold where the treatment practices of a practitioner
are under scrutiny, since the practitioner should not be faulted for what
was then not known. Thus raapo treatment would remain as the safeguard it
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has been for the practitioner who uses it, but would lose this position in
the evaluation of innovative treatment. The two functions would be separated.
Separating the evaluative (research or demonstration) and treatment
functions provides safeguards for the practitioner of raapo treatment.
what of the practitioner of innovative treatment? Given the uncertain nature
of raapo treatment outcomes, and given the fact that research is not the only
avenue to discovery, and that treatment may also provide such an avenue, the
social and personal stakes in innovative treatment are high. I submit that
the principle of concordance also extends to innovative treatment.
is treatment concordance which is involved.
treatment , whatever consent procedures obtain; whatever degree of prior
specification of procedures and alterna tives is required; whatever degree of
evidence of effectiveness and evaluation in terms of cost of treatment, dura-
tion, and possible harm are required; whatever proscription holds against use
of an explicitly designated procedure until it is evaluated further; whatever
degree of post-hoc review is required, -- these might also be required in inno-
vative treatment.
innovative treatment, such treatment concordance might also protect the patients
(clients, students, etc.) at least as well as they are now protected by the
analogous raapo treatments. Where such concordance exists, the fact that
innovative treatments differ from raapo treatments should concern neither type
of practitioner -- until innovative and raapo treatments are evaluated.
was suggested, evaluation of innovation would routinely call for simultaneous
and comparative evaluation of analogous raapo treatment.
But
Here, it
With regard to analogous raapo
In addition to protecting the social and personal stake in
As
The social and personal ends (consequences) contingent or innovation
and research are not served by confusing them, and are best protected by clear
definitions and distinctions between them.
not congruent with science was discussed in a philosophic context by
That innovation (discovery) is
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Reichenbach (1951), who distinguished between the context of discovery and
the context of justification (p. 231).
of the latter which distinguishes science, and it is "the adequacy of the
empirical procedures [which] governs the adequacy of the experiment
and minimally demonstrates the competence of the scientist" (Goldiamond,
1962, p. 310). What it is that is evaluated in this manner can have been
suggested to the investigator "by a theoretical issue, by a procedural issue,
by his own subjective experience, by accident, by mistake, by serendipity,
or in some other way" (Ibid), including treatment. As was noted, the con-
tinued confusion between innovative and experimental is of concern to lexico-
graphers.
It is a particular set of formulations
The formulators of social policy have other concerns.
Innovation which is governed by scientific contingencies should be
considered as scientific in concordance with defining criteria of the rele-
vant scientific communities, and innovation which is governed by treatment
contingencies should be considered as treatment in concordance with such
defining criteria of the relevant treatment communities.
required for research in the context of treatment is that of both communities
for the contingencies in their respective domains.
vative treatment would require evaluation of raapo treatment.
evaluation, since it is governed by scientific contingencies, should meet
the defining criteria of that community, as well as raapo treatment concor-
dance for both innovative and raapo treatments unless concordance were
already there, as in evaluation through historical research.
of different raapo treatments would be similarly considered by both
communities.
The concordance
The evaluation of inno-
Such joint-
Evaluation
It would seem that the principle of concordance contributes not only
to the definition of treatment and research, but also to evaluation of
innovation and treatment, and to protection of the social and personal stake
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in innovation, as well as to the protection of individuals treated thereby.
III. DIFFERENT CONTINGENCIES GOVERNING PATIENTS,
SUBJECTS, AND RELEVANT PROFESSIONALS
In the discussion of occasions-consequences for treatment and research,
it was noted that the patient and the systematic formulation are analogous,
but patient and research subjects are not.
formulation will be treated with analogous respect (or disrespect) since
social support for the systems involved may ultimately be contingent on how
successfully the systems produce their assigned outcomes.
that patients and research subjects, since their positions are not analogous,
will occasion nonanologous professional behaviors in the treatment and
research enterprises, as enterprises . The conclusion that the protection
of patients and subjects requires different types of review procedures is
accordingly a valid one -- as long as the discussion is confined to the
enterprises as enterprises. However, as will be noted in Section IV, there
are overriding commonalities in other social contingencies, which dictate a
different conclusion.
This implies that patient and
This also implies
In treatment, an extended sequence of interactions between patient
(student) and professional is often required for each.
thereby described; the link reinforcers derive their reinforcing properties
from their progressive relation to those consequences for which the whole
sequence is required.
efforts along certain lines are reinforced or weakened by ensuing changes
(depending on direction) of the patient, these then occasion further efforts
on the practitioner's part, these are then strengthened or weakened, and so
on. The three-term contingency is clearly evident. In this interactive
arrangement, the patient's outcomes control the professional's behavior,
An operant chain is
On a day-to-day basis, the practitioner's treatment
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providing both occasions and maintaining consequences for it. The patient's
behaviors are reciprocal:
relief are patient behaviors which are the occasioning and reinforcing stimuli
which bracket the practitioner's behaviors.
well as compliance with other "orders" (the "patient role") are maintained
by the same consequences which maintain the practitioner's behaviors, namely,
their progressive approach to the outcome which maintains the entire sequence.
Thus the ( patient-practitioner ) "mutuality of outcomes" which is used to des-
cribe the terminal outcome of "successful practice" also applies to the
links in the sequential chain.
but reciprocity of behaviors.
receives in the short run a quo for the quid that he contributes" (1969,
p. 338).
It is the social system, for whom this outcome is also meaningful, and to
obtain which it supports the treatment system.
the presentation of complaints and reports of
These patient behaviors, as
There is not only mutuality of outcomes
As Parsons observes, "each participant
It should also be noted that a third party enters into this mutuality.
In experimental research, investigators are engaged in an extended
sequence of interactions with their data. In operant and related single -
organism research, the investigator's manipulations along certain lines are
strengthened or weakened by ensuing changes (depending on direction) in the
dependent variable, these then occasion further manipulations on the investi-
gator's part, these are then strengthened or weakened, and so on. The three-
term contingency is clearly evident. The orderliness of the data controls
the investigator's behavior, providing both occasions and maintaining con-
sequences for it. In most research using statistical inference , this pro-
gressive control by increasing orderliness is evident in a series of experi-
ments, by one or several investigators. Ensuing experiments are governed by
outcomes of the preceding ones. The outcome which maintains the sequence of
investigator-behaviors in a single-organism operant investigation, or in a
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series of statistical studies, is increased orderliness or systematization of
statements.
outcome is also meaningful, and to obtain which it supports the research
system.
The third party here is the granting agency, for whom this
Since the patient's outcomes control the practitioner's behavior, and
the experiment's outcomes control the investigator's behavior, it can be
said that the patients control the practitioner, and the "data control the
experimenter." Indeed, the patient pays the practitioner, who is thus clearly
identified as the agent of the patient.
social system, through its granting agency, that pays investigators.
thereby the agents of the granting agency. They write reports for it, agree
to provide time for it, and so on. The mutuality of outcomes and reciprocity
of behaviors which characterize relations between patients and practitioners
in treatment, also characterize relations between granting agencies and
investigators in research. Patient and granting agency are in parallel
relation.
suggests (1975b). It helps define and separate agent from client in both
treatment and research, in addition to filling other functions to be dis-
cussed in Sections IV and V.
In the case of research, it is the
They are
Payment is, accordingly, critical, and not extraneous, as Levine
Research subjects do not enter this realm of discussion. They
play yet a different role. This role is evident if one first summarizes
profession-agent roles in treatment and research.
A. Treatment: 1a. Professional is agent of patient
1b. Patient is client of professional
2. Professional agent is paid by client patient.
B. Research: 1a. Professional. is agent of grantor.
1b. Grantor is client of professional
a. Professional agent is paid by client grantor.
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C. Research Subject: 1a. Subject is agent of professional.
1b. Professional is client of subject
2. Subject agent is paid by client professional.
Vis-a-vis the subject, the professional is in a reversed position from
Since the professional is an agent of the either of the two preceding ones.
granting agency, the subject by extension is also.
described as being in a "line position" rather than in one of continual
interaction with the professional or the granting agency.
The subject can be
A fourth relation of interest can now be considered. This is the
situation where research is conducted in the context of treatment.
D. Research-Treatment: 1a. Professional is agent of patient (A-1)
1b. Professional is client of subject(C-1)
Since the subject is also the patient, the same person is both client
and agent.
holds on this side, as well.
in person, both may be similar in role, since they are agents of the same
client institution (hospital or university) which pays their salaries. Unless
the relations are made explicit, and steps are taken to separate the functions
(some of which will be discussed), there will be problems in a variety of
areas, including coercion and consent (see Gray, 1975, for some of the con-
tamination).
If the practitioner is also the investigator, this confounding
If practitioner and investigator are separate
Since the investigator pays the subject and the patient pays the pro-
fessional, when investigator and professional are the same, and subject and
patient are the same, each should both pay and be paid. Indeed, the cancella-
tion or lowering of patient fees in many clinical-research units supports this
statement.
Means-ends relations
It is frequently asserted that since the research subject lacks whatever
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protection the patient gets from the mutuality of patient-practitioner
outcomes, the subject requires special protection.
in this case is that the subject may be used as a means to obtain the
investigator's end , namely, general knowledge.
helpful to the subject, it may be harmful. Where research is conducted in
the context of treatment, it is at best simply extraneous to the outcome of
treatment, and at worst, in opposition to it.
The particular jeopardy
This may not only be Un-
In research, human subjects are considered specially subject to abuse
since a variety of social consequences are contingent upon the investigator's
contribution to knowledge. Dependent on publication are prestige, promotion,
income, research funds.
characterized by the mutuality of patient-practitioner outcomes which
characterize treatment.
course grade used to maintain subject participation.
fore liable to abuse -- the consequences cited are strong ones and are not
shared by the subject.
These outcomes for the professional can not be
Nor are they even congruent with the payment or
The subject is there-
In treatment, however, similar consequences are also likely to hold.
Presumably, dependent on the practitioner's success in treatment are such
consequences as prestige, promotion, income, and access to facilities.
These outcomes are not characterized by mutuality of patient-practitioner-
social outcome.
was the occasion for the anguished cries of Linus in the Peanuts comic
strip series when he discovered that his teacher was getting paid; he was
broken-hearted to discover she was not governed by his learning.
consequences for students in elementary school systems for which the governing
outcomes are other than student progress are more disastrous.)
dimensions along which critical differences may lie, when one views the
systems as systems, are in the different socially-defined contingencies pre-
viously discussed, which distinguish treatment from research.
Such divergence in outcomes between professional and client
(The
The
The ethical
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issues, in part, reside in the fact that the outcomes determined by the
social systems in the two cases do not consider research subjects. The
outcomes are, in one case, treated patients, educated students, trained
technicians, and so on, and, in the other case, are treated and better
organized systems of knowledge. Where there is abuse, it resides partly in
the specific procedures used by particular systems, and partly in the rela-
tions which research and treatment share with a host of other social
institutions, and which will be discussed in Section IV, and not simply in
the use of the subject as a means, since the patient may also be used in
this manner.
IV. ABUSE OF POWER: COERCION AND CONSENT
A variety of interpersonal relations including those of research and
treatment may be described as power relations. The common contingencies
related to this common descriptive term make possible the abuse of power
they share.
the context of coercion.
it applies to the abuse of power and to consent.
will consider informed consent in the context of contractual relations.
The issue of consent is addressed, in part, to such abuse in
The present section will consider coercion as
Section V, which follows,
Ethical issues are raised when power is abused. Interpersonal power
relations may be found not only for investigators and their subjects, and
doctors and their patients, but for governors and governed, officers and
enlisted men, employers and employees, teachers and students, ward committee-
men and appointees, husbands and wives, parents and children, to mention
but a few. In each of these, power flows both ways, but the alter
powers, unlike alternating currents, differ in topography. The focus here
will be on the first party, who may be said to be the "exclusive vendor"
or distributor of the occasions and consequences which critically bracket
socially-relevant behavior of the second party and may thereby control
it. In this model, the comparable control exerted by the second party is
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trivial.
does not derive from consequences supplied by the second party, it would
appear to be under other control.
Since control over exercise of the powers of the first party
One model used to describe such other control is "self-control," which
may (or may not) be-related to an ethical code. That such codes are
addressed to the asymmetric power flow described is suggested by consider-
ation of "the moral law as such [as being governed by] a transcendent
motivation" (Jonas, 1969, p. 232; cf. Goldiamond, 1968). Stated otherwise,
it transcends control by the consequences supplied by the second party.
Violating the (code is immoral or unethical and censure is applied by peers,
that is, by those with parallel dispensation powers.
The appropriate exercise of these powers may be considered to be a trust
as defined by an explicit social fiduciary model, whereby kings, officers,
employers, bankers, and husbands exercise their powers for protection and
benefit of their wards (not only did the French general address his enlisted
men as "mes enfants", but the Russian enlisted man addressed his commander
as "Otyets", i.e., Father).
fiduciary ( L. fidere , to trust).
Fulfillment of a trust is involved. Hence
Needless to say, when the behaviors by which one party controls the
behaviors of a second are not controlled by the second, and the first party
is then considered to be under self-control or control by a code of ethics,
the underlying assumption is that the first party's behavior is under some
form of control. The necessity of internalizing the control, in the form
of ethical adherence to a trust, derives from dissatisfaction with an ex-
planation of control by a subordinate. However, the control may derive from
a superordinate system which establishes and maintains the institutionalized
relation between both parties, both of whom are therefore its agents.
social behavior of establishing and developing institutionalized trust
The
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contingencies, like the support given the treatment, research, and legal
institutions, is maintained by the outcomes the system gets when it provides
such support. As in the case of the use of a term as difficult to define as
intent, the problem to which a term as difficult to define as internalized
adherence is addressed may be resolved by consideration of social contingencies.
That they bear on an important social problem is indicated by consideration of
at least one form of abuse of power.
Such a case of abuse of power is defined when a member of the first
party makes the social contingency (which governs the institutionalized
relation) contingent on behaviors by the other which are outside the
social contingency, or applies the social contingency in other ways to
get such behaviors.
and provided the occasion for an explicit moral sermon.
vein, Peters, in Ethics and Education , notes that "It is one thing for a
university teacher to have an affair with his colleague's wife, but it is
quite another thing for him to seduce one of his students" (1967, p. 210)
The latter case permits an abuse interpretation: grades and prestige,
socially approved to govern academic compliance, are made contingent on
a different pattern of compliance. Thereby, it will be noted, society
is not obtaining the occasion-consequence reversal which reinforces social
support of universities: the untrained student has not become (academically)
trained thereby. The teacher, accordingly, may be jeopardizing social
support of universities.
and may then censure him in some way.
(nonreinforced).
These terms approximate the relevant terms in the social contingency.
"has violated his trust" refers to the fiduciary model.
abuse of power" refers to the asymmetrical power model.
The David and Bathsheba episode is an early instance
In a more modern
His university-supported peers may therefore suffer
And the social system is frustrated
He has "hurt his profession" by his "antisocial behavior."
He
His "unethical
All derive from
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the social contingencies discussed.
An interpersonal relation in which power derives from coercion is fertile
ground for unethical abuse since it permits easy control of behaviors out-
side the contingency. Thus, a patient under tremendous distress which can
be alleviated only by an emergency treatment is subject to abuse by the sole
dispenser of that treatment. The dispenser can make dispensation contingent
on a variety of requirements -- including consent for research as well as for
a variety of treatments. The validity of consent obtained under such con-
ditions, no matter how well-informed the consent was, might be questioned.
It might be argued that the procedures represented a flagrant abuse of power,
and that the consent was spurious.
not freely given.
It was obtained under coercion and was
The person was not in a position to consent.
It is evident that in order to consider the validity of any type of
consent, we must first examine freedom and the coercion assumed to negate it.
Contingencies of freedom and coercion
Freedom will be defined in terms of the genuine choices available. Choice
will be defined by degrees of freedom ( df ) a scientific term which will be
used here to define the number of variables in a system whose values have
to be specified to determine the system. The volume of a cube is given by
V=1wh, and given any three values, the fourth is determined (v1w to determine
h, Vwh to determine 1, and so on). Thus, df = 3, as it is to specify the
coordinates of a point in 3 dimensional space.
behaviors , and we shall use decision theory as our model.
two well-defined sets of behavior are required (for example, being at home
or at work are well-defined alternatives, but being at home or elsewhere
introduces the poorly-defined set of elsewhere, which can include a moon and
Jupiter), and the sets are related by the equation a + b = 1.00.
value of either then determines the value of the other, df = 1.
Our concern is with alternative
Here, at least
Since the
Where
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a+b+c+d+e = 1.00, df = 4. There is a greater degree of choice, that is,
there are more degrees of freedom. The df term is a useful one. It not
only suggests that freedom is a matter of degrees, but also implies that
coercion (to be defined presently) is also a matter of degrees.
The parallel between intuitive notions of freedom and the df usages
is suggested by the fact that when the only work available is in a mine,
and otherwise the person goes hungry, then working in a mine may not be
considered a matter of free choice and, indeed, union experience has taught
that miners are then more vulnerable to abuse than they are at other times.
With regard to work as the referent, since there are no work alternatives,
df = 0.
expression.
there is greater freedom, workers can feel "more independent," and abuse
is less likely.
of df , is greater.
There are no degrees of freedom. This accords with the common
If there is a choice between mine, mill, factory, or farm, then
Here, df = 3. Freedom, as defined intuitively or by values
that a critical consequence (to be defined) is contingent solely on a
class of activities, then dc , or degree of coercion , is inversely related (the
Freedom is related to coercion in the following manner. To the extent
term is used figuratively, rather than exactly) to df . Assuming temporarily
that survival is such a critical consequence, then when one works in the mines
or starves, coercion is maximal, since the maximum value of dc will be given
when df =0. Where there was a choice between mine, mill, factory, and farm,
coercion was less since df had a higher value, but for the set of unskilled
labors represented and starvation, there is coercion and the complaint of
the uneducated that their freedom of choice is confined to jobs undesired by
others, becomes understandable.
possible tasks as opposed to survival can be considered coerced. Accordingly,
the issue is never coercion versus no coercion, since df + dc = 1.00 (roughly.
That is, one defines the other, and they are codefined).
At any point, of course, the set of all
The issue is the
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amount and type of coercion we are willing to accept, and the protections
against abuse we set up. These should be defined.
It was noted at the beginning of this section that choices had to be
genuine. Genuineness relates to contingency repertoires. Someone with a
high school education who scans the want-ads, has no choices when all
openings require a college education.
working as a miner or as a physician when there are openings in both fields.
Here, df = 0 because of the behavioral repertoire.
is not announced, or is circulated in channels not available to the seeker,
or in a language the seeker cannot read, the existence of the appropriate
repertoires is irrelevant, and df = 0 because of the opportunity component
of the contingency repertoire. Further, there is experimental evidence that
given occasions which are in the repertoire, given behaviors in the repertoire,
and given potent consequences, the individual may persist in behaviors which
result in loss of consequences, or may switch to those which rapidly produce
them, depending on the manner in which the consequences were previously
contingent on behavior (Weiner, 1972).
as when the type of food available is forbidden by a powerful religious
code.
alternatives, no matter how well their availability is made known in an
informed consent procedure, is reminiscent of Anatole France's statement on
the impartiality of the law which "in its majestic equality forbids the
rich as well as the poor to sleep on the bridges, to beg on the streets, and
to steal bread" ( Le Lys Rouge , Chapter 7).
He does not have a choice between
Where job availability
Finally, the consequences enter,
Failure to distinguish genuine choice from simple availability of
Some consequences are at certain times more critical than others, depend-
ing on a variety of conditions whose investigation is being pursued in the
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laboratory.
choice between two consequences, with response costs and other variables
held equal.
only be measured but can be manipulated experimentally.
through deprivation, often referred to as need, or drive.
body weight may prefer the opportunity to exercise over the opportunity to
eat, but if they are deprived of food, the order of preference may be
reversed. Other procedures may be utilized by the investigator, and all of
these will be subsumed under the general term of conditions which make a con-
sequence critical, that is, one which is preferred in all choice situations.
In one branch of such research, the organism may be offered a
The extent to which one is valued more than the other can not
One method is
Organisms at full
Coercion accordingly may be defined as most severe when there are no
genuine choices ( df = 0), and the consequences contingent on behavior are
critical.
coercion is involved, giving consent may simply be one more behavior added to
the packet required to obtain the critical consequences. Where indignities
are required, consent may simply become another indignity required to get
the critical consequence or to avoid its absence, to state it in terms of
negative rather than positive reinforcement. (For fuller discussion of
coercion under negative reinforcement, see Goldiamond, 1974, and for both
negative and positive reinforcement, see Goldiamond, 1975a, b.)
Coercion obviously relates to consent, since to the extent that
Two types of institutional coercion will be distinguished. In the first,
the institution which delivers a critical consequence has set up the very
conditions which make the consequence critical.
which delivers a critical consequence has not made it so.
lizing, so to speak, on an opportunity provided by a state of nature (actual
or manmade). I shall designate these as Institutionally Instigated Coercion
(IIC) and Institutionally Opportune Coercion (IOC). They will be considered
separately.
In the second, the institution
It is merely capita-
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Institutionally Instigated Coercion. A familiar research example with
a nonhuman subject is the conventional operant pigeon experiment. Here, the
experimenter (or the assistant agent) deprives the pigeon of food and brings
him down to 65-70% of normal body weight.
to food contingent on required patterns of behavior.
of these patterns, the occasioning stimuli, or both, it has been possible
to establish extremely complex patterns of behavior and discrimination,
almost without error.
reinforce the response required to make it available; it is the experimenters
who have so arranged it that delivery of food serves as a reinforcing stimulus.
This they have done through prior deprivation of the organism. They need not
deprive the organism to achieve this effect.
doses of heroin to an animal with an indwelling catheter.
ditions may be manipulated.
The investigator then makes access
By careful programing
In technical jargon, delivery of food serves to
They may simply provide a few
Yet other con-
If deprived pigeons could consent, and were required to do so, before
undertaking the training program which is their only means of obtaining food,
such consent could be considered as having been obtained under severe
coercion, rendered all the more severe by the fact that it was the experimental
system itself which made potent the reinforcer it provides.
four-link chain required to make food available, for example, pull a wire,
turn a counterclockwise circle, press a pedal which illuminates a disk, and
peck that disk 15 times, then get food, a sixth and fifth link would then be
added:
then pull a wire, turn
illuminates a disk, and peck that disk 15 times, and get the food, blessed
food.
To, say, a
intelligently discuss your options, then sign consent to participate,
a counterclockwise circle, press a pedal which
The coercion would not be reduced; it might even be exacerbated.
Consider the case of human inmates of a penitentiary. If they partici-
pate in a particular biomedical research project, such cooperation, by
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demonstrating to the parole board the "acquisition of prosocial attitudes",
renders them eligible for earlier parole.
of liberty or earlier release from incarceration (negative reinforcement)
is contingent on an institutionally-provided opportunity to participate
as a subject.
Henry to remind us how critical a consequence liberty can be.
is made all the more severe by the fact that the very penal system which
makes the delivery of liberty a reinforcer is part of the same judicial-penal
system which deprives the inmates of liberty. The analogy with the pigeon
is almost a homology, and the meaningfulness of any consent obtained under
these conditions would be questioned.
research does not fall into this category will be considered shortly).
same strictures hold even if the prisoners are offered their choices of reha-
bilitative programs, if each is linked to earlier parole. These then become
elements in a coerced set.
Stated otherwise, restoration
The bicentennial notwithstanding, we do not need a Patrick
The coercion
(Conditions under which prison
The
In one form of "brain-washing" the person is deprived of the usual
social support through isolation by physical or pharmacological restraints,
or through isolation from the hitherto supporting community by a special
communal arrangement.
gent on individual behaviors which meet its requirements. The most effective
behavioral requirements are those behaviors whereby the person, by assaulting
the sensibilities of the original referent group, is further isolated from
that group by his or her own behavior, making the support of the new group all
the more critical.
example.
Social support by the new group is then made contin-
The parent who makes a child dependent is a clinical
What is probably the starkest case of institutionally-instigated-coercion
Relief from pain is made contingent is the use of torture to obtain evidence.
on behavior which meets the system's requirements. It is the system which
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supplies the painful stimuli which make relief from it a potent reinforcer.
No civilized court would accept consent obtained under such means.
equation with. coercion makes clear the contingencies involved, which are
often otherwise obscured by rehabilitative or other idealistic statements.
Continuing on the same stark note, we routinely question the morality
of those who create shortages and then profit from the delivery they mono-
polize.
Their
In a less dramatic manner, the requirement of a department of psychology
that each student in an introductory class participate as a subject in some
experiment to obtain a passing grade belongs in this coercive category,
to the extent that passing this course is critical to the student's academic
program.
contribution of the experiments is typically in accord.
However, the coercion is mitigated by its trivial nature, and the
(In a possibly facetious tone, the statement that "the lawyers" have
us in their clutches may reflect not only their inescapability for us, but
the existence of some overlap between the legal system which provides relief
and the system which sets up the conditions which make its delivery a potent
consequence.
decipher seem to be a case in point but, in actuality, social and political
considerations often govern the rules.] The suggestion that legal practice
be reviewed by committees composed of representatives of other interest
groups may reflect not only retaliatory pique against legal advocates of
"consumer" groups such as patients, prisoners, and students, but may also
reflect the regulator-regulated issue raised by expertise which was noted
earlier, as well as other professional issues. There is, after all, a
legal profession which provides services to clients through socially-supported
systems.
[The tax lawyers who write rules which only tax lawyers can
It would be surprising if some of the issues raised in our discussion
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of treatment and research did not apply here, as well. There is legal
research as well as legal service delivery.)
In all events, consent to participate in some activity, where the
consequence contingent on participation was made critical by the consequence-
delivery system, should be considered as having been obtained under coercion.
This does not automatically exclude such consent or such activities from the
pale since, as was noted earlier, the issue is not freedom from coercion,
but rather the degrees and type of coercion we tolerate, and what safeguards
against abuse these require.
peculiar nature of the contingencies described which designate the activities
and consent as coerced.
It should also be noted that it is the
The same activities and consent can be governed by
other contingencies, which are not institutionally coerced. Given such con-
tingencies, and where the activities are socially and personally beneficial,
conditions appropriate to their support might be considered.
institution as coercive and therefore to assume that all related activities
are coerced, is akin to certain characterological descriptions of individuals
or classes of individuals which then subsume all individuals and all behaviors.
Both ignore the different contingencies which govern the different and
varying behaviors of any complex social institution or, for that matter,
any complex social individual.
To label an
Institutionally opportune coercion. There are situations in which
the system which makes critical consequences contingent on institutionally-
defined behavior has not produced the conditions which make these consequences
critical.
belong in this category (iatrogenic disease is an exception, but is con-
sidered an undesirable).
coercion is still defined.
institutionally instigated, nor is it lessened by its social prevalence,
The "helping professions", of which medicine is a prime example,
Where Jf = 0, and the consequences are critical,
It is not lessened by the fact that it was not
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inevitability, or desirability. The coercion is exacerbated when the
institutions set up to, treat the problem are operating under a "legally
granted monopoly" over "a captive audience" (Freund, 1969b, p. 315).
effect, a critical consequence is not only solely contingent on submission
to a particular form of treatment, but in addition, that form of treatment
is provided solely by a system with monopoly control over its dispensation.
The coercion possibly provides the system with an opportunity for socially
appropriate practice or for abuse, which opportunity is not as generally
available outside it. Accordingly, any consent obtained under such con-
ditions requires careful examination.
In
In the next few sections, I shall consider some possible arrangements
whereby consent may be considered as possibly meaningful, when the person's
entry into the system was coerced, whether coercion was institutionally
instigated or institutionally opportune.
sideration, this will be noted. Three major arrangements will be noted,
separating critical consequences from the activities, converting mutuality
of outcomes to mutuality of contingencies, and noncoerced participation
in programs specific to coercive systems.
Separation of critical consequences and activities
Where these require different con-
In a prison situation, when earlier parole is independent of whether or
not an inmate participates in a program, then consent to participate in that
program is not related to the release which the penal-judicial system made
critical.
person attends church, then it is clearly not capitalizing on this opportunity.
Similarly, if the same treatment is available whether or not the person
consents to serve. a-s a research subject, then the situation is similar to
the church arrangement. Separation of critical consequences and activity
If a church provides food during a famine, whether or not the
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simply removes this form of coercion.
instate other requirements to make consent meaningful.
sidered later.
It does not, however, automatically
These will be con-
If making a critical consequence such as treatment contingent on research
participation raises questions of appropriateness, it is partly because
research is considered extraneous to the occasion-consequence reversal which
characterizes treatment, and partly because of social values attached to
relief of distress, among others.
making treatment contingent on ability to pay.
United States will soon join other advanced nations which have eliminated
this requirement. However, in the meantime, an ethical and social policy
problem is posed by hospitals which make reduced payment or no payment con-
tingent on serving as a research subject.
meets the exchange system logic of patient-pay, subject-paid, research
patient-pay-paid, therefore fees cancelled.
fit to this model, providing free services in return for research partici-
pation poses questions about the ethical fit. Where treatment is contingent
on payment, the treatment consequence is critical, and the type of treatment
offered is not genuinely (as defined earlier in terms of contingency
repertoires) available elsewhere, the payment is coerced.
necessity is beside the point -- it is still coerced.
the financial resources (repertoire), making service as a research subject
a substitute for payment, substitutes research service for coerced payment
in the coercion arrangement described.
since research is thereby coerced, it is open to abuse, and consent must
be carefully examined. Few commentators have been sensitive to this
issue, but Eisenberg is on target when he doubts "that we will find a way of
These considerations would also hold for
It is highly likely that the
It was noted earlier that this
However the goodness of its
That it is a social
For someone who lacks
It must then be recognized that
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distributing risk across all segments of society until we have a national
health service for all citizens” (Eisenberg, 1975, p. 97).
arrangements, enrollment in a research-treatment program would be governed
by considerations other than research substitution for coerced payment.
Under such
Payment also enters into prison research (or special treatment programs).
Where early parole and other institutionally-instigated critical consequences
are not made the consequences contingent on research-treatment participation,
this form of coercion is removed.
sequence though not necessarily a critical one for people who are otherwise
fed, sheltered, and clothed. To the extent that it approaches being critical
in a situation (as judged by its selection above other consequences), and to
the extent that df approaches 0, the required activity approaches coercion.
Critical nature and df will be assessed separately.
Money, of course, is an important con-
With regard to critical nature, or uses of money to an inmate, it
should be noted that the penal system deprives an inmate not only of liberty,
but also of other amenities available in the world outside.
institutionally-instigated coercion is defined not only when the system
makes liberty contingent on some behavior, but also when it makes the other
Accordingly,
amenities of which it has deprived the inmate contingent on behavior. Where
money buys freedom, it is evident that its payment has been coerced, and
the behaviors upon which the wherewithall to pay is contingent are also
coerced.
amenities of which the prison system has deprived the inmate, and into the
research/work programs which produce such payment.
are hastily condemned, an important qualification raised earlier should be
reiterated.
coercion as well as of freedom. As was then noted, when work is the issue,
availability of work in the mines, mills, factories, and farms is described
By the same logic, such coercion also enters into payments for
Before such programs
This is that coercion is not absolute, but there are degrees of
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by df = 3. However, given the set of menial work (mines, mills, factories,
farms) and a starvation alternative to that set, df = 0, and menial work is
coerced.
support to Ogden Nash's verse, "I could live my life in ease and insouciance /
were it not for making a living, which is rather a nouciance." This form of
coercion occurs in the world outside and is acceptable -- and, indeed, is necessary
there (exceptions such as inherited wealth exist, of course).
of concordance with such outside facts of life may then be extended to define
an acceptable form of work-coercion in the institution, as well. The general
rule involved would take a form such as: to the extent that the institutional
work programs follow the work-requirements of inmates (or people with their
skills in legally accepted work) in their usual world, institutional work-
requirements provide an acceptable form of coercion. Exceptions derive, of
course, from criminal work, e.g., the system would have to provide a forger
with other work arrangements.
be given work concordant with that available for people with skills and
experience similar to theirs, or might get necessary training.
lines, it should be noted that at least one European prison provides for
daily medical practice outside the walls for physicians serving their terms, and
similarly provides fur construction and factory work, etc., for skilled and
unskilled workmen.
In these institutions, the inmates also pay, from their earnings, for their
room and board, as well as the extra costs which their incarceration incurs.
Such institutions are special institutions with special programs prior to
such arrangements, and during them.
outside provides payments for research subjects, and in some cases, such
payments are competitive with those for work. (Some nutritional research
programs, for example, have provided salaries for college students during their
This can be extended to "higher" levels ad infinitum , lending
The principle
Similarly, inmates who had never worked might
Along these
Earnings on the outside are at the going rates there.
It should be noted that the world
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summer breaks.) To deprive inmates of such work/research possibilities has
the effect, at the very least, of depriving them of options concordant with
those holding outside. Other effects have been cited by advocates of penal
reform or abolition, and will not be discussed here.
The value of n in df = n is, of course, resolved by application of
the foregoing concordance principle.
are given by the socially-accepted skills of the inmates, the positions
available and the exigencies of the institution. And there is no reason to
exclude the option of serving as a research subject, providing the payment,
conditions, and protection are concordant with those provided for a volunteer
outside for whom other options are available.
As many options might be available as
This approach to research participation might also enter into institutions
whose coercive control is opportune, rather than institutionally-instigated.
Stated otherwise, arrangements for research participation of patients under-
going treatment might be concordant with the arrangements for research parti-
cipation of paid normal subjects of the type described. Where the research
is related to treatment, and the problem is a rare one, the subject/patient
is then not a routine research employee but one with special and hard-to-find
qualifications. Arrangements should be commensurate and concordant with those pro-
vided for skilled employees outside. Where the problem is more common, subject/
patients should be easier to find, and the situation is more competitive.
Even under such conditions, as anyone who has conducted long-term research
knows, the investment in the research patient or research pigeon is con-
siderable, and the concordant arrangements discussed earlier would also hold
here. It is assumed, of course, that for the patient, research is an option
and not a requirement for treatment. Otherwise, institutionally-opportune
coercion holds, and the research-patient may be in greater jeopardy than a
prisoner with other-than-research options.
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The issue of social versus individual needs is, I believe, inappropriate
to this context.
ment needs must occasionally be subordinate to social research needs,
citing the drafting of young men as soldiers (pp. 472-3). Indeed, Beecher
asserts that "parents have the obligation to inculcate into their children
attitudes of unselfish service.
in research for the public welfare if judged important and there is no dis-
cernible risk" (1969, p. 282). The children of mothers on diethylstilbesterole
(DES) some twenty years ago might judge that "no discernible risk" to have been
otherwise.
and disfigurement is well-publicized.
with social contingencies, and the same fate for the local army accords with
social contingencies of the enemy. It might be said that the volunteer con-
centrates on the social contingencies of his side, and the draftee concen-
trates on those of the enemy -- hence the coercion applied to his recruit-
ment. Any analogy to research, whether in a medical setting or in a prison
is far-fetched. As Jonas notes:
for science" (1969, p. 222).
Converting mutuality of outcomes to mutuality of
contingencies
Edsall (1969) argues, for example, that individual treat-
This can be extended to include participation
The war situation is not analogous. The possibility of death
Such outcomes for the enemy accord
"NO one has the right to choose martyrs
In a treatment system, it is the individual's responses (behavioral or
physiological or both) which provide the occasions and outcomes whose reversed
relation ultimately supports the profession and its professionals.
extent that the individual's behaviors are brought into the same contingencies
which govern the professional's behaviors, the professional's task is
simplified.
motivated by the same outcomes, or that their behaviors be governed by the
To the
This requires that both work toward the same goals, or be
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same consequences, to use three different descriptive systems.
holds for research as well as treatment. We shall consider treatment
first, since such mutual outcomes are assumed to characterize treat-
ment systems.
organized to deliver, the treatment-relevant behaviors of individuals
and professionals are often also (or instead) governed by different con-
sequences. These may frustrate one or the other or both.
individuals and professionals may not be apprised of what the other is
doing.
ments of the other.
Accordingly, it may be worthwhile to examine how a system which is organized
to deliver common outcomes might set up arrangements which facilitate such
delivery, and under which arrangements informed consent might be meaningful.
We might then see how these arrangements could be extended to a system in
which it is assumed that common outcomes do not characterize individual and
professional -- the subjects and investigators of research systems.
This
Despite the mutuality of outcomes such systems are
Further, the
They may not be apprised of the relation of outcomes to the require-
Any of these may make informed consent meaningless.
Although treatment systems are characterized by " mutuality of outcomes"
it was noted earlier that they are also characterized by " reciprocity of
behaviors."
follows; the teacher teaches and assigns, the student learns and follows;
the trainer trains and provides experiences, the trainee learns and
utilizes.
behaviors required are not. Further, the behaviors of one are the
occasions-consequences of the other. The analysis suggests that regard-
less of identity in culminating chain outcomes, the contingencies in the
links of the chains are different in every component for professional and
individual. Occasions, behaviors, consequences differ. For the individual's
behaviors to be optimally governed by the same consequences as are those
The physician orders and prescribes, the patient obeys and
Accordingly, although the culminating outcomes are mutual, the
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of the professional then, not only must the individual's behaviors
be governed by the same general outcomes as the professional, but the
explicit occasions, behaviors, and consequences of thr links in the chain
must also be the same for both professional and individual. To make the
contingencies the same suggests that it is only when individuals have access
to the same data about themselves which the professional has that it becomes
possible for these to come to govern their behavior, as they do govern the
behavior of the professional. And in the difference between "come to
govern" and "do govern" lies the professional training of the practitioner
(The importance of past histories for a contingency analysis was noted
earlier in the discussion on genuineness of choice as it relates to con-
tingency repertoires. Among the major considerations was the "manner in
which the consequences were previously contingent on behavior"). And I believe
it might then be a part of the professional's task to educate the individual.
The education need not be of the kind or depth which produces a skilled
professional. It might be one which simply supplies the individual with
the tools for analysis and change in the problem areas of treatment concern.
The individuals are the experts in the data and conditions of their own
lives. If they are tought where and how to look, they can supply data and
suggest relations which professionals can use to advantage for the solution
of the presenting individual problems. Such data are otherwise not
available. And individuals can also begin to analyze their own responses
and occasions of concern, and try to figure out what to do about them,
trying this tack and that, even as professionals analyze the same responses
and try out different approaches -- procedures which they and the common
language confuse with experimentation. Professionals keep written records
and are guided by them. The system suggested would require individuals to
do likewise, and professionals would have access to their records in
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concordance with the individual's access to professional records.
It should be noted that as chronic problems increase in importance,
and as the influence of the environment is coming under increasing
scrutiny, at least one system of treatment, namely, medicine, is turning
increasingly to such individual self-management. Health delivery systems
are trying to train individuals in self-examination (e.g., breast cancer)
and self-monitoring (e.g., home sphygmomanometers), and physicians are
beginning to substitute education and joint-decision making for the assump-
tion that if they fulfill their trust in a fiduciary relation with their
patients, these wards should cooperate and meet their obligations of
obeisance and recovery.
A treatment system which requires individuals to keep explicit records
in concordance with staff records can readily be converted into a research
system, as well.
was noted, otherwise not available.
responses of the individual under different conditions, and about the
settings in which the problems occur which can be useful for research.
Just as professionals often interpret the same data differently, the
possibility of different interpretations of data from the same individual
records may suggest itself to the individuals when they are required to
interpret, or to individual and professional in their regular conferences.
And just as in the course of professional conferences, the resolution may
be to wait, to get more data, or to try this and try that.
should also be noted that waiting (collecting more observations over time),
or getting more data (running the same subject under more conditions),
or trying this and that (manipulating different variables) are also means
employed by experimental investigations for resolution of problems or
The extensive data which such records provide are, as
They provide information about
And it
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conflicts in explanatory systems.
system which is supplied to the individuals, the interventions suggested
for them to make, and other procedures are in concordance with those
behaviors which enter into the definition of a research contingency,
individual records can contribute to research. Is such research use of
records and interventions separate from treatment use?
treatment in the context of self-management for prevention, melioration,
or maintenance, then research use by the individual becomes necessary for
treatment use by both individual and professional.
oneself, about "how I function," through distinguishing poor "explanations"
from better ones, can be quite important for self-management or for improved
professional management.
method is an excellent means for distinguishing acceptable formulations.
Just as the treatment professional educates in the formulations and pro-
cedures of that area, the research professional educates in the formula-
tions and procedures of that research area. In a research-treatment system
of the kind described, the individuals may gain insights which are important
for the practical resolution of their problems. The investigators may
gain insights into those general functional relations whose resolution is
important for the resolution of systematic problems in their disciplines.
In such a research-treatment system, research and treatment go together
because each is required for the other.
both "research and therapeutic allies" who share what intelligence the joint
effort requires be shared, while having their own separate sources.
To the extent that the recording
If one views
Finding out about
And the "context of justification" of the scientific
Individual and professional are
This setting describes for research and treatment the "collegiality"
between individual and professionals which Parsons (1969) sees as ideal,
and which Mead (1969) reports as obtaining in field anthropology (at least
in those projects in which she has been involved).
14-53
Where the treatment does not require research for its fulfillment,
treatment can take place within the congruent-contingency system dis-
cussed for treatment alone. Individual and professional are then
"therapeutic allies" who share what intelligence about each other their
joint effort require's, and reserve to themselves what is not required.
For research alone, the congruent-contingency system would involve investi-
gator and-research subject.
reserve corresponding intelligences.
As "research allies" they would share and
In certain treatment areas (clinical, educational, or training), the
outcome-producing program is well-formulated, with each step having been
validated experimentally.
1967, 1974), the title of the text gives the outcome.
the text resembles a mini-contingency.
responds, usually by writing in a blank provided, the appropriate answer
is then available for comparison.
dence, the student is then presented with the next frame, and so on.
by, outcome repertoires are established which are far removed from those
with which the student entered (The derivation from operant laboratory
research is evident).
opportunity to move ahead (a consequence), contingent on adequacy of the
student's response, may be considered as professional surrogates.
always explicitly presented -- if the individual does not advance to the next
step in "treatment", the reason is clear.
may be detoured to other steps, i.e. to differences in treatment before the
main program is rejoined.)
mance and its adequacy at every step.
system application known as p.s.i., where the instructions may be entire
lessons, cf., Sherman, 1974). Although individual and professional
In programed instruction (p.i., cf Hendershot,
Each of the frames in
An instruction appears, the student
If there is a response-answer correspon-
There.
The instruction which opens the frame, and the
They are
(In a branching program, the student
The students have access to their own perfor-
(The steps are longer in the classroom-
14-54
are not colleagues, or therapeutic or research allies, the explicit
presentation to the individuals of the same information about them which
the professional has (albeit by a surrogate professional), which enters
into collegiality, also holds here.
assisted instruction, this electronic surrogate-professional functions
almost as freely as a professional, (cf. Markle, 1975).
In the form of p.i. known as computer-
One implication of the quest for collegiality in the p.i. context
should not be overlooked. The implication derives from the question: when
are individuals and professionals colleagues in such programs, if ever?
Students are presented with detailed steps, hence are not allied with
the professional in their choice of them.
reference to the development of the program.
for collegiality between program developer and individuals in the analysis
of each step and its judgment as wheat or chaff.
research is done in the context of treatment -- teaching, in this case.
Here, there is room for considerable flexibility and trying this and that
which, in a good program, is concordant with research behavior. 0nce the
program is developed, it is simply available for application, and there can
be several different programs which explicitly produce the same outcome in
different ways. The parallel with clinical treatment is evident. The
major implication is that collegiality may be necessary when the steps in
the program (linear, or branching) have not been validated.
development would require both treatment and research.
that when the program is developed, it is still necessary to provide
individuals access to the same data the professional gets.
The question is answered through
Here, there was opportunity
The developmental
Further, such
And a corollary is
The foregoing arrangements are obviously limited in their applica-
bility.
time.
Among other limitations, they assume extended interactions over
In treatment, such interactions are found in chronic care, education,
14-55
or training.
term recovery, or maintenance, or prevention programs.
extended interactions are found in laboratories which require extended
experimental intervention, or where acute studies have long-term effects.
Establishing arrangements of the type discussed is not an easy task. It
requires careful and long-term contingency analysis which operant investi-
gators and practitioners are familiar with, but in an area which is
generally foreign to them, and whose required formulations have not been
considered in the simpler operant arrangements studied thus far.
They are also found in acute care when coupled with long-
In research,
Although such arrangements would seem to be of only limited applica-
bility to acute care or acute research (those situations where inter-
actions between individual and professional cover only a short span of
time and are confined to a few episodes per patient-subject), they may
suggest some principles which might be applied.
if the episodes are considered as condensed interactions which follow the
same rules as the more chronic ones.
analysis which the more leisurely and more magnified chronic situation
permits.
This would hold especially
They occur too rapidly for the
Other settings and types of relations or problems or individuals
may also suggest limitations.
ality arrangements apply there might be considered.
Nevertheless, the extent to which collegi-
An example of one such research-treatment system is provided by our
laboratory-clinic (Goldiamond, 1974).
with such an explicit congruent-contingencies system.
been requiring individuals to keep daily records of the problem-relevant
contingencies of their lives, even as we require of ourselves.
been trying to have them analyze these records, even as we would.
records are used by us for basic research in behavior analysis and
We have been developing and working
We have thereby
We have
The
14-56
behavior change in the context of treatment.
come from the well-educated middle class, as befits a university clinic,
but lately we have been doing research in heroin abuse and have found the
recording system to be applicable for urban poor with little education.
As an illustration of how collegiality arrangements of the type discussed
can lead to application of professional analysis and intervention by
patients for their own problems, I shall cite the report of an out-
patient upon his return from vacation.
tion for schizophrenia (his brother was recently hospitalized for the
same problem).
him alone in the motel.
and staring at my rigid finger," he said. "So I asked myself: 'NOW what
would Dr. Goldiamond say was the reason I was doing this?' He'd ask what
consequences would ensue. And I'd say: 'Hospitalization.' And he'd
say: 'That's right! Just keep it up and they'll take you away.' And
then he'd say: 'But what would you be getting there that you're not
getting now?' And I'd say: 'I'll be taken care of!' And he'd say:
'You're on target.
without going to the hospital and having another hospitalization on your
record?' And then I'd think a while and say: 'Hey! My sister. She's
a motherly type, and she lives a hundred miles away.'"
he dragged himself together, packed, and hitch-hiked to his sister who took
him in with open arms.
of several months of written records.
Noncoerced Participation in programs specific
to coercive systems.
Most of our patients have
He had had a history of hospitaliza-
During his vacation, his wife walked out on him, leaving
"I found myself sitting in bed the whole morning,
But is there some way you can get this consequence
He reported that
The education occurred in the process of analysis
In a system using institutionally-instigated coercion, consent is
suspect when it is obtained for participation in some program, research or
14-57
treatment, whose consequence is diminution of such coercion.
is institutionally-opportune coercion, the same precautions hold but, in
this case as in the first, the social task is to define the amount and
types of coercion we are willing to accept, and the protections against
abuse we set up.
Where there
As was noted earlier, one solution is to separate programs from
coerced consequences.
would not be contingent on research or academic or training programs, but
other consequences might be attached. The congruent contingencies of the
preceding section might be considered in this connection.
tingencies for noncoerced programs (outcomes and subject matter) in IIC
systems would tend not to be specific to those systems, but concordant
with those of the world outside.
In a prison, for example, diminution of coercion
The con-
There is, however, one type of program which is specific to the
coercive system, rather than being concordant with the world outside,
which might seriously be considered for both IIC and IOC systems.
is a program of research, treatment, or both whose maintaining outcome
is nonrecidivism. Under appropriate precautions, such programs may be
characterized by noncoercive mutuality of outcomes as well as by congruent
contingencies for program-relevant behaviors of professionals and inmates/
patients/students/research subjects.
This
In a prison system, a course of study which prisoners often readily
enter into is how to avoid being sent up next time.
course, are informal and are taught by colleagues sub rosa .
recidivism at issue is defined by them as operationally as it is by any
sociologist, namely, nonreturn.
in nonreturn reflecting nonrepetition of offense:
oner goes forth and sins no more.
The courses, of
The non-
The social intent, or contingency, is
the discharged pris-
The contingencies governing the
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inmates may be otherwise: how to get away with it.
operational definitions and operant contingencies notwithstanding, the
popularity of the courses and their prevalence commends them to our
attention as indicative of voluntary enrollment.
contingency permits the following suppositions.
develop (research/treatment) a program in the institution which trains
complex repertoires and skills concordant with those on the outside.
Suppose these would then provide consequences critical to the inmate.
Suppose the skills are socially acceptable.
program is not governed by consequences made critical by the institution,
but by consequences concordant with those outside, as discussed earlier,
and that enrollment here is one of several options available?
Differences between
Returning to the operant
Suppose we try to
Suppose enrollment in the
In a clinical situation, an analogous program, applicable as well
to the world outside, would be a prevention or nonremission program.
In a mental hospital setting, Fairweather et al (1969), set up a
research-treatment program whose subject/patients worked together in the
institution to develop skills for each other which would maintain them
in their own community-setting outside.
conjunction with carefully articulated programs of increasing approach to
such skills, in accord with p.i.
controls with similar problems in socially-desired measures such as self-
esteem while in the program and recidivism thereafter are striking.
et al report related use of a token economy for alcoholics in a community
of their own.
A token economy was devised in
Differences between these patients and
Keehn
Consideration of the specific procedures used and their rationales
is beyond the scope of this discussion.
of its relevance for consent, coercion, and social contingencies. Many
The issue is raised only in terms
14-59
types of responses can be established within institutional settings
involving IIC and IOC.
convenience for the staff, or demonstration of lawfulness for the
investigator.
gation, development, and treatment of nonrecidivism for a variety of
socially important contingencies, suggests the possibility of noncoerced
participation in programs which typically utilize coercion, since their
outcomes are specific to the coercive systems involved. These programs
provide consequences for the individuals, the professionals, and the
social systems which are important to each.
The maintaining consequences are often increased
That programing procedures can be applied to the investi-
V. CONTRACTUAL RELATIONS
The social fiduciary model (f.m.) assumes inequality in powers. One
party exercises its powers in the fulfillment of a trust for the protection
of its wards, the other party.
tractual model (c.m.) between two consenting parties assumed to be equally
capable of consent.
exchange for mutual benefit.
the exchange is explicitly stated.
An alternative model is the social con-
The powers are exercised in fulfullment of a future
What each party delivers the other in
It has been customary for practitioners and investigators to regard
themselves as functioning within a f.m., and attentive to the welfare of
those entrusted to their care.
are indignant over what they interpret as an unjustified mistrust, they
need but reflect on the steady public erosion in acceptance of the social
f.m. (as distinguished from legal f.m.), and the steady substitution of
social c.m. (as distinguished from legal or commercial c.m.).
is reflected in relations between governments and citizens (formerly
governed, or rulers and subjects),
and wives, to mention but a few. Indeed, it would be surprising if
And if these professionals are hurt by or
The change
employers and employees, and husbands
14-60
treatment or research escaped this trend.
us do the driving" may sit well in advertisements for a bus company, but
it is being treated as skeptically when the practitioner states it in one
form or another (trust us to decide for you; we'll keep our own house in
order) as when government officials make such statements about their
operations.
The slogan "Sit back and let
It is interesting to note that the Constitution in essence follows a
model which tries to balance distrust of those in power with the necessities
of effective exercise of power, and allows the federal government only
those powers explicitly granted it. All nonspecified and residual powers
are reserved to the (States and) people, the other socially contracting
party.
professionals consequent on their substitution of a reversed model, in
which the treatment system has all powers except those it grants its
charges (Goldiamond, 1974).
of the constitutional c.m., and is much closer to f.m. assumptions.
Elsewhere I have discussed the difficulties faced by mental illness
This model is contrary to the assumptions
Each of the contracting parties is assumed to be equally capable of
consent.
will be considered in the next section.
might be reflected in equal specificity of the terms mutually agreed
upon. However, contracts are often biased in specificity, imposing
greater requirements for specificity upon one side rather than the other.
A familiar example of a contract where the burden of specificity is
My present concern will be with the equality relation. Capability
If there is to be equality, it
upon the client (payer) is the apartment lease.
of the tenant are detailed so explicitly that they must be printed in
small type in paragraph after paragraph.
premises provided by the agent (payee), provision of heat, access and other
agent responsibilities are stated in general terms, which are kept to a minimum.
Here the responsibilities
Aside from description of the
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On the other hand, the burden of specificity is upon the agent
(payee) in the consent forms for patients to sign before admission to
hospitals or for procedures within them. What the hospital or staff might
or might not do, that is, its responsibilities are often spelled out in
such explicit detail that they require paragraph after paragraph of small
type. What is required of patients is minimally explicit, and quite
general.
While the burdens of detail imply a breakdown in trust-relations,
differences in sidedness of the general-detail relations also imply the
direction of whatever trust relation remains.
are to entrust the care of their persons to the professionals.
apartment, the landlords are to entrust the care of their property to the
tenants.
whereas tenant-landlord relations follow mainly from a commercial c.m.
Accordingly, trust is involved in both cases. Indeed, mutual obligations
and responsibilities entered into the feudal f.m., even as faith and trust
enter into commercial c.m. But the fact that I trust the manufacturer from
whom I purchase my refrigerator to have exerted reasonable standards and
precautions in its manufacture (with legal sanctions contingent on their
violation) puts our relations no more on a f.m. than the mutual obligations
of feudal ism (with sanctions contingent on violation) put relations between
noble and serf on a commercial c.m.
assumptions of trust and one does require a f.m. for a trust relation.
We are loyal to certain stores and products and suspicious of certain
professionals.
In the hospital, the patients
For the
However, patient-professional relations follow mainly from a f.m.,
Commercial c.m. are compatible with
It is likely that the existence of elements of each model in the other
derives from differences in social decision rules and other relations
applied historically at different times, with the resultant present
14-62
situation representing different historical weaves.
interaction of these weaves and changing modern conditions is that a
One outcome of the
fiduciary relation with which professionals felt comfortable and had worked
from since the days of, say, Hippocrates, at least, is being interpreted
Accordingly, as delegation of carte blanche powers to the professional.
legal redress is being sought and other models are being applied.
this period of confusion, certain protections accorded to the individual
by the social f.m. are being retained, while obligations upon the pro-
fessional by the social c.m. are being added.
In
It is probably in this con-
text that statements by professionals that patients have obligations, too,
are to be considered.
tion and individuals should not only spell out in detail what its obli-
gations are (as is the present case), but would also spell out in equal
details what the patient/subject obligations are (as is not the present
Viewed in c.m. terms, a contract between an institu-
case).
tions should be changed to the explicit exchanges required by social c.m.
If the field is moving to the social c.m., then the f.m. obliga-
Otherwise, both treatment and research delivery may suffer. Possibly
this is necessary to preserve or produce a balance.
division is considered as one-sidedly favoring the professional. Perhaps
advancing technology is producing lop-sidedness in this direction, unless
correctives are instituted.
treatment and research delivery suffer, so too, will present and future
patients, and the social system.
Possibly the present
However necessary such corrections, if
In all events, we might start making explicit what is involved and
required. If a f.m. is to be retained, I am suggesting that this decision
be treated as a decision, rather than as an article of faith or precedent.
This would involve comparison of this option (retain f.m.) with at least
one well-defined alternative (substitute c.m.), in addition to the other
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explicit requirements of such analysis, including costs and benefits of
each, and the decision rule we might follow.
Service and outcome contracts. Two types of social c.m. will be
noted, a time/effort (service) c.m., and a specific outcome c.m.
In the time/effort c.m., the professional guarantees time and effort
and the client pays for these.
guarantee neither recovery nor cure (occasion-outcome reversal) but simply
that they will put in the time and skills necessary and paid for. The
physician, teacher, and automobile mechanic are paid for time/effort by
their patient, student, customer clients. This type of c.m. also applies
to research grants.
university guarantees neither results nor contributions (occasion-outcome
reversal), but simply that it will guarantee the time and skills of its
principal investigator.
In return for payment, the practitioners
Here the granting agency pays and in return the
The time/effort c.m. of a research grant might serve as a model with
which treatment c.m. are to be concordant.
as was noted earlier, keeps track records of the accomplishments and
previous awards of its principal investigator.
gator keep similar records.
in detail, and the agency examines these with equal attention.
The client granting-agency,
The university and investi-
The p.i. specifies procedures and rationale
The patient, of course, is the client in clinical treatment. Lest
it seem far-fetched to suggest that clients keep track-records of practi-
tioners, at least one consumer group is now doing so in at least one
branch of clinical treatment. Track records of different educational-
treatment institutions for client-student use are available to potential
students and, in some case, are prepared by professional educational
associations themselves. Peer evaluation is thus made available to
clients in education, as it is in grant review (the client is the agency),
and this is not considered unprofessional.
14-64
The time/effort type of c.m. is generally used when outcomes are
uncertain, or procedures have not been expressly validated.
research is about, of course, and this may underlie the confusion of
experimentation with practice by practitioners.
certain, where validated procedures are used, a different type of relation
holds.
This is what
Where outcomes are more
In the specific-outcome c.m., the professionals guarantee the delivery
of outcomes or products which will meet explicit specifications. They
are paid in return for this guarantee or performance.
belongs in this category. In the educational treatment system, perfor-
mance contracting has been tried, with mixed results. Here, the educa-
tional system is paid contingent on stipulated levels of performance by
its students, following training. Since specific-outcome c.m. assume
validated procedures, the procedures and delivery can be cost-accounted,
and fees can be fixed. In health care, the "Blues" and other third-party
payers often provide fixed-fee imbursement for specified procedures; this
would appear to assume validation and certainty. It is of interest that
in the field of psychotherapy, behavior modification is moving in such a
direction. Its practitioners speak of imposing upon themselves requirements
which generally do not characterize other branches of psychotherapy nor, for
that matter, most other branches of treatment. These generally follow
the grant model. It is of further interest that behavior modification
contracts make explicit not only what the therapist does at each step,
but what the client is required to do.
records are explicit in terms of the chain-transactions of each of the
parties in the interactions, with regard to payment, the fees at present
are mostly for time and services.
belong in the grant category, that is, the first one mentioned.
The research contract
Although most such contracts and
Accordingly, in most cases, the programs
14-65
Contracts in which the agency is paid for time/effort ("professional
services rendered") or for outcomes delivered have differing costs and
benefits which are beyond the scope of the discussion (one of the major
accusations against time/effort c.m. is that the delivery system, being
reinforced for these, may maximize such reinforcement by increasing time
rather than improving effort, which can better be accomplished through
outcome contingent c.m. On the other hand, the system may then select
its treatments in terms of payment, rather than actual service). How-
ever, the fact that the outcome c.m. ("research contract") seems appropriate
where the "state of the environment" is known, and the time/effort c.m.
("research grant") where it is unknown, suggests the possibility of a
decision model with shifting strategy criteria, depending on states of
knowledge, outcomes, and decision rule to be followed.
Informed consent
The social contractual model assumes that two consenting parties
are equally capable of consent, and have given it. Fulfillment of the
contract is not binding on the party which is deficient in either.
Capability may be considered in terms of much of the preceding dis-
cussions, which will be summarized for this purpose. Degrees of coercion
are defined by the number of genuine choices between alternative options,
the critical nature of the consequences which govern the behaviors
involved, and the conditions by which the consequences are made critical.
Degrees of coercion are inversely related to degrees of freedom,
defined in terms of alternative well-defined sets of behaviors.
df = 1, that is, there are two equally available options.
Minimally,
Genuine choices involve such options when contingency repertoires
are equal.
opportunities or occasions, equally available patterns of behavior, equally
Equality of contingency repertoires requires equally available
14-66
potent consequences and, since these are contingency repertoires and
repertoires require establishment over time, equally functional contingency
histories.
Critical consequences are those which are generally potent over others
when made contingent on a particular individual's
broad sets of conditions.
behavior, given certain
Where, for genuine choices, df = 0, and critical consequences are
attached to the option(s) and the consequences have been made critical
by the system which provides them, coercion is then defined for that
option, and no consent is meaningful.
sequences are attached, consent is meaningful to the extent that it and
the contingencies involved are concordant with those obtaining for similar
options in the world outside. If research participation meets these con-
ditions, it is acceptable.
Where df 1, and noncritical con-
Where, for genuine choices, df = 0, and critical consequences are
attached to the option(s), and the consequences were not made critical
by the system which provides them, consent must be examined critically,
unless other arrangements discussed are provided.
those holding in the preceding case, as well as those holding when mutuality
of outcome is converted to mutuality of contingencies.
These include some of
By and large, these define the conditions under which consent can
be meaningfully obtained. They by and large define capability for consent.
What about the retarded, the illiterate, people who do not under-
stand the language, and so on? Illiteracy and differences in language
would seem to be governed by unequal-availability of occasions, which
was discussed under genuineness of choice.
available guide which covers these cases as well as the retarded and
other "incompetents".
There exists a more readily
This derives from consideration of the social and
14-67
commercial c.m. If we apply the simple rule of concordance of accepta-
bility of consent in the ordinary contractual case to the acceptability
of consent in the c.m. governing individuals and patients, few special
rules seem necessary. Consent to the terms of a car contract signed by
imbeciles would not be binding on them, nor should consent to treatment
or research contracts be binding on them.
under the assumption of validity of consent will face the same problems
in a court of law as a
probably face problems more severe if the harm is greater. And the
same holds for a person speaking
defined other situations as well. Institutionalization in a mental
hospital does not deprive mental patients of certain privileges and
rights of citizenship, including freedom to enter into or decline certain
programs.
which question treatment/research consent under such conditions is
probably derived from the fact that the professionals are not attuned
to the applicability of contractual arrangements to their bailiwicks,
rather than from their ignorance of the contractual relations involved.
They encounter these daily as members of a complex commercial -industrial
society.
The professional who proceeds
car salesman who proceeds likewise -- and will
a foreign language. Courts have
Whatever genuine surprise is engendered by judicial opinions
It would seem that attention to concordance with conventional con-
tractual relations obtaining outside would eliminate at least some of the
confusion surrounding the area. Whether the contracts are for time/effort
or for outcome, the requirements on each party might be stated explicitly,
as they often are outside. Where the issue is disclosure of data obtained
during treatment or research, for research publication or for didactic
presentation to improve treatment, and there is possibility of damage
14-68
through identification, or invasion of privacy, or in other ways, the tort
law prevailing on the outside, for damages unrelated to contractual ful-
fillment, might be considered. Or where contracted disclosure was
violated, the breach of contract model might be considered.
It is probable that the laws and social arrangements are changing in
these areas, even as the social contingencies they reflect are changing.
Time-honored models whose definitions are implicit rather than explicit
(e.g., intent and fiduciary models) make related social policies subject
to varying interpretations and therefore to abuse by those in power who
are so inclined.
models, and the resultant confusion provides no fixed guides. In such
cases, solutions to problems in the area of patient-subject protection
may provide precedents and help provide solutions for a society that
needs all the help it can get.
These models are gradually being joined by more explicit
In the meantime, we might profit from its past efforts and solutions.
But this interchange can best be facilitated if the models applied to
our areas of concern are consonant with those the rest of the social
order is finding to be of increasing applicability.
include the contributions of the scientific systems of consequential con-
tingency analysis found in behavior analysis, transactional analysis,
exchange theory, decision theory and cost-benefit analysis; the con-
tributions of the legal systems faced with requirements for explicitness;
and the contributions of the larger and equally explicit social contractual
models they all reflect.
And these models
14-69
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Proceedings of the First Annual Alcoholism Conference of the National
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Clinical Problems and Special Populations.
Institute of Alcohol Abuse and Alcoholism, NIMH. 153-176.
Inter-
Research on Alcholism:
Rockville, Md.: National
14-71
Ladimer, Irving. Ethical and legal and aspects of medical research on
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Clinical investigation of medicine:
Boston: Boston University, 1963, 189-194.
In Irving Ladimer and Robert W. Newman (Eds.)
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Levine, Robert J. The boundaries between biomedical or behavioral research
and the accepted and routine practice of medicine.
to the National Commission on the Protection of Human Subjects in
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Paper submitted
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and the accepted or routine practice of medicine. Addendum to paper
submitted to the National Commission on the Protection of Human
Subjects in Biomedical and Behavioral Research. Washington, D.C.
September 24, 1975. (b)
Markle, Susan M. Good Frames and Bad. Chicago: Tiemann Associates,
1975 (3rd edition).
McDermott, Walsh. The risks of research. Experiments and research with
humans: Values in conflict. Washington, D.C.: National Academy of
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Mead, Margaret. Research with human beings: a model derived from anthro-
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Moore, Francis D. A cultural and historical review. Experiments and
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National Academy of Sciences, 1975. (15-30).
Moore, Jay. On the principle of operationism in a science of behavior.
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Parsons, Talcott. Research with human subjects and the "Professional
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Peters, R.S. Ethics and education. Glencoe, Ill: Scott, Foresman and
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Reichenbach, Hans. The rise of scientific philosophy. Berkeley, Cal.:
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Robbins, Frederick C. Overview. Experiments and research with humans:
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Sherman, J.G. (Ed.). Personalized system of instruction. Menlo Park,
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Skinner, B.F. Contingencies of reinforcement: a theoretical analysis.
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Skinner, B.F. About behaviorism. New York: Knopf, 1974
Weiner, H. Human behavioral persistence. Psychological Record, 1972,
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Wexler, David,. The surfacing of behavioral jurisprudence. Behaviorism,
1975, 3 (2), 172-177.
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15
BOUNDARIES BETWEEN RESEARCH AND THERAPY,
ESPECIALLY IN MENTAL HEALTH
Perry London, Ph.D
and
Gerald Klerman, M.D.
Boundaries Between Research and Therapy, Especially in Mental Health:
Perry London University of Southern California
and Gerald Klerman
Harvard University
Terminology and Scope of Treatments
There is no universally accepted terminology covering the many
kinds of treatment used in the field of mental health. The vast
majority of such treatments, however, consist more or less completely
of some kind of verbal dialogue between the person administering the
treatment and the person who receives it. This is true of virtually
all treatments which go under the titles of counseling , case work ,
insight therapy (including psychoanalysis in most of its forms and
variants, and client-centered or non-directive therapy), psychiatric
or psychological interviews or consultations , encounter groups ,
humanistic or existential therapy , Rational-Emotive Therapy , Transactional
Analysis , and most forms of group psychotherapy and behavior therapy.
A second order of psychotherapeutic activity also uses verbal
interactions as the main instrument of treatment, but in more dramatic
or unusual forms than that of conventional conversation, and often
combined with specific behavioral methods of rehearsal or with altered
states of consciousness. Included in this category are Psychodrama ,
15-1
Gestalt Therapy , Assertion Training , Relaxation Training , Sex Therapy ,
Desensitization , Implosive Therapy , Behavior Shaping or Operant
Conditioning , and Hypnosis .
Finally, a third class of mental therapy makes active use of
equipment or of physical manipulation of the body by variations of
massage. Included here are Aversion Therapies , Biofeedback , Bioenergetic
Therapy , and Rolfing .
energizing, antidepressant, and other psychotropic drugs is also,
logically, in this class of treatments, as is electro-convulsive
therapy (ECT).
which use drugs as the active agent for producing aversive responses,
such as the treatment of alcoholism by Antabuse, and the combination
of psychotropic drugs with verbal and other psychotherapeutic methods
is increasingly common and very promising.
tropic drugs is already regulated by the FDA, however, it is not
included in this discussion. Most aversion therapy uses mild electric
shock as the repulsive agent, and this usage is not currently regulated.
The psychotherapeutic use of tranquilizing,
In fact, there are some forms of aversion therapy
Since the use of psycho-
It should be noted, moreover, in discussions of this class of
treatment, that Biofeedback , despite its use of often very sophisticated
physiological recording equipment, is not strictly comparable to the
other treatments which involve very specific manipulations of the body,
either by inducing physical discomfort (aversion therapy) or by massage
Biofeedback equipment simply records ongoing (bioenergetics, r o l f i n g ) .
physiological processes and then gives the patient information about them
15-2
in the form of auditory, visual, or tactile signals. The patient can
then learn to alter the body processes by learning how to manipulate the
sensory signals.
are literally forms of biofeedback.
technology, despite the equipment involved, may actually be more closely
related to some simple forms of Behavior Therapy, such as Relaxation
Training, than to treatments which manipulate the body. I have
included it in this class only because most biofeedback treatment
involves the attachment of electrodes to the body connecting it to
complex machinery, which gives the whole thing an aura of scientific
quality which can easily mislead patients, research subjects, and
legislators into thinking it is either more dangerous or more effective
than is necessarily the case.
Taking one's own pulse or observing one's own breathing
The therapeutic use of this
The listing above does not include all the named forms of mental
health treatments by a long shot.
names.
therapy used by psychiatrists, psychologists, social workers, nurses,
counselors, and all those professionals and paraprofessionals who
claim expertise in this domain except neurosurgeons, whose work is not
discussed here. Since there is no single term which adequately covers
the field, moreover, I shall use the terms "mental treatment" (or
"therapy"), "psychological treatment" (or "therapy"), and "psychotherapy"
Estimates vary up to 130 or more
It does, however, include representatives of every kind of mental
15-3
interchangeably to refer to all treatment methods and classes in the
entire field of mental health, except where specified otherwise.
Distinguishing Research from Therapy
Intent
From the perspective of protecting subjects, the first thing that
So distinguishes research from therapy is the intent of the subject.
the first mandate of the researcher is to explicate to the subject
whether, and to what degree, the manipulations involved are aimed at
getting knowledge, independent of whether they will help the person.
You don't need to place the same burden on the therapist, since
therapists' and subjects' aim always coincide anyhow -- that is, the
reasonable presumption is, when someone goes to the doctor, that they
are going for some benefit to themselves, not for the primary purpose of
benefitting the doctor by giving him information.
The biggest problem arises when the intent of the subject is primarily
to get help and the intentions of the therapist are mixed either by a
compound of scientific and therapeutic motives or by the fact that the
only treatments available are experimental, that is, new enough or
controversial enough so that their suitability for the given case is
doubtful. The latter case, of innovative or experimental treatments,
subsumes the case of mixed therapist motives.
reduces to:
The problem, in turn,
"When should we define a therapeutic activity as being
15-4
research , regardless of the declared intentions of patient or therapist
to label it 'treatment'?"
For the purposes of the Commission, this says, establishing the
boundaries between research and the routine and accepted practice of
mental therapies does not require the definition of research, but only
the definition of therapy, because we are saying that anything which
purports to be therapy and is not routine and accepted as such, is
automatically research.
The issue of therapist or investigator intent is not logically
important for our purposes.
be considered research, it is research, in terms of needing safeguards
for protecting subjects, regardless of whether its methods are intended
to be therapeutic. But not all that is intended to be therapy, is therapy,
for these purposes. This means, in effect, that we do not need to define
research at all. We can attack the problem of boundaries meaningfully by
recognizing that the practical problem is that many therapeutic methods
are well intended, but poorly established (in terms of safety, efficacy,
and economy). One cannot demonstrate the efficacy of a therapy in terms
of the intentions of its proponents, because nice guys, in addition to
finishing last, may propose ineffective treatments. And they may even
propose harmful therapies with the best of intentions . No more can a
therapy be considered routine and acceptable on the basis of authority.
Only evidence will do.
If someone intends that his work should
15-5
Peripheral Problems
Once it is clear that the central problem of boundaries can be
settled adequately by limiting our inquiry to the definition of therapy
and the assessment of routine and accepted practice within that definition,
several problems which may be important in other contexts become
peripheral here and may be dismissed from this discussion:
Who pays whom, who asks for help from whom, whether the primary goal
is the accumulation of knowledge rather than the assistance of an
individual, is there a research protocol, all become irrelevant questions
for our purposes. Nor is there any need to distinguish here between
"research'' and "experimentation", or to separate either of them from
"experimental" or "innovative" therapy. Dictionary aside, from the
vantage of protecting subjects, they are all the same.
Distinquishing Mental Health from Other Medicine
The problem of "accepted and routine practice" in the field of
mental health differs somewhat from the same problem in other fields of
medicine for three reasons:
people, in and out of the learned professions, who have legitimate
input into this field is considerably greater than is true in any other
branch of medicine.
respects, lean on the specific training, licensure, or certification of
the practitioner to help define the behavior in question.
1) The number and variety of nonmedical
So routine and accepted practice cannot, in most
2) The specific
15-6
practices which can be defined as therapeutic overlap so much with
equally valid definitions of them as educational, recreational, or
religious, that it is presumptuous and impractical to try to restrict
these practices completely to medical or therapeutic functions or
functionaries. 3) The goals for which mental therapies, however
defined, are sought, and the sensible criteria for deciding whether they
have been achieved, are so diverse that they cannot all be contained
within any definition of health short of the WHO definition, and
that definition is too broad for legislative use.
If these problems are recognized at the outset, it may then be
reasonable to seek boundaries between therapy and research in the many
contexts where the distinction between them can be meaningfully designed
to protect the subjects of research, without trying to comprehend and
include every context in which such distinctions are possible. The
development of meaningful regulations in this connection might not,
for instance, seek to restrict a church from conducting Transactional
Analysis meetings for its members, even were it clear that the procedures
involved are technically considered innovative or experimental therapy.
A more immediate illustration, perhaps, is Institutional Review
Boards, which automatically review anything that purports to be research.
The question for them is:
be therapy, or that do not claim to be research?
have to review all training and demonstration grant proposals in which
what things should they review that claim to
Evidently, they would
15-7
the procedures to be taught or shown fall outside the scope of "routine
and accepted practice". To do so, however, they would have to have
therapeutic guidelines. At the present time, the only such things in
the field of mental health are FDA guides for the use of drugs.
are no equivalents for psychotherapy or counseling.
IRB whose members were very knowledgeable about the state of the art in
psychotherapy would find themselves hamstrung.
guidelines, as we shall see, seems virtually inescapable if the
protection of human subjects in this domain is to be meaningfully regulated.
There
Without them, any
The need for such
Outcome Criteria
The problem of deciding when a therapy, treatment or training
program has been sufficiently tested so that it is no longer experimental
is, on the face of it, the same as the problem of when a drug achieves the
status of acceptability, so that it no longer has to be considered
experimental. By and large, the things at issue are safety , efficacy ,
and economy .
economy may be subsumed under efficacy because one of the most important
criteria of acceptability in psychotherapeutic kinds of treatment is
the length of time and amount of effort it takes for a treatment to
work in comparison to other treatments and in comparison to nontreatment
conditions.
In the case of therapy in the field of mental health,
The problems of safety and efficacy in mental treatments are not
15-8
necessarily the same as with drugs -- in general, efficacy is a bigger
problem, safety a smaller one, and both more complicated. Both issues
are joined as the problem of outcome criteria, which has plagued the
field of mental health since the advent of modern psychotherapy.
That problem, stated briefly, is:
What are the goals of psychological treatment?
How can we tell whether they are being met?
What dangers attend the treatment process?
In the early history of psychotherapy, the goals of treatment tended
to be clear.
such as phobias and other anxiety states, the repair of hysterical
conversion reactions, such as hysterical blindness or paralysis, or of
dissociative states, such as amnesia, the relief of disabling obsessional
thought patterns and complusive rituals, and the restoration of good
feeling in people incapacitated by depression. Insofar as such specific
symptomatology is to be found in people who are given psychotherapy, relatively
efficient outcome criteria can be established, because the clear definition of
the problem permits a fairly clear determination of whether or not it has been
relieved.
are of this kind.
They were the relief of specific symptoms of neurosis,
A large proportion of neurotic and psychophysiological conditions
Safety . Since the end of World War II, however, and more pronouncedly
since the 1960's, when encounter groups became very popular through the
offices of humanistic psychologists and the "human potential movement,"
15-9
more and more psychotherapeutic activity has been undertaken for
nonspecific conditions , where the people requesting treatment would not
admit to specific problems of the kind contained in conventional
psychiatric nomenclature. Some of these conditions were represented
as general malaise, disaffection with one's circumstances, or unhappiness,
that is, as existential problems which might properly lie completely
outside the purview of mental health, in its technical sense. Others
were represented as recreational, educational, or quasi-religious,
that is, as the desire of people who were not only free of symptoms,
but were even happy with their lives, to have therapy as a "positive
growth experience'' which, on the face of it, is even further removed
from the domain of mental health technology. These conditions are
matters of concern here because, while the definition of the problems
in such cases, places them outside the arena of mental health, the
methods which are applied to those problems may be potentially harmful
to some of the people they are used on.
The recreational or educational character of psychotherapy is
comparable, in this respect, to elective cosmetic surgery. Your
intention, in getting a "nose job," may be to get more beautiful,
rather than to get healthier -- but the surgeon's knife will do just
as much damage one way as the other, if it slips.
"awareness enhancing" methods of the human potential movement were
specifically developed as psychological treatments and were published
In fact, many of the
15-10
under the authorship of trained and licensed mental health practitioners.
It would be specious to view them as anything other than mental therapies.
This definition of the method may necessitate that some such treatments
have to be regulated under the outcome criterion of safety , even if the
nonspecific character of the "problem" makes the positive efficacy of
the treatment method irrelevant. In practice, this could mean that
encounter groups of the kind run at "growth centers" such as Esalen, or
Arica, or EST (Erhard Seminar Training), might all be subject to scrutiny
as innovative or experimental psychotherapies, even though they do not
claim to be mental health treatments and even though their customers do
not claim to need or want mental health treatment.
As if the foregoing were not complicated enough, from the vantage of
practical regulatory measures, the very same logic might apply equally
well to the increasing deliberate application of behavior modification
principles to routine classroom teaching problems, such as the improvement
of reading or arithmetic skills; and it could also apply to self improve-
ment programs such as Weight Watchers, which increasingly makes
deliberate use of behavior modification to help people control obesity.
Indeed, applying the safety criterion to the methods in question may
necessitate just such scrutiny, regardless of where those methods are
to be used.
The judicious application of the safety criterion would probably
exempt both Weight Watchers and arithmetic teachers from regulation,
15-11
however, because enough research already exists predictably to show
that the application of the behavior modification principles involved
has very low probability of doing any specifiable damage to any arithmetic
student or obese person under almost any circumstances.
research would be less likely to exempt encounter groups or EST,
however, and the establishment of reasonable guidelines would not be
easy for deciding "how safe is safe", that is, how much of what kind of
harm is "allowable" to what percentage of people who undergo that
"treatment".
Existing
In principle, the safety problem with psychotherapy is the same as
with drugs. But in practice, it is more complex and less ominous at the
same time.
incapacitated, and the few who do, tend to do so by such slow stages
that reasonable observers might attribute the damage to other circum-
stances than the treatment. Even so, some people are harmed by
psychotherapy, and more potentially can be harmed as mental treatments
become more efficient, which they will -- so the need to regulate the
protection of research subjects must logically include the implementation
of some means for regulating the safety of innovative mental therapies,
however complex the problem is. Drugs undoubtedly kill and injure more
people, but the determination of their safety is aided significantly by
the fact that the damage they do tends to be more specific, more
dramatic, and sometimes visible on other animals than human beings.
Few people, if any, die from psychotherapy, or get grossly
The
15-12
safety of psychotherapies is a more complex problem of definition and
of empirical determination -- therefore, it is also a more complex
problem of regulation.
Efficacy is a bigger problem than safety in mental health treatments,
because their downside risk is more likely that of being harmless and
useless than of being very potent in either a beneficial or dangerous
direction. Even so, the means by which efficacy is established for
psychological treatment of all kinds is, in principle, essentially the
same as the means by which effective outcomes are determined in any
other domain -- by empirical assessment of the relative precision with
which a given technique achieves a predetermined result in comparison
with all other conditions under which the same result is or is not
achieved. The foregoing proposition states, in clumsier than usual
language, the principle by which the syllogistic determination of cause
and effect (If a, then b; if not b, then not a) is applied to all
scientific problems. Translated into the specifics of mental health,
it says:
A psychological treatment is effective if it achieves its specified
goals. The faster it achieves them, and the more people it achieves them
on, and the more thoroughly it works on those people, the more effective
it is. The comparisons involved are comparisons of the treatment in
question to other possible treatments, including no treatment at all.
The specifics of the kinds of cost-benefit analyses which would go
15-13
into the actual assessment of any given therapy are somewhat variable,
but there is no need to pursue them in detail in this essay because the
principles involved are well known and unequivocal: They are the funda-
mental principles governing all scientific investigation -- measurability
and replicability. For a therapy to meet the efficacy criterion, it
must be measurably better than other treatments and than nontreatment
by standards which permit independent observers, using the same methods
he did, to disconfirm the results of the original investigator. When
others have tried, and failed to disconfirm, then the efficacy of the
treatment is established. Until then, it is not.
This notion of efficacy has two important implications for the
purposes of the Commission:
1) With respect to mental health problems, it allows for the
legitimacy of idiosyncratic, unconventional definitions of treatment,
or improvement, or cure, provided only that those definitions can be
subjected to the same empirical evaluation procedures as any others.
This makes it possible, for instance, for Thomas Szasz to argue that
the notion of mental illness is a banal fiction and still to propose
treatment models which can be validated as effective mental health
instruments. It separates the empirical problems of treatment from the
theoretical problems of defining the discipline.
2) It implies that the boundaries between research and practice may,
for practical purposes, be established without concern for the intent
15-14
of the investigator or practitioner, if not the patient. If treatment
efficacy is established only when repeated investigation by conventional
scientific rules has failed to disconfirm a treatment's relative
efficacy, and "routine and accepted practice" is routine and accepted
because the treatments involved are effective, then the boundary between
research and practice is the degree to which the knowledge of efficacy
exists . That knowledge is a complex, but inevitable function of the
extent to which the relevant research has already been done and replicated,
not of the intentions of the particular scientist or therapist.
In its most general sense, research means trying to find out something
that you don't know, which makes intent seem critical. But from the
vantage of social regulation, and from that of the scientific community,
the definition of a research problem is not what you know about something,
but what is known about it. From their personal perspectives, little
boys and girls poking around each other in the bushes are doing research
on where babies come from. But from the vantage of the community, the
question is not a proper subject of scientific research because the
answer is already well known. 1
routine and accepted therapeutic practice , in any domain which is
subject to scientific inquiry, depends on the extent to which the
relevant scientific questions have already been answered.
they have been answered, the more
By the same token, the definition of
The more
------------------------- 1
The stork brings them.
15-15
a given form of practice is routine and accepted. The less they have
been answered, that is, the more the questions of efficacy are open to
scientific inquiry , the more a given form of practice becomes research,
no matter what the intentions of the practitioner may be . The size and
quality of the body of inquiry addressed to those questions and the
size and quality of the body of knowledge it has produced index the
permeability of the boundary between the two.
systems of the biomedical and behavioral sciences, far more than in the
physical sciences and their applications, the assessment of that boundary
is a matter for negotiation. For practical purposes, this means that the
determination of the boundary requires continuous, conscientious, and
sophisticated scrutiny, assessment, and reassessment of the scientific
status of the treatment arts.
In the complex variable
Guidelines for Guidelines
The detailed means for best conducting that assessment are not ob-
vious, nor is the process of expert negotiation and consensus which will
best summarize and judge the scientific status of each mental therapy,
disseminate the information in the form of guidelines for review boards
and funding agencies, and assure the proper revision of those guidelines
as new knowledge accrues and old biases surface.
should be created within HEW for this purpose, and perhaps it could de-
rive some guidelines for creating guidelines from the practices now used
by the Food and Drug Administration for evaluating drugs and by NIH for
Perhaps a new office
15-16
evaluating research grant proposals. There are some special problems
connected with evaluating psychological treatments that may require some
thoughtful innovation in regulations and bureaucratic procedures --
the unreliability of psychiatric diagnoses, for instance, makes it harder
to be sure you have met your intended outcome criteria in any given re-
search study than would otherwise be true, even if the specific results
of this study are significant statistically. Additionally, there are
often large variations in therapeutic procedures of a single kind, de-
pending on personal qualities of the therapist unrelated to professional
training or competence, which might further confound the interpretation
of results from one experiment to another, even where the subject selec-
tion criteria in both studies have been reliably the same. And such
vagaries, among others, make the assorted biases of the people doing the
evaluation and review much more influential, potentially, in their judg-
ments of mental health treatments than might be true if they were evalu-
ating drugs. And there are still other special problems.
What does seem obvious, in any case, and despite the problems involved,
is that there cannot be any meaningful protection of research subjects in
the field of mental health research unless there is regulation of inno-
vative, experimental, research-demanding mental health treatments. The
classification of treatments in that box, separating them from routine
and accepted practice, requires, in turn, the preparation of objective
guidelines based on comprehensive, fair minded evaluation of empirical
evidence, and routinely revised as new reasoning and new discovery dictate.
15-17
16
LEGAL IMPLICATIONS OF THE BOUNDARIES BETWEEN BIOMEDICAL
RESEARCH INVOLVING HUMAN SUBJECTS AND THE
ACCEPTED OR ROUTINE PRACTICE OF MEDICINE
John Robertson, J.D.
December 31, 1975
This paper discusses the legal implications of physician activities
that occur on the boundary between research and the accepted practice of
medicine.
characterization of an activity as research or practice, the paper then
discusses whether legal consequences should attach to the distinction,
concluding with a general discussion of policy alternatives for innovative
therapy.
After showing that no major legal consequences turn on the
Boundary activities* require consideration in developing public policy
for research with human subjects 1/
because they subject patients
the guise of therapy to risky, untested procedures without the safeguards
that apply to experimentation. The problem arises because physicians often
undertake diagnostic or therapeutic procedures about which little is known
and which deviate substantially from routine, accepted practice. This may
occur because there is no known effective cure and the physician seeks a
procedure helpful to the patient, or because the new procedure appears to
be superior in cost, efficacy, or side- effects to the standard procedure.
Because data establishing efficacy may be lacking, its use may be said to
be experimental.
used without controlled clinical trials to the detriment of patients,
and may even come to be accepted as standard therapy, when later experience
shows that they are actually inefficacious or harmful.
under
The concern here is that untested therapies will be
Current HEW policy views such activities as placing a subject at
risk and hence subject to IRB review because they " depart from the applica-
tion of those established and accepted methods necessary to meet his
needs." 2/
In addition, whatever the physician's specific intent in
*In this paper the terms " boundary activity" and " innovative therapy" are used as synonyms.
16-1
employing the new procedure, the consequences are likely to resemble
the consequences of activities done with a specific intent to do research.
The application of an innovative therapy will often yield knowledge that
affects treatment of future patients in the same situation. Also,
experience with one or several patients may lead to publication, and thus
for the physician approximate the consequences of the research enterprise.
At the same time, however, treatment of all boundary activities as
research poses conceptual and policy problems because an experimental
intent may be lacking. The physician using an innovative therapy may
have no research or experimental aims beyond helping his patient. If
asked, he will say that he is engaged in therapy only, and intends only
to treat this patient rather than conduct research beyond that involved
in any diagnosis or therapy. Moreover, a public policy
that treats all boundary activities as research will implicate the govern-
ment in physician practices far beyond those directly funded by HEW or
occuring in HEW funded institutions, 3/
and will intrude into the doctor-
patient relationship far beyond current regulation. 4/
The question to be addressed is what safeguards, if any, beyond those
applying to ordinary medical practice are needed when a physician, through
application of an unaccepted or untested procedure, attempts to confer a
therapeutic benefit on a patient. Is every intentional departure from
accepted practice to be considered research and subject to controls for
research? Or can some instances of innovative therapy be
distinguished from research and be treated separately?
lies in an examination of the risks created by boundary activities,
the efficacy of current controls, and the incremental costs and
benefits of additional controls, such as those applied to federally
The answer
16-2
funded research. To illuminate these issues this paper first analyzes
the legal implications of characterizing a medical activity as research
or therapy and then considers the policy alternatives that follow from
these implications.
I. LEGAL CONSEQUENCES OF CHARACTERIZING MEDICAL ACTIVITY AS RESEARCH
OR PRACTICE.
While characterization as research or practice may ultimately have
policy significance, at the present time it is reasonably clear that the
labelling of a medical activity as research or practice has no major legal
consequences in terms of who may engage in the activity, the circumstances
under which a negligence award will be made, or the amount of information
that must be disclosed to the subject of the activity. In the context of
therapeutic activity that includes elements of research or innovation, no
question of who may perform therapy or research arises, for we can assume
that activities of physicians and other appropriately licensed health
professionals are involved. Moreover, there are no specific criminal
prohibitions on doing research which legally distinguish research from
therapy. The major points of difference, if any, concern liability and
disclosure rules.
A. T o r t L i a b i l i t y
Aside from licensing and medical practice acts that restrict the
persons who may practice medicine, and the general provisions of the
criminal law, the primary legal constraint on physician activity arise
16-3
from the after- the- fact review and damage awards of the tort system.
While conceivably different standards for ascertaining liability and
imposing damages could apply, there appears to be no major difference
between therapy and research in the standard for finding liability.
1. L i a b i l i t y f o r A c c e p t e d o r R o u t i n e P r a c t i c e
A physician will be liable for damages if he fails to possess
a reasonable degree of skill and to exercise this skill with ordinary
care and diligence.
the practice of other physicians in the same or similar circumstances,
though on occasion the courts have required a standard of care higher than
that of
incur no liability for use of a procedure, test or technique if he uses it
in a nonnegligenct way (that is, as carefully as other physicians in those
circumstances), and it is considered by at least a respectable minority
of physicians to be an accepted therapy in the patient's situation.
What is reasonable and prudent care is usually determined by
5/
professional practice. 6/
In general, then, a physician will
2. L i a b i l i t y f o r E x p e r i m e n t a t i o n a n d I n n o v a t i o n
While the earliest American cases involving medical experimentation
or innovation seem to indicate that a physician will be strictly liable
for any deviation from standard or accepted practice, even if done for the
purpose of developing a better therapy, there is now considerable sup-
port for the proposition that liability for innovation depends on the
reasonableness of the use of an innovative procedure in the circumstances
of the patient. 8/
The reasonableness of deviation from the accepted or
routine therapy will depend on the predicted condition of the patient, the
probability of success of customary therapies, the probability of success
7/
16-4
of the innovative procedure, and t h e probability, type, and severity of
risks collateral to the therapy. The innovative departure will be
reasonable if it reasonably appears that the chances of providing a
benefit to the patient beyond that of customary therapy outweighs the
likely risks of the innovation.
of liability depends on reasonableness of use:
As with a standard therapy, the question
It does not follow from the fact that a method of treatment is innovative that it is not reason- able medical practice to use it. Expert testimony on this issue can evaluate the defendant physician's innovative therapy on the basis of the condition of the patient, the probability of success of the therapy, and the nature, severity, and the probability of collateral risks. Such expert testimony would be responsive to the fundamental and long- familiar inquiry: Did the defendant doctor conform to the standard of care of a reasonable practitioner under the circumstances confronting him. 9/
Although the liability rule is identical for activities characterized
as accepted or innovative therapy, the factual inquiry occurring in each
case will differ.
therapy, the factual inquiry will usually concern establishing standard
practice, and proving that the physician in fact deviated from it without
justification, that is, administered or performed the therapy in a
negligent manner. With an innovative therapy, the factual inquiry will
also concern establishing the accepted therapy, but then focus on the
justification for departure from it:
procedure, the likelihood of risks, and the grounds for thinking that it
would bring the patient a net benefit beyond that available with the
accepted therapy.
In an action for damages arising from use of an accepted
what was known of the innovative
In this inquiry particular attention is likely to be
16-5
paid to the physician's consideration or use of customary therapies, the
amount and type of prior investigation with regard to the innovative
procedure, the results of animal research, if any, the conclusions that
one can draw from general scientific principles, what the physician
knew or should have known of those risks, and, in short, whether a
reasonable practitioner, in the circumstances as established, would have
been willing to undergo those risks to obtain the expected benefits.
Thus, in the ordinary malpractice case the question of reasonableness
usually will depend on whether the physician conformed to or deviated
from the accepted standard of care. With innovative therapy, the
question of departure is conceded and the question of reasonableness
concerns whether the departure is justified given the patients prospects
without it and the likelihood of a net benefit with it.
A possible legal consequence could turn on the characterization of
a boundary procedure as research or therapy, if research activities
generally occurred only with the prior approval of an I n s t i t u t i o n a l Review
Board (IRB), as is now the practice for HEW funded research and, in many
instances, for all research occurring in institutions receiving HEW
funds. 10/
Two possible legal consequences could turn on this practice:
(1) immunity from liability if the IRB approves the activity and legally
effective consent is obtained; (2) imposition of Iiability where IRB
approval is not obtained.
With regard to the first question, IRB approval alone would not
provide immunity in a suit based on negligence in undertaking the innova-
16-6
tive procedure, even if the procedure were nonnegligenctly performed,
and legally effective consent were obtained. The claim here would
be that it was tortious to undertake the procedure at all, even with full
consent, and its legal resolution would depend upon the reasonableness
of the experimental procedure - that is, whether the likely benefits to
the patient - outweighed the risks.
persuasive, IRB approval alone would not determine the reasonableness
of the activity. The IRB could have acted negligently or misjudged the
risk- benefit ratio, and in any event, has no legal power to foreclose a
court from independently determining reasonableness. In fact, the IRB's
standard of reasonableness (do the sum of benefits to the subject and
increase in knowledge outweigh the risks to the subject), 11/
which take
account of benefits to others, may well
by the courts.
personal integrity, can be made that the courts should and would exclude
nonsubject benefits in this calculus, and would view the risk- benefit
ratio solely from the subject's perspective.
may be helpful in screening out " unreasonable" research, it is no guarantee
that liability will not attach to procedures that it approves.
Although relevant and possibly
diverge from the standard applied
A persuasive argument, based on the law's concern with
Thus, while prior IRB review
Conversely, failure to obtain or the denial of IRB approval may be
relevant and even persuasive evidence on the question of the unreasonable-
ness of undertaking a research activity that occurred with legally valid
consent, but again it is not determinative. The reasonableness of the
procedure depends on the risks and benefits to the subject.
11a/ IRB review does not alter the risk- benefit ratio of the proposed procedure.
A n a l y t i c a l l y ,
16-7
If the physician could establish that an activity characterized as
research were reasonable in the circumstances, lack of IRB approval
alone should not lead to liability.
An exception to this conclusion could occur if IRB review were
mandated by statute. 12/
violation of the statute was negligent per se, because the statute was
designed to protect the class of persons in which the plaintiff is
included, against the risk of the type of harm which has in fact occurred
as a result of its violation. 13/
However, there would still remain
open such questions as the causal relation between the violation and the
harm to the plaintiff, 14/
and possibly such defenses as assumption of
the risk. 15/
review in this instance would have prevented the activity, either because
it would have found the risk-benefit ratio unfavorable or would have
required a fuller disclosure that would have occurred, which in turn would
have led to nonsubject participation. If the risk-benefit ratio were in
fact reasonable and legally valid consent obtained, it would be difficult
to show that IRB review would have prevented the activity. If the risk-
benefit ratio were unreasonable, or the consent was invalid, l i a b i l i t y
would exist independent of IRB review. Even if it did not, the plaintiff
would still have to show that IRB review would have prevented the injury,
possibly a difficult task with the current lack of empirical data on IRB
effectiveness in preventing harmful research or actually improving consent
16/ procedures.
In that situation a court could find that
The plaintiff would still have to establish that IRB
16-8
B. Consent and Disclosure Requirements
In addition to rules imposing damages for untoward results where a
physician unreasonably deviates from the standard of care, another major
legal constraint on medical activities are rules requiring physicians to
disclose certain information about a proposed procedure for a patient's
consent to be deemed effective. Technically part of tort liability,
consent is sufficiently important to warrant separate consideration.
However, analysis again reveals that with one possible exception disclos-
ure rules do not vary with the characterization of a boundary activity
as therapy or research.
1. Disclosure In Accepted or Routine Practice
17/ Generally, a physician may not treat a patient without consent.
In determining the effectiveness of a patient's consent, the question
arises of how much information concerning the proposed procedure must be
disclosed in order for the patient's consent to be valid.
the rule has depended on the customary disclosure practice of the
18/ profession for the given situation. Generally, the plaintiff has the:
burden to prove by expert medical evidence what a reasonable medical practitioner of the same school and same or similar community under the same or similar circumstances would have dis- closed to his patient about the risks incident to a proposed diagnosis or treatment, that the physician departed from that standard, causation, and damages.
Traditionally,
Recently, with Canterbury v. Spence 19/ and a subsequent line of
cases, 20/
a minority of Jurisdictions have begun to apply a new dis-
closure rule, based not on professional practice, but on the amount of
16-9
information which a reasonable person in the patient's circumstances
21/ would want to know in deciding to undergo the treatment:
(T)he standard . . . is conduct which is reasonable in the circumstances . . . the test for determining whether a particular peril must be divulged is its materiality to the patient's decision: all risk potentially affecting the decision must be unmasked. The topics importantly de- manding a communication of information are the inherent and potential hazards of the proposed treatment, the alternatives to that treatment, if any, and the results likely if the patient remains untreated. The factors contributing significance to the dangerousness of a medical technique are, of course, the incidence of injury and the degree of harm threatened.
In sum, liability for nondisclosure of the risks and other material
details of accepted or routine care will depend on the jurisdiction in
which the nondisclosure occurs. In either case the plaintiff has the
burden of establishing the information required to be disclosed under
either the professional practice or reasonable person standard, that such
information was not disclosed, and that had disclosure occurred, the
plaintiff would not have undergone the therapy.
2. Disclosure in Research and Experimentation
While there are few precedents concerning disclosure requirements
for research or experimental procedures as such, and cases in two jurisdictions
suggest that the experimental or innovative nature of a procedure should
always be disclosed, 22/
it appears that the disclosure rule for accepted
therapy would also apply to innovative or experimental procedures. Thus
in a jurisidction requiring conformity to professional custom, the experi-
16-10
mental or innovative nature of the procedure, its specific risks and
benefits, and the risks and benefits of alternative procedures would be
disclosed only if the custom or practice of physicians in that situation
was to disclose such information.
what must be disclosed would thus depend on an empirical inquiry with
regard to each use of innovative therapy, and whether a local, similar
community, or national custom of practice were applied. Presumably, at
least in some instances, medical practice could include as full or even
greater disclosure than occurs under the Canterbury reasonable person dis-
closure standard, but this would vary with the procedure and the particular
circumstances of its use.
A precise answer to the question
In a Canterbury - type jurisdiction the fact that a procedure is innova-
tive or therapeutic, its risks and benefits, and the risks and benefits of
alternative procedures, would be disclosed only if a jury or court in its
after- the- fact review concluded that such information would be material
to the decision of a reasonable person in the patient's circumstances
whether to undergo the procedure. Arguably such data would be disclosed
under this standard, though the courts have not yet directly confronted
whether the innovative nature of a procedure must also be disclosed.
Elements of consent required by HEW 24/
for research which it directly
23/
funds would probably have little impact on disclosure requirements in a
Canterbury - type jurisdiction, since those elements would appear material
to a patient's decision to consent and hence legally required. However,
they could
disclosure in jurisdictions requiring disclosure in conformity with
be persuasive evidence of professional practice regarding
16-11
professional custom. Despite some ambiguity, the HEW regulations appear
t o require the IRB to assure that consent will not only be
26/ l e g a l l y e f f e c t i v e ,
25/ but also will be " informed," which is defined
to include disclosures that would clearly go beyond professional custom
disclosures, specifically the fact that the procedure is experimental, as
well as disclosure of discomforts, risks and benefits of the procedure,
a n d a l t e r n a t i v e s . 27/
that the HEW consent rules were generally followed by the profession
for all research, a court could
find that the HEW disclosure requirements defined the professional
custom and hence the disclosure rule for experimentation. If that were
the case, then in a professional custom jurisdiction characterization of
a procedure as experimental could have legal significance with regard to
liability for nondisclosure.
showing that the procedure in question was in fact experimental, and
that a custom of submitting all experimental procedures, whatever their
funding source, to IRB review, existed. If, as is more likely, the
custom could be established only for research directly funded by HEW or
occurring in HEW funded institutions, then the HEW disclosure standard
would not appy to all innovative procedures occurring in that jurisdiction.
Thus, while a more stringent disclosure requirement for research might
exist in a professional custom jurisdiction, this standard would most likely
apply only to research in HEW funded institutions, and only then if a
court accepted this argument.
Assuming in a professional custom jurisdiction
But such a conclusion would depend on
16-12
II. The Need for Special Protection in Boundary Activities
Since experimentation is not a legal category with separate
liability and disclosure rules, there are presently no significant legal
consequences that hinge on a boundary activity being characterized as
research or therapy except for a possibly more stringent disclosure re-
quirement in certain circumstances. Moreover, even i f research or experi-
mentation had legal significance as such, legal consequences beyond those
applicable to ordinary therapy would attach to boundary activities only if
they were always regarded as research.
sound reasons for not treating every application of innovative therapy as
research.
As discussed below, there are
The question remains whether legal significance should attach to
boundary activities, no matter how they are characterized. This could
result from creating special rules for experimentation, and treating some
or all boundary activities as research. Or rules more stringent than
for accepted therapies and less restrictive than for research could b e 28/
legislatively or administratively devised to regulate boundary activities.
Alternatives here include criminal prohibitions, disclosure and liability
rules, and prior or after the fact review.
alternatives, however, it is necessary to consider whether boundary activi-
ties
and if so, (2) whether
provide patients sufficient protection.
than the risks of accepted practice exist, and they are not sufficiently
Before considering such
(1) create risks to patients beyond those of ordinary medical practice,
existing legal and peer review mechanisms
If risks to patients greater
16-13
controlled by existing mechanisms, then consideration should be given to
alternative techniques for controlling them.
A. The Problem of Innovative Therapy: The Risks
An important issue is whether boundary activities, which share
features of ordinary practice and innovation, create risks to the patient
beyond those that exist in the application of accepted, routine therapies.
If so, are those risks so similar to the risks of physician conflict and loyalty
future patients existing in pure research that they require similar treat-
ment? Boundary activity or innovative therapy may create additional risks
in at least three ways.
First, simply because a procedure is new or sufficient experience is
lacking, a patient may be subjected to a risk greater than occurs with
standard therapies.
are that through ignorance, intent, or negligence a procedure will be
unnecessarily applied; that it will be applied in a negligent manner;
that it will be ineffective; or that it will cause anomalous injuries or
results.
risks are known and there is some basis for thinking that on balance its
application will benefit the patient. A boundary activity, on the other
hand, subjects a patient to these risks and more.
accepted therapy the patient has some reasonable expectation of benefit, with
innovative therapy the risk is greater that the therapy will not work or
that it will have harmful effects of its own, if only because its effects are
unknown.
In the case of the latter, the risks to the patient
Generally, however, a therapy is standard or accepted because its
For while with an
These risks are greatest with the first use of an innovative
16-14
therapy, but continue to be substantial until sufficient data on its effects
exists.
negligently or without adequate skill, because due to its newness,
p h y s i c i a n s h a v e n o t b e c o m e s k i l l f u l i n a p p l y i n g i t . 29/
There is also a
greater chance of anomalous results occurring if only because it will not.
yet be known which patients are subject to anomalies.
include both the loss of an alternative, accepted therapy (though inadequate),
and injuries directly caused b y application of the new therapy.
There Is also a greater risk that the therapy will be applied
These risks
While some added risk appears likely because of less experience with
an innovative therapy, it is a question for empirical research how signifi-
cant this additional risk is.
validated as effective, and to some extent, may impose risks similar to
those of innovative therapy. On the whole, however, it seems reasonable to
differentiate accepted and innovative or boundary activities by the knowledge
that is known about their likely risks and benefits.
in our knowledge of the effectiveness of standard therapies does not
change the fact that in using a therapy that is relatively unknown, the
risks of injury or ineffectiveness is apt to be greater.
Many accepted therapies have never been
Serious deficiencies
A second type of risk in boundary activities is that the physician's
decision to undertake the procedure and his disclosure to the patient may be
influenced by scientific, career and future patient factors rather than by
the interests of the patient alone.
a procedure that imposes an undue risk ( u n f a v o r a b l e r i s k - b e n e f i t r a t i o ) on
the patient, and perhaps to influence or manipulate the patient's consent.
With accepted therapies, as debates over prepaid delivery systems and
These factors will lead him to undertake
16-15
utilization review show, factors such as profit, efficiency, or
specialty orientation may also conflict with the patient's interest.
While such decisions are deemed unethical and are decried by the medical
profession, they may be inherent in the practice of any profession, and
hence are left to professional discipline or tort remedies.
With a boundary activity, which involves a departure from standard
practice out of a sense that a better procedure exists, there exists, in
addition to the conflicts inherent in any professional practice, the
possibility that the physician's activities will be motivated or influenced
in part by scientific or career aspirations, or by the desire to develop
a technique that will benefit future patients. That is, the physician's
decision, and his communication with the patient concerning it, will be
influenced to some extent by personal or career considerations that go
beyond the immediate interests of the patient, thus leading to a decision to
employ an innovative therapy that would not have occurred if the patient's
i n t e r e s t s a l o n e w e r e c o n s i d e r e d . T h e r e c o g n i t i o n t h a t t h e
investigator's loyalties to the subject- patient were under great pressure
from loyalties to future patients and career goals has led, in the case of
experimentation, to the development of review and consent procedures to
assure patients' interests do not suffer, presumably because existing
control mechanisms were inadequate to protect patients.
With boundary activities, the question thus is whether, and under what
circumstances, patient or other interests are likely to perdominate.
may be that with many boundary activities the return to the doctor in terms
of career and future patient goals is no different than In the application of
It
16-16
an accepted therapy, or that if some nonpatient concerns are present, they
are neither so strong nor dominant as they are in formal research.
other instances, such as the case of Florentino v. Wagner, 30/
where a
surgeon's decision to use an innovative spinal operation led to serious
injury to several patients, the decision to use the innovative therapy
and the information disclosed to the patient may be strongly influenced
by the desire to develop a procedure at the expense of the patient.
Since boundary or innovative activities may involve both poles of
patient concerns, an important question is (1) ascertaining the
frequency and (2) identifying the circumstances in which patient
interests are likely to be secondary.
In
In addition to increasing risks to the patient, a third potential
problem with boundary activities is that they generally do not occur in
a manner likely to maximize the reliability of data deriving from
their use.
procedure whose efficacy or risks are still so unclear that it has
not yet become accepted therapy, it is important from the perspective
of future patients and medical science generally that reliable information
be obtained about the activity's benefits, risks and efficacy. Without
such data the future patient who receives or does not receive a particular
innovative therapy is at greater risk than if the earlier uses of the
therapy had occurred under circumstances and in a manner that would have
maximized the chance of obtaining reliable data.
that most boundary activities maximize the chance of deriving reliable data.
By definition, as it were, the physician will not conceive of his activity
Since a boundary activity involves a therapeutic use of a
It is unlikely, however,
16-17
as being experimental, and hence will not apply it in a methodologically
sound way, for in most cases he thinks he is doing therapy. Even if
nonpatient considerations are strong in the decision to use a therapy,
at best the result will be a one patient experiment, whose outcome cannot
always be meaningfully extended, even if it is disseminated, to other
cases. There is also the danger that innovative therapies which are
effective when used in an uncontrolled setting will appear successful and
become accepted when they are actually harmful or ineffective.
accepted, it is difficult to conduct the controlled trials to test
their efficacy which may be desirable, and even necessary, to protect
patient interests.
of innovative therapies being widely adopted for a period as standard
because early uses did not occur in the context of methodologically
sound clinical trials which could have yielded reliable data regarding
use of the therapy with future patients.
B. Adequacy of Present Controls
30a/
Once
The recent history of medicine contains several examples
31/
While it seems reasonably clear that use of innovative therapy
creates risks to the patient beyond those that exist in the ordinary
therapeutic situation, risks which may be similar in kind to those that
exist in research, and also creates the risk that maximum possible know-
ledge will not be forthcoming from each instance of use, it does not
follow that new controls must be devised for boundary activities.
Rather, the adequacy of existing control mechanisms in minimizing these
risks must be examined.
innovative therapy will be examined to determine whether it is likely that
Two types of controls that impinge on the use of
16-18
either or both provide physicians with sufficient incentives to minimize
the risks to patients,
1. T o r t L i a b i l i t y
The possibility of tort liability impinges on the use of
innovative therapy in two respects. First, a patient injured from the
use of an innovative therapy can seek money damages in a civil suit
claiming negligence or malpractice in the decision to use the innovative
therapy. 32/
accepted, standard professional practice, recovery will depend upon
whether reasonable, prudent care in the circumstances would encompass use
of the innovative therapy.
itself and the foregone alternative are greater than the likely benefits,
Since the physician will by definition have deviated from
If the risks to the patient from the therapy
then the physician will be liable whether or not the patient consented to
undergo those risks. 33/
On the other hand, the physician will not be
liable if he can show that it was reasonable to think that the benefits of
the innovative procedure outweighed the risks, including the loss of
benefits from foregone alternatives.
Second, a physician could be liable for the use of an innovative
therapy if he failed to disclose information required for legally effective
consent. Depending on the jurisdiction, recovery here will depend on
the amount of information disclosed. In the majority of jurisdictions
the physician will be required to disclose only that information which
physicians in that situation customarily disclose. Since it is unlikely
that there will be a practice established concerning disclosure for the
specific therapy involved, the question will be what physicians disclose
16-19
about innovative therapies in general, or about innovative therapy for this
type of disease. 34/ A strong minority of jurisdictions, however, require
that the physician disclose all information material to the decision of
a person in the patient's position whether or not to undergo the procedure.
Ordinarily the risks and benefits of the proposed procedure, the risks
and benefits of alternative procedures, and probably, the innovative or
experimental nature of the procedure would have to be disclosed.
The question, thus, is whether the possibility of tort l i a b i l i t y
for unjustifiable uses of innovative therapy or for failure to disclose
relevant facts will induce doctors to use innovative therapy only when it
will reasonably provide a net benefit to the patient, and the patient
consents.
questioned.
ation from ethical conduct.
occurs, Use of innovative therapy may be highly unethical as where
the risk is much greater than any benefit to the patient, but unless
the risk materializes, no tort remedy is available. Second, where the
risk does materialize, a number of factors may operate to prevent a
successful suit. The patient may be unaware of a wrong, the injury may
not be worth the cost of litigation, he may be unwilling to sue, he may
lack the resources, etc. Finally, if a suit is filed, the chances for
recovery may be slim.
doctor. 35/
The patient will have to show that he is worse off than he
would have been if he had not undergone the innovative therapy, and this
The ability of the tort system to achieve these goals must be
The tort system is not calibrated to deal with every devi-
First, it operates only after an injury
Most malpractice cases are decided favorably to the
may be difficult. For all these reasons, the threat of a law suit and
16-20
legal liability may not prevent physicians from using innovative therapy
in situations that ignore patient interests, if use otherwise seems
j u s t i f i e d .
the more careful when using innovative therapy precisely because the
chances of l i a b i l i t y are greater, but empirical data to evaluate this
claim is lacking.
Of course, one might argue that the physician will be all
Similarly, the law of informed consent will not necessarily assure
that the patient will be informed to the same extent that ethical prac-
tice requires, or that would occur through some other control process.
First, the standard for disclosure will be considerably less in those
jurisdictions that allow medical custom to define the limits of disclos-
ure, 37/
and even in Canterbury- type jurisdictions, it is not yet established
that the innovative nature of a procedure must be disclosed.
whatever the standard for disclosure, implementing the standard legally
will depend on the occurrence of injury, willingness and ability to sue,
and establishing that if additional information had been disclosed, the
patient would not have consented. Though not insurmountable, these
are formidable barriers raising doubts about the efficacy of tort liability
to assure ethical practice in disclosing relevant information about the
use of an innovative procedure.
36/
Second,
Two further aspects about tort liability should be noted. The
first is that in at least one respect, the tort standard of reasonableness
based on a calculus of risks and benefits to the patients may be more
favorable to the patient than the HEW standard employed by IRB's because
benefits to future patients will probably not count, as the HEW standard
allows. Second, the limitations of the tort system arise from the way
16-21
the system is presently constituted. Changes in tort liability rules
that permit awards of damages on the showing of injury alone, or that
otherwise facilitate suit, may well make the liability system an effective
device for controlling the possible abuses of innovative therapy.
2. Peer Review
In addition to the incentives provided by the legal system to
give primary weight in boundary activities to patient interests (that is,
to judge the risk- benefit ratio in terms favorable to the patient), a
variety of professional norms and review mechanisms also provide such
incentives. In discussing them, the question to be kept in mind is to
what extent they are likely to counter tendencies in the innovative
therapy situation to disregard patient interests and thus assure an
acceptable quality of care in these activities.
a. Professional Ethics and Codes
Professional ethics, as exemplified in codes and medical ethical
writings, generally require loyalty to the patient, and do not sanction
compromise of patient interests for personal or career goals, or even
simply to advance science. 38/
Since such codes and norms are generally
hortatory, carry no specific sanctions, and may often not be clearly
applicable to boundary activities, one might justifiably display skepti-
cism as to their efficacy in assuring protection of patients in innovative
therapy situations. No doubt many physicians have internalized and comply
with these ethical precepts, but at present there is not substantial
evidence showing that adherence to a code of medical ethics alone will
prevent patient abuses in Innovative therapy or improve the methodologies
16-22
with which they are used.
b. Informal Peer Review Mechanisms
Another mechanism that might provide incentives to apply
innovative therapy in ways protective of patients are various informal
and formal professional review mechanisms. Medical audits, utilization
review, tissue committees, credential committees, academic rounds, and
the like, all review physician decisions to some extent and presumably have
various sanctions to induce compliance. To the extent that colleagues
and review committees reviewed boundary activities and evaluated their
e t h i c a l j u s t i f i c a t i o n , a physician might be induced to make decisions
with appropriate risk- benefit ratios and consent procedures, for fear
of peer disapproval, censure, nonreferrals, or perhaps more stringent
sanctions such as limitation or termination of hospital staff privileges.
Without data available on the precise scope and details of these
review mechanisms, it is difficult to evaluate their efficacy in
minimizing the abuses of innovative therapy.
cast doubt on their efficacy.
However, a number of factors
First, there is no guarantee that most
boundary activities will come to the attention of peer review mechanisms.
The frequency of review will vary with the setting and type of activity,
and no doubt may occure more often with surgical procedures 39/
practice in an academic setting. 40/ Secondly, even if particular boundary
activities are reviewed, one cannot be sure that the criteria and standards
applied will coincide with the socially desired criteria.
standards as to when risks and benefits of an innovative therapy are
appropriate might unduly weigh scientific and future patient interests
or
Professional
16-23
over those of the patient. Also, medical audit and review programs
do not generally look at the consent process. 41/
Finally, peer review
mechanisms do not always carry the sanctions that would induce more
desirable behavior, though the potential for so doing could be there.
One situation in which peer review mechanisms may be effective is that of
the internally or externally imposed clinical moratorium on further uses of
an innovative procedure, when great risks to patients become apparent. 42/
While the moratorium phenomena has operated effectively with innovative
cardiac surgery, it appears subject to the same deficiencies as other peer
review mechanisms. 43/ In sum, various peer review mechanisms, if they
exist at all, do not appear geared to review innovative therapy in a
manner necessarily coincident with what is most socially desired. For
this reason, they do not appear to provide sufficient incentives to
assure protection of patient interests in innovative therapy situations.
c * PSRO
A brief word about the relevance of PSRO is in order, since once
they are functioning, PSRO's will be the most comprehensive peer review
mechanism in operatior. 44/
both institutional and outpatient care, they are likely to pick up more
instances of innovative therapy than any other review mechanism. PSRO's
also have the power of the purse to enforce their standards, since they
may deny payment for inappropriate or unnecessary services.
because PSRO review is limited to medicare and medicaid patients, most
doctor-patient encounters will not be within their ambit.
Because of their nationwide scope and review of
However,
A key question
16-24
concerns whether PSRO standards will exclude payment for boundary
activities that appear unjustified from the patient's perspective.
Since norms will be set by physicians, this will depend on whether norms
reflect patient or professional interests. Secondly, whatever the norms,
their efficacy will depend on their implementation - on the willingness
of PSRO's to take a firm stand against dubious professional practices.
One can expect the more outrageous conduct to be
penalized, but many cases of innovative therapy may not fall into that
category.
prevent abuses of innovative therapy that slip by the tort system
and other review mechanisms.
particularly PSRO's, may help define standards of acceptable practice,
their efficacy in preventing or deterring unacceptable instances of in-
novative therapy is unclear.
provide incentives beyond that of the tort system to honor patient interests
in applying new therapies.
Moreover, it is not clear that PSRO's will identify and 45/
In sum, while some peer review procedures,
Data is lacking on the extent to which they
16-25
I I I . Alternatives for Control
If one concludes that the risk to patients from boundary activities
is significantly greater than with accepted practice and that tort and
peer review mechanisms provide insufficient incentives to protect patient
interests, then several alternatives for minimizing patient injuries from
innovative therapy may be considered. Each alternative, however, has
costs, ranging from the costs of administrating a review system to the
costs borne by patients when an innovation beneficial to them is not
available.
benefits in patient protect ion, personal autonomy, and increased knowledge -
With each alternative the inquiry is the same: do the
outweigh the costs.
Before analyzing specific suggestions for improving tort and peer
review mechanisms, it is necessary to consider whether boundary activi-
ties should be thought of as experimentation. Whether a special set of
rules or controls are to be applied to innovative therapy depends first
of all on whether a special set of rules is to apply to clear cases of
experimentation. Aside from activities specifically funded by HEW, there
are at present no legal controls on experimentation or innovative therapy
other than general principles of tort law, which appear to treat experi-
mentation and therapy identically. Unless legal controls on experimentation
are developed, it would seem a fortiori that no controls should be forth-
coming for innovative therapy, since the risks they pose seem much less
than those of experimentation.
experimentation are developed, either legislatively or administratively,
a question remains whether
However, assuming that controls for
(1) they should also apply to innovative
16-26
therapy; (2) a special set of rules for innovative therapy should be
developed; or 3) innovative therapy should be treated like accepted
practice.
vative therapy, no problem of definition arises, for experimentation can
be broadly defined to include at least all intentional deviations from
customary practice. 46/
therapy is to be treated differently from experimentation, either with
or without a special set of rules - then criteria for distinguishing
innovative therapy from experimentation must be developed.
if the same rules are to apply to experimentation and inno-
If situation (2) or (3) applies - innovative
47/
A. Should Innovative Therapy Be Treated as Experimentation
Assuming that through legislative or administrative action
experimentation will .become a distinct legal category with specific
liability, disclosure or review requirements, the question is whether
experimentation should be defined to include all intentional deviations
from standard practice, including innovative therapy, as many current
definitions and experts suggest. 48/
usually insufficiently proven or tested to be established as effective,
calling it experimental seems appropriate. Moreover, the incentives
that exist in the clearly experimental situation to disregard the
patient’s good in order to advance the interests of the researcher or
third parties, may also exist in a boundary activity, though they are not
as likely to be present or, if present, to be as strong. Defining or
treating innovative therapy as experimentation, with prior review by an
IRB, 49/
will thus lead to risk-benefit calculations more favorable to
Since an innovative therapy is
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patients, will lead to more fully informed patients, and possibly will
improve the reliability of data generated by innovative therapy by
" e x p e r i m e n t a l i z i n g " its use. 50/
Requiring prior review by an IRB for all uses of innovative therapy,
as well as for experimentation, however, may pose significant problems.
Assuming the requirement is legislatively imposed, then IRB's will have
to be constituted in numerous institutions and settings where they do not
For while research may occur in limited settings, innovative
In addition,
now exist.
therapy is likely to occur wherever medicine is practised.
it is not clear that all uses of innovative therapy in an office practice
can be brought under an IRB umbrella.
a governmental intrusion into medical practice far greater than has yet
existed. It is highly likely that the medical profession would resist an
enactment of such legislation or would challenge it in court if passed.
Indeed, it is not at all clear that the dangers of innovative therapy are
so great that the incremental benefit from IRB review would constitute
the compelling state interest justification necessary if such legislation
is to be constitutional under Doe v. Bolton.
Such a requirement would constitute
51/
52/
If IRB review is required only for innovative therapy in institutions
receiving HEW funds, problems still exist. First, if the requirement Is
the receipt of any HEW funds, then most hospitals and many physicians
would qualify, if they receive Hill- Burton, Medicare, or Medicaid funds.
Secondly, existing IRB's would be hard- pressed to review every instance
of innovative therapy given their present resources and workload.
permanently constituted review process, with staff, etc.,
A
16-28
would be essential.
passed on to consumers, thus increasing the cost of health care.
some degree of intrusion into the doctor-patient relationship will occur,
This expense would probably be
Third,
with additional constitutional difficulties as to Congress's power to
condition federal grants on regulation of nonfunded activities. 53/ IRB
review could be limited to innovative therapy directly funded by the
government, but then only a small percentage of boundary activities would
be regulated. 53A/
In addition to problems of constitutionality, scope, administrative
cost and implementation, two further factors cast doubt on the wisdom of
requiring IRB approval of all innovative therapy, as many institutions now
purport to do in the general assurances given DHEW. 53b/ One is that
despite similarities to experimentation, innovative therapy may be primarily
therapeutic and for the benefit of the patient and only secondarily
may involve the concern for science and future patients that creates the
researcher's conflict of interest in experimentation. Such incentives
may occasionally operate, but on the whole, they appear to be consider-
ably diminished in strength and alone may not justify the tremendous
costs and burdens of a prior review system, particularly when existing
liability and disclosure rules will prevent the most egregious abuses.
Secondly, these doubts are all the more compelling when we consider
IRB review will not necessarily assure more complete disclosure or
better risk-benefit ratios for patients. No data establishing IRB
efficacy in either regard now exists. In fact, available data suggests
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that they may have little effect, particularly on improving the consent
process. 54/
Moreover, IRB balancing of total benefit against patient
risk could put the patient's interests secondary to scientific advance-
ment, though this may be only a theoretical concern. While IRB's in
some places may be effective monitoring and protective devices, or may
become so with certain changes, given existing data and the institutional
context in which IRB's operate, one should hestitate multiplying them and
expanding their scope at great cost unless there is a reasonable chance
that they will achieve the goals desired.
This position differs with Robert Levine's statement that " in general
innovative therapy should be conducted and reviewed as if it were research." 55/
He further states:
For practical purposes, the definition of research as provided in this paper, includes innovative therapy (or innovative practice). This means that any innovative practice in which the deviation from customary practice is substan- tive should be conducted so that it most closely approximates the standards of good research (as defined by the relevant scientific discipline) without obstructing the, intent, to bring direct health benefit to the patient- subject. means that the proposed innovative activity should be reviewed by an IRB, that the consent negotiation indicate that the activity is being performed with - at least in part - research intent, and so on. 56/
It further
While recognizing that emergeny 57/
and nonsubstantive deviations 58/
from customary practice might not warrant treatment as research, Levine's
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position rests on a particular definition of research and on the need
to maximize knowledge from a particular use of an innovative therapy.
This position seem erroneous In three respects.
First, defining research as including all nonsubstantive deviations
from customary practice seems overinclusive.
below, neither deviation from customary practice nor intent to obtain
new knowledge adequately distinguishes research from primarily thera-
peutic activities.
primary intent to obtain new knowledge beyond the needs of the patient.
When applied to innovative therapy, this criterion will distinguish
emergency and "nonsubstantive" uses of innovative therapy, as well as
substantive uses of innovative therapy which are primarily therapeutic
in intent and only secondarily involve obtaining knowledge beyond the
patient's needs.
As discussed more fully
Rather, the distinguishing feature should be a
Use of untested therapies is certainly of concern,
and may require special safeguards. But when their use is not influenced
by interests contrary to the patient's needs there is no need to treat
innovative therapy as research.
Second, Levine may place undue emphasis on the need for studying
all innovative practices systematically during the process of
innovation. 59/
The goal is certainly a worthy one and should be
encouraged. However, one should not be overly optimistic that IRB
review will lead to better controlled uses of innovative therapy,
without more evidence that they are capable of turning single uses of
innovative therapy into controlled clinical trials. 60/
Also, this
concern places the interests that future patients have in safe,
16-31
efficacious therapies above the immediate interest of the patient and
doctor in applying an innovative therapy.
in which use of an innovative therapy is delayed or even denied, to the
detriment of a patient, because the physician cannot readily experi-
mentalize its use, in order to maximize knowledge from its application.
Although better testing of innovative procedures is desirable,
achieving that goal should be separated from the different goal of
protecting patients from the conflicting interests of research
situations.
There may well be situations
Third, Levine overlooks the legal and administrative problems
that would arise if all nonsubstantive innovative therapy had to
obtain prior approval of an IRB.
other than those directly funded by DHEW, political, legal and
constitutional problems arise, not to mention the cost and administrative
difficulties in setting up new IRB's or overloading existing IRB's
with substantially more business.
If review is required for activities
Administrative difficulties alone
should not prevent protection of human subjects. But these costs should
not be incurred unless there is a reasonable certainty that they will
actually produce greater benefits for patients.
B. Should Innovative Therapy Be Treated Differently From
Accepted Therapy
If there are good reasons for hesitancy in treating all
innovative therapy identically with experimentation, particularly in
the respect of prior IRB review, the question remains whether there
should be any special controls for boundary activities (though short of
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the controls for research), or whether innovative therapy should be
handled like accepted therapies. In either case, however, it will
be necessary to define a boundary between research and innovative
therapy, no matter how innovative therapy may be regulated. This
section first discusses distinguishing innovative therapy from experi-
mentation by the physician's intent, and then discusses the costs and
benefits of various alternatives for dealing with innovative therapy.
1. Distinguishing Innovative Therapy From Experimentat ion
The criteria proposed to distinguish those activities that
are to be regarded as research and subjected to a special set of
controls, generally include three elements: (1) untested or unproven
e f f i c a c y ;
(3) an intent or aim to develop new knowledge. For example, the DHEW
regulations, through a definition of " subject at risk" stress deviation
from standard practice:
(2) a deviation from standard or customary practice; and/or
61/
activity which departs from the application of those established and accepted methods necessary to meet his needs.
62/ Robert Levine defines research both in terms of intent and deviation:
any manipulation, observation, or other study of a human being - or of anything related to that human being that might subsequently result in manipulation of that human being - done with the intent of developing new know- ledge and which differs in any way from customary medical (or other professional) practice.
16-33
63/ Martin Norton focuses on lack of proof of efficacy and intent:
Experiments can be described as: procedures that are untested or unproved with respect to clinical efficacy or are by their very nature not related to the therapy of the patient but rather performed solely for the purpose of obtaining scientific data.
Those
These definitions, which are typical of current attempts to
define researce, 64/
suffer from under or overinclusiveness.
is overinclusive if it is so broad that it encompasses clearly
accepted medical procedures, as would occur if experimentation meant
every use of an unvalidated or unproven procedure, as Norton and others
suggest.
deserve close scrutiny, but the fact that an accepted medical procedure
used with therapeutic intent has not been reliably validated does not mean
that it is experimental. While such a definition of experimental serves to
call attention to the need for more thorough testing of ordinary therapies,
it clashes with common usage and risks confusing the problems of insufficient
testing with the quite different problems that arise when persons are
used in biomedical experimentation.
A definition
Unvalidated practices may well pose risks for patients and
A second criterion of the experimental — deviation from customary
practice — also appears overinclusive.
practice for many reasons — out of ignorance, negligence, disagreement with
One may deviate from standard
the standard, or in an attempt to find a better therapy. Since we do not
regard every deviation from standard practice as an experiment, this
criterion will not do. Indeed, if it were sufficient, it would also be
underinclusive, for it would exclude experiments with an accepted
16-34
therapy, though clearly one could conduct an experiment to compare the
efficacy of two accepted therapies. 65/
research or experimentation are deviations from accepted therapy.
Of course, most instances of
However,
this seems due to the aim, intent or purpose with which they are done and
not simply because they are a deviation from a customary practice.
A third criterion focuses on the state of mind of the physician and
asks whether there is an intent, aim, or purpose to develop data or
knowledge. Even this criterion risks overinclusion unless qualified, for
most tests and procedures in accepted therapy are done with the intent or
aim of obtaining knowledge, such as knowledge about the patient, his body
functions, the effect of a therapy, and the like. Furthermore, this
knowledge is usually new, in that it was not previously known about the
patient.
to obtain new knowledge, for that intent clearly characterizes therapeutic
activities, as Moore, Norton, and others have recognized. 66/
Rather, the
intent must be to test or gather knowledge about a condition, test, outcome,
or procedure beyond the needs of the patient, even though the patient may
also benefit from the effort.
focuses attention on interests and aims other than the immediate interests
of the patient, which is why there is concern with experimentation.
deviation from standard therapy which benefits a patient would be research
if it would not be done if no intent to gather data beyond the needs of the
patient existed, and would not be research if it would have been done
absent an intent or purpose to gather data about the procedure beyond the
immediate needs of the patient.
Thus the intent necessary to define research cannot be the intent
The utility of this definition is that it
Thus a
A deviation from standard practice done
16-35
solely with the intent of benefitting the patient may amount to negligence
or quackery if there is no reasonable chance of helping the patient.
This definition should serve to distinguish those activities for
which special protections are needed because nonpatient interests are
paramount. Though the intent criterion applies both to conformity to
and deviations from accepted therapy, it also distinguishes those instances
of deviation from customary practice which should be treated as experi-
mentation because of the presence of interests that conflict with those
of the patient.
considered research if done primarily with intent to develop new knowledge
about the procedure or test, beyond the needs of the patient, and therapy,
if done primarily with an intent to benefit the patient, and knowledge
about the procedure itself is secondary.
Intentional deviations from standard therapy are thus
Two problems with the intent criterion should be mentioned. One
concerns a distinction between general and specific intent. In law one
is often held to intend the natural and probable consequences of one's
act, even though one specifically intended or aimed only to do the act
producing those consequences. 67/
Since a particular therapeutic use of an
innovative therapy may naturally yield knowledge concerning use with other
patients, one might argue that a general intent to use the therapy should
be treated as an intent to derive knowledge for other uses, merely because
such knowledge is a likely or natural and probable consequence of its use,
Usually a physician will know that such knowledge will result, so that the
possibility of a nonpatient benefit might, albeit subconsciously, influence
his decision to use the therapy, even though at the time of use he specifically
16-36
intends only therapy and benefit to the patient. However, if an interest
conflicting with the patient's operates only on the subconscious level, it
does not differ from the physician's interests in extra income, time, etc.
that may conflict with patient interests in situations of ordinary therapy
and which arguably deserve no special protection. The strongest case for
treating the general intent to use an innovative therapy as equivalent to
a specific intent to acquire knowledge beyond the patient's interests
would exist in the first use of a drug or new surgical procedure. Here
the development of knowledge is inevitable,
and here it is likely that the intent
to gain new knowledge is strong, or at least equivalent to the therapeutic
intent. 68/
Thus a standard of specific intent to produce new knowledge
for use by others will identify most of the situations of innovative
therapy that are of concern.
first uses of a new procedure, this would not change the fact that later
uses may be specifically intended only to benefit the patient.
Even if a special rule were justified for
A second problem with an intent criterion is its implementation. If
the presence of such intent transforms a therapeutic situation into research,
and thus touches off a need for prior review or other procedures, then a
review system will be overdependent on the good faith of physicians, when
their loyalty to patients is itself the issue.
to be subject to special controls, the physician will have to determine
what his primary or specific intent is.
is research, then he must submit the procedure to review or whatever other
mechanisms exist. Such a system, it may be argued, lends itself to abuse,
For a boundary situation
If he determines that his intent
16-37
because physicians will have (1) an incentive in searching for their
purpose to emphasize its therapeutic aspects, when research plays a
dominant role; and
submit to a review process, even if the requisite intent is present,
because it could never be established that they possessed a research
rather than a therapeutic intent.
No doubt some physicians, as a result of this system, might be quick
(2) no sanctions can be applied for their failure to
to downplay or deny nontherapeutic intent in boundary situations.
certain level, however, every regulatory system is dependent on the good
faith of the regulated. Defining all innovative therapy as experimentation
would not, unless every physician decision were monitored, yield better
results, because it would still be dependent on a physician recognizing
or admitting that a procedure is, in fact, a deviation from standard
practice and, then, deciding to submit it to review. As with the intent
standard, the physician will have incentives to find that his procedure is
actually recognized or accepted by some segment of the profession, or if
that is impossible, of simply not submitting it to review. 69/
Absent
a monitoring system, there will not be any behavioral indication that the
procedure is innovative rather than accepted, as there might be with
c l e a r - c u t e x p e r i m e n t a t i o n . 70/
While the intent standard may pose compliance
problems, those problems are not likely to be greater than would exist
with a deviation from customary practice standard, which, as we have seen
may be underinclusive anyway. It does have the advantage of drawing a
fairly clear line, which each physician can personally feel (and if in
doubt, can call research). Since any control system will have to rely
At a
16-38
on physician compliance to an important extent, that fact alone should not
render the intent standard unworkable. 71/
2. Controls for Innovative Therapy
If one agrees that all innovative therapy need not be treated like
research, and that a boundary based on specific intent is a workable device
to identify those instances of innovative therapy which involve research,
the question remains whether therapeutic deviations from standard practice
primarily to benefit the patient need any safeguards or controls in addition
to those that apply to accepted therapy.
a. Argument for No Additional Controls
The argument for no additional controls would be that where the
physician intends to use an innovative therapy primarily to benefit the
patient, no special protection is needed because no nonpatient interests
beyond those that ordinarily exist in therapy are operative. Rather, the
risk is that through ignorance, misinformation, or negligence a physician
will miscalculate the risk- benefit ratio and impose unreasonable risk on to some extent
patients. However, this danger, / exists in any therapeutic situation, and
the physician will have the usual incentives to work for the benefit of
the patient. Moreover, he is likely to be especially wary of a lawsuit
where a risk of injury is greater because of uncertain knowledge and hence
will be more careful about obtaining consent and assuring that the patient
stands to benefit.
the innovative nature of a procedure, the legal system already provides
enough protection.
P a r t i c u l a r l y i n j u r i s d i c t i o n s requiring disclosure of
Further controls would be an unnecessary and unwarranted
16-39
intrusion into medical practice.
The validity of this argument rests on whether one thinks that
sufficient incentives to respect patient interests and autonomy already
exist, or whether because of lack of knowledge or deficiencies in the
legal system, physicians are apt to miscalculate risks and benefits to
the detriment of the patient.
b. Additional Controls
If one thinks that on balance physicians may, even when acting
primarily for the patient's benefit, tend to miscalculate risks and benefits
to the patient's detriment more often that would occur with accepted
therapy, several alternatives to improve their calculation exist
(1) New Liability and Disclosure Rules
One alternative would be to change current liability and disclosure
rules, to assure that the physician accurately judges that potential
benefits outweigh the risks, and that full disclosure occurs.
since it is unlikely that special liability and disclosure rules for
innovative therapy would be enacted independently of such rules for
experimentation the question is whether enacting special liability and
disclosure rules for experimentation is warranted.
liability, physicians engaging in experimentation could be strictly
liable for any injury resulting from use of the experimental procedure,
whether or not negligence occurred.
to internalize to the research project itself the costs of injuries now
borne by the subjects. 72/
I f e f f e c t i v e , it would force the researcher
Again,
With regard to
The effect of this rule would be
16-40
(or institution) to calculate the chances of such injury and to determine
whether this additional cost is outweighed by the benefits to be achieved
by the research.
that the physician is in the best position to decide whether the likely
benefits will outweigh the costs.
Strict liability would thus be justified on the ground
Such a rule would be socially desirable if, in fact, physicians made
fairly accurate predictions as to all the costs and benefits of an experi-
ment, including benefits to future patients and the costs to subjects, and
if they were in a position to capture enough of the benefits to cover the
costs they will i n c u r i f l i a b l e .
the benefits they capture do not outweigh their costs, even if all bene-
fits outweigh their costs, then socially desirable research will not take
place and future patients will unnecessarily suffer.
If they are bad predictors, or if
A more precise analysis of a strict liability scheme for experimentation
injuries, which is needed before such a rule can be recommended, is
beyond the scope of this paper.
approach will adequately compensate injured patients while not reducing
research below a socially optimal level.
for experimentation, the question is whether it should be extended to
The key question concerns whether such an
Assuming such a rule existed
innovative therapy that is primarily therapeutic in intent. 74 Again,
the answer to this question will depend on whether such a rule will deter
uses of innovative therapy that, on balancing risks and benefits, seem
justified.
medical injuries, physicians may well avoid deviations from standard
therapy aimed at benefitting the patient, because of fear of liability,
Unless a nonfault or strict liability rule applies to all
16-41
even though on balance the patient will be better off.
A similar inquiry would occur if the new liability rule were less
drastic, as would be a rule which shifted the burden of proof in cases
of intentional deviation from standard therapy to the defendant physician,
requiring him to prove that the likely benefits to the patient outweighed
the risks. Such a rule might well induce doctors to be more careful in
their use
of a new therapy in which the benefits outweigh the risks to the patient.
of innovative therapy, without preventing those applications
Enactment of special disclosure rules for both experimentation and
nonresearch innovative therapy poses fewer problems than do liability
rules. In Canterbury-type jurisdictions, disclosure of all information
material to a patient's decision to submit to experimental or innovative
therapies is now the disclosure rule.
jurisdictions for both experimental and innovative procedures, if it is
not already required because of a professional custom in having more
complete disclosure for research, 75/ should pose no major problems.
might increase the time a physician spends in obtaining consent, but the
benefits thereby obtained seem greater.
of risks might lead some patients to reject an innovative procedure which others
would have chosen, this should not be of major concern, for the lost
benefit will be a result of the patient's informed choice.
Requiring a similar rule in all
It
While more complete disclosure
At the very least, then, a disclosure rule should be enacted which
requires that patients be informed of risks, benefits, and discomforts
of experimental, innovative and alternative procedures, and the new or
16-42
experimental nature of a proposed therapy.
rule for injuries resulting from experimental or innovative therapeutic
procedures requires a more precise analysis beyond the scope of this paper
and should be explored. Shifting the burden of proving the reasonableness
of a procedure, however, poses fewer problems and could fruitfully be
enacted now.
Enactment of a strict liability
(2) Improving Peer Review
A second alternative, if one finds existing controls inadequate
for innovative therapy primarily therapeutic in intent, would be to
develop peer mechanisms that through review and feedback to the physician,
induced physicians applying innovative therapy to make better risk-benefit
calculations and more complete disclosure to patients.
range from education and development of precise norms and criteria for use
of innovative therapies, to monitoring of physician activities on a
continuous or random basis.
one should not be overconfident of its impact.
effective, but involves tremendous costs and difficulties in arranging.
If created solely for uses of innovative therapy, the costs may be hard
to justify.
medical decisions is far from realization. Consideration should at
least be given to developing and enforcing a practice of preuse
consultation, and after-the-fact review of applications of innovative
therapies, though the precise details of such a system await further
study.
Alternatives here
The former may be a useful addition, but
The latter might be very
Yet developing effective quality control mechanisms for all
16-43
IV. CONCLUSION
Public Policy for innovative therapy depends on the extent to which
innovative therapy poses risks for patients beyond those that exist in
ordinary therapy, and, secondly, on the efficacy of existing legal and peer
review mechanisms in minimizing those risks.
special set of controls is needed, a major policy issue is whether all
innovative therapy is to be regarded as research and subject to the controls
applicable to research, or whether there are some instances of innovative
therapy to which the controls of research need not apply.
may use innovative therapy primarily for the patient's benefit, with no
intent to acquire knowledge beyond the needs of the patient, the career,
scientific, and future patient, interests that call for special protections
in research may often be absent. In those situations, distinguished by the
specific intent of the physician, treatment of innovative therapy as research
is unnecessary to protect patients from the conflicts of interest inherent
in research. Requiring IRB approval for all innovative therapy would also
raise serious administrative, political, and legal problems at a time when it
is unclear that IRB review will substantially enhance patient interests
and lead to more informed consent, where no research intent is present.
If one concludes that a
Since a physician
Where there is a specific intent to acquire information about the
procedure beyond the needs of the patient, it is appropriate to regard the
physician as engaging in research. The intent to obtain knowledge may
influence the physician's disclosures to the patient, and his decision to
use the therapy. Innovative therapy in this situation should be subject
16-44
to the same controls as research, including prior IRB review and the same
liability or disclosure rules. The key policy issue here is whether these
controls will apply to all research, to research occurring in institutions
receiving federal funds, or only to research directly supported by federal
funds. Each alternative raises unique problems of scope, political feasi-
bility and constitutionality which recommendations for controlling research
should not ignore.
Having divided the universe of innovative therapy into two classes on
the basis of physician intent, the question remains whether primarily
therapeutic innovative therapy should be subject to special controls or
whether it should be treated like ordinary therapy.
these controls should not be more stringent than the controls enacted for
Assuming the former,
research, because the risks are smaller. While further study of a strict
liability rule for injuries occurring in primarily therapeutic innovative
therapy is needed, shifting the burden of proof to the defendant physician may
be more feasible. Requiring as complete disclosure as occurs for research
in a Canterbury- type jurisdiction is clearly in order. In addition, the
medical profession should be encouraged to develop clearer standards for
using innovative therapy and review mechanisms that will informally monitor
physician use of them.
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FOOTNOTES
1. Congress, in establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, explicitly recognized the problems presented by boundary activities. cally directed the Commission to consider " the boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine" , in carry- ing out its study of ethical principles, guidelines and recommendations to the Secretary of HEW. P.L. 93- 348, Sec. 212(B)(i).
45 C.F.R. Sec. 46.3(b). from standard therapy does not place a subject at risk if there is a reasonable basis for thinking that only such a departure could benefit the patient. In that case such a departure would be one of " the established and accepted methods necessary to meet his needs," if in fact it is standard medical practice to depart from accepted therapies when there is no reasonable hope of success and the benefits of the non- standard procedure outweigh the risks.
There is currently ambiguity, if not actual confusion, as to whether DHEW has the authority to require that institutions receiving DHEW funds submit all research with human subjects, whatever the funding source, to the review procedure required for research directly funded by HEW. take the position that an institution's general assurances pursuant to 45 C.F.R. Secs. 46.1 - .22 must include an assurance that all behavioral and biomedical research, however funded, will be reviewed by an IRB and consent protected.
However, the authority for this position is less than clear. Section 212 of P.L. 93- 348, directed the Secretary of HEW by regulation within 240 days to require entities applying for grants under the Public Health Service involving research with human subjects to give assurances that all research involving human subjects at the institution would be reviewed. The regulations issued pursuant thereto, 40 Fed. Reg. 11854- 58 did not include such a regulation. Although one could argue that 45 C.F.R. Sec. 46.21(b)(2) accomplishes the mandated purpose, it is sufficiently ambiguous, and so clearly preceded P.L. 93- 348, that it hardly seems to discharge the duty required of the Secretary.
Assuming the existence of the regulation required by P.L. 93- 348, its constitutional validity remains an open question. While Congress may attach conditions to its grants under the spending power, the Tenth Amendment would require that there be some limits on the condi- tions it may attach. Based on language in United States v. Butler, 297 U.S. 1 (1936) one may argue that grant conditions must be reasonably related to the purpose of the grant, and cannot regulate
I t s p e c i f i -
2. One could argue, however, that a departure
3.
As a matter of practice, HEW presently appears to
16-46
Footnote #3 continued
activities which are not funded under the grant. If the courts so limit Congress' conditional spending power, P.L. 93- 348 and similar attempts to regulate non- government funded research with human sub- jects would be unconstitutional. For a more detailed discussion, see " Comment, The Federal Conditional Spending Power: Limits," 70 Northwestern L. Rev. 293- 331 (1975).
Under Roe v. Wade, 410 U.S. 113 (1973) and Doe v. Bolton, 179 (1973), such intrusion would be unconstitutional unless a compelling state interest that outweighs the physician and patient's right to privacy in their relationship, can be established. far from clear that the possibility of abuse in using innovative therapy is so frequent that its avoidance would constitute a suf- ficiently compelling state interest.
A more technical formulation of the general rule is: " a physician has the obligation to his patient to possess and employ such reason- able skill and care as are commonly had and exercised by reputable, average physicians in the same general system or school of practice in the same or similar localities." Waltz and Inbau, Medical Juris- prudence 112 (1971); See also Louisell and Williams, Medical Malpractice 8.03- 8.07 (1973).
See, e.g. Helling v. Carey, 519 P.2d 981 (Wash. 1974).
A Search for
4. 410 U.S.
It is
5.
6.
7. Carpenter v. Blake, 60 Barb. 488 (S.Ct. N.Y. 1871); Smith v. Beard, 56 Wyo. 375, 11 P.2d 260 (1941); Hodgson v. Bigelow, 335 Pa. 497,
7 A.2d 338 (1939); Sawdey v. Spokane Falls and N. Ry., 30 Wash. 349, 70 P. 972 (1902); Jackson v. Burnham, 20 Colo. 532, 39 P. 577 (1895); Kershaw v. Tillbury, 214 Cal. 679, 8 P.2d 109 (1932); Graham v. Dr. Pratt Inst., 163 III. App. 91 (1911); Medical Exam of Indiana v. Kaadt, 221 Ind. 625, 76 N.E.2d 669 (1948). See generally, Krisanovich, " Medical Malpractice Liability and Organ Transplants," 53 U. San. Fran. L. Rev. 223, 272- 277 (1971), and Waltz and Inbau, Medical Jurisprudence, pp. 179- 202, on which this and the following paragraph are largely based.
Waltz and Inbau, 190; Karp v. Cooley, 493 F.2d 408, 423- 424 (1974). Although some cases have referred to experimentation as a separate ground of liability, the evidentiary requirement for establishing liability remains whether a reasonable and prudent physician would have experimented in those circumstances.
Karp v. Cooley, 493 F.2d 423. While this clearly applies to experi- mentation occurring in a therapeutic situation, its applicability to non- therapeutic situations is less clear. In those cases liability is likely to depend on the adequacy of consent. reported instance of damages awarded a volunteer for injury result- ing from tests conducted soley for purposes of medical research, see Halushka v. University of Saskatchewan, [1966] 53 D.L.R.2d 436 (1965) (Canada) (ineffective consent to anesthetic tests; injuries included " diminution of mental ability" ; verdict for $22,500). In any event, this paper deals only with experimentation occurring in therapeutic situations.
8.
For the only
16-47
Footnotes
9. Id., Waltz and lnbau, 190.
10. See note 3, supra.
11. 45 C.F.R. Sec. 46.2(b)(1).
11a. However IRB review might be said to alter the likelihood of the risks occurring, given an unfavorable risk- benefit ratio. This issue is treated in the discussion of causation that occurs later in this paragraph.
12. According to the discussion in note 3, supra, this is not now the case, even for research directly funded by HEW. review is not now required by statute for all activity characterized as research, whatever the funding source.
In any event,
13. Prosser, Law of Torts, 200- 201 (4th ed. 1971).
14. Id.
15. Even if violation of the statute is found to be causally related to the plaintiff's injury, a plaintiff who provided a legally valid consent, depending on the information disclosed, could be found to have assumed the risk that injury would occur. of assumptions of the risk, see Prosser, 434- 457. lnbau seem to view the matter differently. Op. cit., 199.
A similar analysis would apply if IRB review for research, though not statutorily required, was customary practice for (1) HEW funded research, (2) research in HEW funded institutions, or (3) all research whatever the funding source. views would not in itself produce liability, though a court could hold that it was unreasonable. of such as assumption of risk and the problems they raise would still exist.
See generally, Waltz and Inbau, 152- 177, and sources cited therein; Louisell and Williams, Sec. 22.01.
18. Wilson v. Scott, 412 S.W.2d 299 (1967).
19. 464 F.2d 772 (D.C. Ca. 1972).
20.
For a discussion However, Waltz and
16.
Failure to conform to a custom of re-
Questions of causation and defenses
17.
See, e.g., Cobbs v. Grant, 502 P.2d, (Cal. 1972); Cooper v. Roberts, 286 A.2d 676. (Pa. 1971); Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972); Trogun v. Fruchtman, 207 N.W.2d 297 (Wis. 1973).
21. 464 F.2d 787- 788.
22. Fortner v. Koch, 201 N.W.702 (S. Ct. Mich. 1935); Fiorentino v. Wagner, 227 N.E.2d 296 (N.Y. 1967).
23. Presumably the two jurisdictions which adopted the rule, see note 22,
standard.
supra, would continue, to require such disclosure, even though these statements occurred before adoption of a Canterbury- type disclosure
16-48
Footnotes
24.
25.
26. 45 C.F.R. 46.3(c)(1-6).
27.
45 C.F.R. 46.3(c)(1-6).
45 C.F.R. 46.2(b)(3).
Depending on the precise disclosure rule in effect in a non-custom jurisdiction, HEW rules could require more disclosure than would occur even under a reasonable person standard.
28. See pp. 28-45, i n f r a .
29. This is especially true with surgery.
30. 227 N.E.2d 246 (N.Y. 1967).
30a. He also may intend to experiment with this procedure, but intend only a one-patient experiment, rather than undertake to develop a formal clinical trial.
A widely noted example was the development of portacaval anastomasis for bleeding esophageal varices which when finally tested was found to lack the supposed efficacy. Warren, " Controlled Clinical Research: Opportunities and Problems for the Surgeon," 127 Amer. J. Surgery 3-8 (1974); Spodnick, " Numerators without Denominators: There is no FDA for Surgeons," 232 JAMA 35-36 (1975); Strauss, " Ethics of Experi- mental Therapeutics," 288 N.E.J.M. 1183-1184 (1973).
Since there is a greater risk of unskillful application with a new procedure, a finding that unskillful application due to newness is negligent would also be a disincentive to use. Aside from this possibility, the possibility of damages because the innovative procedure may also be negligently applied would not appear to create additional disincentives to use.
Waltz and lnbau suggest that the plaintiff's assumption of the risk, as manifested in a legally effective consent, would not bar recovery if use of an innovative procedure is unreasonable in the circumstances. See Waltz and Inbau, 199.
The disclosure custom will also depend on the effect given the HEW regulations as evidence of a disclosure practice.
Report of the Secretary's Commission on Medical Malpractice, 5-20
31.
32.
33.
34.
35.
See pp. supra.
(1973).
16-49
Footnotes
36.
37. This statement assumes that the HEW regulations will not be taken
Of course, physicians may disclose more information than the law requires.
as evidence of disclosure practice,
See e.g., Nuremberg Code of Ethics in Medical Research (1949); Declaration of Helsinki (1964) in Waltz and lnbau 379- 383.
Presumably scrutiny of surgery by tissue committees and departmental review occurs more frequently than does review of medicine.
In patient rounds in an academic setting the justification for using an innovative procedure is more likely to be questioned, though even here the prestige of the attending physician may prevent rigorous criticism.
One court has held that the hospital has no duty to assure that a physician obtain legally effective consent from the patient. Fiorentino v. Wagner, 227 N.E.2d 296 (N.Y. 1967).
For a thorough analysis and account of the moratorium as a peer control device, see Swayzey and Fox, " The Clinical Moratorium: A Case Study of Mitral Valve Surgery" , in Freund, ed. Experimentation with Human Subjects, 315- 351 (1970).
Swayzey and Fox, however, might find the clinical moratorium to be more effective than I suggest. No doubt it has been effective in some instances, but without further evidence it does not appear likely to operate in most applications of innovative therapy.
For an account of the history and functioning of PSRO's, see Note, Federally Imposed Self- Regulation of Medical Practice: A Critique of PSRO, 42 Geo. Wash. 822 (1974).
Since innovative therapy by definition will depart from PSRO standards, PSRO review could discourage some applications of innovative therapy. This will depend on the willingness of PSROS to accept a physician's justification for departure from accepted practice. Conceivably, the frequency of boundary activities will not be affected.
The use of an innovative therapy is, by definition, an intentional deviation from standard practice.
38.
39.
40.
41.
42.
43.
44.
45.
46.
16-50
Footnotes
47. Criteria for distinguishing innovative therapy from other forms of research would also be needed if one wishes to regard all innovative therapy as research, and then subject innovative therapy to control procedures different than those applied to all other forms of research.
48. See pp. 34- 35, i n f r a .
49. While the rules for experimentation need not include IRB review, given the history of federal controls on experimental activities it is likely that public policy will require some form of IRB review. What is unclear is whether IRB review will be required for all research with human subjects or just for research funded by the government or occur- ring in government funded institutions. Depending on the scope of the IRB requirement, and the means used to impose it, constitutional considerations may become relevant. See note 3, supra.
This assumes that IRB's actually do achieve these goals, though empirical data verifying their efficacy does not exist. It is particularly unclear whether IRB's will require innovative therapies to be applied in rigorously controlled circumstances, thus tending to turn each use of an innovative therapy into a formal clinical trial. While an IRB could have this effect, the author's experience on one IRB suggests that it may be unrealistic to expect significant gains in this regard.
50.
51. For example, the PSRO legislation was challenged in an unsuccessful federal suit. Assoc. of Amer. Phys. and Surgeons v. Weinberger, 395 F.Supp. 125 (1975).
See note 4 supra. than it confronted in the PSRO litigation because the regulation of innovative therapy is not conditioned on receipt of federal funds.
52. The government would face a more difficult challenge
53. See note 3 supra.
53a. If Medicare and Medicaid funded therapy was included in this category, the administrative problems discussed above would occur.
53b. The general assurances do not speak explicitly of innovative therapy, but rather commit the institution to adhere to the policies and pro- cedures contained in 45 C.F.R. 46.1 - .22. 45 C.F.R. Sec. 4613(b) defines subject at risk in a manner that appears to include innovative therapy. See note 2, supra.
16-51
Footnotes
54. See Barber, Research on Human Subjects (1973); Gray, Human Subjects in Medical Experimentation 235- 256 (1975). While both the Barber and Gray studies give little solace to IRB advocates, their find- ings may be reflect a temporary phenomenon that will pass with greater IRB experience and development of more effective procedures. The National Commission for the Protection of Subjects of Biomedical and Behavioral Research may generate data showing greater efficacy in both regards, or at least ways of increasing IRB efficacy.
Levine, Addendum to Boundaries Paper, September 25, 1975, p. 10a. 55.
56. Id. at 18a.
57. Id. at 17a.
58.
59. Id. at 17a.
60. See note 50 supra.
61.
62.
Id. at 10a, 11a.
45 C.F.R. Sec. 46.2(b)(1).
Levine, " Boundaries Paper" , prepared for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, pp. 6- 7, 17, July 14, 1975.
Norton, " When Does an Experimental Innovative Procedure Become an Accepted Procedure,'' Pharos Oct., 1975, 161- 162.
Francis Moore, for example, defines human experimentation " as either the intentional employment of normal human subjects as volunteers for physiologic experiments, or the study of patients (in a way that would not directly benefit them) to gather information on a disease or its treatment." " Therapeutic Innovation: Ethical Boundaries in the Initial Clinical Trials of New Drugs and Surgical Procedures" , Daedalus, Spring, 1969, p. 502. Similarly, a subcommittee of the IRB of the Center for Health Sciences of the University of Wisconsin recently came up with this definition:
63.
64.
" any organized propsective process which seeks to secure new information from humans or about humans and/or which differs in any way from customary or generally accepted medical practice."
16-52
Footnotes
65. Robert Levine's definition also appears to exclude this possibility though elsewhere he acknowledges that such activity is research. See Levine, p. 10.
See Moore, op. cit., note 58, supra; Norton, op. cit., note 57, supra.
LaFave and Scott, Criminal Law 196 (1972).
Francis Moore, for example, expresses special concern for the safety of patients in the first use of a new drug or procedure. Op. cit., note 58, supra. However, the situations he discusses appear to involve an experimental intent, and thus would be subject to review on that basis.
Consider also the first heart transplant or use of a mechanical heart. A therapeutic intent in those situations cannot be denied, but it would be very difficult for Dr. Barnard or Dr. Cooley to maintain that they had no intent to gather knowledge about the procedure beyond the needs of the patient.
This appears to be the case currently with most instances of innovative therapy occurring in institutions receiving HEW funds. Few instances of innovative therapy are submitted for review, either before or after their use.
On the whole this statement appears to be true, though one can easily imagine therapies whose innovative or non- accepted status would be apparent to an observer, e.g., covering a patient with newspapers to treat cancer.
Robert Levine appears to reach a similar conclusion when he states:
66.
67.
68.
69.
70.
71.
" The definition of research provided in this paper is designed, in part, for the benefit of the professional who will wish to distinguish which of h i s a c t i v i t i e s may be viewed (by others) as research. He may be advised that, at some moment when he is considering performing some activity, he can consider whether his intent is in part or in whole research as contrasted with practice. to express his intent in the form of a protocol and have it reviewed by an IRB. He may also be advised to conduct his consent negotiations with the prospective subject so as to make clear his intent to that individual."
In that case he may be advised further
Addendum to Boundaries Paper, 5a- 6a, Sept. 24, 1975.
16-53
Footnotes
72. If the injury results from negligence, the subject might be able to recover damages. However, if there is no negligence, the subject is left bearing the cost of the injury.
73. Havighurst, " Compensating Persons Injured in Human Experimentation" ,
74.
169 Science 153- 157 (1970).
For discussion of the complexities of such a decision see Calabresi, The Cost of Accidents (1970); Havighurst and Tancredi, " Medical Adversity Insurance - A No- Fault Approach to Medical Malpractice and Quality Assurance" , 51 Health and Society 125- 168 (1973).
See the discussion of this point at pp. 11- 14, supra. 75.
16-54
17
THE BOUNDARIES BETWEEN BIOMEDICAL RESEARCH INVOLVING HUMAN
SUBJECTS AND THE ACCEPTED OR ROUTINE PRACTICE OF
MEDICINE, WITH PARTICULAR EMPHASIS ON
INNOVATION IN THE PRACTICE OF SURGERY
David Sabiston, M.D.
In the introduction of Levine's thoughtful position paper, he empha-
sizes the fact that it is fortunate that sharp definitions between the boundaries
of biomedical or behavorial research and accepted and routine medical prac-
tices are not required, a fact of much importance. As one pursues this sub-
ject, it becomes evident that there is no dividing line which can be consist-
ently agreed upon by any group of authorities on the subject. In fact, it is
generally recognized that such an arbitrary division is simply impossible, at
least if determined on a rational basis. Therefore, an objective of an apprais-
al of this subject might be the development of a series of approaches leading
to an improved and more complete understanding of this increasingly impor-
tant issue.
At the outset, it can be stated that there are two parts of the spectrum
which are definite: (1) those diagnostic and therapeutic areas in medicine
about which the overwhelming majority of authorities would agree that the
test or treatment is established beyond reasonable doubt. Fortunately, this
portion of the spectrum in medical practice comprises the vast majority of the
field today, and clearly this is true as applied to the surgical disciplines. At
the opposite end of the spectrum are those studies which are clearly experi-
mental and are being pursued for the acquisition of basic knowledge without
any intent to suggest by implication or fact that the patient will immediately
benefit. Again, the first portion of the spectrum represents a large area of
daily endeavor and the latter a much smaller one. Between these two posi-
tions, there is a definite "gray zone" in which it is difficult to classify objec-
tively the diagnostic test or the therapeutic program as accepted practice
versus experimentation.
17-1
One point which can be appropriately made is the fact that the role of
the intent of a given procedure might be profitably minimized, since it is al-
most always impossible to prove this point, certainly from a legal point of
view. Moreover, insofar as an individual patient is concerned, it might be
said that there is often little difference in the approach to therapy and an ex-
periment since in modern medicine one should outline in detail the benefits
and risks in both situations. Moreover, quality control of patient care is and
should be monitored by peer review groups, whereas human investigation
should be controlled by institutional panels designed to review each protocol
with membership of the panel broadly chosen, including informed members of
the laity. In this connection, the comments of Philip Handler, President of the
National Academy of Sciences, bear repetition. He succinctly summarizes the
present status of human experimentation as follows: "It is no longer possible
for an isolated investigator to go off on his own and simply do as he pleases.
He is now accountable to his colleagues, in advance, before he may undertake
any proposed experiment. Indeed, that very process has increased the sophis-
tication of current medical research." Ultimately, all relationships between
physicians and patients rest upon a personal agreement between the two parties.
While it is recognized that in many instances such relationships between physi-
cians and patients have eroded by comparison with the past, it is equally impor-
tant to stress the need for a return to this important and much to be desired re-
lationship.
In Dr. Levine's comments concerning "patients and subjects" and their
relationship on the one hand to a health care professional and on the other as
17-2
an individual who is to be observed or experimented with by an investigator
do represent the situation at the two ends of the spectrum, but a significant
number of persons fall into an intermediate category difficult to define. His
comments on the natural history of various diseases are also quite significant
since it is such data that provide the physician and surgeon with the appro-
priate facts to discuss with the patient the problem, and frequently the need
for experimentation in an effort to improve both the quality of life as well as
its length. The thoughts expressed about fiduciary relationship of experimen-
tal studies are also well taken. While monetary reward is often significant in
terms of separation of therapy from pure research, such is not an adequate
or appropriate classifying device.
Every physician, and indeed many informed laymen, recognize that
most of the advances in medicine have derived from what must be defined as
"human experimentation." The surgeon generally insists first upon the per-
formance of new operative procedures in the experimental animal with careful
attention being given the clinical course as well as the biochemical, physio-
logical, and pathological changes which follow. Nevertheless, when the op-
eration is first performed on humans, by definition it must be termed an ex-
periment, although one being done with sound preliminary knowledge. Un-
der these circumstances, it is imperative that the patient be fully appraised
of everything that is known and of the risks involved. Obviously, informed
consent in the fullest meaning of the term is essential.
It is also recognized that many medical advances have been made as
a result of totally healthy human volunteers who have nothing to gain except
17-3
personal gratification, at least immediately, from the scientific information that
might be derived from an experimental study. For example, the entire field of
the transplantation of human organs has been greatly advanced by those healthy
donors willing to undergo an operation for removal of one of the two normal kid-
neys to be transplanted into a patient with life-threatening renal insufficiency.
It is apparent that while the total risk of the operation upon the donor is low,
nevertheless it is real and could indeed in rare instances be life-threatening.
Despite this fact when the need arises, it is usual for a volunteer to be forth-
coming and with full realization of the potential hazards which might occur.
A classic example of the advantages to mankind from human experimen-
tation is summarized in the following historic citation: "Professor Forssmann:
As a young doctor, you had the courage to submit yourself to heart catheteri-
zation. As a result of this, a new method was born which since that time has
proven to be of great value. It has not only opened new roads for the study of
the physiology and pathology of the heart and lungs, it has also given the im-
petus for important researches on other organs." This short, yet profound,
introduction of a historic contribution to medical science comprised the cita-
tion to Werner Theodor Otto Forssmann when he was awarded the Nobel Prize
in Medicine in 1956. The interesting feature of this monumental achievement
is the fact that as a 25 year old intern in surgery this pioneer, after repeated
trials of cardiac catheterizations in the cadaver, introduced a catheter into his
own arm vein and passed it into the right ventricle of his heart. Despite the
17-4
fact that he had approached a member of the faculty and a fellow intern to as-
sist with the procedure, both refused to assume any responsibility for the ex-
periment.
In current surgical practice, it is well recognized that the majority of
operations performed in this country are those which are widely accepted as
standard practice with results of proven efficacy. Thus, the removal of the
appendix for acute inflammation, removal of stones from the common bile duct
in obstructive jaundice, the removal of most neoplasms (especially those with-
out evidence of metastases), and the surgical drainage of purulent abscesses
are typical examples. However, many procedures might appropriately be clas-
sified in an intermediate category including operations such as intestinal by-
pass operations for control of obesity and for hyperlipidemias.
In the recent past, much emphasis has been given the subject of revas-
cularization of the heart for myocardial ischemia (coronary arterial bypass
procedures). While it is clear that the non-operative management of angina
pectoris and its complications is often effective, nevertheless in many in-
stances, this form of therapy leaves much to be desired. The development
in the past decade of the coronary bypass procedures has led to the wide-
spread adoption of this technique with an estimated 50,000 or more of these
operations being done annually in the United States. Nevertheless, justifi-
able controversy continues concerning the indications for such therapy and
indeed of the long-term results. On the basis of the data available, it is gen-
erally accepted that the relief of pain is achieved in approximately two-thirds
17-5
of the patients and an additional 15 to 20 percent receive partial relief of an-
ginal discomfort. One of the most desired results of this operation is the pro-
longation of life, and upon this point there is conflicting evidence. However,
at this point in time the preponderant view supported by accumulated statis-
tics indicates that the operation does not extend the length of life when com-
pared with appropriate controls managed medically. For example, the Veter-
ans Administration Hospital system has recently completed a five year random-
ized study of a series of patients with documented angina pectoris due to sig-
nificant atherosclerotic obstructing lesions in the coronary arteries. All pa-
tients were reviewed by a cardiological and surgical panel in the cooperating
centers, and it was agreed that each was an appropriate candidate for surgi-
cal treatment by contemporary criteria. The plan for the randomized study
was carefully reviewed with each patient and explained in appropriate detail.
Following this, an envelope was opened which committed the patient either to
medical or surgical therapy. Thus, among the patients in the study, half
were operated upon with the performance of a bypass graft and the remaining
half were managed by customary medical (non-operative) therapy. The inves-
tigators chose not to study the relief of anginal pain in these patients, but rath-
er directed their interest toward longevity. It was interesting that the life ex-
pectancy of these patients was the same in each group, with the exception that
those patients who had significant stenosis of the left main coronary artery had
an improved life expectancy following surgery.
of the left main coronary artery comprises approximately 10 percent of the total
(In most series, obstruction
17-6
patients undergoing coronary arteriography for angina pectoris.) Thus, while
this operation is widely employed, attention should be directed toward the known
facts concerning the benefits which can reasonably and objectively be expected
from the procedure.
Every surgical procedure is in a sense an experiment, since one cannot
predict with accuracy the development of postoperative complications which may
ensue, as for example the appearance of a wound infection. In fact, in his orig-
inal report of the cardiac catheterization upon himself, Forssmann mentioned that
he developed a wound infection in the self-made incision.
Thus, from a surgical point of view, innovations are being made daily as
an individual surgeon finds improved results with specific changes in operative
technique. While these may be minor, it should be noted that they often arise in
specific situations not previously encountered and call for a decison to be made
immediately in order to prevent a perilous outcome. Since the patient is anesthe-
tized and usually cannot be safely awakened, total informed consent is not pos-
sible. An example of this type is the pioneering contribution of Dr. Bertram M.
Bernheim. A student of the noted surgeon, William S. Halsted, in 1915 Bern-
heim operated upon a patient with a painful and expanding aneurysm of the pop-
liteal artery which threatened to rupture. Prior to operation, he had demon-
strated that temporary occlusion of the femoral artery above the aneurysm pro-
duced clinical signs of ischemia in the leg distally. Therefore, he knew in ad-
vance that it would be necessary to leave a portion of the aneurysm to allow con-
tinuity of blood flow from the femoral artery above into the popliteal artery below
17-7
otherwise gangrene of a portion of the leg would ensue. However, at opera-
tion the aneurysm was so thin-walled and the tissues of such poor quality that
none of it was available for restoration of continuity of the artery above with
that below. Therefore, rather than simply ligating the two ends of the arteries,
which were quite far apart and not available for direct anastomosis, he removed
a segment of saphenous vein and used it as a substitute. Dr. Halsted, in com-
menting upon this pioneering achievement, called it the "ideal operation for the
treatment of a popliteal aneurysm." However, this was not predictable before-
hand but represented a reasonable alternative to what otherwise would have
been a disastrous result, that is, amputation of a limb. Obviously, Dr. Bern-
heim was willing to assume the responsibility for his action, and it is clearly an
example of appropriate judgment and action in an admittedly difficult situation.
Summary
In the consideration of boundaries between biomedical or behavorial re-
search and the accepted routine practice of medicine, it is apparent that while
the establishing of such distinctions is desirable, it is nevertheless extraordi-
narily difficult. In the surgical sciences, innovative changes are both essen-
tial and desirable in daily practice. Moreover, in the clinical setting of sur-
gery, it is not always possible to predict the situation which will be encount-
ered and therefore to have the opportunity to provide total informed consent.
Nevertheless, the key feature of both modern therapy and research is based
upon a detailed and frank exchange between the physician or investigator and
the patient. While it is important to define the intent, from a legal point of view
17-8
such is exceedingly difficult to prove. In the vast majority of instances, the
most appropriate means of monitoring quality control in medicine is by the
peer review mechanism, whereas monitoring of human investigation is best
achieved by review panels broadly composed to specifically evaluate and de-
cide upon each protocol proposed. Clearly, human investigation in the sur-
gical disciplines, as well as in all of medicine, is essential if the advances
characteristic of the past several decades are to continue.
17-9
18
WHAT PROBLEMS ARE RAISED WHEN THE CURRENT DHEW REGULATION
ON PROTECTION OF HUMAN SUBJECTS IS APPLIED TO SOCIAL
SCIENCE RESEARCH?
Richard A. Tropp
What Problems Are Raised When the Current DHEW Regulation on Protection of Human Subjects
Is Applied to Social Science Research?
Richard A. Tropp Formerly Office of the Secretary, DHEW
Question Presented
What amendments, if any, should be made in the current DHEW regulation on "Protection of Human Subjects" (hereinafter, "Part 46") in order to facilitate the application of the regulation to social science research? What issues and problems are raised by application of Part 46 as it stands to such research?
It is assumed, for purposes of this analysis, that the expression "social science research" includes behavioral research conducted outside of the clinical psychological setting. purposes of the analysis, and for drafting possible amendments to Part 46, to reach the issue of where "social science research" is discontinuous with "behavioral research"--although it is precisely this thorny boundary question which has been the focus of the greatest wrangling between the agencies within DHEW which have been discussing possible amendments to the regulation.
Background
Under the gun of imminent passage by Congress of the National Research Act, the Secretary of DHEW on May 22, 1974 signed a regulation on "Protection of Human Subjects" for Federal Register publication on May 30. by NIH staff, assisted by DHEW General Counsel staff assigned to, and housed within, NIH. The Department's other line agencies--the Office of Human Development, the Social and Rehabilitation Service, the Office of Education, and the National Institute of Education, inter alia--were not involved in that drafting process; the staff offices within the Office of the Secretary were not involved until very late in the game.
Consequently, the regulation came as a great surprise to the rest of the Department, which was collectively taken unaware not only by the applicability of Part 46 to all Department activities, but also at finding out that the Guidelines preceding Part 46 had, on their face, applied to the other agencies all along. At the time Part 46 was published, substantial differences had arisen within the Department--and, under the deadline pressure, had not been resolved--on the applicability of the regulation to non-biomedical research and to demonstration and service delivery programs.
Notwithstanding the absence of consensus within the Department, the regulation was published in order to meet the perceived needs of the Congressional conference committee then considering the National Research Act (now P. L. 93-348). It was understood within the Department--and
18-1
It is unnecessary for
The regulation was the product of an extended drafting process
alluded to in the preamble to the regulation--that discussion and negotiation would proceed among the agencies and the OS staff offices in order to construct a regulation appropriate to social science research
the decision to publish the regulation, for example, that income mainte- nance and health services financing experiments not be constrained by a regulation written with biomedical research as its conceptual framework.
Extended discussion among the affected organizations within DHEW has made it clear that the agencies generally are responding to the regulation by ignoring it, as they did the Guideline which was its predecessor. The discussion has, however, begun to educate policy-level agency staffs on their responsibilities under the regulation, and has generated reflection on how the regulation might be optimally structured so as to protect subjects involved in non-health-services research. There has been some clarification of precisely what questions Part 46 raises, and whose interests each question affects.
This analysis will identify those major questions, and will suggest some alternative remedies available to the Commission if it should choose to consider amending Part 46 in order to maximize its applicability to all Department research.
and to operating programs. It was intended by the parties involved in
1. Explicit Coverage of Social Science Research
Although social science research is implicitly covered by the Applicability section of Part 46, the history of the regulation has caused many, if not most, grantees and contractors to assume that only biomedical and clinical psychological research funded by the agencies within the "H" part of DHEW is covered. 46 as being ambiguous on whether human subjects at risk arising from social science research are protected.
The language of the informed consent requirement, which seems to many grantees and contractors to be particularly tailored to biomedical research, reinforces their predilection--and that of agency staff outside the "H" organizations--to assume that the regulation simply does not apply to them.
In order to send a clear signal to grantees and contractors, and to all agencies of the Department, that all DHEW-funded research is to be covered by Part 46, perhaps the regulation should specify that its scope of coverage incorporates social science research. perhaps the preamble to the regulation ought to specify that the ambiguous Congressional language "behavioral research" should be construed to encompass all non-biomedical research funded by DHEW.
Other agencies within the Department see Part
Alternatively,
2. Coverage of Intramural Research
For most of its history, Part 46 has not covered human subjects involved in research conducted by employees of the Department (intramural research), only research conducted outside DHEW under grants and contracts (extramural research). NIH has long protected subjects of its own intramural research, but no other agency of the Department has had its own procedures to
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regulate intramural social science research and behavioral research conducted outside of a clinical psychological setting.
In August 1975, as an afterthought to the regulation on fetal research, a new subpart was added to Part 46 in order to achieve the end of regu- lating all DHEW intramural research. That new subpart tries to say that the substantive standards which Part 46 applies to extramural research will hereinafter apply to all DHEW intramural research as well, but that each agency may--emulating NIH--set up its own internal procedures to enforce the application of those substantive standards. was to permit "H" to retain its current internal procedures, while compelling the other agencies to establish procedures which they presently lack.
Assuming that this approach is the optimal one, the new intramural research subpart is at best unclear on just precisely what it is that the agencies have to do. body of the regulation, it is generally unknown within DHEW. minimum, it would seem useful for the substance of the new subpart to be transferred to the Applicability section of Part 46, and for it to be rewritten so as to be specific in its guidance to agency heads on what it is that they have to do tomorrow as a consequence of this new wrinkle in the regulation.
It may be, however, that the approach of many different agency procedures is not the optimal one, on the ground that it is neither seemly, nor consistent with the intent of independent review of research proposals, for employees of an agency to review assurances of compliance from other employees of the same agency.
Under the section Submission of Assurances (§46.4 of Part 46), assurances of compliance with the regulation must be filed by grantees and contrac- tors with the Department, and must be approved as consistent with Part 46 prior to funding of the research. amended to require that when agency staffs propose to conduct intramural research, assurances of compliance must be filed with, and reviewed by, one of the staff offices within the Office of the Secretary or, alternatively, a board of outside advisors to the Secretary. Research involving risk of physical injury, and research conducted in a clinical psychological setting, could remain within the bailiwick of H's intramural review procedures.
Establishing a procedure within OS to review agency research for compliance with the regulation, and requiring that intramural research must receive OS compliance approval, would maximize uniformity across the Department of protection of subjects involved in behavioral and social science research. A body of administrative case law could be established to which agencies would turn for guidance. An OS staff office procedure, or an outside board, would be of assistance to an agency head caught in cross-pressures on whether he should authorize an ethically dubious intramural project.
It would be useful for the Commission to examine (i) whether it is satisfied with the current approach of many different agency internal procedures enforcing one uniform substantive standard; (ii) if so, whether it is satisfied with the extent to which the new subpart clarifies for agency
The intent
Since it is not incorporated into the main At the
Perhaps that section should be
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heads what is to be construed as "procedural" (and therefore subject to variance) and what as "substantive" (and therefore not subject to discre- tionary implementation by an agency head), and whether the language is, generally, sufficient guidance to agency heads and research staff; and (iii) if not, what alternative, possibly including OS staff or advisory board review, would be most likely to ensure substantive compliance with Part 46 by Department employees who conduct intramural research.
3. Protection of Individuals at Risk Who Are Not "Subjects" of Research
In social science and non-clinical behavioral research, persons may be placed at risk of harm even though the research does not generate data about their behavior; and is not intended to intervene in their lives. The researcher never encounters them in the course of administering his research project, but he may be unable to prevent external diseconomies which accrue to them from his experimental intervention or from the data collection process. For example,
(i) Apartment rents may be driven up in neighborhoods which house a threshold mass of housing allowance experiment subjects. The effects of the price rise will be felt by nonparticipant neigh- bors of the subjects, and by those who seek to move into the neighborhood.
(ii) Labor supply prices may be driven either up (if subjects opt out of the labor market) or down (if subjects remain in the labor market, but become willing to take much lower-paying jobs as long as they also obtain an income supplement with an acceptably low marginal tax rate on earnings) in the labor market which contains a threshold mass of income maintenance experiment subjects. Depending upon which way prices go, either nonpar- ticipant employers or nonparticipant competing employees will be financially harmed.
(iii) A police deployment or patrol pattern experiment may transfer some kinds of crime from one neighborhood to another, thereby benefiting some nonparticipant individuals and harming others.
(iv) A health insurance experiment may increase the price, and decrease the supply, of some scarce medical resources in a particular area. At the extreme, a nonparticipant individual may die as a consequence of being priced out of the market for a scarce life-saving resource, which goes instead to an experimental subject whose purchase of the resource is subsidized by the research.
The current regulation does not extend its protections to anyone who is not directly a subject of research. cable to all behavioral and social science research, arguably the definition of "subject at risk" (§46.3) should be amended in order to create a new class of persons at risk who are protected even though the researcher does not perceive or treat them as subjects. current regulation because the definition of "subject at risk" was drafted within the conceptual framework of a biomedical research model.
If the regulation is to be appli-
There is no such class in the
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Some DHEW attornies have argued that nonparticipants at risk arising from social science research should not be protected by Part 46, or should not be as rigorously protected, since the Department owes them no duty under current law. by the biomedical researcher toward his subject. to extend those responsibilities to the nonparticipant at risk, DHEW would open itself, and its research contractors and grantees, to novel legal liability.
It is quite true that the case law of informed consent has thus far been limited to factual contexts involving face-to-face contact between a biomedical researcher and his subject. It does not follow from that, however, that the courts will find a nonparticipant at risk to have no claim. The matter has simply not risen to judicial attention. It may readily be argued that a court will soon find a plaintiff nonparticipant at risk to be, with respect to social science research, in the same position as the subject of biomedical research, and therefore to be entitled to protections analogous to those of Part 46.
Even assuming that judicial remedy would be restricted to subjects who have chosen to participate in research, so what? The limitations of current law need not constrain either the Secretary or the Commission in parsling out what kinds of protections are ethically--if not legally-- owed to nonparticipants at risk arising from research funded by DHEW. The current regulation, in fact, offers protections to subjects which
The Commission can recommend, and the Secretary can make, new law.
It has also been argued that creation of a new class of administratively protected nonparticipants at risk would be detrimental to some biomedical research, since family members and friends of subjects could claim harm solely by virtue of their relationship with a subject who is actually at risk of harm arising from his participation in an experiment. Assuming that it is undesirable to compel biomedical and behavioral researchers to seek the informed consent of family members and friends who may be at risk solely because of their contact with a research subject, the problem can be avoided by incorporating into the regulation a new definition of "physical injury" and, perhaps, of "psychological injury". The definition could specify that injury cannot be claimed, for purposes of invoking the protections of Part 46, solely by virture of a person's family or other relationship with a research subject.
Were that definition written into Part 46, creation of a new legally protected class of nonparticipants at risk would not constrain biomedi- cal research. It would, however, protect nonparticipants unwittingly at risk arising from social science research.
Case law has, in contrast, established clear responsibilities Were Part 46 to be amended
exceed the protections upon which the judiciary has reached consensus.
4. Should Participants in National Demonstration Programs and Service Delivery Programs be Covered by the Regulation?
Part 46 presently extends its protections to participants in all "research, development and related activities" funded by DHEW. related activities" is undefined, and may be construed to cover non-biomedical demonstrations and service delivery programs. the regulation language seriously, a number of interesting problems would follow:
"Development and
Were the agencies to take
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(i) National demonstration programs such as Head Start and youth services systems would be required to have each grantee create an institutional review board. In the politically supercharged community environment within which the grantees function, the constitution of such a board--and its power to constrain a program director-- might well become political footballs tossed between community groups struggling for legitimacy and power. That is a cost arguably worth incurring when there is more than minimal risk to a child, but is it still worth it when the IRB is to be established--and consent sought from every parent--simply because Head Start and youth ser- vice systems depart from the established and accepted methods of reaching children?
In the eyes of managers of these and a number of other non-biomedical national demonstration programs, the prospect of creating an IRB and seeking consent from every participant's guardian is an explosive, and unnecessary nightmare.
and IRBs of every grantee who conducts a service delivery program which departs from established and accepted methods of meeting participants' needs--even though the risk is marginal, and even though the program is not perceived by
mental health centers would be required to conform to Part 46, for instance, as would schools which receive compensatory education funds under Title I of the Elementary and Secondary Education Act.
Conformity with Part 46 by these kinds of program raises, on a national scale exceeding that of demonstration programs, the prospect of widespread community infighting triggered by allegations of marginal risk.
(ii) On its face, the regulation would also require consent
DHEW as either an experiment or a demonstration. Community
Although the non-"H" agencies have striven to avoid applying Part 46 to national demonstrations and to service delivery, it seems inescapable from the face of the regulation language that they will have to begin doing so. If the Commission and the Secretary deem that to be a desi- rable outcome, it would be helpful to agency managers if Part 46 were amended to make it explicitly clear that the intent is to include all DHEW grantees and contractors, not only those engaged in research and developent.
Alternatively, perhaps the regulation should be amended to specifically exclude from its protections persons receiving benefits from national demonstrations and from service delivery programs, save for biomedical national demonstrations which--like clinical trials or HMOs--may involve risk of physical harm to participants.
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5. Should the Regulation Protect Subjects and Others Against Injury
Part 46 protects a subject at risk of "psychological injury" or "social injury", without defining those expressions. Absent a definition of "psychological injury", someone may claim risk of injury if the interests of his racial, ethnic, religious, economic, or community group seem to conflict with a particular research project--even if there is no other risk of harm to the individual separate from the alleged harm to his group. or friend of someone who has for instance, or has lost self-esteem) by research.
With "psychological injury" already a component of' the definition of risk, the additional expression "social injury" opens a Pandora's box of allegations of injury to an individual in his capacity as member of a group or community. particular research project is injury to a group or commmity, a large dose of political hoopla will doubtless accompany the establishment of an IRB and the submission of a general or special assurance under the regulation.
Given the inevitable political conflict, the question is whether alle- gations of group or collateral psychological injury should be sufficient to trigger the protections of the regulation, absent a separately iden- tifiable risk of individual injury. injury" should be stricken from the regulation, and a new definition of "psychological injury" should be added to Part 46, specifying that risk of such injury refers only to that injury which a person may suffer in his individual capacity, and not merely in his capacity as a relative or friend of a research subject, or as member of a group or
Suffered by Them in Their Capacity as Members of a Group?
Moreover, someone may claim risk solely because he is a relative actually been injured (has become depressed,
If the only risk alleged with respect to a
If not, the expression "social
community.
6. Should Risk of Financial Injury be Covered?
Part 46, drafted within a biomedical conceptual framework, contains no reference to risk of financial injury. The regulation consequently fails to protect persons participating in income maintenance, health insurance, and other social science research funded by most of the agencies in DHEW.
Assuming that Part 46 is to protect persons at risk in all research conducted or supported by DEW, risk of loss of present or anticipated assets or income ought to be incorporated into the definition of risk.
7. Risks Arising from Publication or Policy Application of Research Results 1/
Social science research is sometimes met with interest group or community protests on the ground that publication of a research conclusion (cf. Arthur Jensen's research), or government policy changes based on the research results (cf. the income maintenance experiments, particularly in Gary, Indiana), will be harmful to the group or community as a whole, although specific risks to specific individuals cannot be identified.
The regulation is silent on whether such alleged risk triggers its
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protections, but a number of grantees and contractors have run up against the question. Where it has arisen, it has been highly politicized.
If indeed we do want such risks explained to subjects (in, for instance, educational performance research which will compare ethnic or economic group performance on IQ or achievement tests), and considered by IRBs, then that intent should be made explicit in the definition of risk. If not, it would be helpful to those conducting field social science research if language were added to the definition of risk providing that, except as research results pertain to a named or identifiable person, "risks arising from publication or policy application of research results" will not be deemed sufficient to trigger invocation of the protections of Part 46.
The exception for research results pertaining to a named or identi- fiable person will protect the subject of biomedical or clinical psychological research whose case history has been taken, and whose privacy would be invaded by publication of material from that case
8. Must All Research Procedures, and the Purpose of Research, be
Part 46 presently requires that all research procedures be explained, in all types of research, regardless of whether particular procedures do or do not cause a subject to be at risk. part of the informed consent process (§46.3(c)), that purposes be fully explained to the subject, regardless of whether particular purposes are material to his determination of risk to him.
DHEW's Guidelines until 1974 did not specify that purpose be disclosed, and the American Medical Association's principles still do not. Disclo- sure of purpose is, however, required in the Nuremberg Code, the Decla- ration of Helsinki, and the World Medical Association Code. 2/ Several of the participants in the recent Brookings conference on social experi- mentation went out of their way to suggest that "There should be no ethical responsibility to inform subjects in analytical detail about the intent of the research," 3/ and
(i) " /T/ o disclose the purpose of the research may jeopardize
history.
Explained to the Subject?
It is also required, as
the scientific validity of the results. This is certainly true in social science research since it is concerned with the behavior of subjects....This behavior may be influenced not only by the pure treatment, but by...the subject's perception of the experimenter's expectations. a subject in a health insurance experiment that you will be interested in how he utilizes medical services may well
To tell
bias his response, particularly if the explanation is followed by frequent questions about health." 4/
(ii) "The most appropriate course / for the researcher, in obtaining informed consent from a subject/ seems to be to emphasize the important facts that will influence their decisions to participate...." 5/
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(iii) " /E/ xperimenters have no moral obligation to give subjects more information than they need to act in their long-run best interests, particularly if there is a risk that subjects might respond differently...." 6/
subjects all information relevant to their own decision to participate." 7/
The problem is that explanation of research purpose, and of some research procedures, will skew research results in many types of behavioral and social science research, because the subject's beha- vior will be affected by his acquisition of the knowledge. Whether or not a subject takes a job while he is receiving benefits under an income maintenance experiment, for instance, may well be affected by his knowledge that the major purpose of the experiment is precisely to discover whether or not the income supplement affects his labor market decision.
What the Brookings conference participants generally argue is that research purpose and procedures should be disclosed only insofar as the information is material to the subject's decision process as to whether or not he will participate in an experiment, and on what terms. An alternative formulation is to require explanation only of those research procedures which may cause an individual to be at risk, including identification of any procedures which are experimental. risk is disclosed, perhaps research purpose may be omitted most of the time in securing informed consent.
Whether the Commission elects to adopt the Brookings conference consensus (explain what is material to the subject's decision), the risk test (explain only what is material to determination of risk; omit explanation of purpose entirely if it is not), or a third alternative, this is an issue which badly needs examination. As currently drafted, the language of the regulation's definition of informed consent is inappropriate to non-biomedical research. It erects for behavioral and social science research a disclosure requirement which goes far beyond what is necessary to enable a subject to make rational choices in the informed consent process, and it does so at the cost of skewing research results.
Practically, what seems to be happening now is that DHEW agencies, including those agencies within "H" which conduct and support behavioral research, simply ignore this requirement, or effectively waive it through an inappropriate use of the regulation's modification clause (§46.10(c)). The seemingly stringent requirement for complete disclosure of procedures and purposes has the effect, in the real world of research, of protecting subjects much less than a moderated, enforceable requirement would.
(iv) "The only thing he / the researcher / can do is.. .give the
If only information material to the calculation of
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9. Must Benefits Expected from the Research, and Alternative Procedures, be Explained to the Subject in Social Science Research?
Part 46, within the framework of the biomedical model, currently requires explanation to the subject of benefits which he may expect from the research, and of "appropriate alternative procedures that might be advantageous to the Subject".
Explanation of benefits, like explanation of research purposes and of some research procedures, may skew social science research results by affecting the subject's behavior, particularly if the subject is in a control group and understands the difference between the benefits which he is receiving and those which accrue to members of an experimen- tal group.
In biomedical research, there may be standard and accepted procedures which are real alternatives for a subject in research. science research, no such beneficial alternatives usually exist, while an infinity of benefit permutations (how much money and what kinds of services we provide in an income maintenance experiment, for instance) may be available. Explanation of all possible benefit packages would burden the researcher to no gain by the subject, and may cost the researcher loss of subjects.
Perhaps the informed consent definition should be amended to provide that all benefits and alternative procedures need be explained only, as in biomedical and some behavioral research, when a standard and accepted therapeutic option is available. be maintained for those types of research to which it is material, while a needless burden would be removed from social science researchers.
Alternatively, perhaps benefits and alternative procedures should be explained whenever a standard and accepted option is available (when, for instance, the subject in a housing allowance experiment could obtain a higher subsidy from another program, were he to withdraw from the experiment), irrespective of whether the option is "therapeutic" within the biomedical and clinical psychological models.
10. Should Possible Breach of Confidentiality of Data Collected in
In social
The same requirement could
Survey Research be Considered a Risk Which Triggers the Protections of This Regulation?
Survey research raises most acutely a problem inherent in all data collection: is breach of confidentiality of the data collected to be considered a risk which triggers invocation of Part 46? The current regulation is silent on the issue, permitting the inference that breach of confidentiality may be or risk reasonably to be expected" (§46.3(c)). It follows, if the inference is made, that the survey researcher must, before he begins to ask his questions, describe in detail the various ways in which respondent confidentiality may be breached, and obtain the respondent's formal informed consent.
construed as an "attendant discomfort
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If the research investigator has to proffer a lengthy explanation of the risk and obtain a consent form, the probability is high that he will lose many of his chosen respondents, thus making it difficult or impossible for him properly to randomize or stratify his sample. or many of those whom he does not lose will prove less than frank in their answers, destroying the utility of his data.
Breach of confidentiality under judicial or other governmental subpoena definitely is a risk, as David Kershaw recounts in the Brookings con- ference in noting that a grand jury, at least two welfare departments, the General Accounting Office, and the Senate Finance Committee attempted to secure confidential data from the New Jersey income maintenance experiment (mostly in order to track down fraudulent welfare recipients) 8/
There is, moreover, the simple danger that gossip by survey research employees engaged in data collection or analysis will harm a respondent.
The effect of rigorous imposition of the informed consent requirement in survey research can, on the other hand, destroy the utility of the research design and instruments:
Some
"In short, informed consent procedures are going to make social research inaccurate. remain forever undeterminable.... The study clearly demonstrates that the inclusion of informed consent procedures in some types of social science /survey/ research will lead to serious loss of data and /to/ response bias in some circumstances." 9/
The amount of error is unknown, and will
In order to minimize the effects of data loss and response bias, moreover, it is--as Donald Campbell has noted 10/ --essential for data to remain available for sample reinterview. This is particularly true when surveys are focused on service delivery by states and units of local government, and when there is a need for Federal auditing of the data in order to ensure that services have actually have been delivered as reported. Data verification, whether for these purposes or simply to check interviewer honesty and competence (Campbell's concern), imposes additional risks of breach of confidentiality which, if explained to the respondent, will induce further respondent loss and response bias.
One way to handle the problem may be to amend the definition of informed consent, in Part 46, to provide that if the survey research investigator has established measures to ensure confidentiality of collected data, and if he has tersely informed the respondent that the risk of breach exists and that the measures exist, the risk of breach of confidentiality will not be considered an "attendant discomfort or risk reasonably to be expected", and will therefore not trigger the protections of the regulation. What would be required of the survey researcher is that steps be taken to actually protect confidentiality, and that the sub- ject be informed that such steps have been taken.
The effect of such an amendment would be, assuming that the researcher met the prerequisite conditions, to specify that the researcher need not explain in detail what each of the risks of breach are, and need not obtain formal informed consent as a prerequisite to asking survey questions.
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Alternatively, the Commission may wish to make such an amendment appli- cable to all social science research, or all research funded by DHEW, not merely survey research.
Whatever the resolution of the problem, there is a need for it to be addressed. Abundant feedback from the survey research community indi- cates that it is confused as to its responsibilities under Part 46, and that it is generally reacting to that confusion by ignoring the regulation. Whatever the treatment of the confidentiality problem in survey research is to be, there should be language specifically addressed to it in the definition of informed consent or, alternatively, in the definition of risk.
11. Should Waiver of the Informed Consent Requirement be Permitted Under Exceptional Conditions in Social Science Research?
The present regulation provides (§46.10(c), Documentation of Informed Consent ) that there may be modification of the form of documentation that consent has been given by subjects in a particular research project. DHEW agency staffs, and grantees and contractors indicate that this "modification" clause is frequently used to effect a waiver of some of the elements of informed consent. This has been done when it has appeared that a particular research project could not proceed if the whole informed consent procedure were to be implemented--if, for instance, all procedures employed in the research were explained to subjects whose behavioral responses were to be measured by the research.
It is clear that the modification section needs tightening up to ensure that it cannot be used as an invisible justification for abdication of some elements of the informed consent requirement.
Widespread use of the modification clause to avoid some of the substan- tive protections of the regulation, however, does suggest that there may be circumstances in which the Secretary, the funding agency, or an outside advisory board should be empowered, pursuant to strictly drawn criteria, to waive some of the elements of informed consent for particular research projects. For example,
Reports from "H" staff supervising behavioral research, other
(i) What if, as in a housing allowance or a police patrol experiment, it is impossible to identify all of the nonparticipants at risk arising from the experiment? Alternatively, what if they can be identified only at prohibitive cost?
(ii) What if they can be identified, but it is impossible to obtain consent at reasonable expense from a large non-subject population at risk, with whom the researcher would not ordi- narily establish contact in the course of the research?
(iii) What if, as in unobtrusive measures research, there is a research design need to prevent individuals from knowing that the research is being conducted, in order to avoid skewing of otherwise natural behaviors which the researcher seeks to observe?
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In social science research in which such circumstances are present, and perhaps in other cirumstances as well, we may want to empower the Secretary or another party to waive some of the elements of the informed consent requirement, provided that:
(i) The waiver would apply only to nonparticipant persons at risk arising from the research in question, not to subjects who are identifiable ex ante and from whom data is collected. In a housing allowance experiment, for instance, waiver might be granted with respect to neighbors whose rents may be affected by the experiment, but not with respect to subjects who actually receive the allowance.
(ii) Waiver would be granted only upon a showing that it is "demonstrably infeasible" to obtain informed consent from a specified nonparticipant population, on the ground that one of a number of narrowly specified triggering conditions exists. The regulation could specify that the expression "demonstrably infeasible" (or some analogue) be strictly construed, and that the criteria--the conditions precedent-- be very strictly construed. It could be specified that the intent of the strict construction is that waiver be infrequently approved.
(iii) Waiver would be granted only under the condition that the information withheld be given, where the persons at risk are identifiable, to the affected persons in a debriefing after the research procedure has been completed.
(iv) Waiver would be granted only under the condition that the research investigator attest in writing that the risk to nonparticipants reasonably to be expected from the research is deemed insubstantial in probability and in magnitude.
In the event of waiver, and if the nonparticipants at risk reside prin- cipally within a particular unit of local government or, alternatively, within a single state, perhaps the regulation should require surrogate consent by an official of the local or state government. This proxy for individual agreement would be intended to provide local control over the acceptability of risk to non-subject persons, and to maximize the willing participation of the community affected by the research.
Given the realities of local government, the probability is that members of the community disinclined to have their local government consent to an experiment will be able to have their way, even though their numbers be few--simply because they will care much more about the research than those community members inclined to permit proxy consent to be given to a particular research project. care most intensely about an issue are generally able, absent similar intensity of feeling on the other side of the issue, to prevail at the local govemnent level.
11/ Several of the Brookings conferees indicated their enthusiasm for surrogate local government consent as a means for protection of
Those who
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non-subject populations at risk from research which affects an entire community, labor market, or commodity (such as housing, or hospital services) market. There were some caveats, however:
"For large-scale social experiments... it is unlikely that any group with a prior definition will ever be quite unanimous in its consent--or unanimous without what some commentators have been calling 'undue inducements.' (Or, as probably happens, a majority coerces the minority to shut up and sign up, or a minority coerces the majority to do so.)" 12/
"This extension of the consent principle /proxy consent by elected representatives of affected nonparticipants/ may not always have the intended effect. When representatives of the Department of Housing and Urban Development took their proposal for a housing allowance supply experiment before the city council of Green Bay, Wisconsin, and carefully explained that local house prices might increase as a result, the council's immediate response was eagerly to calculate the implicit rise in property tax revenues." 13/
Surrogate consent will be pernicious and arbitrary in its effect upon nonparticipant subjects when the interests of politicians making the consent decision diverge from the interests of the affected population, and when the researcher can offer inducements to the politicians to make a decision unrelated to their constituent interests. council perceived a way to raise taxes without incurring the political costs to themselves, and weighed that personal interest above the inte- rests of their constituents at risk.
If a surrogate consent provision should be added to the regulation, it should be specified that all of the elements of information which must be presented to a subject in order to gain individual informed consent must be presented in writing to the local or state official who executes the affidavit of surrogate consent. Although the proce- dure be different, and the giver of informed consent not the person affected, the substantive elements of consent should remain.
It seems clear that, absent addition of a waiver provision to Part 46, either it will be impossible to perform some social science research within the constraints of the regulation, or the modification clause will continue to be used as an invisible, unregulated, unarticulated waiver. actually increase the protections available to nonparticipants at risk in social science research funded by DHEW.
Surrogate cansent of some form will, assuming the availability of waiver or modification, maximize the protection available to non-participants with whom the researcher does not come into contact.
In Green Bay, for instance, it appears that the city
Addition of a waiver would, assuming the latter prognosis,
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14/ 12. Compensation of Subjects; Restoration of Status Quo Ante
The regulation is silent an whether, and under what researcher or the Department has the responsibility to compensate a subject. For example,
circumstances, the
(i) Should the Department sponsor, and should each research investigator be required to pay premiums into, a no-fault insurance system which will compensate subjects for unfore- seen harm, the possibility of which was not mentioned to the subject by the investigator in the process of obtaining informed consent?
(ii) If such a system is established, should subjects be compen- sated not only for unforeseen harm but also for improbable catastrophic harm, the possibility of which had been foreseen and explained by the investigator to the subject in the process of obtaining informed consent?
harmed nonparticipants from whom informed consent was never sought, in comparison to subjects who gave informed consent after having been warned of the small risk of foreseeable catastrophic harm? Assuming that the harm is not catastrophic, is there greater responsibility to compensate nonparticipants who never gave consent, in comparison to subjects?
What is the operational meaning of that greater duty toward nonparticipants who did not give consent, if such duty exists?
investigator have the responsibility to insure the status quo ante --to ensure that subjects are left after the experiment no worse off than they would have been had they never partici- pated in it, or no worse off than they were when it began? Does the researcher have, for instance, the obligation to guarantee reinsurability for participants in a health insurance experiment who have allowed their pre-existing policy to lapse, or to ensure that subjects in a housing allowance experiment can obtain, if and when they are compelled to leave their experimentally subsidized housing at the end of an experiment, housing equivalent in quality and price to what they had before they began receiving the allowance?
the status quo ante for a subject who withdraws in the middle of a research project?
(vi) Has the investigator a similar responsibility toward a non-subject in the experimental community who emerges harmed at an experiment's termination?
(iii) Is there more of a duty to compensate catastrophically
(iv) After a social science experiment is over, does the research
(v) Has the investigator a similar responsibility to restore
These, and other compensation issues, warrant amendments to Part 46 and consideration by the Commission.
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Conclusion
Based upon the conceptual framework of a biomedical research model, the current regulation on protection of human subjects is inappropriate, in a number of major respects, to effective regulation of social science research. The response to the regulation, both by non-"H" agencies of the Department and by private research investigators, indicates that it is either not being applied to social science research at all or, where applied, has the potential of skewing substantially the data collected by that research.
The Commission ought closely to examine the current regulation in order to determine what amendments to it, if any, should be recommended in order to maximize the protection actually available to human subjects and to other persons at risk arising from social science research funded by the Department.
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Footnotes
1. On risks arising from publication or policy application of research results, see also Alice M. Rivlin and P. Michael Timpane (editors), Ethical and Legal Issues of Social Experimentation, Washington, D. C.:
/hereinafter, "Brookings conference"/, The Brookings Institution, 1975 pp. 73, 78, 81.
2. Ibid. , p. 52.
3. Ibid. , p. 78.
4. Ibid. , p. 73
5. Ibid. , p. 65
6. Ibid. , p. 107.
7. Ibid. , p. 114.
8. Ibid. , pp. 69-70.
9. Lloyd B. Lueptow (Summarized by Keith Baker), Bias and Non-Response Resulting from Informed Consent Procedures in Survey Research on High School seniors, unpulished, DHEW: Off ice of the Assistant Secretary for Planning and Evaluation, January 1976, pp. 43, 6.
10. Donald Campbell et al, Protection of the Rights and Interests of Human Subjects in Program Evaluation, Social Indicators, Social Experimentation,
Sketch, January 1916, p. 13. and Statistical Analyses Based Upon Administrative Records, Preliminary
11. Brookings conference, pp. 77, 95, 110. 125, 171-72.
12. Ibid. , p. 172.
13. Ibid. , p. 110n4.
14. On compensation of subjects and on restoration of status quo ante, see ibid. , pp. 11, 18, 54, 57, 63, 70, 76, 77, 103, 174.
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IV
RISK/BENEFIT CRITERIA
19
SOME PERSPECTIVES ON THE ROLE OF ASSESSMENT OF RISK/BENEFIT
CRITERIA IN THE DETERMINATION OF THE APPROPRIATENESS
OF RESEARCH INVOLVING HUMAN SUBJECTS
Bernard Barber, Ph.D.
December 1975
INTRODUCTION
The draft of a recently compiled Annotated Bibliography on
the Protection of Human Subjects in Social Science Research
(Washington, D.C.: Bureau of Social Science Research, 1975, mimeo.)
speaks of "the scarcity of material which is explicitly concerned
with the assessment of risk for subjects involved in social science
research." This scarcity or lack has now, fortunately, been consider-
ably corrected by Dr. Robert Levine's staff paper for the Commission,
"The role of assessment of risk-benefit criteria in the determination
of the appropriateness of research involving human subjects," (mimeo.,
Oct. 27, 1975). Since Dr. Levine did not limit his discussion to
biomedical research but referred to behavioral research as well, and
since I find his analysis altogether excellent in its cogency, its de-
tail, its comprehensiveness, and its examples, I can be most useful by
directly orienting my paper to his. In the first part of my paper, as
I take up some general issues in the assessment of the risk-benefit
ratio in behavioral research, I will be trying to add to, refine,
extend, set in perspective, and evaluate Dr. Levine's discussion. In
the second part of my paper I will present some findings from a small
study I have done of the actual experience during the last three years
of the Columbia University Human Subjects Review Committee, the peer
review committee responsible for all the non-medical research carried
out by the Columbia faculty.
data on actual experience in peer review groups with the risk-benefit
issue. Finally, in the third and last part of my paper, I would like to
say something about ongoing and needed research on the risk-benefit issue.
I will also present a few other available
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Too much of the discussion of the ethical problems of using human
subjects in research proceeds in terms of ethical abstractions not
clearly related to the empirical data they are supposed to clarify
in order for us to make ethical decisions. I find the ethical ab-
stractions of values not all that hard to come by; they are not
esoteric; they are usually available even to informed common sense.
But the facts to which they refer, those that make it possible to
estimate the weight of the several ethical abstractions and to bal-
ance off these values one against another in the process of ethical
decision, those are often not available in any systematic and reliable
form, nor are they easy to collect. That is why we need so much re-
search for all aspects of the Commission's deliberations. For ex-
ample, there is no lack of ethical abstractions for the discussion of
fetal research or psychosurgery, to take two issues on which the
Commission is specifically charged with responsibility. What has been
lacking are reliable data on which to base established ethical principles
for these two areas. The Commission has now supported useful research
in both of them. More research is also essential to the Commission
for its deliberations on the ethics of behavioral research on human sub-
jects.
SOME GENERAL ISSUES IN THE ASSESSMENT OF THE RISK-BENEFIT
RATIO IN BEHAVIORAL RESEARCH
1. Is the assessment of the risk-benefit ratio in behavioral re-
search fundamentally different from or similar to such assess-
ment in biomedical research?
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During the last few years, as behavioral researchers have become
aware that their work was to be subject to ethical peer review in the
same way as that of their biomedical colleagues, they have responded
with much of the same uneasiness, hostility, and conservatism earlier
displayed by these biomedical colleagues.
"Liberalism Stops at the Labaratory Door," 1975, mimeo., and Barber,
"Social Control of the Powerful Professions," 1975, mimeo.) As a part
of their complaint against the imposition of ethical peer review on
behavioral research by the D.H.E.W. regulations in 1971, they have
said that their work should not be covered by "the medical model" that
they allege is implicit in the D.H.E.W. regulations.
work with human subjects, and just how the problems of ethical control
in their area, are different from "the medical model," they do not make
quite clear. Yet they are raising an important question. How different
are the ethical problems of behavioral and biomedical research? Is the
assessment of the risk-benefit ratio different in behavioral and bio-
medical research?
(See Bernard Barber,
Just how their
Perhaps just because Dr. Levine did not in his paper set himself the
task of answering this question directly, indeed he did not take it as
in any way his task, I find the answer that is implicit all the way
through the paper all the more convincing.
as I read and re-read Dr. Levine's paper, is that the similarities are
far, far greater than the differences between biomedical and behavioral
research in respect of the problem of assessing risk-benefit ratios. I
found large and fundamental similarities with regard to such matters in
Dr. Levine's discussion as: (a) the basic meanings of what are injuries,
what are benefits; (b) the specification of the significant dimensions
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That answer, it seemed to me
of risks (likelihood, severity, duration, reversibility, early
detection, ability to treat or correct) and benefits (Dr. Levine
himself says, p.38, "The benefits may be analyzed similarly whether
the research is in the biomedical or in the behavioral field.");
(c) in his classification of categories of risks and benefits
(physical, psychological, individual and social, legal, and economic);
(d) in his list of some of the specific psychological harms that may
occur from biomedical research (fear of rejection, guilt and self-blame,
distrust); (e) in the nature of the task of assessment of the balance
of risks and benefits; and, (f) in the question of where authority and
control in the assessment process ought to exist. As is indicated in
the sentence on p.38 of Dr. Levine's paper quoted above, occasionally
even he makes the fact of similarity quite explicit. It is also clear
from his frequent references to examples and consequences of behavioral
research; the implicit assumption of these references is the similarity
to biomedical research.
list of Ethical Issues in Social Experiments" prepared after a recent
two-day Brookings Institution Conference on Ethical and Legal Issues of
Social Experimentation, a Conference in which social and medical experi-
ments were explicitly compared with one another. The Checklist's section
on the question, "Have you specified and reviewed the benefits and harms
of your experiment?" is no different from what such a section would look
like for biomedical research.
eds., Ethical and Legal Issues of Social Experimentation, Washington,
D.C.: Brookings, 1975. See also, Henry W. Riecken and Robert F. Boruch,
eds., Social Experimentation: A Method for Planning and Evaluating Social
Intervention, New York: Academic Press, 1974, pp.246-8, 252-3.)
This similarity is also manifest in "A Check-
(Alice M. Rivlin and P. Michael Timpane,
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Fundamental similarity is not, of course, identity. While the
principles and procedures of risk-benefit assessment in both fields
are fundamentally the same, we should be alert to and responsible for
such differences as also occur. But I think we get a better start on
understanding risk-benefit assessment in behavioral research if we
start with the fact of similarity and the useful immediate guide that
gives us to good practice with respect to behavioral research.
there is no good evidence that peer review groups considering behavioral
research protocols have not been able to operate with the standard
D.H.E.W. regulations for all research.
of an argument for difference, whether it is a general argument or
applies only to specific points, lies with those behavioral researchers
who choose to assert it.
Indeed,
It seems to me that the burden
On one important matter of similarity or difference between be-
havioral and biomedical research, the relative overall amounts of
riskiness or injury, on the one hand, and of benefits, on the other,
I am not now committing myself. This is a more complex aspect of the
problem of similarity and difference, hard to discuss in the absence
of data, not to be left to mere opinion or prejudice.
to this issue later after considering a little further what we mean by
risk and injury.
I will come hack
My summary view, then, is that there is very large similarity and
overlap in all fundamental aspects of the problem of assessment of risk-
benefit ratios in biomedical and behavioral research. Some consequences
follow from this similarity which it is useful to point out. One
consequence is that despite the fact that research institutions often
have different ethical peer review committees for behavioral and bio-
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medical research because of the different technical substance in-
volved in these two kinds of research, these different committees,
because of the great similarity of their tasks, ought to have much
more communciation and cooperation with one another than they now
do. Another consequence is that it would be very helpful all around
to include more behavioral researchers in the process of establishing
general principles and rules for ethical treatment of the human subjects
of research. We all owe a great debt to N.I.H. and D.H.E.W., where
this process has been chiefly located, but it has perhaps been too
largely in the hands of biomedical researchers. Behavioral scientists
would be especially valuable for their awareness and insistence on the
necessity for researched-based data and decisions in all aspects of
the ethics of experimental research on human subjects.
2. The dimensions of "risk": amount and probability of injury.
Before proceeding further, it will be helpful to discuss a small but
important definitional point made by Dr. Levine at the very beginning
of his paper.
the ambiguity in the meaning of the term "risk" as it is now used in a
taken-for-granted way in all discourse on risk-benefit ratios.
right that this now-standard usage actually implies two different elements,
one the amount of injury or harm that may be done to research subjects,
two the probability that the estimated amount will occur.
these two elements explicit, by calling one "amount of injury" and the
other "probability," we gain a number of advantages.
explicit that we are talking about injury, a very concrete term and one
that leads on quite directly to making very specific statements about the
nature of that injury. Second, we see more easily that there can be a
He is quite right, I think, in feeling uncomfortable with
He is
If we make
First, we make it
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varying relationship between injury and probability. Small injuries
may be very probable and large injuries may be most improbable.
various combinations are important for the decisions made by peer
review groups.
peer review groups may want to require him to furnish, a set of
possible injurious outcomes of research, consisting of different
combinations of amount and likelihood of injury under different con-
ditions. Anything we can do to be clear and specific will make our
peer review group decisions easier and better.
which amount of injury and its probability of occurrence are both
specified so far as possible, would be equally applicable and equally
valuable in both biomedical and behavioral research.
Such
Indeed, the researcher may want to provide, and the
This new usage, in
3. The "biological person" and the "social person".
We may clarify the underlying issues and see the fundamental
similarity in the outcomes of biomedical and behavioral research a
little more clearly still if we adopt for present purposes a somewhat
different classification of the types of injuries ("risks") and
benefits than the one Dr. Levine has taken over from common usage
(physical, social, psychological, etc.) We may speak of injuries
or benefits being done to or occurring to either the "biological
person" or to the "social person".
discussion of the ethics of the use of human subjects to say that there
are two essential issues, "the risk-benefit ratio" issue and
"informed voluntary consent" issue.
speaking is that the first issue, risks and benefits, concerns
only the "biological person" and that the second issue, informed
It has been the pattern in
The implication of this way of
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consent, concerns the "social person". But we can now see from Dr.
Levine's discussion and examples that the injuries and benefits of
biomedical research, as much as of behavioral research, involve the
"social person" as well as the "biological person".
can injure the "social person" by causing him to feel guilt or
anxiety or a sense of being discriminated against; it can injure the
social body by creating distrust between physician-investigators and
their patient-subjects or by discriminating in its selection of research
subjects, as by using the poor disproportionately often, for all types
of experiments and, even worse, disproportionately often for those
experiments where the risk-benefit ratio is unfavorable. (For the
data on these two patterns of discrimination, see Bernard Barber,
John Lally, Julia Makarushka, and Daniel Sullivan, Research on Human
Subjects, New York: Russell Sage, 1973.) For biomedical research, then,
it is not just "informed consent" that applies to the "social person"
but all aspects of that research.
Biomedical research
Indeed, perhaps we can see this point more vividly by noting
that to a considerable extent it is the social and cultural definitions
of a society that determine what is to be considered an injury even
to the "biological person".
of what is to be considered an injury to the fetus or the terminally
ill as "biological persons," we see how much the "biological person"
is socially defined. Even for biomedical research, then, the
"biological person" and the "social person" overlap and blend into one
another.
As we consider the difficult questions of
For behavioral research, of course, the overlap and merging
are clearer.
of harm to the "biological person," though Dr. Levine gives some
examples from psychiatry where this occurs. The primary concern in
For one thing, there is less possibility, obviously,
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behavioral research is with injury to the "social person". In this
perspective, there is no difference for behavioral research between
the "risk-benefit ratio" issue and the "informed consent" issue.
All injuries on either ground tend to be to the "social person".
Violations of informed consent regulations are as much injuries to
the "social person" as are injuries to personal esteem or reputation.
"Deception" in psychological experiments or in social research (through
the use of "unobtrusive measures") are injuries even though a peer
review group may mark them down as a violation of the rules of informed
consent.
In sum, when we consider the degree of relativism in our defi-
nitions of the "biological person" and the "social person," when
we see how they overlap and interact with one another, we are impressed
with the great similarity of the possible injurious outcomes of
biomedical and behavioral research. In making ethical decisions
about the use of human subjects in any kind of research, ultimately
what we are interested in is the moral status of the "social person".
4. The fact and necessity of risk-benefit assessment.
Absolutistic and perfectionist thinking about risk benefit
assessment procedures, which occurs among some biomedical and behavioral
researchers, and not least of all among those of them who are opposed
to such procedures, is the great enemy of realistic and continuing
attempts to achieve improvement in these matters. We should be
impatient with absolutistic and perfectionist thinking which expresses
itself in such declarations as, "You can't truly get informed consent,"
or "You can't really make a risk-benefit ratio assessment". Realistic
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thinking on risk-benefit ratio assessments, whether in biomedical or
behavioral research, proceeds on the premise that a considerable
amount of such assessment will in fact be easy, another and smaller
amount may be difficult but still possible, and that only a very small
amount will be so difficult as to be considered "impossible".
practical and moral necessity for such assessment is obviously there,
and the fact of relatively successful performance is also clear.
as we make rough but approximately satisfactory risk-benefit assess-
ments in the thousand-and-one routine and extraordinary activities
of daily life, so we now have a considerable experience with the
fact that biomedical and behavioral research peer review groups are
making risk-benefit assessments on the same terms and in a routine way.
For the majority of such assessments, the easy ones, there is no great
moral or cognitive strain on the peer assessors. But for the more
difficult ones, as we learned by mail questionnaire and personal
interview from the six hundred or so biomedical researchers who par-
ticipated in our two studies and made such risk-benefit assessments
for us of "hypothetical but real" research protocols, there is some
strain.
number of cases, not only among our study respondents, but in actual
peer review groups, scientific peers do overcome this strain and make
conclusive assessments.
The
Just
(See Barber, et al ., op . cit .) Nonetheless, in a sufficient
We should remember that, even where difficulty and strain occur
in the assessment process, they are worthwhile just because the process
of making assessments has value over and beyond the outcome or product
of the process. Whether routine or difficult and causing strain, the
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process of explicitly estimating injuries (amount and probability)
and benefits (again, amount and probability) is important in itself.
The process is in itself "consciousness-raising;" it leads to higher
ethical awareness. One hopes that the product , now or eventually, will
also be better, but that happy condition we should not expect ourselves
to guarantee. We should not expect, and certainly not require perfec-
tion of risk-benefit assessment in all cases from our biomedical or
behavioral review groups.
and heavenly worlds. Moreover, we should inform the general public
that we do not guarantee perfection of assessment product but only
excellence in the process . We should inform them that we are prepared
to defend scientific research assessment, when it is conscientiously
and competently carried out by professional peer review groups,
against all demands for utopian perfection of product .
Perfection in all cases is for utopias
Another way in which unrealistic expectations for risk-benefit
assessment products express themselves is in the call for quantitative
and complexly mathematical formulations and specifications of the risk-
benefit balance in any particular piece of biomedical or behavioral
research. I do not think that the use of the terms "outweigh" and
"sum" in the D.H.E.W.
intended to be anything more than metaphorical.
language, certainly, we use such terms in full understanding of their
regulations about the risk-benefit ratio is
In everyday
metaphorical character. The D.H.E.W. regulations enjoin the peer review
groups only to be prudential, to do the best they can as they think
about; "balances," "sums," and "weights". We have too much the
fearful tendency to think that D.H.E.W. is expecting more of us than
we can produce, that we must search for hidden meanings and covert
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expectations in its necessarily vague and metaphorical language.
There are, of course, those who have developed elaborate and formal
mathematical equations for a variety of social processes, systems,
and "cost-benefit" ratios; they would love to have peer review
groups try out their exercises.
when he says (p. 48) that "At this point it seems appropriate to
avoid using mathematical models to calculate risk-benefit ratios...".
Rougher and simpler modes of "measurement," what the sociologist
Paul F. Lazarsfeld has called "qualitative measurement," is more than
adequate for a satisfactory ethical process right now in making
risk-benefit assessments.
even mathematical modeling are possible, of course, they should be
encouraged, as in some epidemiological studies of injuries and
benefits from biomedical or behavioral research. But most risk-
benefit assessment processes cannot be fully quantitative just yet.
On another aspect of these assessment processes, on the answer
(pp. 53ff.) Dr. Levine has given in his memorandum to his question,
"Who has the authority or responsibility to assess risk-benefit
criteria in the determination of the appropriateness of research?"
I should like to make some comments. I agree with Dr. Levine that
a "central role" should be assigned to the IRBs, though, as I have
argued elsewhere (Barber, et al ., op . cit ., Ch. 11), it is important
that IRBs should include lay outsiders in all cases and, in some,
also medical specialist outsiders from other research institutions. I
further agree with Dr. Levine that the subjects themselves have an
important part to play in prudential assessment processes. Finally, I
think he has well described the role that national review boards could
But I think Dr. Levine is correct
Wherever more quantitative measurement or
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play in especially difficult assessment decisions and also in improving
and making easier the work of the local committees.
Nevertheless, because the social interaction processes involved
both in risk-benefit ratio assessments and in informed consent
procedures are quite complex, include a number of different significant
social actors and an extended time period not covered by the
and control mechanisms Dr. Levine has discussed, I would like to
see other authority and social control mechanisms included. The
ethical education of the physician, either in medical school or
thereafter, is not yet satisfactory. A more satisfactory education
ought to be an important additional support for satisfactory and
authoritative risk-benefit assessments. So too ought strengthened
and more self-conscious informal peer control mechanisms, such as
informal conversations, consultations, advice and even interventions.
Finally, I would like to see some better education for potential
research subjects, who are all of us, in both their rights and obli-
gations as research subjects. Here, as in other social realms,
there is probably a useful role for a variety of responsible "consumer"
protection agencies, especially with regard to the protection of
the particularly vulnerable social categories such as children,
prisoners, and the mentally ill, where their own resources are not
sufficient to participate prudentially in the process of being
research subjects. Certainly, for the improvement of risk-benefit
assessment processes we need to pay a good deal of attention to who
is involved in those processes, and how, that is, what knowledge of
and control over the processes they actually have.
matters will be valuable.
authority
Research on these
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5. Is behavioral research less injurious than biomedical
research?
One way of summing up our comparative perspective on risk-benefit
assessment in biomedical and behavioral research is to ask ourselves,
Is behavioral research less injurious than biomedical research? That
is, overall is there a better risk-benefit balance for biomedical than
for behavioral research? The quick and all-too-current answer, of
course, is yes. Since biomedical research is more often than
behavioral research a life-and-death matter, both causing grievous
injury sometimes but more often bringing life itself, it is on the
whole productive of a better risk-benefit ratio.
And yet, before we think there is a great dissimilarity, we
need to look at a few qualifying facts. First, it is important to
remember that there is very little life-and-death research even in
biomedicine. The study my colleagues and I did of some 300 biomedical
researchers using human subjects and who reported to us about 424
different research projects in which they were involved showed that
most research is both scientifically and ethically trivial, far from
being a life-and-death matter. Taking note of this fact, and
remembering also that we do not have even a rough calculation of the
total amount of harm and good that either biomedical or social
research has given us, we may well express a little hesitation about
making firm and precise comparisons of the two.
to remember that many people consider some social injuries and benefits
even more important than biological health and life itself. Orwellian
1984'ish nightmares about social slavery and total thought control
can seem more real and more horrible to people than harm, or even
Finally, we have
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death, done to the "biological person". Insofar as it is conse-
quential for such fundamental injuries and benefits, behavioral
research is obviously of great importance to us. The assessment of
its risk-benefit ratios is not a small or indifferent matter.
In sum, while we may agree that, overall, probably more hangs
in the balance from biomedical research, still a great deal of the
greatest importance is involved in the injuries and benefits of
behavioral research. The assessment of the balances of these injuries
and benefits is of the first importance for the ethics of scientific
research using human subjects.
problem we have in this field, neither can it by any moral or
prudential standard be called unimportant.
If it is not the most important
SOME EMPIRICAL DATA ON RISK-BENEFIT ASSESSMENT IN BEHAVIORAL RESEARCH
I have been arguing for the fundamental similarity, in principles
and procedures, of risk-benefit assessment in biomedical and behavioral
research.
for policy as this one, should be supported by facts, and preferably
systematically collected and reliable facts.
regarding actual processes of risk-benefit assessment in biomedical
and behavioral research?
Arguments, of course, and especially one so important
What are the facts
Unfortunately, but just as is the case in nearly all areas
of the ethics of research using human subjects, good data are hard to
find. What we have instead are mostly scattered, unsystematic
statements, as well as a few more systematic facts, not so much
because they prove the case for or against the argument of fundamental
and a background for the better data similarity, but simply as a basis
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that ought to be built on them.
For eventual comparative purposes, though the data for precise
comparison from behavioral research are not now available, we may
start with some data on risk-benefit assessments in biomedical research.
First, as to amount of risk (probability of risk occurring was not asked):
When we asked some 300 biomedical researchers at University Hospital
and Research Center to estimate the amount of risk involved in 422
different studies they were doing on human subjects, they said that
1% (4 studies) involved "high risk," 2% involved "moderate" risk,
8% involved "some" risk, 45% involved "very little" risk, and 44%
involved "no risk at all".
Second, when we asked these researchers also to estimate amount
of benefit for subjects, and amount of possible benefit for future
patients, we were able to establish risk-benefit ratios. We dis-
covered that in 18% of the studies, risk outweighed benefit to subjects ;
these we called the "less favorable" studies. We also discovered
that some of these 18%, amounting to 8% of the total of 422 studies,
were what we called the "least favorable" studies because the risk-
benefit ratio was unfavorable even when we added benefit to future
subjects to benefit to present subjects .
(Barber, et al ., op . cit ., pp. 39,45.)
(Ibid., pp. 47,50)
For present comparison with these data, all we have is some
unsystematic data from three institutions, University of California,
San Diego; University of California, Berkeley; and Columbia University.
The San Diego data were presented by Professor George Mandler at a
recent symposium on the ethics of research on human subjects at an
annual meeting of the American Psychological Association. (Behavior
Today, Sept. 29, 1975, 573-574.) Mandler reports that his university
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has separate committees for behavioral and biomedical research; this
practice is followed by many major universities, though we do not
know how many. He further reports that at San Diego, whereas "about
90% of the research projects generated by the medical school involve
some risk," only 25% of the research submitted to the behavioral
peer review group involves some risk. It should be noted that the
90% "some risk" figure for the San Diego biomedical group compares
with a figure of 56% in the university hospital and research center
studied by me and my colleagues.
In his "DHEW Regulations Governing the Protection of Human
Subjects and Non-DHEW Research: A Berkeley View," (mimeo., 1975)
Professor Herbert P. Phillips, the Chairman of the Committee for
Protection of Human Subjects, a committee which covers only behavioral
research, reports that "the vast number of projects currently examined
by the CPHS involve 'no risk' or extremely low risk to the human
subjects". What does "vast number" mean? Professor Phillips
continues: "Under the present review system, no more than 10-15
out of every 100 cases that we examine require a modification of
research design to better protect the human subjects; and in the
vast majority of these 10-15 cases the 'risks' to the subjects are
so self-evident that the cases would have to come to the CPHS's
attention, whatever the system of review."
concludes with a statement that is representative of the views of
those behavioral researchers who would like to alter the present
procedures of risk-benefit assessment for their field:
not seem reasonable to have 85-90% of Berkeley researchers, and members
Professor Phillips
"It just does
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of the CPHS, waste so much of their valuable time and energy on
lengthy, but essentially meaningless expositions proving that
no harm will come to their subjects, or, conversely, that they are
morally upstanding scholars. There is an element in this process
that is clearly reminiscent of the California 'Loyalty Oath'".
Being very much aware of the lack of empirical studies of risk-
benefit assessment in behavioral research, when I was asked by the
Commission to prepare the present paper I decided to do a small study
on the experience in this field of Human Subjects Review Committee
at Columbia University. I have
the past three years and am now its Chairman.
experience that I am reporting. Unfortunately, we do not ask our
member-reviewers to do more than indicate whether there is "some risk"
or "no risk," so my data are not finely graded either as to amount or
probability of risks.
been a member of this Committee for
It is on this
I should also report that I set down my pre-research impressions as
to what my findings might be. The fact that these impressions proved
wrong turned out to be instructive. My pre-research impression was
that there would be relatively few expressions of concern about harm
or injury from our reviewers; I felt that informed consent would be
the primary issue of concern. The data showed me wrong and I realized
that I had been thinking of injury as only to the "biological person".
When injury of various kinds to the "social person" is assessed, then
the risk-benefit issue turned out to have been of greater importance
to the members of our Committee than informed consent shortcomings.
It was this finding that led me to see the usefulness of the distinction
between the "social" and the "biological" persons that I have presented
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at the beginning of this paper.
What are my actual findings? During the period from September,
1972, to August, 1975, the Columbia University Human Subjects Review
Committee screened 90 behavioral research proposals that passed
through the University's Office of Projects and Grants. The members
of the Committee include Community members, university research staff,
and faculty members from anthropology, law, business school,
social work, sociology, and psychology. Since it is our procedure
to have three members review each proposal, there should have been
270 reviews for the 90 proposals.
and we report on these.
were unqualified approvals with regard to both issues, risk-benefit and
informed consent.
informed consent.
called "risk".
"confidentiality".
where there were any, could add up to more than 50% because a reviewer
could mention both issues in the same review.) Thus, one in three
of the individual reviews raised explicit questions about what our
We could find only 249 in the files
Of these 249, just about half, 123 (49%)
48 of the reviews (19%) raised questions about
79 of them (32%) had questions about what we
and 49 (19%) had questions about what we called
(It should be noted that questions by reviewers,
standard check-list calls "risk". But though an additional 49 (19%)
of the mentions were about what the check-list calls "confidentiality,"
it is clear from the comments of the reviewers who mentioned this
that they were thinking of injury to the "social person" just as
much as when they mentioned "risk". For them, violations of con-
fidentiality were just as much injuries as is the "risk" of damaging
the individual's self-esteem or his social reputation. "Risk"
factors seem to be those that directly cause such harm as embarassment
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or loss of reputation.
juries though the harm it causes in the form of embarrassment is indirect ,
a result of making the individual's identity visible and thereby
exposing him to harm.
is thought by our reviewers to occur more often than just the
explicit mentions of "risk" would suggest.
H.S.R.C. experience indicate that some amount of risk is a not
infrequent occurrence in behavioral research.
"Confidentiality" still involves potential in-
Altogether, then, injury to the "social person"
These data from the
What are some of the injuries our reviewers mentioned? The
list contains no surprises: embarrassment, loss of privacy,
disclosure of confidential information, danger of arrest, adverse
effects on family or larger social network relationships, anxiety,
fear, self-incrimination, and harmful new self-awareness. Each of
these general categories includes a number of different specific
cases; it is the useful function of the Committee reviewers to
discern the general harm in the variety of specific concrete cases.
would probably be a helpful guide to researchers if a list of such
general categories of potential harm could be published, including
several recurrent and representative cases for each category.
It
SOME CURRENT AND NEEDED RESEARCH
I should like to end this paper as I began it, with an emphasis
on the need for more and better research on the problem of risk-benefit
assessment in behavioral research. Such research should be explicitly
comparative with research on biomedical risk-benefit assessment. It
should also be systematic and cumulative, with each piece of work
building and imporving on research that has gone before. Research
19-20
should test all our assumptions and seek to make the process of
risk-benefit assessment both more effective and more efficient.
For we want assessment orinciples and procedures that will do their
job well and will be least costly of researchers' and other parti-
cipants' time.
Fortunately, we have a few studies underway that will add to our
knowledge and serve as valuable models beyond the very few that now
exist.
IRB's.
and Mitchell Balter, "Public Judgments Regarding Ethical Issues in
Research."
One of these current studies is the Commission's own study of
The other is the N.I.M.H. funded study by Drs. Glen D. Mellinger
We should remember that the improper use of human subjects in
research has only recently become widely defined as a social problem.
The task of ameliorating this social problem is not simple and is bound
to take time.
social change in several social circles.
social research of the kind represented by the Commission's study of
IRB's and the Mellinger-Balter study of public views has an essential
part to play in making this social change possible.
Effective remedies will require no small amount of
Expert, and expensive,
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20
THE ROLE OF RISK/BENEFIT ANALYSIS IN THE CONDUCT
OF PSYCHOLOGICAL RESEARCH
Gregory Kimbl e, Ph.D.
The Role of Risk/Benefit Analysis in the
Conduct of Psychological Research
Gregory A. Kimble
University of Colorado
Concern about the ethics of psychological research is a fairly recent
development and the reasons for the development of this concern are of
some interest. As long as the psychological investigator confined himself
to rats learning mazes, to college students mastering lists of nonsense
syllables, to his own colleagues' psychophysical judgments of stimulus
intensities in the interest of constructing scales of sensory magnitudes
and to studies of eyelid conditioning aimed at uncovering the basic "laws"
for a behavior system there were no serious problems. About the most
serious moral accusation anyone could make about such research was that
it was pretty much of a bore for the subjects who participated. It was
when the science began to study obedience to authority, racial differences
in cognitive abilities, the behavior of homosexuals in public places, the
decision-making activities of the members of juries and the personal
characteristics of people hired for and fired from governmental positions
that serious questions began to arise. The general point to draw from
this comparison is that the more important the topic of investigation, the
more sensitive are the ethical issues it raises. Research on the more
recent topics invades the privacy of the individual in important ways.
In some cases disclosure of the information obtained might put the person
in danger of losing his reputation or of being arrested and jailed.
Looking to the future it is clear that we will have to continue to
face these ethical issues for two reasons, first psychology has developed
20-1
methods that allow the effective investigation of important social and
personal issues and second the situation in the world demands such investigation
whatever the consequences produced directly by research.
As my grandmother would have put it, "The world is going to Hell in
a handbasket," or as the more polite would say "The quality of life is
deteriorating." The earth is overpopulated and there are places where
people starve to death. Our supply of fossil fuel is about exhausted.
Alternative sources of energy are not being developed rapidly enough and
people have not changed their behavior in ways that would conserve what
we have. The concern of people for the welfare of each other has reached
a new low, the well documented refusals of people to come to the aid of
others in trouble being the obvious reference on this point.
night's paper there was the story about a gang of teenage hoodlums who
boarded a bus in San Francisco, beat up and robbed passengers and tried to
repeat the performance on another bus before the police stopped (but did
not arrest) them. Over fifteen percent of the population have failed to
develop the intellectual skills required to deal effectively with a
newspaper ad for groceries. The list could go on:
"child abuse," "the alienation of youth," "the frustrations of middle
life" and "the indignity of old age" suggest just some of the problems
that could be presented in more detail but that is not my purpose here.
My immediate purpose is to direct your attention to the fact that
most of the problems I have hinted at above are psychological problems.
Physical technology will not provide the required solutions which must
come from knowledge about behavior.
exist and only research will provide it.
In last
"pollution," "divorce,"
Unfortunately the knowledge does not
Research, however, puts the
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research participant at risk.
discussed: Are these risks appropriate given the benefits research provides?
This last point poses the question to be
Risk/Benefit Analysis
Consider, to make the point concretely, the research of M. M. Berkun
and his colleagues (1962) on stress in simulated wartime situations.
one experimental condition a group of army recruits were passengers aboard
an apparently stricken plane that had to crash land.
recruits were subjected to a reported threat of accidental nuclear
radiation, to the telephoned information that a forest fire had surrounded
their outpost, and to a fictious report that they were being subjected to
artillery fire by members of their own army.
the realism of the crisis was enhanced by the use of noise, darkness,
rugged terrain, smoke or whatever was required.
the recruits' radio transmitters, the most likely instrument for securing
help, "failed" and the behavior of interest was the recruits' effectiveness
in trying to repair it. Under the stress of the situation some of the men
left in cowardly retreat and many showed other signs of severe distress.
Was it all worth it?
In
In other conditions
In all of these situations
In each of these situations
The standard answer to this question these days takes the form of a
"risk/benefit" analysis. The risks born by the subjects in the experiment
(the experience of terror, being deceived, living with the knowledge of
cowardly behavior) are to be weighted against the benefits provided by the
study (development of psychological screening measures, better knowledge
about the effects of stress, possibly a more effective army). If the
aggregate of benefits
justified; otherwise it is not.
outweighs the risks the experimental procedure is
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In the rest of this essay I shall subject the risk/benefit analysis
to its own analysis. I shall show, I think, two things:
respectable mathematical sense of the concept risk/benefit analysis is a
practical impossibility in this context but (2) that it brings certain
considerations into focus in ways that contribute to the decision as to
whether a particular piece of research deserves to be carried out.
(1) that in any
The Dimensions of Complexity
In the abstract the idea of subjecting research plans to a risk/
benefit analysis is very attractive. What would be involved would be
the development of the ratio:
all the risks.
Ratios less than 1.0 would put a stop to it.
aggregate of all the benefits/aggregate of
Ratios greater than 1.0 would allow research to procede.
In practice, however, the
situation is a bit like that of Alice in Wonderland after she had eaten
the cake that made her shrink:
"The first thing I've got to do," said Alice to herself,
as whe wandered about in the wood, "is to grow to my right size
again; and the second thing is to find my way into that lovely
garden. I think that will be the best plan."
It sounded like an excellent plan, no doubt, and very neatly
and simply arranged:
idea how to set about it....
With risk/benefit analysis things are similar.
the only difficulty was that she had no
(Carroll, 1946)
The plan is excellent--
very neatly and simply arranged--but faced with the problem of carrying the
plan out it seems unlikely that anyone has any idea of how to set about
it. I turn now to some of the reasons for this state of affairs.
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Number of Variables
One of the most obvious points to make is that even for a single piece
of research the number of risks and benefits that have to be considered is
enormous. In his extensive review of this topic Levine (1975) breaks
risks and benefits down into categories that apply to individuals and
categories that apply to groups. Then he proceeds to identify several more
specific items in each grouping. They include physical, social, legal and
economic risks and benefits.
down into many specific types of risk and benefit the list quickly becomes
so long that it seems unlikely that a manageable risk/benefit equation could
be constructed from these terms.
Subjectivity of Risks and Benefits
Since each of these can be further broken
There is also another point to make: the significance of the components
of the equation involve matters where there must be great individual differences
and great differences among various social groups.
consider what must be the most controversial psychological research from
an ethical point of view, that of Milgram (e.g. 1965). As most readers
of this essay will know Milgram demonstrated that a good many Americans,
prodded by nothing more than firm direction to do so, will administer
a dangerously strong electric shock to a fellow human being just for failing
to produce the right answers in a faked study of paired-associate
learning.
In this connection,
The ethical question raised by this research involves the consequences
For most for a subject of discovering this unpleasant truth about himself.
people the effect would probably be ego-destructive.
reaction would vary for different people and for members of different social
The extent of this
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groups (Smart and Smart, 1965).
would require (sometimes unattainable) information about the reactions of
different individuals and groups to the same treatment.
later obtaining such information raises ethical questions of its own.
the moment it is important only to note that the subjective nature of risks
and benefits adds to the problem of putting them into any realistic ratio
form.
The Problem of Aggregation
The assessment of risks, for this reason,
As we shall see
For
Even if a catalogue of all the possible risks and benefits of
psychological research existed, this information would only set the stage
for further problems of great difficulty.
references in the literature in this area which suggest that it is the
"sum of" the risks and benefits that are to enter the risk/benefit ratio
(Levine, 1975, page 45 ff.).
risks and benefits combine according to the rules of simple addition, it
is unclear as to how they do combine or that the rules of combination
would be the same for all conceivable ways of looking at a risk/benefit
ratio. Such unclarity comes about largely because of the nonexistence
of an appropriate metric for the quantification of risks and benefits.
Quantification of Risks and Benefits
It is possible to find
Although it seems improbable that the various
Risks and benefits appear to have three properties that might enter
into the process of assigning quantitative values to them.
vary in a) probability of occurrence, b) the magnitude of the effect
(positive value of the benefit and seriousness of what is risked)
c) the number of people affected.
of these quantities.
Both terms
and
I shall concentrate on the first two
As the discussion develops it will become clear
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that these alone raise so many problems that it will not be profitable to
say much about the third.
Risks. Confining ourselves to the major risk of subjects in the
Milgram experiment in order to have a concrete example, we might note that
each subject began participation with some probability of finding out an
unpleasant truth about himself and this unpleasant truth would be in
some measure destructive to the individual's self-esteem. But what values
shall we place on these two aspects of risk?
We know that the actual probability that this subject would deliver
the very strongest shock to the second individual in the experiment was
about .60. Perhaps this should be the probability value. This quantity
was one of the results of the investigation, however, and could not have
served in a calculation designed to decide whether or not the experiment
should have been done.
estimated--say by college students who have considerable experience as
Perhaps this probability of .60 could have been
subjects or by psychiatrists who have professional knowledge of human reactions.
Other research tells us that this would not have produced realistic
estimates, however. When the experiment was described to groups of college
students and psychiatrists the students estimated that 3% of the subjects
would administer the strongest shock; the psychiatrists estimate was only
1%. Obviously prior
to the Milgram experiment this aspect of risk could not have been evaluated.
Without developing the argument in much detail the same conclusion
Both were very far short of the actual probability.
seems to apply to the estimate of the seriousness of the self-revelation
experienced by many subjects in this experiment.
participating in the study the subjects could not know how they would react.
Without actually
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or how they would react to their own reactions
Benefits. If anything, the points just made about risks apply with
greater force to benefits but for a rather different set of reasons. Although
subjects may benefit slightly from their participation in research--for
example, by learning a little about research and knowing that they have
contributed to an important enterprise--the eventual benefits usually go
to others than those who actually participate in an investigation. The
risks on the other hand are here and now.
As a brief aside it may be worth noting that for some people this
state of affairs raises the question of whether it is right for some to
take risks now when the benefits go to others later. The answer to this
question appears to be that we benefit now from the contributions of
those who served earlier and that the bargain is not so unfair as the question
may make it seem to be.
Returning to the matter of quantifying benefits, there are several
considerations that lead me to believe that it is unreasonable to
expect any more success here than in the case of risks.
1. Applications of much research cannot be anticipated. This point
has been made many times but I might add one item from my own research
history.
learning, I did a preliminary experiment in which I showed that rats
responded in two quite different ways to relatively weak and relatively
strong electric shocks. The purpose of this pilot work was just to
establish ranges of intensities to use in the main experiment on the effect
of various intensities. As it turned out, however, the preliminary
experiment had important practical applications.
In an old study (Kimble, 1955) of shock intensity and avoidance
The two reactions were
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affected differently by drugs and this fact made important contributions
to the study of psychopharmacology.
2. The effects of research are cumulative. Whereas risks tend to
be localized in time and centered on particular individuals, benefits
are diffuse and may have their effects more through a change in attitude
and atmosphere than through a direct influence upon any single aspect of
the world.
I might cite, as an example of what I have in mind here, all of the work
done since 1898 or so by the Thorndikeans, Skinnerians, and Hullians on the
law of effect. Although I doubt that any single one of these thousands of
studies ever was the basis for any significant educational innovation, the
cumulative impact of the tradition was important. The current emphasis
on reward for accomplishment rather than punishment for failure and the
stress on student interest and motivation seems a direct consequence of
the major ideas in the law of effect tradition.
3. How does one identify a benefit? The previous example will
already have suggested to some of my readers that the neat (if implicit)
categorization of the consequences of research as beneficial or the opposite
is far too simple. Surely there are those who believe that the catering
to student interest and the neglect of punishment in the schools mentioned
above is to blame for the deteriorating cognitive competence of our
population. Equally surely there
the same conditions as being responsible for the fact that American
Scholars are the most productive
and the other wrong the question of
If both arguments are correct,
are others who would point to exactly
in the world. If one argument is right
benefit hinges on which side is correct.
(which is possible if the effect of
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reinforcement interacts with certain aspects of individual difference) the
risk/benefit waters become very muddied indeed.
It is also important in this connection to make a related point. The
knowledge generated by research is morally neutral.
care whether it is used for human benefit or harm.
I does not know or
It may in fact benefit
some people and harm others simultaneously. To illustrate, suppose that
research on persuasive communication tells a candidate for political office
how to run his campaign so as to win. In that case the product of
research has benefited the winning candidate and harmed the loser.
A very similar conclusion arises from considerations relating to what
happens to a single participant in an experiment. Referring to Milgram's
work once more, suppose that a subject in such an investigation finds out
that he is capable of inflicting cruel and possibly fatal punishment upon
another person under the slightest of provocation.
not? It could be a benefit one might argue, because it is better to know
such things about oneself in order better to control such tendencies. But
with equal force it could be argued that such knowledge is the opposite
of a benefit because of the damage it does to self esteem and the
possible negative effects on ones life later. Obviously the assessment
of benefits is a much more complicated issue than first impressions may
suggest.
A Temporal Consideration
Is this a benefit or
Although I have certain objections to the model it is possible to
draw an analogy between risk/benefit analysis and multiple approach-
avoidance conflict situations.
plication feature enters the picture.
If one does draw the parallel another com-
The values of the conflicting
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components of a conflict change in time.
thing must happen with risks and benefits.
It seems certain that the same
To illustrate: suppose someone signs up to particpate in an experiment
next week. The chief negative aspect (risk) in the experiment is that it
will involve electric shock, perhaps so strong that the participant will
not be able to tolerate it. The chief attraction (benefit) is that the
subject will recieve $50.00 for his participation. Since the subject does
sign up obviously benefits outweigh risks--but that is a week before
the experiment.
During the week things change. If conflict theory provides a guide
both the subject's fear of the painful shock and his desire for the $50.00
increase as the moment of participating in the experiment approaches. The
fear increases faster than the desire for money and possibly to a higher
level. It may lead the subject to drop out of the experiment just before
the appointed hour.
What actually happens is not so important for our purposes as the fact
that fear increases according to a steeper function than monetary desire.
This means that a risk/benefit calculation involving these elements will
have different values which depend upon the point in time where the
calculation occurs.
Conclusion
My own conclusion, having developed all of these points, is that the
plan actually to calculate a risk/benefit ratio as an aid to making
decisions about the value of a particular piece of research is unrealistic.
There are too many variables to consider.
risks or benefits exist and none seems likely to be developed soon.
No quantitative indices of either
The
20-11
operational bases for constructing such scales are difficult to specify.
About all that one can say is that the scales should probably be based upon
the values of individual subjects.
were available there is reason to suppose that ratios based upon them
would change in complicated ways in time. To repeat, the formal use of
risk/benefit ratios for the purposes of making ethical decisions about
research seems difficult or impossible.
Finally even if the basic measures
The Ethics of the Ratio Itself
Suppose we decide that the evaluation of research plans with the aid
of risk/benefit ratios is not impossible but only very difficult.
then? At least one "then" appears to be that we have raised some issues
that are partly logical and partly ethical.
What
Much of what I have covered in the foregoing pages of this essay
makes the critical point.
of research are born by individual people.
that most of us would agree that the assessment of risks should be
heavily weighted (if not totally determined) by those risks as they are
perceived by the individual.
Largely the risks, but not most of the benefits,
For this reason I suppose
To illustrate what this means and where the argument leads let us
Suppose we consider the Milgram type of experiment for one last time.
are trying to recruit a particular subject for experiment and want to make
a calculation of risks for him.
inform him of the fact that he will probably be led to treat another
For perfectly obvious reasons we cannot
human being in a way that will make him feel guilty and ashamed of himself
for a long time.
than the fact that the odds are 60/40 that he will obey and if he does
Even if we could the subject would want to know more
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obey that he will be conscience stricken as a result. He would (or should)
want to ask what the odds are specifically for him and how guilty he will
feel.
Fortunately or otherwise, psychology does not have the ability now
to answer such questions.
that implies. It would mean that if we had the necessary information
about this person's early upbringing, habits of cruelty, ways of experiencing
guilt, relationships to authority and God knows what else we would be able
to answer the questions raised specifically for him. But note that along
the way we have invaded the privacy of the individual's personal life and
that some of the information might, if disclosed affect his reputation or
even put him in jail.
benefits for any purpose seems certain to increase the risks.
But sometime it probably will and consider what
In short the effective assessment of risks and
Such considerations add a new dimension to the issue under examination.
Most of this paper has been devoted to making the point that risk/benefit
analysis probably cannot be carried out for practical reasons. This brief
section has made the further point that perhaps it should not be carried
out for ethical reasons.
Implications
So where does all of this leave us? If the formal application of the
risk/benefit calculus to the planning
and morally objectionable, what alternative are available?
there are no alternatives. Some form of risk/benefit thinking is the
of research is practically impossible
In my opinion
only reasonable way of looking at the
this essay I shall argue for
problem. In the concluding pages of
the application of a redefined and less
formal risk/benefit equation as an aid to decision making in the conduct
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of research with human beings.
A General Position
The redefined risk/benefit ratio I wish to propose looks like this:
Amount of Knowledge to Come from Research Risks as Seen by Reasonable People
I turn now to a discussion of the components of this proposed equation.
Knowledge as the benefit of research. It is clear of course that it
is not the process of research itself that is potentially beneficial
to mankind. Rather it is the product of research--the advances in knowledge
to which it leads. This obvious point raises several questions that
deserve comment.
Is it important to distinguish between the potential benefits of
applied and basic research? In my opinion the answer to this question
is "no," at least for the forseeable future in the behavioral sciences.
The point I have in mind here is that our knowledge in the behavioral
sciences is so limited that it will be important to carry out basic research,
applied research and research that attempts to bridge the gap between the
two.
It is probably well understood that it would be a mistake in any science
to restrict research strictly to applied problems.
limited programs is that they are apt to produce results of limited
usefulness.
very specific problem and fail to generalize to other specific problems.
A part of the aim of basic research is to obtain more general knowledge.
Beyond that, as was mentioned earlier, the benefits of research are less
predictable than one might hope and seem about as likely to come from
basic research as any other kind.
The trouble with such
Typically the data obtained in applied research bear on some
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On the other hand, at least in psychology, the time has come to make
the heretical point that basic research carried out in the absence of any
concern for applicability has its own failings. The history of research
on the psychology of learning from roughly 1929 (Hull's Functional Interpretation
of the Conditioned Reflex) to roughly 1952 (Hull's A Behavior System) will
serve to make the point.
in this period was probably more "scientific" than research that is being
done now. The trouble with it, however, was that the areas of investigation
(the non-threatening topics mentioned in the first paragraph of this essay)
appear to exist only within the artificial confines of the laboratory.
was when the psychologist of learning turned to more realistic lines of
investigation (free recall, lapes of memory exemplified
tongue" phenomenon, memory for the content of paragraphs)
advances began to occur. This point now seems well on the way to receiving
general acceptance in experimental psychology. The former disdain for
application has now nearly been replaced by a concern for the "ecological
validity" of experiments.
In my personal estimation research carried out
It
by the "tip-of-the-
that more useful
Research quality and ethical behavior. The proposal that the numerator
of the revised risk/benefit equation should be "amount of knowledge to come
from research" has an interesting implication:
an index of ethical research behavior (as I intend that it should) the
conduct of bad research is unethical . This is because research that is
poorly conceived, improperly executed or inadequately analyzed will add
nothing to knowledge and might even contribute a negative increment.
Under such circumstances even the most trivial risks to subjects are
If the equation provides
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1 unwarranted.
1 I owe an expression of appreciation to Verna Shmavonian who started
me thinking about how the quality of research enters the ethical picture.
She is in no way responsible, however, for the curious twist this thinking
finally took.
Risks as seen by reasonable people. As with the case of benefits we
can begin this discussion with an obvious point. It is unreasonable to
ask for a complete accounting of risks prior to deciding to conduct a
particular bit of research. The risks are too numerous and impossible
to predict.
is in terms of what they mean for individual subjects) assessing the
risks would sometimes pose greater ethical questions than the research itself.
This last statement identifies my reason for leaving the assessment of risks
up to the judgment of "reasonable people."
Moreover, (since the only sensible way to look at these risks
But who are these reasonable people? I think there are three classes
of them--the investigators themselves, subjects and institutional review
groups.
cases investigators will be the individuals in the best position to identify
the risks. This is not just a self-serving evasion of the issue and I wish
to push the point somewhat vigorously.
The ethics of investigators. Why is it important for me to write
Beyond that it seems to me that in the great majority of the
this essay? I think because the times require it. The methods and motives
of those who do research with human subjects are not very well understood
by the general public. This is part of a generally anti-intellectual
climate that places a low value on knowledge, scholarship and research.
In such a climate it is not surprising to find that a cloud of suspicion
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surrounds research with human beings.
an irresponsible player of trivial games or else he is cast in the role
of the bad guy--a behavioral voyeur whose aims at best are to expose the
most scandalous aspects of the human condition. Under such assumptions
is it not reasonable to demand a complete ethical accounting of those
involved in research?
Either the investigator is seen as
Although I have no intention to minimize the importance of the ethical
issues I do think that it is essential to attempt to restore perspective
and I have two general points to make. The first is that the devaluation
of scholarship is a serious threat to our survival even as a species. More
of that later. The second has to do with the ethical values of investigators.
Put bluntly, I suspect that these values tend to be considerably higher
than those of a good many people with whom subjects have daily contact--
for example the used car salesman, the TV repairman and the precinct
politician. Moreover the research scientist is sensitive to the ethical
issues. Long before the current spate of codes of research ethics began
to appear on the scene, similar codes had been developed in the behavioral
sciences.
subjects, the research investigator is, I think, in a better position than
almost anyone to make the ethical decisions.
By reason of a history of concern for the welfare of his
Without going into great detail on any point the following list of
ethical principles taken from the code of the American Psychological
Association (Cook et at., 1973) illustrates the range of considerations
which the ethical investigator takes into account in his assessment of
risks.
-- The investigator is personally responsible for the ethical conduct
of his experiments.
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-- This responsibility extends to assistants and colleagues.
-- The investigator must secure the subject's informed consent to
participate.
-- Deception if used should be undone at the end of the experiment.
-- Participants may not be coerced into participation and must be
free to drop out at any point.
-- Participants must understand the procedures to be employed.
-- Subjects must be protected from physical harm and mental stress.
-- The responsibility to correct undesirable effects of the experiment
remains with the investigator after the experiment is over.
-- Misconceptions and misunderstandings arising in the experiment
must be removed.
-- Complete confidentiality is required of all information obtained
about participants.
This list provides the responsible investigator with a series of
questions to ask himself about the treatment of participants in any
experiment: "DO I have the subjects' informed consent?", "Is deception
necessary?", .... and most importantly, "Have I and my colleagues and my
assistants done everything we can to protect the welfare of our subjects
as is required by the ethical code." Only if such an analysis of risks
to the participant yields satisfactory answers does the ethical
investigator proceed.
Subjects' assessment of risks. As was mentioned in an earlier
section subjects in research typically are in no position to evaluate
the costs of their participation until they have had the experience. Then
it is too late by definition for this experience to contribute to a
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decision about the ethical aspects of the research. This state of affairs
does suggest one important point to make. Most investigations require a
certain amount of pilot work. The few individuals who participate at this
stage of the research might well be asked about their reactions to the
experimental procedures for purposes of uncovering risks that may have
escaped the analysis described above.
in directions designed to minimize these newly recognized risks
Procedures could then be modified
Institutional Review Groups. At least on university campuses the
existence of Institutional Review Groups is an important scientific fact
of life these days.
to assess risks in the cases where the investigator may not be a "reasonable
person" because of his investment in his research or an insensitivity to
the feelings of subjects.
projects come to these groups.
detect any problems the investigator has overlooked.
Summary and Comment
In the typical case these groups are in a position
In most situations even slightly sensitive
In my own experience they almost always
I have proposed that the risk/benefit equation be rewritten in
realistic terms:
Amount of Knowledge to Come from Research
Risks as seen by Reasonable People
The major advantage of the rewritten equation is that it removes the
necessity for making an impossible calculation. As we have seen many
times now risks and benefits in the usual meaning of those terms present
insurmountable obstacles to quantification. The terms as redefined seem
to be susceptible to statements involving judgments of at least more and
less. Although this is not exactly a precise formula for ethical decision
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making I think that it is a step in the right direction.
I have left the main responsibility for making the risk/benefit
calculation up to the investigator and have placed upon him two main
obligations: 1) to be as sure as one possibly can that his research will
lead to an advance in knowledge and 2) to assess the costs to participate
and to minimize them.
I have rejected the alternative of assessing risks for individual
participants because of the practical impossibility of the task and because
such an assessment would surely invade the potential participant's privacy
and would potentially lead to other ethical risks. Although the regress
entered into in that way might not be infinite, the interesting thought
does occur that, once started on such a process of detailing risks, it
might be difficult to recognize the proper stopping place.
I have noted that the input of subjects might play a role in the
investigator's assessment of risks. One could add to this point that
taking such a view of the subject's participation might foster a sounder
relationship than sometimes now exists between experimenter and participant.
Finally I have noted that Institutional Review Groups protect the
subject's welfare at another level.
The Ultimate Risk/Benefit Equation
As a way of bringing this essay to an end I would like to return to
the point with which I began and to direct the reader's attention to
what might be called "the ultimate risk/benefit equation." In this equation
the benefits are those which research will contribute to the solutions
of the big problems of society. The risks are those entailed by not
doing research at all and trusting to common sense and accumulated wisdom
20-20
to solve these problems.
dealt with quickly. Common sense, intuition and accumulated wisdom have
been with us forever. They seem to me to be as responsible as anything is
It seems to me that this alternative can be
for the sorry state the world is in now--where the disappearance of Man
as a species is more than a fanciful abstract possibility. The time has
come (if it has not passed) to turn to other sources of guidance and the
only reasonable alternative is the knowledge provided by research.
20-21
References
Berkun, M. M., Bialek, H. M., Kern, R. P. and Yagi, K. Experimental
Studies of Psychological Stress in Man. Psychological Monographs ,
1962, 76, 534 (whole No. 15).
Carroll, Lewis. Alice's Adventures in Wonderland . New York: Random
House, 1946, pp. 44-45.
Cook, S. W., Hicks, L. H., Kimble, G. A., McGuire, W. T., Schoggen, P. H.
Ethical Principles in the Conduct of Research with and Smith, M. B.
Human Participants . Washington, D.C.: American Psychological
Association, 1973.
Hull, C. L. A Behavior System . New-Haven: Yale University Press, 1952.
Hull, C. L. A Functional Interpretation of the Conditioned Reflexes.
Psychological Review , 1929, 36, 498-511.
Kimble, G. A., Shock Intensity and Avoidance Learning. Journal of
Comparative and Physiological Psychology , 1955, 48, 281-284.
Kimble, G. A., Garmezy, N. and Zigler, E. Principles of General
Psychology , 4th Edition . New York: Ronald, 1974.
Levine, R. J. The Role of Assessment of Risk-Benefit Criteria in the
Determination of the Appropriateness of Research Involving
Human Subjects. Preliminary draft. Unpublished manuscript, 1975.
Milgram, S. Some Conditions of Obedience and Disobedience to Authority.
Human Relations , 1965, 18, 57-75.
Smart, M. S. and Smart, R. Children: Development and Relationships .
New York: Macmillan, 1967.
20-22
21
A PHILOSOPHICAL PERSPECTIVE ON THE ASSESSMENT OF RISK-BENEFIT
CRITERIA IN CONNECTION WITH RESEARCH
INVOLVING HUMAN SUBJECTS
Maurice Natanson, Ph.D.
A PHILOSOPHICAL PERSPECTIVE ON THE ASSESSMENT OF RISK-BENEFIT CRITERIA IN CONNECTION WITH RESEARCH INVOLVING HUMAN SUBJECTS
by Maurice Natanson
"The doctor said that so-and-so indicated that there was so-and-so inside the patient, but if the investigation of so-and-so did not confirm this, then he must assume that and that. If he assumed that and that, then...and so on. To Ivan Ilych only one question was important: was his case serious or not? But the doctor ignored that inappropriate question. From his point of view it was not the one under consideration, the real question was to decide between a floating kidney, chronic catarrh, or appendicitis. It was not a question of Ivan Ilych's life or death, but one between a floating kidney and appendicitis. And that- question the doctor solved bril- liantly, as it seemed to Ivan Ilych, in favour of the appendix, with the reservation that should an exami- nation of the urine give fresh indications the matter would be reconsidered."
--Leo Tolstoy: The Death of lvan Ilych
I. On the Relationship between Philosophy and Science
When philosophers discuss medical matters, there is a
legitimate need to delimit their professional competence, for
even when the issues involve ethical problems, it is by no
means obvious that the philosopher is on solid ground in his
inquiry. Just as the physician faces subtle and complex ethical
difficulties in making some of his most important medical
21-1
decisions, so the philosopher confronts recalcitrant, technical
medical issues which frequently transcend his training and
understanding. The philosopher must rely largely on a reading
of the literature on the subject; direct clinical experience is
denied him. And, of course, what used to be called "recent
advances" in medicine now give way to new fields of specialization.
A few words (such as "genetic engineering") herald the ambiguities
of a new age. The philosopher who yesterday may have been con-
cerned about occasional pockets of scientific ignorance, today
is overwhelmed by entire wardrobes of illiteracy. Elsewhere 1
I
have briefly discussed some aspects of the need for the training
of individuals who have some comprehension of both philosophy
and medicine. That problem is not before us now, but its impli-
cations cannot be wholly overlooked. The fact is that what the
philosophers know about ethics and what the scientists know about
medicine seldom come together in a
for either side, let alone for the social good. But the problematic
relationship between philosophy and medicine may be seen as part
of a more general rubric: the interdependence of philosophy and
knowledge.
way which is satisfactory
Rather than viewing philosophy and science as disparate
disciplines which can be brought together only in artificial and
cursory ways, it is possible to approach them as integral in
their inner signification, as intimately related facets of the
unitary reality of knowledge. Merleau-Ponty presents such a
conception of unity:
21-2
"The segregation we are fighting against is no less harmful to philosophy than to the development of scientific knowledge. How could any philosopher aware of the philosophical tradition seriously propose to forbid philosophy to have anything to do with science? For after all the philosopher always thinks about something : about the square traced in the sand, about the ass, the horse, and the mule, about the cubic foot of size, about cinnabar, the Roman State, and the hand burying itself in the iron filings. The philosopher thinks about his experience and his world. Except by decree, how could he be given the right to forget what science says about this same experience and world? Under the collective noun 'science' there is nothing other than a systematic handling and a methodical use-- narrower and broader, more and less discerning-- of this same experience which begins with our first perception. Science is a set of means of perceiving, imagining, and, in short, living which are oriented toward the same truth that our first experiences establish an urgent inner need for. Science may indeed purchase its exact- ness at the price of schematization. But the remedy in this case is to confront it with an integral experience, not to oppose it to philosophical knowledge come from who knows where." 2
In these terms, the physician who is making a decision regarding
the life of his patient, the experimentalist who is seeking con-
sent from a subject for a procedure which entails serious risk
to that individual, the lawyer or governmental agent or advisor
who is charged with the task of formulating codes for ethical
conduct on the part of researchers which will assure approp-
riate protection of subjects for experimentation --all are
tacitly involved in philosophical work. In addition to their
connection with ethical matters, they are bound to try to
appreciate the systemic unity of the domains of knowledge in
which they operate. Philosophy is not something added to the
recipe
comprehend human experience. In this view, science and philosophy
are both located within the unitary world which is experienced
by all of us.
for knowledge; it is inevitably part of any effort to
21-3
The point with which I am concerned is that ethics and
ethical considerations cannot be extirpated from the corpus of
philosophy in order to become useful to the scientist. More
strongly stated, if ethical systems or judgments are extracted
for specific scientific purposes, they may, perhaps serve as
heuristic guides for inquiry, but their full force will be
diluted, if not destroyed. In my judgment, ethics is rooted in
the soil of philosophy but cannot be handled in the way in
which nurserymen secure trees for replanting. Ethical problems
are fundamentally tied to conceptions of Man, of the human
reality. We face an ambivalent situation with regard to the
ethical aspect of medical experimentation on human beings
because the physician, the scientist, and even the lawyer are
apt to turn to ethics in the narrower rather than broader
sense, i.e., they are searching for specific recommendations of
what is ethical in a context whose basic moral nature is defined
by the study of Man. I do not think that the needs of the
researcher and of the social order which seeks to protect the
individual can be served by divorcing ethics from philosophical
anthropology --the effort to respond to the question What is Man?
In fine, those analyses which are most likely to illuminate the
underlying moral issues in experimentation on human beings are
least likely to be the ones which offer concrete definitions,
propositions, and calculi built out of such propositions in order
to assist the formulator of ethico-legal codes. The paradox is
that the more specific the ethical recommendation, the less
chance there is for advancing the development of those primordial
21-4
philosophical analyses which can tell us something significant
and lasting about ourselves.
The philosophical perspective from which I am writing is
that of phenomenology and existentialism. More specifically,
my fundamental approach to the problems which form the substance
of this paper is indebted to the phenomenology of Edmund Husserl
and Alfred Schutz and to the existential thought of Jean-Paul
Sartre. I will avoid any attempt to summarize the essential
doctrines of these thinkers, but a few words about their theoret-
ical enterprise may prove useful to the reader. Husserl, Schutz,
and Sartre disagree about important matters, but they are united
in their concern with Man as the human reality, with Man as a
being whose consciousnesss helps to build the microcosm in
which he lives, and with Man as situated in the reality of daily
life. Husserl speaks of the cardinal importance of the "Life-world,"
the stratum of mundane experience within which we locate our
perceptual experience, our values, and our action. Schutz
stresses the typified character of everyday existence, the
projects of action through which ordinary human beings interpret
their own and each other's meaning in the traffic of daily life.
Sartre emphasizes the notion of situation itself. He writes:
"For us, man is defined first of all as a being 'in a situation.' That means that he forms a synthetic whole with his situation --biological, economic, political, cultural, etc. He cannot be distinguished from his situation, for it forms him and decides his possibilities; but, inversely, it is he who gives it meaning by making his choices within it and by it. To be in a situation, as we see it, is to choose oneself in a situation, and men differ from one another in their situations and also in the choices they themselves make of themselves. What men have in common is not a
21-5
'nature' but a condition, that is, an ensemble of limits and restrictions: the inevitability of death, the necessity of working for a living, of living in a world already inhabited by other men. Fundamentally this con- dition is nothing more than the basic human situation, or if you prefer, the ensemble of abstract character- istics common to all situations."3
In terms of the Life-world, man in daily life understands
or misunderstands his situation in concrete ways, has a lucid
or opaque sense of his own interests, and carries with him the
resources of a sometimes acute and sometimes baffled intelligence.
Yet it is within the range of those talents and debilities that
he is compelled to construct and interpret the meaning of his
experience. Scientific models of explanation of human conduct
are abstractions of a very restricted and specialized sort which,
so phenomenologists believe, must attend closely to and be
responsive to the naive models of interpretation and action which
common-sense human beings build out of their insight into and
bewilderment with the materials of their own existence. In the
realm of problems of risk and benefit in research and experimen-
tation on human subjects, the resources and needs of the Life-world
must not only be respected but must be studied in the most
searching fashion, for what happens to all of us, ordinary men
and women and physicians and researchers alike, remains rooted
in mundane life and, ultimately, must be interpreted and evaluated
by the categories of mundane rather than scientific experience.
21-6
II. The Concepts of "Risk" and "Benefit"
The notion of the Life-world provides a point of access to
the understanding of risk and benefit because it makes it poss-
ible to distinguish between risk and benefit as quantifiable
terms and risk and benefit as primary and endemic features of
everyday experience. Of course, risk and benefit have an enor-
mous range of reference. At one end of the spectrum, risk is a
commonplace feature of the most taken for granted acts. As one
writer points out, "...the baby could suffer fatal injury if
dropped while being weighed." 4 We shall be concerned with more
substantial risk than that. At the same time, however, it must
be recognized that whereas the formulation of risk (and benefit
as well) is the professional responsibility of the investigator,
whatever the formulation turns out to be must be interpreted by
the subject or patient. What I am concerned with here is not
simply the question of translating the language of the scientist
into that of the layman. Presupposed in all such translation is
the conceptual stance of the ordinary individual, the categories
through which he comprehends the elements of his experience and
their implications for his well being. Were the essential problem
of "informed consent" just a matter of the effective restatement
of technical language into straightforward, everyday language,
the difficulties arising out of securing informed consent would
disappear rather quickly. The difficulties are persistent because
they are functions of something other than the mere efficacy of
translation. In the instance of risk and benefit, the translation
21-7
of those terms and their implications into the Life-world of the
patient or subject entails a primordial interpretation on the
part of the individual who is doing the risking or expects to be
benefited or have others benefited.
There are axioms of mother wit: there is no absolute
assurance that what is reasonably expected will necessarily follow
from an experiment; traditional and medically conservative
measures may nevertheless produce undesirable effects in a
particular case; benefit sought from a given procedure may carry
along with it undesirable side effects; benefit to others may
prove to be illusory or even detrimental; the relationship between
what may be good for the individual and what may be good for
society is generally uncertain, unstable, and revocable. Whether
or not the individual formulates such axioms in the way I have,
their import is naively grasped by everyone who wishes to avoid
trouble, to preserve good health, and to survive under optimal
circumstances. The axioms of mother wit are implicit assumptions
which are part of the fabric of common sense. To be sure, there
are some who are ignorant not only of elementary features of
human anatomy and physiology but who are too timid to ask their
doctors for more information. Not long ago, I read in a newspaper
medical column a letter by a young man whose physician had told
him that he had a spleen. How serious was that? the author of
the letter wanted to know. There are also those who do not want
to be told what the case is, what the possible dangers are, what
the full implications of an experimental procedure might be. It
is not possible here to proceed casuistically. Instead, I propose
21-8
to turn directly to the concepts of risk and benefit without
losing sight of the notions of the Life-world and of situation.
A. Risk:
It is necessary to distinguish between risk for the indi-
vidual undergoing treatment by his own physician or surgeon and
risk for the individual who is being asked to participate
voluntarily in an experiment in which he is to be a subject. The
more pressing problems for our consideration appear to fall in
the second classification, but the complex connection in therapy
and experimentation between the two categories must be considered.
To begin with, it is not unusual for writers on
point to the problematic nature of the treatment-experiment
relationship, As Maurice B. Visscher says, "...it is difficult
to draw the line between what is experiment and what might be
called medical treatment." 6
Or as Herman L. Blumgart puts it,
"Every time a physician administers a drug to a
a sense performing an experiment." 7 But the same circumstance does
not pertain in the distinction between, on the one hand, experi-
menting on one's patient for purposes directly related to trying
to cure or alleviate his specific medical problems at a time
when such therapeutic efforts are deemed necessary by the
physician and, on the other hand, asking an individual to partici-
pate in an experiment from which he will not personally benefit
in medical terns. Otto E. Guttentag recommends that "...a climate
of spiritual values should be fostered in which experiments done
5
this subject to
patient, he is in
21-9
not for the immediate good of the experimental subject but for
the welfare of mankind would be performed only by experimenters
who are not simultaneously responsible for the clinical care of
these experimental subjects." By separating physician in charge
of the care of his patient from experimenter in control of his
subject, it is hoped that the conflict of therapeutic-experimental
interest may be avoided, though something of a paradox is
generated in the process: the person best able to care for his
patient is the physician; the person charged with the welfare of
his subject --the experimenter-- is not primarily oriented toward
8
caring for his subject. 9
The paradox we have pointed to goes beyond the question of
whether the clinician and the experimenter should have different
roles with respect to patient and subject. The broader issue is
the relationship between care , which is committed to the welfare
of a concrete human being who is ill by a fellow human being, the
physician, and treatment , which may indeed be all that is offered
by some physicians whose interest in their patients is rather
limited but which , in an experimental context, is tied to a
different goal: the appropriate completion of the experiment.
The risk to the experimental subject is far greater than the risk
to the patient. Obviously, the degree of risk may, empirically,
be reversed in the two situations under certain circumstances. The
patient may be risking his life in a therapeutic procedure
involving dangerous surgery, whereas the experimental subject
may be submitting to routine and completely safe testing having
to do with moderate changes in diet for a normal individual.
21-10
Indeed, the experimental subject may be part of a control group
to whom nothing is done. But the paradox remains: when the patient
becomes the subject, he needs more rather than less care , yet the
risk of receiving that care from the experimenter is substantial.
For the experimental subject who is not a patient, the risk is
even greater. What , exactly, is risked? Most simply, that the
well being of the subject is not the dominant concern of the
experimenter, who may be more interested in the intellectual-
scientific challenge of the experimental work itself, who may be
strongly motivated by the expectation of publishing his results
in the hope of advancing his professional career, or who may be
unduly influenced by his colleagues in an experimental team. Such
desires and pressures are not in themselves wicked and unethical;
they are implicit hazards, however, for the subject who may assume
that the experimenter places the well-being of his subject above
personal gain.
B. Benefit:
In the case of the patient, benefit is directly correlated
with the treatment of his illness. That is hardly to say that
benefit is assured; it is only to say that what is being risked
is being risked for the possibility of individual betterment.
When it comes to the subject, however, benefit is correlated with
a larger domain: those afflicted with a certain disease, those who
would benefit if an effective and safe vaccine were developed for
the innoculation of those who might develop a certain disease,
21-11
those who might benefit indirectly from knowledge gained in
research on one medical problem which has or may prove to have
relevance for another problem. Ultimately, society itself is
said to benefit from the advance of medical knowledge. We shall
say something about society and the individual shortly, but for
the moment, it might be suggested that the concept of benefit is
vague and fugitive to the subject in many cases and may serve as
a shield not only to the experimenter whose medical ethics are
questionable but also to the ethical experimenter who may be
unwilling to face the full implications of a procedure which
legitimates risking harm to one group of individuals for the sake
of another group of individuals. Yet it would be unacceptable to
reduce the meaning of benefit to patient-benefit alone. The
decisive consideration is that benefit and risk be viewed in
integral fashion. That means that what benefits human beings
usually carries with it risk, and that risk which is deemed
"minimal" or "acceptable" nevertheless may mean severe suffering
or death to some. Chauncey D. Leake writes:
"There is no absolute safe and effective chemical agent that may be used for biological effects in humans, not even common table salt. The Gaussian distribution curve inevitably fits any drug, if it is used on enough people: in a few there may be no effect at all from the same quantitative dose that may produce serious injury or death in some. Here, social welfare must be considered, as when the Canadian authorities went ahead with mass protection against polio using oral vaccine, although four people out of some 2,OOO,OOO met death ascribed to it. Even a hedonistic ethic would take the chance of 1 in 500,000." 10
A hedonistic ethic might very well accept the risk of
1 in 5OO,OOO, but we are left with the question of whether to
accept a hedonistic ethic. In the case of the polio vaccine,
21-12
it is essential to recognize the nature and scope of the suffering
and incapacitation of polio victims, the widespread awareness of
the character of the disease, and the likelihood of permanently
eliminating the devastating effect of polio on thousands of
people. In assessing benefit, in this instance, there is a clear
recognition of the quality and quantity of suffering and sufferers
in the past. Benefit is directly related to the history of concrete
and widespread anguish of victims and of those that love them.
In the absence of such a history, it is prudent to reflect more
thoroughly on the problem of justifying the death of some,
however few, for the sake of the health of the many, no matter
how many. The reasons which are accepted for justifying the
risking of the life of the few are of critical importance in
justifying the integrity and morality of the social order. In each
case, those reasons must be intimately associated with the reality
of suffering and the reality of sufferers. Furthermore, those
reasons must be explained to both risk-takers and to those who desire
them to take risks, to ordinary people and to physicians, experi-
menters, and, perhaps most important of all, to medical students
and graduate students going into medical research. Not only
giving reasons but defending those reasons in the context of the
social order is essential to the protection
those who are involved in any way in experimentation on human beings.
and honor of all
If a casuistic analysis of risk and benefit problems lies
beyond the scope of this paper, it would seem that all that can
be recommended consists in generalizations which falter before
the determination of concrete cases. Earlier, I pointed to the
21-13
desirability of a phenomenological-existential approach to the
problems before us. What help can such an approach provide if
specific determinations in concrete cases can only be loosely
guided by general recommendations? In fact, the central diffi-
culty in trying to find a way in the thickets of risk-benefit
problems is that where detailed and highly specified protocols
are issued, the physician and the experimenter who are highly
ethical individuals may well be compelled, by constraint of law,
to circumscribe their care and treatment of the patient and
subject to the medical disadvantage of both risk-taker and the
social good, whereas a more open and flexible set of guidelines
may be misused in such a way as to injure or endanger the well
being of the patient or subject and, in turn, threaten the moral
fabric of society. Faced with a somewhat analogous paradox, the
law tends to favor the more generalizing alternative. According
to Paul A. Freund:
"As part of its conservatism, the law tends to generalize on the basis of a balance of risks. If, for example, it is thought that there is a predominant risk of perjury in claims that oral contracts have been made, the law enacts a statute of frauds requiring as a general rule, as an invariable rule, that there be a writing for important contracts, even though in some cases there is created a counterrisk that thereby some genuine oral agreements will not be recognized. If there is a pre- dominant risk of suppressing information and criticism by enjoining the publication of allegedly libelous matter the law will make a general rule of refusal to enjoin, even though there is a countervailing risk that some actually defamatory matter will thereby be allowed to circulate. The law takes refuge in general rules as metaphysics resorts to absolutes." ll
In the case of medical practice, viewed from an ethical perspective,
it is not evident that the analogy holds true. The law might
require a written consent form in cases of experimentation, but
21-14
it is not clear what would constitute an "important" case, nor
is it obvious what would be accepted as a "predominant" risk.
paradigms for "important" and "predominant" can usually be
provided; but individual instances are uncertain and boundary
cases are ambiguous. In any event, what is being risked and what
is hoped for as benefit may be uncertain in the minds of both
subject and experimenter. The paradox of concreteness and
generalization continues to bedevil our discussion. But paradox
need not lead to demoralization or to ethical paralysis; rather,
it is the inescapable medium through which the tension between
concreteness and generalization finds its expression.
III. The Needs of Society and the Rights of the Individual
The contrast between society and the individual may be
understood as the contrast between the individual and other
individuals. The common good cannot be divorced from the good
of individuals. But the good of individuals presupposes a
recognition of values which transcend the individual --let us
call them moral values-- at the same time that they define the
character of society. Society may embody and exemplify moral
values, but it does not provide a ground for the legitimation
of morality. Society is "moral" to the extent that it commits
itself to the good of the individual, a good which transcends
the individual for the sake of the individual. A double trans-
cendence reveals itself here: the individual is transcended
21-15
insofar as moral values go beyond any one person's interests
and needs, and society is transcended to the extent that the
moral values it represents are not themselves justified on the
sole grounds of the common good. During an epidemic, physicians
and government officials have the right to segregate individuals
who are likely to contaminate others, but that right (and
obligation) does not carry with it an authorization to destroy
those who endanger the lives of others. Certain rights of the
contagious minority must be respected by the endangered majority.
The moral value at issue here is that human beings are, by nature
of their humanity, committed to the care of the afflicted. Should
there be a situation in which the only way to protect the rights
of the unafflicted is by destroying the afflicted, the social
order would be challenged in its own moral inwardness. Nor is the
moral tension eased if the minority involved is a tiny one. Hans
Jonas writes:
"Society, in a subtler sense, cannot 'afford' a single miscarriage of justice, a single inequity in the dispensation of its laws, the violation of the rights of even the tiniest minority, because these undermine the moral basis on which society's existence rests. Nor can it, for a similar reason, afford the absence or atrophy in its midst of compassion and of the effort to alleviate suffering --be it widespread or rare-- one form of which is the effort to conquer disease of any kind, whether 'socially' significant (by reason of number) or not. And in short, society cannot afford the absence among its members of virtue with its readiness to sacrifice beyond defined duty." 12
The rights and obligations of society toward its members
and future members (and past members as well) are limited by
its implicit as well as explicit commitment to the good of the
concrete individual who seeks his physician's care. The physician
21-16
honors the good of society insofar as he respects the good of
his patient. Apart from situations of pestilence, widespread
starvation, natural disasters, or catastrophes of war where,
for the time of the emergency, traditional commitments may be
qualified or suspended, the needs of the patient have primacy.
No equivalent primacy exists, in ethical terms, from the stand-
point of society. It is misleading to emphasize the good of
future members of society at the expense of present members,
As Jonas puts it, "our descendents have a right to be left an
unplundered planet; they do not have a right to new miracle
cures. We have sinned against them if by our doing we have
destroyed their inheritance...; we have not sinned against them
if by the time they come around arthritis has not yet been
conquered (unless by sheer neglect)." 13 But it is evident that
all physicians do not subscribe to this view. It is further
evident that physicians who are fundamentally involved in
research may interpret the society-individual relationship in
a different way than physicians who are primarily concerned
with
categories coincide, some interesting problems arise, Renée C.
Fox has presented a thorough description of the difficulties
experienced by one team of research-physicians in determining
the limits of ethical medical conduct in treating patient-subjects.
She writes:
caring for their patients. When the two overlapping
"The Metabolic Group was also engaged in a considerable amount of research which they undertook primarily to advance general medical knowledge, and only secondarily or incidentally because they thought it might be helpful to patients who consented to act as their subjects.
21-17
The members of the Group 'hoped' that the patients who participated in these experiments might gain some clinical benefit from doing so, and they were pleased when this happened. But to the limited extent that medical ethics allowed them to do so, they subordinated their clinical desire to serve the immediate interests of the particular patients involved in such experiments, and gave priority to the more long-range, impersonal research task of acquiring infomation that might be of general value to medical science." l4
It is not easy to reconcile medical intervention done with a
bare minimum of ethicality with serving the good of society.
It would seem that such intervention has only a limited connec-
tion with the welfare of the patient-subject but a powerful
relationship to the abstract development of medical knowledge.
I do not think that an ethical balance can be struck between
the needs and rights of the individual and the needs and rights
of society if what is relinquished in the former is the trust
that tacitly undergirds the relationship between patient and
physician or if what is compromised in the latter is the morality
which is based on the inviolability of human freedom. In fact,
the very notion of "balance" in this context is unacceptable if
it leads to a "give and take," a "more or less" of qualitative
human assurances which are irreducible and, in principle, incapable
of being negotiated in terms of a quantitative calculus. One such
human assurance is the patient's right to expect that anything
done for him is being done in his interest, as that interest is
interpreted by the physician who cares for him. In the case of
the subject-experimenter relationship, the fundamental human
assurance is that the most honest, non-selfserving effort has been
made in a well-designed experiment to inform the subject clearly
and with appropriate fullness about what will go on in the
21-18
experiment, about what known dangers there may be, about the
possible injurious side effects that are deemed plausible, or
about the vaguer risks which are being taken by the subject,
given the status of what is not known about the possible results
of the procedure at issue. The words "appropriate fullness" may
seem to beg the question. The acceptability of the phrase depends
ultimately on the honesty of the person who seeks "informed
consent" from the subject. "Honesty" hardly implies omniscience;
it does imply that the subject's good is not given secondary
consideration merely because he has volunteered for the job. In
the case of patient-subjects, appropriate fullness demands of
the physician-experimenter that serious risk be taken only when
the patient-subject's welfare is of primary concern. As Henry K.
Beecher states:
"Considerable or even great risk is not necessarily an absolute injunction against acceptance by the investigator or the subject. Indeed, some procedures have been assoc- iated with a fatal outcome and yet may still provide advantages great enough to outweigh the hazard involved. One cannot forbid what may be a perilous procedure on the basis of unknown risk alone. It seems to me, however, that great risk should usually be accepted only if the subject promises to profit directly from it." 15
We are still left with the category of fully informed,
consenting subjects (including some patient-subjects) who volunteer
for potentially hazardous experimentation from which it is unlikely
that they can derive any personal medical benefit. Granted the
problematic status of the notion
still possible to say that among the rights of individuals is the
right to serve as a volunteer
others. However, society is obliged to guard against abuse by
of "informed consent," 16
it is
in an experiment which may benefit
21-19
experimenters of the rights and needs of those who are most
vulnerable to unethical conduct by those doing research: the
sick, the old, the retarded or mentally ill, children, prisoners,
the impoverished, and those whom life has neglected or betrayed,
Perhaps it is not really possible to arrive at an absolute state-
ment of the sufficient conditions for fully informed consent, but
it is possible to state more comprehensively the necessary con-
ditions which must be met. 17
Medical codes, guidelines, and
protocols already exist which serve to protect both subjects and
experimenters, but the inevitable paradox of the concrete and the
abstract arises once it is asked how a general recommendation or
requirement can be applied in a specific case. Henry K. Beecher
warns:
"There is the disturbing and widespread myth that 'codes' (all of which emphasize, above all else, consent) will provide some kind of security. While there is value, doubtless, to be gained from their examination as guides to the thinking of others on the subject, the reality is that any rigid adherence to codes can provide a dangerous trap: no two situations are alike; it is impossible to spell out occurs, in the course of experimentation, it will be easy for the prosecution to show failure to comply fully, and an endless vista of legal actions opens up. It is a curious thing that lawyers for even the greatest insti- tutions are much more likely, in my experience, to cripple themselves and their institutions with inevitably imperfect codes than are the investigators involved, who usually understand the pitfalls represented by the codes. Security rests with the responsible investigator who will refer difficult decisions to his peers." l8
all contingencies in codes. When an accident
Nevertheless, such documents as the Nuremberg Code and the
Declaration of Helsinki do more than provide a guide "to the
thinking of others on the subject"; they embody and represent
commitments to moral value which make it possible for both
investigators and subjects to recognize and affirm in these
21-20
formulations the conditions of treatment of and concern for
fellow human beings. The ideality of the codes does not
detract from their primary purpose.
Unethical, irresponsible, or incompetent investigators
(or those who choose to exceed their domain of competence)
cannot be legislated out of existence, but they can be con-
strained by the criticism of those who are ethical, responsible,
and expert. It has been pointed out that editors of medical
journals have a particular responsibility to exert caution in
evaluating articles submitted for publication which are based
on data which were unethically obtained. "Such caution should
make it more difficult for those whose announced plans for
experimentation were found acceptable by their colleagues and
superiors but whose actual practice exceeded ethical standards.
Knowing in advance that important results unethically obtained
will not be published will tend to restrain the unethical
investigator. More difficult to cope with is the situation of
the experimenter who does commit himself to the constraints of
ethical practice but who finds it extraordinarily difficult at
times to treat subjects as moral ends without denying them and
others the utilization of perilous means. The physician-investigator
in particular is haunted by the desire to stand by his patient
while also honoring his commitments to the advancement of medical
knowledge. As I have already suggested, there is no calculus
which can substitute for determining the qualitative good of
human beings. 20
To say that, however, is not to claim that such
a calculus cannot be constructed; it is only to warn that any
21-21
calculus must ultimately be interpreted by human beings and that
the act of interpretation presupposes qualitative factors which
have been incorporated in the initial construction of a mathmatical
model as well as the qualitative character of the act of interpre-
tation itself. No doubt, a computer could be programmed in such a
way as to pick out the best candidates for an experiment; the
choice of those candidates, however, needs to be made by a human
being who is morally obliged to reflect on the meaning of "best
candidates" not only for the benefit of the experimenter but also
for the welfare of the candidate. A computerized blood bank is an
extraordinarily useful instrument, but it tells us nothing about
what is morally demanded of those in charge of it.
IV. On Dignity and Philosophical Method
Discussions of experimentation on human beings and codes
which seek to protect the individual against unethical conduct
on the part of physicians and experimenters frequently stress
the importance of honoring the dignity of the person. So, for
example, the Principles of Medical Ethics of the American Medical
Association includes the following dictum: "The principal objective
of the medical profession is to render service to humanity with
full respect for the dignity of man." 21 Or as Herman L. Blumgart
expresses it, "A person has a right not only to live in dignity,
but also to die in dignity." 22
Between the affirmation of such
norms and the reality of medical practice (which, in turn,
21-22
reflects the reality of societal demands and Commitments) lies
the dark terrain of actual practice: the realm of second and
third-rate medical treatment performed by mediocre and sometimes
incompetent staff in hospitals and offices which are often
teeming with people whose "dignity" is of little consequence to
those who are supposed to "care" for them. The more immediate
concerns are being able to handle the flow of emergency cases,
ascertain the patient's ability to pay for services to be pro-
vided, and sustain basic services under distressing circumstances.
Being able to attend to the patient's dignity in such conditions
may be viewed as a luxury. In any event, the medical microcosm
mirrors the macrocosm of society, where dignity is an ideal
which is often subverted by bad faith. Guido Calabresi points out:
"Accident law indicates that our commitment to human life is not, in fact, so great as we say it is; that our commitment to life-destroying material progress and comfort is greater. But this fact merely accentuates our need to make a bow in the direction of our commitment to the sanctity of human life (whenever we can do so at a reasonable cost). It also accentuates our need to reject any societal decisions that too blatantly contradict this commitment. Like 'free will,' it may be less important that this commitment be total than that we believe it to be there.
Perhaps trapped in the coal mine. After all, the event is dramatic; the cost, though great, is unusual; and the effect in reaffirming our enormous. The effect of such an act many societal values that depend on the dignity of the individual is worth the cost. Abolishing grade crossings might save-more lives and at a substantially smaller cost per life saved, but the total cost to society would be far greater and the dramatic effort far less. I fear that if men got caught in coal mines with the perverse frequency with which cars run into trains at grade crossings, would be loath to rescue them; it would, in the aggregate,
it is for these reasons that we save the man
belief in the sanctity of human lives is in maintaining the
we
cost too much." 23
Surely, affirming the dignity of the patient is axiomatic for his
21-23
doctor, but unless the affirmation carries existential force
along with it, its axiomatic status means that it is simply
taken for granted and that its ideal or normative character
remains distant from specific application. No one wishes to be
on record as opposing the dignity of man, but approving that
sentiment hardly calls for much unless it requires moral practice--
in which case, its demands are profound.
If there is bad faith in society, it does not follow that
there must be bad faith in individual choice. If society "chooses"
to do something about the individual and relatively uncommon but
dramatic case of the trapped miner rather than the more widespread
tragedy of collisions at grade crossings, it is not because the
dignity of one victim is more compelling than the dignity of
another victim. As Calabresi indicates: "The notion is incorrect
that we in some sense choose the number of people who will be
killed in automobile accidents by choosing a market system that
will determine how much safety is worth. The notion is only made
plausible by a verbal trick --by using the words 'we choose' to
describe both the effects of the social system in which we live
and which we tolerate, but which we cannot in fact be said to
choose, and events as to which we can be said to exercise
purposive choice." 24 But in the case of experimentation, choice
does lie with experimenter and subject. Experimentation is
purposive choice. Accordingly, the experimenter, unlike society
at large, is obliged to respect the dignity of the concrete
human beings who come within his professional purview. Just
what does dignity signify in this context? We have returned not
27-24
only to a philosophical issue but, in a way, to the philosophical
approach which we outlined so hastily at the outset of this
inquiry and to the status of the central terms of discourse
which have arisen in the course of our discussion. It is time
to attend further to those problems of philosophical method which
underly our comprehension of the nature of Man.
When we say that it is the professional responsibility of
the physician to care for his patient or when we say that the
dignity of each patient must be respected, we are making trans-
empirical recommendations. The care provided by a physician to
a patient may, in a narrow sense, be reviewed by others; but that
only means that services are being scrutinized. Care, as we have
been using the word, refers to the commitment the physician has
made as a fellow human being to another fellow human being who is
in need. Care in this sense is recognized by those who are immed-
iately involved in the situation of care: physician, patient,
and others who are truly concerned with the well-being of the
patient. In a similar way, respect for and recognition of human
dignity is a function of the individual relationship between
physician and patient. Both care and dignity do not preclude
therapeutic distance on the part of the physician; indeed, such
distance is necessary if he is to function effectively. But
distance does not either damage or replace devotion and
dedication. If care and dignity are transempirical in nature, it
does not follow that they are incomprehensible either to the
patient, the physician, the subject, or the experimenter. To the
contrary, care and dignity are terms whose meaning is rooted in
21-25
the Life-world and whose appreciation, therefore, is available
to ordinary men and women and children. To be treated with
respect and decency is the common desire of all of us. To ignore
the dignity of the person or to treat him without really caring
for him results in human resentment. That such commonplaces are
recognized and affirmed by common-sense people is precisely the
point of self-interpretation within the Life-world. We recognize
as mundane creatures that although we may be replaceable as
organisms, our identitites as persons are not commodities. To
care for and respect the person has little to do morally with
liking the individual, whatever the psychological relationship
may be between physician and patient. Rather, care and respect
are directed toward the privileged being of the person. James
Agee writes:
"Each is intimately connected with the bottom and the extremest reach of time:
Each is composed of substances identical with the substance of all that surrounds him, both the common objects of his disregard, and the hot centers of stars:
All that each person is, and experiences, and shall never experience, in body and in mind, all these things are differing expressions of himself and of one root, and are identical: and not one of these things nor one of these persons is ever quite to be duplicated, nor replaced, nor has it ever quite had precedent: but each is a new and incommunicably tender life, wounded in every breath, and almost as hardly killed as easily wounded: sustaining, for a while, without defense, the enormous assaults of the universe." 25
The same integrity between care and dignity must be retained
or at least struggled for in the relationship between experimenter
and subject. It is possible that unethical means may yield
potentially beneficial results; it is certain, however, that the
21-26
deliberate choice of unethical means will damage the conditions
of trust between human beings which constitute the realm of
moral ends. When I said earlier that the relationship between
risk and benefit must be viewed in integral fashion, what I
meant was that the concrete situation of the individual within
the social order (including its historical dimension) commands
fundamental respect. Understanding that situation means holding
in tension the way in which the individual interprets the meaning
of his own action and the manner in which society comes to self-
recognition through the moral choices made by its agents. When
the subject-volunteer is genuinely and thoroughly informed, when
he knows that the considerable risk he agrees to take cannot
benefit him personally as far as his health is concerned, and
even when he considers himself a co-worker with the experimenter
in the cause of general scientific knowledge, still there
remains a moral (though not an ethical or legal) constraint on
the investigator to do his best by a fellow human being, to
minimize or to try to control whatever pain the subject may
receive, and to do everything reasonably and appropriately
possible to guard against damaging or fatal consequences. Perhaps
the most difficult task the experimenter faces is to refuse to
capitalize on the good will and trust of his subject for the sake
of the experiment. I remain haunted by a fragment from a
physician-experimenter's case history: "This amiable and cooperative
gentleman, having previously been prostatectomized, orchidectomized
and adrenalectomized,
remarkable how this gentleman's amiability has managed to keep pace
reenters to be nephrectomized." 26
It is
21-27
with his cooperativeness, for his prostate, testicles, and adrenal
glands have been removed, and he now faces the further surgical
loss of a kidney. What a sadly punishing history remains locked
in that medical sentence.
My conclusion can be presented in straightforward terms. An
appreciation of the structure and texture of the Life-world, of
the meaning of human action in mundane experience, and of the
fundamental situatedness of persons within the world is essential
to the determination of risk and benefit relationships in all
experimentation on human beings. A phenomenological and
existential approach to these problems offers a valuable point of
access to the interpretation of the nature of medical care and
human dignity. Any assessment of risk-benefit criteria must remain
grounded in the moral imperatives of human beings seeking to
fulfill themselves in their dependence upon their fellow human
beings. The abstractness and generality of moral claims cannot be
reduced to quantitative models for medical decision without eroding
the very goals of a just social order in whose name experimentation
is carried on. Care and dignity are not euphemism for unrealistic
demands; they are the substance of our moral energies and the
means through which we express the paradox-ridden career of man
in the social world.
Maurice Natanson
University of California, Santa Cruz
21-28
NOTES
1. Maurice Natanson, Phenomenology, Role, and Reason (Ch. XIV,
Thomas, 1974, pp. 304-306. "Benefit and Experimentation"), Springfield, Ill.: Charles C.
2. Maurice Merleau-Ponty, Signs (trans. with an Introduction by Richard C. McCleary), Evanston Ill.: Northwestern University Press, 1964, pp. 101-102.
3. Jean-Paul Sartre, Anti-Semite and Jew (trans. by George J. Becker), New York: Schocken Books, 1948, pp. 59-60.
4. Henry K. Beecher, "Medical Research and the Individual," in Life or Death by Edward Shils and others (Introduction by Daniel H. Labby), Seattle: University of Washington Press, 1968, p.124 (note: Beecher attributes this observation to R. A. McCance).
5. Jay Katz makes an important point in this connection: "Dis- tinctions have traditionally been drawn between research con- ducted by investigators on 'normal volunteers' in purely exper- imental settings and by therapist-investigators on 'patients' in treatment settings. It has generally been assumed that more stringent controls should be placed on investigators whose actions are designed to gain knowledge rather than to promote the subject's 'best interests.' Yet in most situations it is difficult to draw lines between 'normal volunteers,' 'patient- subjects,' and 'patients.' Moreover, the therapeutic setting may be the one which deserves the closer scrutiny. While a volunteering subject can be alert to protect his own self- interest, a patient-subject's need for treatment may cause him to overrate the benefits and underestimate the risks of a research technique." ( Experimentation with Human Beings , New York: Russell Sage Foundation, 1972, p. 727).
6. Maurice B. Visscher, Ethical Constraints and Imperatives in Medical Research , Springfield, Ill.: Charles C. Thomas, 1975, p. 64.
7. Herman L. Blumgart, "The Medical Framework for Viewing the Problem of Human Experimentation," Daedalus , Vol. 98, No. 2, Spring 1969, p. 253.
21-29
8. Otto E. Guttentag, "Ethical Problems in Human Experimentation," in Ethical Issues in Medicine (ed. by E. Fuller Torrey), Boston: Little, Brown, 1968, p. 212.
9. Dr. Guttentag is sensitive to the therapeutic imbalance which may result from the effort to protect the needs of the patient as well as the experimental subject. He writes ( ibid ., pp. 200- 201): "With reference to the relationship between experimenter and experimental subject, it is the concept of partnership be- tween the two, resulting from the fact of their being fellow human beings, that reflects our basic belief and cannot be sub- ordinated to any other." Cf. Joseph Fletcher, Morals and Medicine , Boston: Beacon Press, 1960, p. 37.
10. Chauncey D. Leake, "After-Dinner Address: Ethical Theories and Human Experimentation," Annals of the New York Academy of Sciences , Vol. 169, Art. 5, January 21, 1970, p. 394 (note: this is an issue on "New Dimensions in Legal and Ethical Concepts for Human Research"). Cf. the following statement by Henry K. Beecher: "...in discussing new and uncertain risk against probable benefit, Lord Adrian spoke of the rise in Britain of mass radiography of the chest. Four and a half million examinations were made in 1957. It has been calculated that bone marrow effects of the radiation might possibly have added as many as 20 cases of leukemia in that year; yet the examinations revealed 18,000 cases of pulmonary tuberculosis needing supervision, as well as thousands of other abnormalities. The 20 deaths from leukemia were only a remote possibility, but, Lord Adrian asks, if they were a certainty would they have been too high a price to pay for the early detection of tuberculosis in 18,000 people? (in Updating Life and Death (ed. by Donald R. Cutler). Boston: Beacon Press, 1969, pp. 239-240.
11. Paul A. Freund, "Ethical Problems in Human Experimentation," in Readings on Ethical and Social Issues in Biomedicine (ed. by Richard W. Wertz), Englewood C1 iffs, N.J.: Prentice-Hall, 1973, p. 38.
12. Hans Jonas, "Philosophical Reflections on Experimenting with Human Subjects," Daedalus , Vol. 98, No. 2, Spring 1969, pp. 228- 229.
13. Ibid ., pp. 230-231.
21-30
14. Renée C. Fox, Experiment Perilous , Glencoe, Ill.: Free Press, 1959, p. 46 (note: The continuation of the passage from which this quotation is taken deserves special attention (pp. 46-48)): "The following are the basic principles governing research on human subjects which the physicians of the Metabolic Group were required to observe in order to 'conform to the ethics of the medical profession generally...and satisfy democratic morality, ethics and law':
1. Voluntary consent of the subject is absolutely essential. Consent must be based on knowledge and understanding of the ele- ments of the study and awareness of possible consequences. The duty of ascertaining the quality of consent rests on the individ- ual scientist and cannot be delegated.
2. The experiment should seek some benefit to society, unob-
3. The experiment should be designed and based on prior ani-
tainable by any other method.
mal study, the natural history of the disease or problem and other data so that anticipated results may justify the action taken.
4. It should be conducted to avoid unnecessary physical and
5. No experiment should be undertaken where there is reason
mental suffering.
to believe that death or disability will occur, except perhaps where the experimenter may also serve as his own subject.
6. The degree of risk should never exceed that which the importance of the problem warrants.
7. There should be preparation and adequate facilities to protect the subject against even remote possibility of injury, disability or death.
degree of skill and care, should conduct experiments on human beings.
9. The subject should be permitted to end the experiment whenever he reaches a mental or physical state in which its continuation seems to him impossible.
if he his reason to believe that its continuation is likely to result in injury, disability or death.
The physicians of the Metabolic Group were deeply committed to these principles and conscientiously tried to live up to them in the research they carried out on patients. However, like most
8. Only scientifically qualified persons, exercising a high
10. The investigator must be prepared to end the experiment
21-31
norms, the 'basic principles of human experimentation' are formulated on such an abstract level that they only provide general guides to actual behavior. Partly as a consequence, the physicians of the Metabolic Group often found it difficult to judge whether or not a particular experiment in which they were engaged 'kept within bounds' delineated by these principles.
primarily to advance medical knowledge. The justification for this kind of research did not lie in its potential immediate value for the patients who acted as subjects. Rather, it was premised on the more remote, general, uncertain probability that its 'anticipated results...their humanitarian importance...for the good of society' and the chance of achieving them --would exceed the immediate amount of 'suffering' and 'risk' the exper- iment might entail. The criteria on which physicians ought to form such a calculus are not specified by the rules of conduct for clinical research. Thus, without many established or 'clean- cut' bases of judgment to guide them, the physicians of the Metabolic Group were constantly faced with the problem of trying to decide whether the particular experiments they were conducting fell within the limits of their rights as investigators, or whether they were overstepping those rights by subjecting the patients involved to more inconvenience and danger than the possible significance of those experiments for the 'advancement of health, science, and human welfare' seemed to warrant."
This was especially true of the experiments they conducted
15. Henry K. Beecher, "Medical Research and the Individual," p. 124.
16. Henry R. Beecher says: "Again and again I think we are deceiving ourselves if we think we can very often get satis- factorily informed consent. It's the goal toward which we strive, and in striving for it we get a positive value. The positive value is that the subject knows, because of your inquiry, that he is going to be the subject of an experiment. I can tell you hundreds of examples where they haven't known that they were subjects sometimes of deadly experiments, and so I think there is a value in striving toward this goal. But we are deceiving ourselves if we think we ever achieve it in ordinary circum- stances, in any reasonably complex situation." (in Ethical Issues in Biology and Medicine (ed, by Preston Williams), Cambridge, Mass.: Schenkman, 1973, p. 225.
21-32
17. See the material on informed consent included in Jay Katz's Experimentation with Human Beings . In Experiment Perilous , Renée C. Fox provides the following information about consent (p. 112): "Sometimes the Metabolic Group obtained the informal, spoken consent of the patients who participated in their exper- iments. However, for those which involved a considerable amount of hazard and risk, they usually had the patients involved (or their closest of kin) fill out the following form:
I, , hereby certify that I have had explained to me the details of the contemplated procedure and assume full responsi- bility for any results of such a procedure.
Signed Date
Witnessed
Putting the patient in possession of technical information not only protects his welfare; it also fulfills the moral pre- scriptions of science, and, in so doing, helps to perpetuate and give momentum to scientific investigation as an institution. There is evidence to indicate that when these moral precepts are violated, scientific creativity is impaired."
18. Henry K. Beecher, "Consent in Clinical Experimentation-- Myth and Reality," in Experimentation with Human Beings , p. 583.
19. See Henry L. Beecher, "Medical Research and the Individual," p. 150.
20. Robert J. Levine is right in hesitating to recommend the use of mathematical models in determining risk-benefit relationships. In addition to the difficulty he points out in assigning a weight or probability to the experience of pain, there is the question of how a mathematical model, once established, can interpret or help us to interpret the concrete situation of the patient or subject in a world defined not only by the experimenter but, in the first and last instance, by the patient himself. See Levine's manuscript of October 27, 1975 on "The Role of Risk-Benefit Criteria in the Determination of the Appropriateness of Research involving Human Subjects" (prepared for The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research).
21-33
21. Quoted by Richard C. Allen in Readings in Law and Psychiatry (ed. by Richard C. Allen, Elyce Zenoff Ferster, and Jesse G. Rubin), Baltimore: The Johns Hopkins Press, 1968, p. ix.
22. Herman L. Blumgart, "The Medical Framework for Viewing the Problem of Human Experimentation," p. 272.
23. Guido Calabresi, "Reflections on Medical Experimentation in Humans," Daedalus , Vol. 98, No. 2, Spring 1969, pp. 388-389.
24. Ibid ., pp. 391-392.
25. James Agee and Walker Evans, Let Us Now Praise Famous Men , Boston: Houghton Mifflin, 1941, p. 56.
26. Renée C. Fox, Experiment Perilous , p. 44.
21-34
22
ESSAY ON SOME PROBLEMS OF RISK-BENEFIT
ANALYSIS IN CLINICAL PHARMACOLOGY
Lawrence C. Raisz, M.D.
Risk-Benefit Analysis is an extension of common sense decision
making. Faced with any alternative, a rational individual will determine
what the advantages and disadvantages of each particular course might
be and then proceed. When such an analysis is extended from single
individuals to physicians as investigators and patients as experimental
subjects, and particularly when the analysis involves matters of life or
death, health or well being and legal sanction or disapproval, the analysis
becomes more difficult and common sense will not suffice.
This paper will focus on the particular case of the development and
evaluation of drugs to be used in the treatment of human disease. The
following special problems must be considered:
1) In the first phase of drug development in man, the individuals who
take the risks, that is, who are given the drug, are not those who will
benefit from its subsequent use. In phase I clinical trials, normal
subjects are given a drug to examine its pharmacokinetics and look for any
unexpected adverse effects which have not been detected in animal testing.
2) In phase II, when the drug is first administered to patients, these
patients will be selected on the possibility that the drug is effective
in their disease. However, there is no statistical basis on which to guess
the likelihood that the effect will be desirable.
3) While we assume that risks and benefits should be assessed in terms of
weighing statistical probabilities, there are always numerically
undefinable qualitative differences which must be taken into account.
22-1
For example, a much lower per cent likelihood of a fatal reaction is
acceptable for an agent used to treat a non-fatal illness compared with
a drug used to treat a fatal illness. In our analysis we must assess what
per cent of skin rashes should be the equivalent of what per cent of
episodes of blood dyscrasia. This problem is compounded by the fact
that the numbers of subjects are usually so small that the statistical
inferences can only be made within very broad confidence limits. This is
particularly true for infrequent but serious adverse drug reactions.
Historically such reactions have never been fully appreciated until an
agent has been marketed and used in large numbers of individuals for some
years.
4) Finally, risk-benefit analysis should include assessment of the risks
attendant upon failure to develop a new agent or procedure, and the loss
of benefits due to delays in developing an agent or impediments in making
it available for general use. In terms of national and world health this
is certainly numerically the most important kind of failure of any health
system to bring its maximum benefits to the greatest number of individuals.
In Section I of this paper, I will discuss the first problem in some
detail. Section II will touch on other aspects more briefly. My point of
view will be that of a clinical scientist;
will be derived from the diagnosis and treatment of "organic" illnesses,
that is excluding psychologic research and therapy of psychiatric illness
the concepts and examples
22-2
in which I have had no personal experience.
I.
beneficiaries represent totally different populations?
Is it valid to apply risk benefit analysis when the riskers and the
A simple answer to this question might be, "No, but we have to do
something like it, so let's get on with the job." In a phase I clinical
trial there must be prior toxicity studies in animals, sufficient to
predict an extremely small risk of permanent physical injury, particularly
of death, at the doses initially administered in man. Nevertheless, these
risks can never be reduced to zero. The question at issue is to what extent
and with what safeguards will human volunteers be allowed to take such risks
for the benefit of others. While differing enormously in practice, in prin-
ciple, religious sacrifice to appease the gods had the same motivations
and was intended to serve the same needs of society. Societies which
performed sacrifices believed that they would receive important benefits
in the form of more rain, better crops, or victory in war. We expect to
receive benefits in terms of better health by having humans take experi-
mental risks. One major difference is that the scientific method should
enable us to determine, after the fact, whether the expected benefits
were actually obtained and whether the risks in our use of human volun-
teers were actually small. A second difference is that in primitive
societies suffering was considered necessary for sacrifice to be effective
while the goal in human research is the avoidance or mitigation of human
suffering.
22-3
However, one point which is emphasized by recognizing the common
conceptual ancestry is that "not all volunteers are really volunteers."
The Mayans sacrificed prisoners of war; we ask prisoners of society to
volunteer for phase one trials. This does not make the use of prison
volunteers in phase one trials indefensible. We consider ourselves to
be an essentially moral society, so, I suspect, did the Mayans. The
difference lies in the value placed on human life and freedom. Hence,
to satisfy our moral tenets, we must believe that prisoner volunteers
are true volunteers. If a prisoner can obtain decent food and housing,
proper treatment from custodians, or consideration for early parole
only by volunteering then there is coercion. If the only difference
between a prison volunteer and a non-volunteer is a small compensation
for the time and discomfort involved then the system may be truly
voluntary. The gap between morally defensible and morally indefensible
may seem large but as with all such polarities there are many gradations
in between and these can change with time. This is apparent when considering
some of the abuses in human experimentation which lead to our present
concern. Experiments involving the injection of cancer cell and delays
in antisyphilitic therapy seem morally indefensible now, but were
presumably considered defensible by those who carried out or approved
them. If one examines the records of hospital human investigation
committees one can find evidence of changing criteria - recently these
have been largely in the direction of
and freedom from coercion of experimental subjects. The fact that
greater concern for the safety
22-4
prisoners eagerly volunteer to be experimental subjects does not resolve
the moral issue. In fact it may indicate how strong the element of coercion
is, that is the degree to which becoming a subject for a phase one
trial is advantageous to the prisoner and not volunteering is disadvantageous.
If so much benefit accrues that it would be better to take a substantial
risk of physical harm than not to volunteer there is something wrong
with the penal system.
A special case in which the individual taking the risk is less likely
to receive any benefit is the clinical trial in which a placebo or dummy
treatment is used. It could be argued that this is no longer an important
issue in clinical pharmacology since drugs which
better than a placebo are now available to treat a wide variety of sub-
jective symptoms. Hence, any new agent should be compared with the best
agent previously available for that symptom or disease; and thus both the
treated and control groups would be likely to benefit. Except for trials
which are designed to assess minor, quasi-therapeutic effects, such as a
study to determine whether caffeine really helps students stay awake
while studying or trials on agents which may have small or subtle effects
on mood or behavior, the
less justifiable in therapeutic research. Probably the most important
current need for placebo controlled
unlikely to be undertaken because of practical difficulties or societal
condemnation. For example, it might be worthwhile to repeat, using
have been shown to be
use of placebos is becoming less necessary and
trials is in the areas where they are
22-5
modern techniques, a study done years ago in which a group of patients
were subjected to surgery intended to increase coronary perfusion and a
control group actually underwent a dummy operation. The current solution
is to have the control group treated medically, not subjected to a placebo
operative procedure. While this is more easily defensible on moral and
practical grounds, it may well be that the effectivenesss of expensive
coronary bypass surgery will be experimentally validated not because of
its cardio-vascular effects, but because an operation has an extremely
powerful placebo effect.
The principles for obtaining volunteers from other closed populations
such as students, military personnel or patients in chronic care facilities,
should be similar to those for prison volunteers. For students it is
particularly important to separate the roles of teacher and evaluator from
that of investigator so that students will not feel constrained to
volunteer to get better grades or recommendations from faculty members.
Clearly the best method for obtaining volunteers would be by recruiting
from society at large, using appropriate advertisement. Even if volunteers
are truly free, there remains the additional problem of determining whether
some should be prevented from volunteering "for their own good". This
involves both philosophic questions of the limits of individual freedom
and psychiatric questions of the evaluation of mental competence. Society
often errs on the side of excessively restricting individual freedom to
volunteers and undervaluing the mental competence of its members.
22-6
If consent is truly informed and risks
inappropriate to deny the right to volunteer because of what is judged
are minimized, then it seems
to be an inappropriate personality or insufficient mental competence. The
critical judgement should be whether informed consent is
information which is sufficiently comprehended.
to inform individuals who are mentally ill, below the age of legal consent,
or have relatively low intelligence or little education, provided that the
means are appropriate. This is simply an extension of the general problem;
to obtain informed consent one has to provide information in terms that
can be understood by the individuals asked to give consent. If there is
no communication there can be no informed consent. One cannot obtain
consent from fetuses or infants or patients in coma.
based on sufficient
Theoretically it is possible
There remains the most difficult question; whether anyone can
decide that non-consenting human subjects
mental procedure.
must be developed because important advances in the prevention and treatment
of human disease sometimes cannot be achieved by any other means. However,
the usual mechanisms of review by the institution coupled with informed
consent by the parent or guardian are not sufficient. A judicial state
or federal review procedure is
are sufficiently large, the risks sufficiently small and most important,
whether there is no alternative method of
should be used for an experi-
I believe that proper mechanisms for such experimentation
required to determine whether the benefits
obtaining the desired information.
22-7
In a phase I trial on volunteers who are not expected to benefit from
the agent being examined, the usual criteria for informed consent may not
really be relevant. Neither the probability nor the nature of adverse effects
is truly known. Information can be given based on animal trials but its
uncertainty must be emphasized. On the other hand, it does seem appropriate
to tell the volunteers in a study what the expected benefits to the other
members of society might be. In other words, any volunteer should have the
privilege of knowing why they are being asked to take a risk, and be
treated with the dignity and respect that one should accord an active
participant in the research process. If the prospective volunteer doesn't
think a risk is worth taking for
sufficient reason for them to refuse to participate.
the benefit being sought this should be
Even when volunteers are free to give or withhold properly informed
consent, a different procedure may be required to assess the risk-benefit
equation simply because the riskers and beneficiaries are different
individuals. It may help to carry out the initial assessment of risks and
benefits separately before looking at them together for comparative
weighing. There are several reasons for this. First, the assessment of
risk may involve different forms of expertise and certainly involves
different societal considerations than the assessment of benefit. Second,
the risk-benefit equation cannot be balanced internally by a single
institutional review committee. The risks will be taken in one institution
but the benefits will accrue outside it. Of course, in any experiment there
is potential benefit to individuals and society outside the purview of the
22-8
institutional
the institution and the review group will have some understanding of these
problems or access to local experts who do. Where the benefits are external,
separate expert consultants and advocates are needed to assess the potential
benefit of the research.
review group, but some potential beneficiaries will be in
In assessing the risks for a volunteer group in a phase one trial one
needs information from animal studies and an analysis of potential risks
based on the experience of clinical pharmacologists whose special area of
competence is adverse drug reactions. In addition, the volunteers need an
advocate both to assure their general rights and to ascertain that there
is no coercion. In assessing the benefits there should be input not only
from those who are sponsoring the drug, but also from disinterested experts,
in the therapy of the disease or condition for which the drug is intended
who can testify as to the degree of need for additional or new therapy and
the likelihood that the therapy to be tested will fill that need. An
additional advocate who represents the patient population at risk should
have input. The final review must assess the material on risk and benefits
coming from different sources and attempt a balance. This should be carried
out by a group which is not only broad in composition, but includes indivi-
duals who are independent of the institution where the initial research
is carried out. Appropriate mechanisms could be developed at the community,
state or federal level. The level used might depend on the nature and ma-
gnitude of the project. Ideally multiple levels should be available for
22-9
appeal. At present review is carried out at the federal level by the
Food and Drug Administration. The mechanisms are over-centralized,
sometimes cumbersome and community and societal interests, particularly
these of potential beneficiaries, may not be fully appreciated. It seems
inappropriate to ask the FDA to add to its already heavy administrative
load such an extensive consideration of the ethical, moral and social
issues which are so often involved in clinical trials. The formation of
a separate national review body might be a logical extension of the work
of the National Commission.
The tripartite approach discussed above may sometimes also apply to
risk benefit analysis in studies of non-therapeutic procedures. While
not ordinarily considered a part of clinical pharmacology, such studies are
an important part of clinical research. Generally a diagnostic procedure,
although experimental, is intended to be of benefit to the patient upon
whom it is performed. However in the development and evaluation of a new
diagnotic test, values on a series of control subjects are generally needed.
Where only blood and urine samples are obtained, this does not present
great problems; the normal volunteers undergo essentially no risk and only
the minimal discomfort of a venipuncture. The control material for tests
involving biopsies are ordinarily obtained from autopsy material, however
there is considerable current interest in utilizing tissue and organ culture
to examine biopsy specimens functionally. To evaluate functional diagnosis
in disease properly it is essential that similar material be obtained from
22-10
unaffected individuals. Hence volunteers may be asked to undergo skin, bone,
intestinal and liver biopsies. In addition there are many diagnostic proce-
dures which involve the injection or ingestion of drugs or dyes which can
produce occasional adverse reactions. Since the risks in these two instances
here are quite substantial and those taking the risk will not benefit
medically, the complex tripartite evaluation scheme recommended for phase
one trials ought to be applied. Unfortunately this direct and suitably
monitored approach has often been circumvented by obtaining "control"
data from those patients subjected to a particular procedure who do not
turn out to have the disease in question. Such an approach leads to the
temptation, perhaps unconscious, to test for a diagnostic possibility in
a patient in whom the possibility is highly unlikely, simply to obtain
additional data on a particular test or procedure. In this case risk-
benefit analysis is applied in the more usual way discussed in part II
of this paper, but in fact those asked to take the test are really not
potential beneficiaries if the test is irrelevant. The best way to
avoid this misapplication of a diagnostic test is to insist that the
risk-benefit analysis be applied by the tripartite method.
Finally I would like to mention a disparity between riskers and
beneficiaries which the National Commission may not consider as part of
its charge, but which could reflect on our national morality. We are
increasingly dependent on other countries for the development and
evaluation of new drugs. We congratulate ourselves on avoiding the use
22-11
of thalidomide, but we could only know the risk because others took it.
Clearly we should not take risks simply because investigation and review
bodies in other countries are willing to do so. However we must also be
careful not to use this willingness for our own benefit. On a recent visit
to Africa I was concerned that foreign pharmaceutical firms might be using
African patient populations to test new drugs with less regard for
safety than they would have had in using their own nationals as subjects.
To apply rigid criteria at home and tacitly approve less safe trials
abroad is not morally defensible.
II. Risk-benefit analysis when the risks and the benefits are likely
to accrue to the same individuals or groups.
This problem can be divided into two parts:
A) those circumstances in which the risks
of sufficient substance to make an analysis worth considering and,
b) those circumstances in which both the risks and benefits are large. The
latter applies to the development and evaluation of therapy for serious
illnesses for which current treatment is not adequate. The circumstance
in which the risks are large and the potential benefits small is obviously
one to be avoided. However as examplified by the thalidomide disaster, and
the experience with chloramphenicol the existance of excessive risks
may not be appreciated until extensive trials have been conducted.
Investigators and review groups must be alert to this possibility so that no
further studies will be conducted once this disparity between risk and
or the benefits are small, but
22-12
benefit known to exist. The situation in which the risks are small and
the benefits large is simply a desirable extension of the second category.
A. Many trials in which both risks and benefits are small involve dispari-
ties between those who take the risks and those who will benefit but
approach may be different from that considered in part I. Research in
clinical pharmacology often involves the evaluation of agents which are
expected to bring definite but limited benefits to the subject and to
other patients with similar disorders. Such agents may turn out not to
be beneficial to many of the patients treated initially. For example, in
the evaluation of a new analgesic designed to replace aspirin in patients
who cannot tolerate aspirin, the new drug might be used in patients who
can tolerate aspirin and therefore are best treated with the older established
drug.
and the benefit to others appreciable. Similarly in the reevaluation of
currently available drugs or particular uses of those drugs which are
of questionable merit, the expectation may be that there will be little
benefit to the patients in the trial. There would be a benefit to future
patients and to society if it could be clearly shown that a particular
use of that particular agent should be discontinued. Risk-benefit analysis
in this situation usually does not-present unsurmontable difficulties and
does not require the complex tripartite evaluation discussed in Part I.
The risks are usually well known for already established agents. If the
the
Such use can be justified because the risk is small and transient,
22-13
agents are to be used for relief of minor symptoms, low risk must be
demonstrated and the benefits are usually such that both physicians and
non-physicians can appreciate and evaluate them.
One serious problem in risk-benefit analysis for drugs of this type
is in dealing with what might be termed the information-use gap. Information
derived from a trial is rarely used optimally for several reasons: 1) It
may be difficult or inappropriate to apply the information of the trial to
the larger population at risk. Consider the television advertisement for
a drug taken predominantly for headache, in which the huckster points
out that in studies on "pain other than headache, doctors at a teaching
hospital and major medical center found agent X to be superior". 2) Indi-
vidual clinical trials can be assessed by appropriate statistical means
and careful descriptions of the patient population can be presented, but
only after the accumulation of a number of such trials and the analysis
of many relevant patient and disease factors can
concerning the therapy of larger populations. The validity of this con-
sensus cannot be tested by ordinary statistical means. It is a matter of
weighing evidence which seems more judicial than scientific. Hence we find
physicians telling about their clinical judgement and
the difficult problem of deciding which physician's judgement to accept.
Perhaps some of the difficulty in this area would be resolved if those
who are asked to weigh the evidence were trained not only as physicians and
scientists but as lawyers and judges. The group which make such decisions,
be they hospital pharmacy committees, state or federal purchasing agents
one arrive at a consensus
we are faced with
22-14
or the National Research Council Advisory Boards to the FDA might profit
from more input by those familiar with judicial procedure. Scientific
conclusions based on reproducibility, statistical validity and quality
of the experimental design could be enhanced by the judicial assessment in
the traditional terms of competence, relevance and materiality. 3) While
such an approach might help us make a better assessment of therapeutic
questions, it will not insure that new judgements, whatever their quality,
are distributed appropriately. The availability of a careful assessment
is not sufficient to close the information-use gap. After the risks and
benefits of a particular therapy have been analyzed these must be presented
so as to be understood by those who will use the therapy. The proportion
of adverse reactions to a given drug which occur due to misinformation,
misunderstanding or misuse by the physician or patient is generally
much greater than the proportion of adverse reactions which occur
because of unavoidable side effects during correct use of that drug.
There is no absolute way of ensuring that the appropriate instructions will
be carried out by physicians, patients or society. We have few groups
which attempt to monitor the use and distribution of therapeutic agents
and the findings of such groups may have little effect on the general use
of an agent. This is a particularly severe problem in a capitalist system
where profit has a powerful impact on the development and distribution of
drugs. In the past beneficial drugs have not been marketed, because they
were not profitable. The problem is compounded by the fact that physicians
22-15
use drugs in a highly independent manner. They regard, in some cases
correctly, the advice and instructions in package inserts and other
informational material as excessively and inappropriately restrictive.
Thus the information-use gap may also occur because the official infor-
mation has not kept pace with non-official information which nevertheless
influences current use.
B. In considering the problem of assessing risks and benefits when both
are large we need to take a fresh look at the relationship between patient
and healer. Traditionally, the patient with a serious illness for which
definitive therapy is not available is advised to seek out an outstanding
physician (usually defined as one in whom others have much confidence), put
themselves in the hands of that physician and do what they are told. This
demonstration of faith is the fundamental tenet of the primitive healing
arts, and remains the principle by which quackery, folk medicine and a wide
variety of dubious cures still gain acceptance. On the other hand good
healers, dedicated to their patients welfare and well-versed in scientific
medicine also make extensive use of "faith in the physician" to carry out
their therapy. Is it appropriate to ask a patient to accept this relation-
ship and at the same time ask them to take part in an experiment? In this
setting it seems more appropriate to engage the patient as fully as
possible as a partner in a scientific enterprise. To do this effectively
may require a change in the attitude of society towards therapeutic
research. Today sick patients are generally ill-prepared to take an active
22-16
role in decision making. I do not believe this is because sickness robs
them of their judgement or because sick patients are intrinsically inca-
pable of taking part in a decision concerning their own welfare. Rather
it is because the tradition of faith in the physician is currently so
powerful and pervasive. How common it is, after a long explanation of a
patient consent form to hear the patient say: "I'll do what ever you think
best, doc.". We must realize that the reason for this response may be
that patients think that physicians expect it and are afraid to voice their
underlying concerns. A substantial amount of education of both physicians
and patients would be required to change this response. Nevertheless I
believe that such education is necessary if we are to pursue clinical
investigation actively in an era when new and powerful agents are continuously
being made available, and require rapid induction.
Two additional problems arise when the risks are large and the
potential benefits are great. One is the problem of whether, even with
informed consent, individuals can be asked to take a substantial risk on
the possibility that their health will improve. We allow individuals to
take much greater risks for financial gain. How can a society which permits
and sometimes even encourages death-defying stunts prevent a sick individual
from taking a substantial risk in the hope of gaining health, or even stop
a heroic martyr from taking a
better
practice explosion may have a powerful
substantial risk in the hope of achieving
health for others? Fear of legal reprisals as a result of the mal-
but inappropriate influence on
22-17
risk-benefit analysis in this situation. Better methods must be devised
for dealing with the malpractice issue in clinical research.
III. Recommendations
Much of what follows has already been suggested in the discussion
above. My recommendations for better procedures for risk-benefit analysis
have been generated from experience in academic medicine in a hospital
setting, as a clinical investigator and as an active participant on both
sides of the institutional review procedure.
1. My major recommendation is that new procedures be developed for risk-
benefit analysis of studies in which those taking the risks are different
from those who benefit. As described above, I believe that there should
be a tripartite review system for such studies. One group would have the
appropriate expertise to analyze the risks and judge the propriety of the
selection of volunteers to be certain that there is no element of coercion.
The second group would consider the potential benefits and provide a disin-
terested evaluation of the likelihood that such benefits will eventually
accrue. These two groups should then present their findings for actual
risk-benefit analysis to a third group. This third group has the most
difficult task. They must weight the personal risks taken by the volunteers
against societal and personal benefits for others. It is clear that this
group has a quasi-judicial function and should have the benefit of indi-
viduals trained in judicial and legal procedure. In carrying out this
review, the risks of not doing the study should be carefully presented
and considered.
22-18
The review system should have an appeal procedure embodied in it. It
is possible that this could occur in several steps beginning at the local
or institutional level and carrying through to the State and Federal
levels. However it is implicit in a tripartite review system that the
adjudicating group should not represent the institution at which the
experiment on volunteers is to be conducted, but should have larger
community representation.
2. For that large proportion of human investigation in which the patients
asked to undertake a risk are also likely to benefit, because the therapy
under study is designed for their disease, the present system of institu-
tional review appears to be quite adequate. Such institutional review groups
in hospitals, medical schools, and research institutes should have guide-
lines to help them determine whether in a particular instance risks and
benefits are so separate that the more complex tripartite procedure might
be appropriate. This problem can be identified easily when a specific
phase I study of a new drug is being carried out in such an institution.
The evaluation of a laboratory test in normals might come under further
scrutiny, but only in those instances where there is some substantial
risk involved. In the present composition of institutional review groups
the regulation that representatives of the legal profession, the clergy and
lay persons be included seems reasonable. At the moment it does not seem
necessary to require that there be specific research advocates, that is
individuals who will take it as their duty to point out the usefulness of
22-19
research, and the risks of not doing research. It may be that as review
becomes more stringent and regulations become complex this function of
institutional review will also have to be specified.
3. Probably the most important and difficult problem is that of improving
the dissemination and application of therapeutic information and closing
the information-use gap. No single approach will solve this problem.
A large number of changes ranging from reorganization of the distribution
of medical care to improvement in public relations and the development of
better instruments for informing physicians of new developments in thera-
peutics must be considered. The important first step is to recognize formally
that this gap represents a major defect in our health system. Efforts to
close it must be supported at all levels; local, State and Federal, from
both the public and private sector and using a wide variety of techniques.
22-20
V
INFORMED CONSENT
23
NATURE AND DEFINITION OF INFORMED CONSENT
IN RESEARCH INVOLVING DECEPTION
Diana Baumrind, Ph.D.
January 28, 1976
Preface
My charge from the Commission is to discuss the nature and definition
of informed consent in research involving deception. The discussion will
not present a balanced and impartial view of all sides of this admittedly
complex issue. Rather, I shall speak as a social scientist and to those
issues which affect social scientists. Only in passing shall I be concerned
with related ethical problems as they apply to biological and medical research.
For more than 20 years, I have been actively engaged in the practice of
behavioral science research, and for more than half that time with the ethical
issues which are raised whenever one does research with human subjects. I am
known to hold a non- permissive position regarding the use of deception, and
I shall speak as an advocate of that position. This I feel free to do in the
expectation that Dr. Berkowitz, who has been asked to prepare a paper on the
same subject, will argue in defense of research employing deception. Taken
together, our two approaches should provide-- at the least-- one basis for a
much needed dialogue.
By comparison with journal writing my style will be leisurely and to
some extent repetitive. I shall risk redundancy for the sake of clarity and
assume that the repetition of the same argument in different contexts is a
necessary-- if sometimes tiresome-- corrective to possible misunderstandings.
I shall use the male pronoun to stand for the human person because I find its
avoidance in a philosophical paper too cumbersome.
Definition of Problem
Nature of Deception
Deception can be classified as nonintentional or intentional. Noninten-
tional deception, which includes absence of full disclosure, failure to inform
and misunderstanding, cannot be entirely avoided. Full disclosure of everything
that might affect a given subject's decision to p a r t i c i p a t e is a worthy ideal
23-1
but not a real possibility.
partially disabled adults the investigator must content himself with absence
of dissent and with assent rather than consent. While the youngest child can
communicate unwillingness to participate (dissent) and a somewhat older child
can indicate willingness to participate but without full understanding of
what will be required (assent), only the mature, reflective adult is truly
capable of fully informed consent.
acceptable studies of public behavior commit " failure to inform," another
form of nonintentional deception. And finally, since perfect communication
is impossible to achieve there is probably always some degree of misunder-
standing in the contract between researcher and subject.
such misunderstanding is inevitable and as such is not a proper subject for
this essay.
For example, in the case of young children and
All secondary analyses of data and some
However regrettable,
My concern in this paper is primarily with intentional deception. This
includes the withholding of information to obtain participation, concealment
in natural settings, manipulation in field experimentation, and deceptive
instructions and manipulations in laboratory research.
The function of deception in social psychological experimentation is to
construct relevant experimental controls by means of fictional environments.
Fictional environments are designed to induce specific sets or expectancies in
subjects by the creation of false social norms, by the use of misleading verbal
instructions or by the presence of nonfunctional visual props including elec-
trical and electronic gear (Seeman, 1969). The presumed function of conceal-
ment and withheld information is to cancel the effect of the observer on the
phenomena being observed in the interest of objectivity-- a goal that physicists
have long since rejected on theoretical grounds (the Heisenberg principle).
23-2
Incidence of Use of Deception
The use of deception continues to be the rule rather than the exception
in social psychological research today. No professional organization abso-
lutely prohibits deceptive practices of the kind it associates with good
research.
ation (attached) (1973), does not prohibit inobtrusive surveillance; the
extremely perfunctory code of the American Sociological Association (attached)
(1968), contains no prohibitions at all nor does it require informed consent;
and the extensive revised code of the American Psychological Association (1973),
while advising against deceptive experimental practices, condones deception in
all cases where the presumed benefit exceeds the presumed cost.
The very thoughtful code of the American Anthropological Associ-
Several surveys document the use of intentional deception in social psycho-
logical research. Stricker (1967) surveyed the four major social-psychological
journals published in 1964, ( Journal of Abnormal and Social Psychology (JASP),
Journal of Personality (JP), Journal of Social Psychology (JSP), and Socio-
metry ).
to the exclusion of nondeceptive strategies.
and 72% of cognitive dissonance and balance studies involved deception, while
such strategies rarely occurred in learning and attitude studies. Seeman (1969)
analyzed the total published literature in the JP and the JASP from 1948-1963
for use of deceptive strategies.
and for 1963, 38.17%.
the percentage of studies reporting use of deception was 16% in 1961 and 38%
in 1971.
code of ethics giving careful consideration to the issues of informed consent
and deceit in laboratory and field settings. If the revised code effectively
reduced the incidence of deceptive practices we might expect to see a drop in
He found that some areas of research use deceptive strategies almost
Thus 81% of conformity studies
The mean figures combined for 1948 is 18.47%
According to Menges (1973), also surveying JP and JASP,
In 1973 the American Psychological Association (APA) revised its
23-3
the incidence of published reports. I therefore examined the September 1974
issue of Journal of Personality and Social Psychology (JPSP), the official
journal of the APA in the areas of personality and social psychology (which
now replaces both JP and JSP),to see if a drop had indeed occurred. Of the
15 empirical studies reported, six used deceptive instructions in an intention-
al attempt to manipulate the subjects' set or to create false social norms.
Thirteen months later (October 1975) I examined JPSP again for incidence of
deception. The Table of Contents is included as Table 1. There were 20
empirical reports among the 22 papers. Of these, 13 employed deceit. Of the
13 that employed deceit, three were trivial instances (numbers 8, 12, and 17)
in which (in my judgment) no harm, including loss of trust, could ensue either
from the procedures themselves or from the disclosure of deceit in the de-
briefing. In number 8, subjects were told that their discussions were being
videotaped when they were not; in number 12 that they would be " overcrowded"
when they were not; and in number 17 that the lists of digits presented to
them followed a certain order when in fact the order was random.
Ten studies employed nontrivial deceit which in my view involved clear
violations of the ethical principles of the APA and/or could result in real
psychological harm to the subjects. Of these 10, six made no mention of de-
briefing. Subjects, with two exceptions, were introductory psychology students
or freshmen.
as altruism or conformity and thus could be justified by the usual cost/benefit
rationale. One of these ten (number 3) used deceptive instructions with 7- 10
year old children to measure altruism; subjects were exposed to adult models
behaving either altruistically or selfishly and were told that their winnings
(preset, not genuine, scores) could be donated to poor children. Were debrief-
ing used (none was mentioned) the children who had behaved selfishly would have
Most of these studies dealt with such socially important themes
23-4
Table 1
JOURNAL OF PERSONALITY AND SOCIAL PSYCHOLOGY
VOLUME 32, NUMBER 4 OCTOBER 1975
Environmental Noise Level as a Determinant of Helping Behavior/ Kenneth E. Mathews, Jr., and Lance Kirkpatrick Canon . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 571
2 Does the Good Samaritan Parable Increase Helping? A Comment on Darley and Batson's No- Effect Conclusion/ Anthony G. Greenwald . . . . . . . . . . . . . . . . . . 578
3 Saying and Doing: Effects on Observer Performance/ Marnie E. Rice and Joan E. Grusec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 584
4 Implicational Principles and the Cognition of Confirmatory, Contradictory, Incomplete and Irrelevant Information/ Gordon Bear and Alexandra Hodun 594
5 A Closer Examination of Causal Inference: The Roles of Consensus, Distinc- tiveness, and Consistency Information/ Bruce R. Orvis, John D. Cunning- ham, and Harold H. Kelly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 605
6 Effects of Personality- Situation Locus of Control Congruence/ Thomas K. Srull and Stuart A. Karabenick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 617
7 Skill Versus Luck: Field and Laboratory Studies of Male and Female Prefer- ences/ Kay Deaux, Leonard White, and Elizabeth Farris . . . . . . . . . . . . . . . .
Thomas C. Monson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 637
629
8 Persons, Situations, and the Control of Social Behavior/ Mark Snyder and
9 An Experimental Study of Crowding: Effects of Room Size, Intrusion, and Goal Blocking on Nonverbal Behavior, Self- Disclosure, and Self- Reported Stress/ Eric Sundstrom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 Differential Effects of Jury Size on Verdicts Following Deliberation as a Function of the Apparent Guilt of a Defendant/ Angelo C. Valenti and Leslie L. Downing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
645
655
11 Attraction and Expectations of Harm and Benefits/ Barry R. Schlenker, Robert C. Brown, Jr., and James T. Tedeschi . . . . . . . . . . . . . . . . . . . . . . . . . 664
12 Waiting for a Crowd: The Behavioral and Perceptual Effects of Anticipated Crowding/ Andrew Baum and Carl I. Greenberg . . . . . . . . . . . . . . . . . . . . . . . . . . 671
13 Effects of Noncontingent Reinforcement on Tasks of Differing Importance: Facilitation and Learned Helplessness/ Susan Roth and Larry Kubal . . . . 680
14 Visual Versus Verbal Information in Impression Formation/ Shigeru Hagiwara 692
15 Frequency of Reciprocated Concessions in Bargaining/ S. S. Komorita and James K. Esser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 699
16 The Mediation of Aggressive Behavior: Arousal Level Versus Anger and Cog- nitive Labeling/ Vladimir J. Konecni . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 706
17 Need Achievement and Risk- Taking Preference: A Clarification/ John C. Touhey and Wayne J. Villemez . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 713
23-5
Table 1 - Continued
18 Sex Differences in Moral Internalization and Values/ Martin L. Hoffman . . . . 720
19 Psychological Differentiation as a Factor in Conflict Resolution/ Philip K. Oltman, Donald R. Goodenough, Herman A. Witkin, Norbert Freedman, and Florence Friedman . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 730
20 Children's Use of the Multiple Sufficient Cause Schema in Social Perception/ Michael C. Smith . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 737
21 The Relationship Between Attitudes and Beliefs: Comments on Smith and Clark's Classification of Belief Type and Predictive Value/ Kerry Thomas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 748
22 When Self-Interest and Altruism Conflict/ Robert J. Wolosin, Steven J. Sherman, and Clifford R. Mynatt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
List of Manuscripts Accepted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 747
752
23-6
suffered shame and guilt.
about their own performance and that of adult models.
11 and 23), experimenters delivered mild electric shocks as well as false
instructions to undergraduate students with no debriefing by one (number 11).
At best, all subjects were left with false notions
In two studies (numbers
Another study (number 6) encouraged college students to cheat by using false
Data from two studies (numbers 1 instructions; no debriefing was mentioned.
and 2) investigating helping behavior were obtained by staging incidents
with " victims" supposedly in need of assistance.
nontrivial deceptive practices were used, informed consent was entirely pre-
cluded.
In the 10 studies where
Nature and Definition of Informed Consent
Under the APA code of ethics and the present HEW guidelines, informed
consent means the consent of a person (or his or her legally authorized
representative) so situated as to be able to exercise free power of choice.
Free power of choice, in turn, implies that choice be made on full and accurate
information, including an accurate explanation of the procedures to be followed
and a description of any attendant discomforts or risks reasonably to be
expected.
In order to distinguish my use of the term informed consent from the usual
literal interpretation, I will follow each element with a comment.
As usually stated, there are six basic elements of informed consent.
1. A fair and understandable explanation of the nature of the activity, its purpose, and the procedures to be followed, including identi- fication of any procedures which are experimental.
The investigator should not be required to disclose to the subject the
The requirement that in effect the investigator purpose of the experiment.
share his hypotheses with subjects would invalidate most social science research.
Obviously subjects' behavior will be affected by explicit knowledge of the
investigator's hypotheses. It is deceitful for the investigator to misinform
23-7
the subject as to the purpose of the experiment, but not to explicitly with-
hold information. It is sufficient to indicate to the subject that such
information cannot be shared during the initial briefing but will (or will
not in some cases) be disclosed at the debriefing.
informed of the possibility that there will be secondary analyses of data.
Some potential subjects may refuse to participate on the grounds that they
Subjects should also be
will not be permitted to censor future use of the data. That is their right.
However, having been informed and having consented, subjects should not be
given the right to veto in primary or possible secondary analyses the inves-
tigator's use of his findings.
2. An understandable description of any attendant discomforts and risks reasonably to be expected.
3. An understandable description of any benefits reasonably to be expected.
Written statements of possible risks and benefits sound to subjects like
threats and promises and are, I think, counterproductive. Where there is a
possibility of attendant discomforts and risks, these should be discussed
with the subject in a briefing interview so that wherever possible procedures
can be accomodated to the subject's needs, or his inappropriate anxieties
dispelled.
back information, referral or money, he can seldom determine in what ways the
experience will be intrinsically beneficial or rewarding, although he can
express his hopes that it will be.
While the investigator may promise specific rewards such as feed-
4. An understandable disclosure of any appropriate alternative procedures that might be advantageous for the subject.
In behavioral research this alternative is not really open to the sub-
ject.
group. It is essential, however, that the subject consent to the procedures
to which he will be subjected.
Generally he must be assigned to a particular experimental or control
23-8
5. An offer to answer any inquiries concerning the procedures.
The heart of informed consent is the right of the subject to be in-
formed as to the actual nature of the experience which he is to undergo.
It is to these procedures that the subject is consenting or withholding con-
sent. Incomplete or inaccurate information here is tantamount to intentional
deception.
6. An understanding that the person is free to withdraw his or her consent and to discontinue participation in the activity or the project at any time prior to its termination without prejudice to the subject.
Provided that fully informed consent has been obtained, the investigator
should retain the right to encourage the subject to continue unless it becomes
clear that the subject is being more than mildly inconvenienced. Certainly
the experimenter should retain the right to withhold payment proportionate
to the loss of the subject's services.
he has responsibilities as well as rights. While not constituting a legal con-
tractual obligation on the part of the subject to continue or complete his
Respect for the subject dictates that
service, acceptance of a prior fee morally obligates him to fulfill his part
This obligation, of course, presumes that the subject has of the agreement.
given his informed consent.
consent is based on adequate information rests with the experimenter, any
evidence that the subject did not anticipate the actual effects upon him suf-
fices to relieve him of his contractual obligations--and this without finan-
cial or psychological penalty. But mere inconvenience should not relieve
the subject of his moral obligation to continue and the experimenter should be
able to exert tactful pressure towards that end, including withholding of pay-
ment for services not rendered.
Cost/Benefit Approach to Justification of the Use of Deception
And since the responsibility for assuring that
Judging by their behavior, social scientists who use deceitful practices
23-9
do not regard such practices as immoral.
not condone the normative use of deceit in everyday personal relations. In
the practice of their profession, however, these scientists use deceitful
practices openly, publish their procedures without apology and indeed with
prideful exhibition of ingenuity (e.g., Milgram, 1963), teach their students
to copy their example and reward them when they do, and vigorously defend
their procedures when attacked. Their justification is contained in the cost/
benefit principle.
not in itself viewed as a cost.
tific or social interest and the methodology adequate, the cost/benefit prin-
ciple can be, and is, in most instances, invoked to justify the use of deceit.
Yet these same scientists would
The experience of being deceived or not fully informed is
Provided the study's objective is of scien-
I will argue that the cost/benefit approach as generally applied serves
to justify rather than inhibit the use of deceitful practices and misinformed
consent.
and the benefits to society are overestimated.
Inadequacy of Cost/Benefit Approach
As a basic principle of adjudication the cost/benefit justification of
Moreover the costs to the subject and society are underestimated
deceptive practices is inadequate.
practices cannot be reconciled with Personalism or any other form of universalist
metaethics, or with rule- utilitarianism provided that what is perceived as con-
stituting the greatest general good prohibits the justification of lying and
deceit. in accord with the deontological or universalist position the basic
judgments of obligation are present as being given intuitively without recourse
to consideration of what serves the common good.
Kant, the principle of justice or of truth or the value of life stands by itself
without regard to any balance of good over evil for self, society, or the uni-
verse. For nontheistic deontologists, morality is, I suppose, equated with
aesthetics, requiring of the moral individual a fine sensibility and intuition.
The cost/benefit justification of deceptive
For deontologists such as
23-10
This is the view of Aristotle, when he states that the decision as to what
determines the golden mean rests with perception. For theistic deontologists
humankind is the bearer of " an alien dignity" rooted in the value God places
on us. Personalism, or the idea that the life and integrity of the person
remain of greater value than any object or function which the person may be
called upon to serve, is central to both the Buddhist and Christian tradition.
Nontheistic deontologists who agree with Wallwork (1975, p. 75) that " persons
are of unconditional value'' and that it is " the right of every person to an
equal consideration of his claims in every situation, not just those codified
into law or professional rules" , must reject the cost/benefit analysis because
it wrongly (from their perspective) subordinates basic human rights to benefits
of whatever kind or value.
if and only if the principle under which it falls is thought to produce at
least as great a balance of good over evil as any available alternative. Un-
like universalist principles, rule-utilitarian rules are culturally and situ-
ationally relative (a good thing, in my opinion).
as a fundamental principle governing an act then deception itself would have to
be viewed as promoting the greatest general good. However, no ethical system
does in fact condone lying and deception as a principle of action, although not
all lies or deceptions are regarded as blameworthy, and many " white" lies are
regarded as praiseworthy.
According to rule- utilitarianism, an act is right
If deception is perceived
Telling the truth and keeping promises are regarded as obligatory in most
systems of ethics for many compelling reasons. Perhaps the most compelling of
all is the belief that the coherence of the universe cannot be maintained with-
out contract. Contracts and promises provide the same security in the social
world which invariant cause- and- effect relations provide in the physical world.
Without invariant cause-and-effect relations in the physical universe,
23-11
goal- oriented behavior would be impossible. Imagine a situation in which
turning a doorknob could release a stream of lemonade or trigger a gun or
any number of other possibilities, as well as open a door.
in accord with agreed- upon rules, keeping promises, and avoiding deceit can
human beings construct for themselves a coherent, consistent environment in
which purposive behavior becomes possible. Thus, the long- range good that
truth- telling promotes
own person.
Only by acting
facilitates self- determination or authority over one's
Rule- utilitarianism (to which I subscribe) unlike universalism does not
pretend to establish the absolute validity of the ends sought.
possibility that deceptive research practices (or killing for that matter) can,
under certain circumstances, be justified. The circumstances under which such
justification is possible are those in which the rule requiring informed con-
sent (or the not taking of human life) may be given a lower priority than the
rule establishing freedom of scientific inquiry (or the rule prohibiting
murder).
precedence over the values that dictate concern for the person- integrity, reci-
procity and justice-- then should those two sets of values come into direct con-
flict, the values of science could be justified as an ethical basis for action.
The crux of the issue, of course, has to do with establishing a hierarchy of
values. This may be done by demonstrating that one rule or value (in a given
culture at a given time) rather than another better facilitates the Good Life of
one's own culture, humankind, or all sentient beings, depending on one's ulti-
mate beneficiary. According to this view, if one believes (as I do) that values
which dictate concern for the person take precedence over the values of science
(in that factually the human values are more facilitative of the Good Life than the
scientific ones), then a cost/benefit justification of deceitful practices
It accepts the
In other words, if the values of science-- to know and report-- take
23-12
is proscribed.
By contrast with a rule- utilitarian, an act- utilitarian must calculate
the costs and benefits of every situation without recourse to the guidance
of overriding rules or principles, an approach which leads to unavoidable
and unresolvable difficulties. Act- utilitarianism, for example, would require
that in each instance the individual calculate anew whether or not to obey the
laws against running a red light or stealing for personal gain. This concrete
approach to ethical judgment occurs in the individual at an early period of
development and is usually superseded by appeal to rule and principle as
soon as the individual is capable of abstract thought. Act- utilitarianism
would seem to restrict the moral sense to a rather primitive level. Moreover,
act- utilitarianism is presumptious.
sight superior to that of the distilled wisdom contained in the principle he
disregards. Should a witness lie in a court of law to save a defendant he
is sure is innocent? Joseph Fletcher, the Situation Ethicist, answers: " Yes,
he should lie if he believes the defendant would otherwise be found guilty.''
(1966). The deontologist answers: " No, a lie is always wrong." The rule-
utilitarian answers: " No. Provided that the court system functions justly,
the common good is best served by truth- telling." The responsibility of the
witness is to present his evidence convincingly.
should his evidence not convince the court?
lie, the witness would have to uphold the right of any witness to lie, pro-
vided that the witness felt sure in his own mind of the guilt or the innocence
of the defendant. The principle which proscribes lying under oath is intended
to preserve the common good by determining truth through consensual judgment
rather than in accord with the strong conviction of any one man. Act- utili-
tarianism is tied to the present.
The actor presumes that he possesses in-
If he truly knows, why
To justify his willingness to
Consider, for example, the guarantees of
23-13
the rights of the accused or the minority in the Bill of Rights.
of these guarantees often creates a situation where the protection of the
rights of an individual will violate the common good, e.g., the exercise of
free speech to support racism.
of Rights in that situation, whereas rule-utilitarians would inquire as to
whether the common good were benefited by universal adherence to the principle
of free speech.
good of violating that principle rather than apply cost/benefit analysis to
this particular instance or act (verbal defense of racism). A r u l e - u t i l i t a r i -
an would argue that if an objection to the content of a statement were used to
justify a violation of free speech in this instance, then any objection to con-
tent could be used to restrict the right of a citizen to speak out, e.g., the
right of a pacifist to speak out against the Vietnam War.
utilitarian, the rule-utilitarian would find the guarantees contained in the
Bill of Rights consistent with his moral philosophy because these principles,
if generalized, would benefit the common good. Act-utilitarianism is en-
tirely pragmatic.
appeal to different motives in humankind than matters of practical judgment.
Suppose that act A and act B result in exactly the same ratio
benefit, but act A involves deceit and breaking a contract, while act B invol-
ves purchasing a cocktail dress rather than a pair of badly needed walking shoes.
A consistent act-utilitarian would view acts A and B as both equally wrong if
they both produced an identical score on the minus side. But from the deonto-
logical viewpoint, or that of rule-utilitarianism, act A must be regarded as
more unethical than act B, otherwise there is no ethical question to be
decided, only a practical one. Most present code of ethics, including the APA
code and the HEW regulations, are written from an act-utilitarian metaethics.
From either a universalist or rule-utilitarian position, the codes and their
The exercise
Act-utilitarians would have to reject the Bill
The rule-utilitarian would evaluate the effect on the common
Unlike the act-
Matters of conscience exercise different capacities and
of cost to
23-14
metaethical justifications are inadequate.
In practice, present codes do not in point of fact regulate the activities
of scientists so that they conform with generally held standards of ethical be-
havior; any rule can be violated merely by proclaiming that the benefits to
humanity justify the costs to subjects.
jects' rights on the basis of a cost/benefit analysis is well presented in the
revised code of ethics of the APA.
or reducing inferential ambiguity The argument for violations of sub-
The obligation to advance the understanding of significant aspects of human experience and behavior is especially likely to impinge upon well- recognized human rights. Significant research is likely to deal with variables and methods that touch upon sensitive human concerns. And if ambiguity in causal inference is to be reduced to a minimum-- an essential of good science-- research must be designed in ways that, on occasion, may make the relationship between the psychologist and the human research participant fall short of commonly held ideals for human relationships. . . (1973, p. 8)
According to the APA code of ethics, when a conflict between scientific rigor
and the rights of subjects arises, the experimenter's ethical obligations to
the subjects may be superseded. To be specific, the following rights of the
subject are recognized explicitly in the APA code but may be suspended in the
interests of scientific rigor:
a. The right of the subject to be involved in research only with his knowledge and informed consent (Princples 3 and 5).
b. The right of the subject to be dealt with in an open and honest manner (Principles 4 and 8).
The right of the subject to protection from physical and mental distress and loss of self- esteem (Principle 7).
c.
d. The right of the subject to a clear and fair contractual agree- ment (Principle 6).
Referring to the cost/benefit approach by which such violations are jus-
tified, the Code states:
Almost any psychological research with humans entails some choice as to the relative weights to be given to ethical ideals, some choice of one particular ethical consideration over others. For this reason, there are those who would call a halt to the whole endeavor, or who would erect barriers that would exclude research on many central psychological questions. But for psychologists, the decision not to do research is in itself a
23-15
matter of ethical concern since it is one of their obligations to use their research skills to extend knowledge for the sake of ultimate human betterment (1973, p. 7).
In making this judgment, the investigator needs to take account of the potential benefits likely to flow from the research in conjunction with the possible costs, including those to the research participants, that the research procedures entail. ... An analysis following this approach asks about any procedure, " Is it worth it, considering what is required of the research participant and other social costs, on the one hand, and the importance of the research, on the other?" Or, " do the net gains of doing the research outweigh the net gains of not doing it?" The decision may rule against doing the research, or it may affirm the investigator's positive obligation to proceed. Such an analysis is also useful in making choices between alternative ways of doing research. For example, " Are the costs to research participants greater or less if they are informed or not informed about certain aspects of the re- search in advance?" ''What will be the effect of these two alternatives on potential gains from the research?" (1973, p. 11)
The revised Code assumes moral dilemmas are inevitable in the research
endeavor; but the function of a system of moral philosophy is precisely to
avoid such dilemmas. In point of fact, the use of a cost/benefit analysis
serves to legitimate the loophole known as the " moral dilemma," that is, the
situation in which the actor believes that he is forced to choose between
equally culpable alternatives. But it is a person's duty insofar as possible
to avoid provoking situations which create conflicts of obligation, since
such conflicts by definition result in harm to some. Act- utilitarianism
presented as a cost/benefit analysis readily lends itself to the " moral
dilemma'' loophole, whereas rule- teleology or rule- deontology do not.
Application of Cost/Benefit Approach
If a cost/benefit approach is adopted, then the costs and benefits must
both accrue to the subject.
weighing of the likely benefits to the patient of a proposed plan of treat-
ment versus the probable costs (risks) to the patient-- financial, physical
and emotional-- of that form of treatment. Thus a physician may present a
woman who has a diagnosis of breast cancer with alternative treatments for
her consideration, including chemotherapy, lumpectomy and radical mastectomy.
In medicine the cost/benefit analysis is a
23-16
It is questionable whether the physician has the right to determine for the
patient the balance of risk over benefit of such alternative treatment plans.
It is certain, however, that the physician is not morally privileged to pass
judgment concerning the balance of risk to the patient versus the benefit to
humankind by using the patient as a medical guinea pig to test these alter-
native procedures.
humankind the patient must, without qualification, have access to all available
information concerning the effects of treatment in order that she, not the
physician, may make that decision knowledgeably.
holds information in effect imposes his perspective upon the subject about
what is good for humankind, therby repudiating the subject's right to his or her own
informed perspective.
If she is to risk her personal welfare for the benefit of
The investigator who with-
Most experimentation with human subjects places them " at risk" in the
sense that they are treated as passive things to be acted upon, means toward
an end they cannot fully understand. An individual may choose to incur some
degree of risk, inconvenience, or pain by becoming an experimental subject.
To accept these risks knowingly for the sake of others may be an act of
charitable concern or an expression of committment to the community.
agreeing to be a subject, a person to some extent relinquishes his sovereign
will. When the subject accepts the research objectives and freely becomes a
participant, he is rewarded by self- affirmation and social approval, much as
is the scientist- participant. By serving an ideal such as progress, knowledge
or human welfare, the subject and researcher accrue merit and a justified
sense of self- enhancement.
ful and fraudulent means cannot recover his sovereign will. He remains instead
a passive and obedient
diminished rather than enhanced by his participation. Common law protects
By
But a subject whose consent is obtained by deceit-
object for the experimenter to manipulate and is thus
23-17
individual freedom by proscribing manipulation of the psychological self.
Possible benefits to mankind cannot justify legally (or morally) any exception
to the requirement of full and frank disclosure to each person of all facts,
probabilities and beliefs which a reasonable person might expect to consider
before giving his or her consent. (See Mishkin's citation, 1975, p. 2, of
Halushka vs. University of Saskatchewan, 1965).
Analysis of Costs of Deception
The costs of deception have been greatly underestimated. These costs are
ethical, psychological, scientific and societal.
or permanent mental or physical disability, then, with rare exceptions, harm
to the subject will not result from behavioral science research. The effects,
harmful and beneficial, are are subtle in behavioral science research than
in medical research. The costs and benefits to the subject and to society
are in the realms of feelings, cognitions and values rather than in physical
and material realms.
If harm is defined as death
I advocate the position that to intentionally deceive subjects or to
obtain their consent fraudulently is to place them "at risk" even if they
do not, as a result, experience additional stress or permanent harm.
It is important to note that all the provisions of the DHEW and APA
codes (including the right to informed consent) apply only after a subject
has been determined to be at risk.
tablished must the investigator determine that " the risks to the subject are
so outweighted by the sum of the benefit to the subject and the importance of
the knowledge to be gained as to warrant a decision to allow the subject to
accept these risks" (Federal Register, 1974).
the substantive rights of subjects should be guarded by the DHEW regulations
Only after probable risk has been es-
It seems evident to me that
23-18
whether or not additional harm from the violation of these rights can be
demonstrated. If there is objection to guaranteeing the rights of subjects
in addition to their welfare, then I would argue that psychological invasion
is itself injurious to the subject's welfare.
that the law is moving " toward a model which protects against the invasion
or manipulation of a person's psychological self ."
I agree with Mishkin (1975, p.2)
Inherent in this broadened perspective on legal liability in behavioral
research is an increased sensitivity on the part of community leaders to the
ethical problems raised in abusing a fiduciary relationship. To the extent
that special privileges are accorded professionals and academics as an exten-
sion of public confidence in their protective functions, a fiduciary relation-
ship may be said to exist between this segment of the community and the rest.
That is, the professional segment of the community in its relationship with
the rest may be viewed as trustees of the values inherent in its activities--
such values as integrity, compassion and trustworthiness.
1. E t h i c a l C o s t s o f D e c e p t i o n . Any moral system which places preeminent
value on humankind's reason and moral autonomy will allow few exceptions to the
rule of informed consent.
of each mature, healthy human being to assume personal responsibility for his
actions.
to participate in research is inviolable, not to be abridged by the investi-
gator, although it may be waived by the subject. Doing research on people
without their knowledge and informed consent is unethical under all circumstances.
Principle 3 of the APA Code of Ethics reads:
Ethical practice requires the investigator to inform the participant of all features of the research that reasonably might be expected to in- fluence willingness to participate, of the research about which the
By moral autonomy is meant the right and obligation
In accord with this view, the right of the subject to choose freely
and to explain all other aspects participant inquires. (But then the
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qualification:) The decision to limit this freedom increases the investigator's responsibility to protect the participant's dignity and welfare (1973, p. 42).
Contained within each of these principles concerned with informed consent is
a qualification which permits the principle to be violated although it is
explicitly stated that ethically acceptable research requires establishment
of a clear and fair agreement between the investigator and the research par-
ticipant and that the investigator is obliged to honor all promises and com-
mitments included in that agreement. But a subject who has been deceived as
to the nature of his agreement cannot enter into a clear and fair agreement
in the first place. These qualifications are not wrong because the subject
may be exposed to suffering, but inequitable because a subject deprived of
the right to informed consent has thereby been deprived of his right to decide
freely and rationally how he wishes to invest his time and person. He has
also been unjustly tricked into thinking his consent was informed when it was
not. If as a result of the experimental manipulations the subject has in
addition been entrapped into revealing to himself and others undesirable char-
acteristics such as destructive obedience, dishonesty or sadism, he has truly
relinquished more than he bargained for. Fundamental moral principles of re-
ciprocity and justice are violated when the behavioral scientist acts to de-
ceive or diminish those whose extension of trust is based on the expectation
that persons to whom trust is accorded will be trustworthy in return.
The experimenter by his deceitful actions violates the implicit social
contract which binds experimenter and subject in which the subject assumes
that the experimenter is both knowledgeable and trustworthy and that his code
of ethics does not contain a " buyer beware'' clause. Neither does the subject
assume that the accumulation of knowledge has priority in the experimenter's
hierarchy of values over decent treatment of the subject- participant. In
23-20
view of the special vulnerability, both personal and moral, which the subject
invites by suspending disbelief and extending trust, the experimenter should
agree to abide by a code of professional ethics more stringent, not less
stringent, than his personal code.
As Kelman (1967) notes, most of us in our interhuman relationships do not
expose other to lies, deliberately mislead them about the purposes of an inter-
action, make promises we intend to disregard or in other ways violate the re-
spect to which all fellow humans are entitled. Yet we do so and feel justified
in so doing in the experimenter-subject relationship. I have argued here that
we ought to abide by a more, not less, stringent code of ethics in professional
situations.
on the basis of our professional role. Thus we legitimize as well as commit
ethical violations. The legitimization itself has harmful effects: it relieves
the investigator of culpability and of the responsibility for devising non-
deceitful alternatives or making reparation; it promotes false values that
worthy ends such as the pursuit of truth justify unworthy means such as the
use of deceit.
Instead we justify our treatment of subjects solely as objects
2. Psychological Costs of Deception. Deceitful practices are most costly
to the person when they have the following characteristics:
a) The implicit or explicit contract between two persons is violated by
one party (aggressor) without the consent of the other (victim) to the benefit
of the aggressor and the detriment of the victim.
b) The effect on the victim is to: (1) impair his ability to endow his
activities and relationships with meaning, (2) reduce trust in legitimate
authority, (3) raise questions about regularity in cause and effect relations,
(4) reduce respect for a previously valued activity such a science, (5) neg-
atively affect the individual's ability to trust his own judgment, or (6)
impair the individual's sense of self-esteem and personal integrity.
23-21
c)
as a model.
The aggressor is respected by the victim and therefore could serve
The effects upon subjects which I judge to be most harmful are those
which result in cynicism, anomie, and hopelessness. In my view, the most
injurious consequence that can befall a person is to lose faith in the pos-
sibility of constructing for himself a meaningful life.
diminishes that faith inflicts suffering and possible harm. College students,
who are the most frequently used subject pool, are particularly susceptible
to conditions that produce an experience of anomie.
Any experience which
I want now to illustrate the way in which I believe deceit and manipulation
place subjects at psychological risk. My former secretary, Paula Lozar, de-
scribed an incident which illustrates the way in which deception in an exper-
imental setting can contribute to a young person's feeling of anomie as loss
of faith in the meaningfulness of life.
When I was 18, a sophomore in college, a psychologist from a nearby clinic came to my dormitory one evening and explained that he was looking for subjects for an experiment which involved simply telling stories about pictures which would be shown them. This sounded inter- esting, so I signed up. At the interview the same psychologist intro- duced me to a girl a few years my senior, who stayed bland and noncom- mittal throughout the time she interviewed me. She showed me a few pictures, and since they were extremely uninteresting I felt that the stories I was making up must be very poor. But she stopped at that point and told me that I was doing very well. I was gratified and said something to that effect before we went on to the rest of the pictures. Then I filled out a form about my reactions to the interview, the ex- perimenter, etc., and she took it and left. After being alone for a few minutes, I looked around the office and noticed a list of the last names of subjects, with " favorable" and " unfavorable" written alter- natively after each one. returned and said that, as I had guessed, what the interviewer had said had nothing to do with my performance. They were testing the effects of praise and dispraise on creative production, and he said so far they had discovered that dispraise had negative effects and praise seemed to have none at all. Since I expressed interest, he promised that the subjects would be given full results when they were "tabulated. (But we never heard from him.)
the deception was necessary to get the proper reaction from me, and that
Shortly thereafter the male psychologist
My reaction to the experiment at the time was mixed. I assumed that
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since I had behaved unsuspiciously the results of the experiment were valid. However, I was embarrassed at having been manipulated into feeling pride at a non- achievement and gratification at praise I didn't deserve. . . Since in my early years in school I had alternated between being praised for doing well and being damned for doing too well, I had always been a poor judge of my own achievements and had no internal standards for evaluating my performance-- although I knew I was very in- telligent and felt that some sort of moral flaw kept me from doing as well as I might. At the time, I was attending a second- rate college and felt (rightly) that my grades had nothing to do with how well I was really doing relative to my ability. This experiment confirmed my con- viction that standards were completely arbitrary. Furthermore, for several years I had followed a pattern of achievement in which I would go along for quite a while doing well in classes, interpersonal relations, etc. Then I would have a moment of hubris in which I was more self- confident or egotistical than it behooved me to be in that situation. At this point someone would cut me down to size; I would be totally devastated, and it would take me a long time to work myself up to my previous level of performance. The experiment had, in a lesser degree, the same effect upon me, and it . . . confirmed me in this pattern because the devastating blow was struck by a psychologist, whose competence to judge behavior I had never doubted before. . . It is not a matter of " belief" but of fact that I found the experience devastating. I told literally no one about it for eight years because of a vague feeling of shame over having let myself be tricked and duped. It was only when I realized that I was not peculiar but had, on the contrary, had a typical experience that I first recounted it publicly. . .
At the time of the experiment, I had arrived at a position common to young adults who have lost confidence in external standards, either ideals or authorities, as a guide to how to live, and was in the process of formulating my own standards. As a result of my early lack of self- confidence and inconsistent school experiences, my task had been laborious and not entirely successful. . . The experiment confirmed me in my lack of success. I had been led into a situation where I was explicity told to disregard my own interpretation of what was going on and made to per- ceive it another way, and then eventually told that both ways I had per- ceived it were wrong. . . The result was to further convince me that my perceptions were useless as a guide for action, and that, since the only person I felt I could trust-- myself-- was not trustworthy, I had no way of judging how to act and hence it was better not to act at all . . .
sonal development at that time. To me, and to most of my classmates, the task of setting one's own standards, of formulating guides to living. . . was one of the most important tasks we faced. This had to do with . . . one's ability to give meaning to one's life. I rather suspect that many of us who volunteered for the experiment were hoping to learn something about ourselves that would help us to gauge our own strengths and weak- nesses, and formulate rules for living that took them into account. Some- thing of the sort was, I know, in the back of my own mind. When, instead, I learned that I did not have any trustworthy way of knowing myself-- or
anything else-- and hence could have no confidence in any lifestyle I formed on the basis of my knowledge, I was not only disappointed, but felt that I had somehow been cheated into learning, not what I needed to learn, but something which stymied my very efforts to learn. 1
I was harmed in an area of my thinking which was central to my per-
1 Lozar, P. Personal communication, 1972.
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Ms. Lozar thus describes the serious effects she felt this deception had
on her, and they are precisely the kinds of effects which I designated
earlier as " most costly.'' Yet many investigators regard none of these
effects as real, demonstrable or serious.
chological costs are to be adopted?
Whose criteria concerning psy-
3. S c i e n t i f i c C o s t s o f D e c e p t i o n . The scientific costs of deception
in research are considerable. These costs include: a) exhausting the pool
of naive subjects, and b) jeopardizing community support for the research
enterprise. If these costs are real it will become increasingly difficult
to do valid research; we may be damaging chances for others to work in the
same locations or on the same problems. This harm may be irreversible.
a) Exhausting the pool of naive subjects. In the experimental
situation, the investigator must assume that subjects accept the reality of
the situation as defined by the experimenter, or that if subjects fail to do
so that the investigator knows this.
that subjects are indeed naive.
psychologists are suspected of being tricksters.
respond by role- playing the part they think the experimenter expects, doing
what they think the experimenter wants them to do (Orne, 1962) or pretending
to be naive.
But there is increasing reason to doubt
As a result of widespread use of deception,
Suspicious subjects may
Wahl (1972) has summarized the growing body of evidence that deception
in psychological research is not effective and subjects are not naive. Wahl
documents his assertions that it is neither theoretically nor practically
defensible to assure subject naiveté by deception, and that experimental
realism obtained through situational deception is not necessarily more suc-
cessful than the realism of deception- free situations. Moreover, Wahl concludes
from his review that experimenters cannot distinguish subjects for whom
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the deception promotes experimental realism from subjects who merely
pretend to be fooled.
likelihood that subjects will be naive, as Wahl's survey suggests, such
practices are obviously counterproductive.
given study is biased already (such as jaded lower- division psychology
students), then the argument that informed consent may be dispensed with in
order to assure an unbiased sample becomes unconvincing.
part of the teaching responsibility of professors to feed research findings
back to the student subject pool through lectures and articles. This cum-
ulative knowledge is then passed on to successive generations of students.
Undergraduate psychology students, the most frequently sampled of all pop-
ulations, are of necessity sophisticated.
interacts with experimental conditions to produce results which may not be
replicable in the general population.
If the widespread use of deceit has decreased the
If the sample to be used in any
It is an essential
We must assume that their knowledge
Any population subject to behavioral science research will be similarly
affected.
sample chose delayed reward under experimental conditions while a normal sample
selected both delayed and immediate reward under the same conditions. The
delinquent sample findings were contrary to predictions and led to further
probings which revealed that similar research had been recently conducted in
that institution so that the subjects were not naive.
Thus Brody (1967) found that almost all members of a delinquent
b) Jeopardizing community support for the research enterprise. The
power of the scientific community is conferred by the larger community.
support for behavioral science research may be jeopardized by investigator's
encapsulation within parochial values if these values conflict with more
universal principles of moral judgement and moral conduct.
of the Commission suggests that the use of unethical research practices has
Social
The very existence
23-25
jeopardized community support.
professional associations to police themselves. We really do not know
the public's attitude today towards the scientific enterprise.
so that these attitudes can be considered when formulating ethical codes,
so that investigators will be more aware of their responsibility to con-
stituents and supporters, and thus to the community at large.
Congress no longer appears to trust the
We should,
4. Societal Costs of Deception. Social science research through its
methods and substantive findings has widespread political and social effects.
It can be argued that by its very nature social science research is
a political act.
charge), are in power with control while other participants (the subjects),
are defined as " objects" of assessment.
to the investigator's values in a highly coercive situation. For example, most
investigators embrace an ideology of individualism which knowingly or unknow-
ingly they impose on subjects. What the subject may have thought of as cooper-
ation may be labelled destructive obedience as in the Milgram situation, or
what he may have thought of as social cooperation is labelled as external
locus of control (e.g., by Rotter). The use of fraud and deceit while the
subject is in a heightened state of suggestibility, as he is when truly
naive, should be thought of as increasing the risk that the subject will intern -
alize at least temporarily the investigator's values, even if these are anti-
thetical to his own. The investigator may be convinced of the rectitude of
his values (as Milgram is) but does he have the right to impose his values on
subjects (as Milgram does)?
In the research endeavor, certain participants (those in
Frequently these " objects" are exposed
The scientific justification for using deception is to assure subject
naiveté. But it is the naive subject who is disproportionately placed " at
risk" by the use of deceit and fraud because he risks disillusion and brain-
washing. The sophisticated subject, already suspicious, is merely confirmed
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in his cynicism by deceitful practices. But to the extent that subjects
are sophisticated, the experimental deception has failed to increase the
scientific or social benefit of the experiment. Thus it would appear that
deception is least justified ethically when it is most successful.
If praxis in the laboratory or natural setting cannot be isolated from
praxis in daily life, the implications are far- reaching. If subjects learn
they cannot trust those whom by social
and whom they need to trust to avoid feeling alienated from society, then the
damage done to the subjects and to society by the enacted values of researchers
is very real.
contract are designated trustworthy
Subjects are given objective reasons to distrust authorities in whom they
should have confidence, and apparently they are affected by this experience.
For example:
Fillenbaum (1966) found that deception led to increased suspiciousness (even though subjects tended not to act on their suspicions), and Keisner (1971) found that deceived and debriefed subjects were " less inclined to trust experimenters to tell the truth," (p. 7). authors (Silverman, Shulman, and Wiesenthal, 1970; Fine & Lindskold, 1971) have noted that deception decreases compliance with demand charac- teristics and increases negativistic behavior. (James M. Wahl, 1972,
Other
p. 12)
Ring, Wallston and Corey (1970), in their follow- up interview exploring
subjective reactions to a Milgram- type obedience experiment reported that many
subjects stated that they were experiencing difficulty in trusting adult authori-
ties.
so that one speculates about the possible unknown lasting corruption of trust
resulting from more severe deceptions.
In most of these studies mild and non- threatening deceptions were used,
Truth- telling and promise- keeping serve the function in social relations
that physical laws do in the natural world; these practices promote order and
regularity in social relations, without which intentional actions would be very
nearly impossible. By acting in accord with agreed- upon rules, keeping promises,
acting honorably, following the rules of a game, human beings construct for
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themselves a coherent, consistent environment in which purposive behavior
becomes possible.
lations and feints.
survival by employing deceit and manipulation as an accepted part of a valued
activity.
Animals, other than man, have limited capacity for manipu-
Humankind may unnecessarily complicate their quest for
I believe that it is good for people to place a value on the activities
of behavioral scientists and on the values inherent in scientific activity.
The disciplined exercise of intelligence in science or art is of value in it-
self and this value does not depend upon the betterment of the material aspects
of life to which it rightfully leads.
experimentation is " You shall know the truth and the truth shall set you free,''
then that rule applies also in the conduct of science. The use of the pursuit
of truth to justify deceit risks the probable effect of undermining confidence
in the scientific enterprise and in the credibility of those who engage in it.
If the rule which justifies scientific
Analysis of Benefits of Deception
There can be societal benefits to the use of deception only if there are
probable scientific benefits associated with its use that are obtainable in
no other way. The basic rationale for the experimental method is contained in
the revised code of ethics of the APA as part of its justification of a cost/
benefit analysis.
Not only do ethical questions follow from the psychologist's pursuit of important independent and dependent variables but the methods that are adequate to make inferences as unambiguous as possible tend to be. the ones that raise ethical difficulties. Many psychologists believe (though some question this) it is often essential that the research participants be naive. The re- quirements of research may thus seem to demand that the participants be unaware of the fact that they are being studied or of the hypotheses under investigation. psychological reality is to be created under experimental conditions that permit valid inference (1973, pp. 8-9).
Many scientists are calling into question the implications contained
that to obtain valid and generalizable data,
Or deception may appear to be necessary if a
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in the above statement, (e.g., Chein [1972], Guttentag [1971], Harré and
Secord [1972], Kelman [1966], and Orne [1962]). Schultz concludes in his
critical examination of the history of human experimentation
... that psychology's image of the human subject as a stimulus- response machine is inadequate and that many studies are based on data supplied by subjects who are neither randomly selected nor assigned, nor rep- resentative of the general population, nor naive, and who are suspicious and distrustful of psychological research and researchers (1969, p. 214).
As a number of critics including Brandt, Guttentag, Mixon and myself
have pointed out, the ecological validity of studies widely acclaimed for their
sceintific merit is so questionable as to raise serious objections concerning
the benefit to society of generalizations based on these findings. A case in
point is the Milgram study (1963):
The following is Milgram's abstract of his experiment:
This article describes a procedure for the study of destructive obedience in the laboratory. It consists of ordering a naive S to administer increas- inly more severe punishment to a victim in the context of a learning experi- ment. Punishment is administered by means of a shock generator with 30 graded switches ranging from Slight Shock to Danger: Severe Shock. The victim is a confederate of E. mum shock the S is willing to administer before he refuses to continue further. 26 Ss obeyed the experimental commands fully, and administered the highest shock on the generator. 14 Ss broke off the experiment at some point after the victim protested and refused to provide further answers. The procedure created extreme levels of nervous tension in some Ss. Profuse sweating, trembling, and stuttering were typical expressions of this emo- tional disturbance. One unexpected sign of tension-- yet to be explained-- was the regular occurrence of nervous laughter, which in some Ss developed into uncontrollable seizures. The variety of interesting behavioral dynam- ics observed in the experiment, the reality of the situation for the S, and the possibility of parametric variation within the framework of the procedure, point to the fruitfulness of further study (p. 371).
The fundamental question Milgram asks is " how does a man behave when he is
The primary dependent variable is the maxi-
told by a legitimate authority to act against a third individual?" (p. 851)
Milgram generalizes his findings to apply to the actions of men in combat and
guards in Nazi concentration camps. According to Milgram, ''within the general
framework of the psychological experiment obedience varied enormously from one
condition to the next." ' (p. 851) Well, then, to what social conditions does
23-29
the laboratory condition reported (1963) have generality? The experimenter's
directive to dangerously shock the victim is, on the face of it, inappropriate
in a psychological setting, and perhaps bizarre. A specialist in the science
of psychology is expected to display compassion and personal integrity, so
that such an order " to act harshly and inhumanely against another man'' (p. 852)
is incongruous. There is nothing incongruous about that order in a setting
such as military combat.
kinds of authorities. The superior officer is an authority in the sense
that he can require and receive submission and is authorized by the state
to command obedience and is given the power to control and punish subordinates
for disobedience.
authority of a specialist in a given field whose statements in that area can
reasonably be considered authoritative. His area of legitimate authority
rests not on power to punish, but upon trust extended by the subject or patient
and based on the psychologist's claim to wisdom, knowledge, and professional
integrity. Both the enlistee and the subject assume an integral aboveboard
relationship not based on personal gain in the narrow sense. But the similarity
cannot be pushed much further provided that normal conditions prevail.
military officer who orders enlisted men to fire upon the enemy engenders in
their minds a very different kind of conflict, if any conflict at all, than
the conflict engendered by the psychologist when pressing the subject to severely
shock the victim. The officer's order to fire upon the enemy is patently ap-
propriate to the situation.
upon comrades further up front in order to prod them forward in the common cause,
that condition might indeed be likened to the experimental condition. There
are situations like that for which Milgram's condition is valid, but they are
not a part of normal social life as he suggests.
An officer and a psychologist are quite different
A psychologist relating to a subject or client has the
The
If the officer ordered the enlisted man to fire
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The dissonant demands made upon the subject in a laboratory setting
might reasonably produce a sense of unreality and absurdity quite different
from that experienced in any normal setting. While in a state of confusion
brought about by this unique juxtaposition of cues, the subject is urged to
act. Disobedience in this setting is as likely to reflect flight and indecision,
or fight against authority, as a moral decision to refrain from hurtful action.
Obedience is as likely to reflect a sense of fair play and employee loyalty
as a lack of moral sense or weakness of character.
Mixon (1974) repeated Milgram's experiment in an effort to understand
the contexts in which subjects obey and disobey.
. . . I found that when it became perfectly clear that the experimenter believed the " victim" was being seriously harmed all actors indicated defiance to experimental commands (Mixon, 1972). Briefly summarized, the All and None analysis suggests that people will obey seemingly in- humane experimental commands so long as there is no good reason to think experimental safeguards have broken down; people will defy seemingly in- humane experimental commands when it becomes clear that safeguards have broken down-- when consequences may indeed be what they appear to be. When the experimental situation is confusing and mystifying as in Milgram's study, some people will obey and some defy experimental commands. (pps. 80- 81)
Another explanation for the behavior of Milgram's obedient subjects is offered
by Brandt.
Had Milgram considered himself as just another human being from whose behavior something can be learned about human behavior in general. . . he would have known that human beings can inflict suffering on other human beings, if they can rationalize their behavior. Self- examination could have told him so. (1971, p. 237)
meaning of the word, the authoritarian relationship can lead the exper- imenter to consider their behavior as " obedience." The implicit assumption is then made that experimental psychologists differ from human experimental subjects to such an extent that similar overt behavior by the two groups cannot be assumed to result from similar covert causes (motivations, needs, drives, etc.). evidenced by explaining similar behavior of the two in terms of dis- similar motivations. jects inflict pain on others. This infliction of pain on others is explained by Milgram as " obedience" when done by the subjects and as ''examining situations in which the end is unknown" (1964b, p. 848) when done by the experimenter. (1971, p. 239)
In the Milgram experiment, the presence of the experimenter sanctioned
When " subjects" are viewed by the experimenter in the dictionary
This distinction between experimenters and subjects is
In Milgram's experiments both experimenter and sub-
23-31
aggressive behavior on the part of the subject as Milgram's authority sanc-
tioned the aggressive behavior of the experimenter and stooge.
Holland (1968), focusing his analysis on the deception manipulation,
demonstrated with three experiments that a high percentage of Milgram's
subjects probably detected the deception without Milgram's knowledge.
(1972) argues that subjects may always be expected to suppose the existence
of at least minimal precautions safeguarding the physical well- being of sub-
jects, and that therefore the judgment that Milgram's obedient subjects
behaved in a " shockingly immoral" fashion is quite gratuitous. The general-
ization of Milgram's findings to real life conditions-- people will comply
with an imperative whose effects they believe harmful to another non- threatening
individual-- is not as self- evident as many social psychologists seem to think.
Mixon
I have questioned in some detail the scientific validity of Milgram's
research because it is frequently cited as an example of using deception in
which the scientific and social benefits are very great, even if they do not
outweigh the costs to the subject. I have tried to show, however, that
Milgram's procedures are not only ethically unjustifiable-- whatever their
presumed benefits-- but also, from a strictly scientific point of view, incon-
clusive. Far from studying real life in the laboratory as he thought he was,
Milgram in fact may have constructed a set of conditions so internally in-
consistent that they could not occur in real life.
Many critics of the experimental method believe that laboratory studies
typically preclude ecological validity. Thus Guttentag (1971) states
Although the classical model holds sway in psychology, there are a number of issues which continue to be raised about it and the logic of statistical inference with which it is associated. . . The indepen- dence of the subject and the experimenter is difficult to assume in much research. . . Another problem is the experimenter's assumption of an essential independence and neutrality of each subject unit; i.e., that human beings are interchangeable. . . Although the logic of
23-32
experimentation and of statistical inference requires the assumption, one may still question whether it is a tenable one . . . . . even when the individuals from such populations are randomly as- signed to experimental conditions; given that people live within social systems, there is no logical guarantee that some condition which affects all subjects uniformly, a condition unknown to the experimenter, is not interacting with the experimental variables to produce a particular set of findings (1971, pp. 80- 81).
The rigorous controls which characterize the laboratory setting may
prevent generalizations to the free social environment. The extent to
which one may generalize from behavior observed in the laboratory to the
life situation is negatively related to the change which containment and
control produce in that behavior. While the subject is familiar with the
individuals, setting, and stimuli in his natural environment, he is unfamiliar
with those in the laboratory setting.
familiar in incongruous settings will affect his behavior. The power relations
are qualitatively different in the experimental setting. There, the exper-
imenter is the controlling party and the subject is an object of control. The
two are in an authoritarian relationship in a setting unfamiliar to the subject.
His reactions to the novel, or to the
We know that ambiguity of causal inference is an inherent part of research
in the social sciences. Yet we continue to act as if the perfect experiment
is just around the corner and, but for our ethical scruples, we would readily
reach that scientific millenium.
Nature and Definition of Informed Consent in Field Research
As skepticism has increased concerning the veridicality of subjects'
behaviors in experimental studies, particularly in personality and social psych-
ology, the use of naturalistic experimentation and naturalistic observation has
grown. In naturalistic experimentation the investigator intervenes to affect
the normal behavior of the person
he does not. In either instance participants may be unaware that they are
observed while in naturalistic observation
23-33
participating in research at the time the data are collected. That research
activity is occurring is concealed in a number of ways, including covert
observation and recording of public behavior, obtaining information from
third parties, disguised field experimentation and covert manipulations.
Silverman (1975) provides us with the following synopsis of prototypic
naturalistic experiments:
1. Persons selected at random are phoned. The caller pretends that he has reached a wrong number, using his last piece of change, and that his car is disabled on a highway. The party is requested to phone the caller's garage and ask them to come for him. The garage number is actually the caller's phone and another experimenter, standing by, pre- tends to take the message (Gaertner & Bickman, 1972).
2. Automobiles, parked on streets, look as if they were abandoned. (License plates are removed and hoods are raised.) Experimenters hide in nearby buildings and film people who have any contact with the cars (Zimbardo, 1969).
People sitting alone on park benches are asked to be interviewed by an experimenter who gives the name of a fictitious survey research organization that he claims to represent. interview, the experimenter asks a person sitting nearby, who is actually a confederate, if he wouldn't mind answering the questions at the same time. The confederate responds with opinions that are clearly opposite those of the subject and makes demeaning remarks about the subject's answers; for example, " that's ridiculous" ; " that's just the sort of thing you'd expect to hear in this park" (Abelson & Miller, 1967).
address of a friend who lives nearby, and asks to use the phone. the party admits him, he pretends to make the call (Milgram, 1970).
A female and a confederate experimenter visit shoe stores at times when there are more customers than salesmen. One of them is wearing a shoe with a broken heel. She rejects whatever the salesman shows her. The confederate, posing as a friend of the customer, sur- reptitiously takes notes on the salesman's behavior (Schaps, 1972).
group that he claims to represent and interviews them about the soap products they use for a report in a " public service publication," which is also given a fictitious name. Several days later the experimenter calls again and asks if the housewives would allow five or six men into their homes to " enumerate and classify" all of their household products for another report in the same publication. If the party agrees, the caller says he is just collecting names of willing people at present and that she will be contacted if it is decided to use her in the sur- vey. No one is contacted again (Freedman & Fraser, 1966).
" Stage blood" trickles from his mouth. he allows the party to help him to his feet. the train slows to a stop, another experimenter, posing as a passenger, pretends to do so and both leave the train ( P i l i a v i n & P i l i a v i n , 1972).
3.
At the beginning of the
4. The experimenter comes to a home, says that he has misplaced the If
5.
6. Housewives are phoned. The caller names a fictitious consumers'
7. A person walking with a cane pretends to collapse in a subway car. If someone approaches the victim,
If no one approaches before
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8. One experimenter takes a seat next to someone sitting alone in a subway car. Another experimenter approaches the person sitting next to the first experimenter and asks if the train is going downtown. The first experimenter intercedes before the party has a chance to answer and gives the wrong information. The second experimenter thanks him and takes a seat nearby (Allen, 1972).
9. Letters, stamped and addressed to fictitious organizations at the same post office box number, are dropped in various locations, as if they were lost on the way to being mailed. Some are placed under auto- mobile windshield wipers with a penciled note saying " found near the c a r . " (For one study with this procedure, the permission of the Post Office Department was obtained to use the names of fictitious organi-
10. Experimenters, walking singly or in pairs, ask politely for either zations; Milgram, 1969.)
10¢ or 20¢ from passersby, sometimes offering an explanation for why they need the money (Latané, 1970). (p. 765)
Both Nash's comment on that paper (Nash, 1975) and Mishkin's later
paper (1975) expound the concept of injury to include protection of the psycho-
logical self. These papers point out that case law now includes deceit, inva-
sion of privacy and violation of civil rights in the concept of liability. If
the research activities summarized by Silverman violate one or more of these
values, investigators may be considered to have abused a fiduciary relation-
ship, ethically if not legally.
In a recent popular presentation entitled Snoopology (1975), John Jung
discusses some probable effects of experimentation in r e a l - l i f e situations
with persons who do not know they are serving as experimental subjects.
include: increased self- consciousness in public places, broadening the aura of
mistrust and suspicion that pervades daily life, inconveniencing and irritating
persons by contrived situations, desensitizing individuals to the needs of others
by " boy- who- cried- wolf" effects so that unusual public events are suspected of
being part of a research project.
These
At present a strong case can be made for the scientific value of field
research using inobtrusive observation. But as the frequency of naturalistic
experimentation increases, the usefulness of these procedures is bound to
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decrease.
Referring to laboratory research, Seeman concluded (1969, p. 1026),
" In view of the frequency with which deception is used in research we may
soon be reaching a point where we no longer have naive subjects, but only
naive experimenters. It is an ironic fact that the use of deception, which
is intended to control the experimental environment, may serve only to con-
taminate it." In the long run this same argument will be applicable to natur-
a l i s t i c r e s e a r c h .
(p. 58) " psychologists are contributing toward their own downfall by estab-
lishing a credibility gap between themselves and the public.
aura of mistrust and suspicion that would pervade daily life would be a high
price to pay." Any research paradigm that precludes the right of the subject
to give informed consent and exercise his right to receive an explanation and
clarification of research findings may be in the long run self- defeating, as
well as unethical.
R e f e r r i n g t o n a t u r a l i s t i c e x p e r i m e n t a t i o n , Jung concludes
And the ensuing
In summarizing the few public opinion surveys on computers, privacy and
record- keeping, Westin and Baker (1972, p. 468) state that " privacy- related
issues are a matter of solid minority concern."
pondents were distressed by what they felt was an erosion of their right
privacy. The public is aware of and appreciates the legitimate needs of govern-
ment and industry for information, but Westin concludes
" that this would be a bad moment in our national history to adopt such a
policy." There is in this nation today a high level of distrust concerning
government surveillance and people fear that where such surveillance by govern-
ment, industry or science is tolerated, repressive action might be directed
against citizens. In countries such as Sweden, Norway and Israel, where such
distrust does not prevail, privacy is not seen as an i m p o r t a n t m a n i f e s t a t i o n
About one- third of the res-
to
(p. 388), and I agree,
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of civil rights. For many citizens and their government representatives
in the United States, however, naturalistic observation and experimentation
present the same danger as a citizen numbering system, databanks, and wide-
spread psychological testing of school children; all these forms of inobtrusive
surveillance are felt to violate individuals' rights to privacy and " inviolate
personality," rights that can be waived but not abused, even by research inves-
tigators.
Legal scholars (e.g., Miller, 1971; Westin & Baker, 1972) encouraged by
appropriate Senate subcommittees (e.g., Administrative Practice and Procedure,
and Constitutional Rights) have been examining the computer- privacy question
at least since 1967 when the National Data Center was proposed. These inter-
ested parties continue to urge lawmakers to consider the new information tech-
nologies and the effects computers may have on individual privacy in contemp-
orary life. We may expect these watchdogs to continue monitoring evidence of
the individual's loss of control over personal information, including unwanted
intrusion through naturalistic experimentation in public or private places.
Strategies for Resolving Problems Associated with Use of Deception
Strategies deemed appropriate for resolving problems associated with
deceitful practices depend upon the metaethical orientation one adopts toward
the use of deception.
is appropriate if the benefits outweigh the costs.
the costs either a) by debriefing, and/or b) by avoiding unacceptable forms of
deception (as determined by public opinion polling). Alternatively, one may
increase the benefits to the subject a) by treating him with the respect due
to a collaborator, and/or b) by reimbursing him with financial or other rewards.
The absolutist approach rejects all justification of deception and requires the
From a u t i l i t a r i a n ( c o s t / b e n e f i t ) a p p r o a c h , d e c e p t i o n
Therefore, one may decrease
23-37
investigator to develop new methodologies that do not require deception.
All these strategies for dealing with the ethical problems associated with
deceptive research practices will now be considered.
Decreasing Costs by Debriefing
The purpose of debriefing in research involving deception is to correct
subjects' induced misperceptions about their own and others' performance and
to reestablish conditions of trust in the professional relationship. There
is some question as to whether even the most effective debriefing can reverse
these undesirable aftereffects of deception procedures. According to section
8- 9 of the APA Code of Ethics:
The investigator has the obligation to assure that research participants do not leave the research experiencing undesirable aftereffects attri- butable to their participation. if the participants are permitted to remain confused or misinformed about important aspects of the study or, more serious still, if steps are not taken to remove effects of psychological stress or other painful conse- quences resulting from research participation.
Such negative consequences can arise
But as Seeman (1969, p. 1027) points out:
When a person is told that he has been deceived, he may quite conceivably be confused as to when the deception had really taken place. Since he will quite appropriately have lost confidence in the person's veracity, the subject may never be able to disentangle the times of truth and the times of falsity in his relationship to the experimenter.
For example, in the Milgram experiment, debriefing would not r e i n s t i t u t e the
subject's self- image or his ability to trust adult authorities in the future.
The subject did after all commit acts which he believed at the time were harmful
to another, and he was in fact entrapped into committing those acts by an indi-
vidual whom he had reason to trust.
It is my observation that investigators concerned about the effects of
revealing deceptive practices are increasingly opting for leaving the subject
uninformed or misinformed.
In my view the investigator must forego the opportunity to engage in
23-38
research that permits only two possible alternatives:
(in which the truth is withheld from the subject because full disclosure
would lower the subject's self- esteem or affect the research adversely); or
i n f l i c t e d i n s i g h t (in which the subject is given insight into his flaws,
although such insight is painful to him and although he has not bargained for
such insight). In section 8- 9 of the APA Code of Ethics concerning the obli-
gation of the investigator to remove misconceptions about the subject him-
self or his performance in the experiment, whether these misconceptions have
been deliberately or unintentionally induced, the question is asked but not
answered: " Must the investigator correct misinformation or provide missing
information even when this will be distressing to the participant?" (1973, p. 76)
The situation, as I see it, is this: the investigator, to further his own
end (i.e., to do worthy research as efficiently and effectively as possible)
contrives a predicament for himself where, as he sees it, he must choose be-
tween two equally unacceptable alternatives in his treatment of subjects, that
is, deceptive debriefing or inflicted insight. The solution to this " dilemma"
is simple. The investigator need only reject his original experimental design
as unethical on the grounds that it allowed him only two alternatives, both
morally unacceptable (i.e., that it placed him in a moral dilemma). He can then
proceed to invent another and more ethically acceptable design. No experimental
procedure anticipated by the investigator to require deceptive debriefing in
order to guard the subject's self- esteem or mental health ought to be considered.
For deceptive debriefing violates the subject's fundamental rights to have mis-
conceptions removed subsequent to the experiment and to receive honest (although
not necessarily complete) feedback concerning the findings of the experiment.
The investigator's duty is clear. Just as he may not intentionally design an
d e c e p t i v e d e b r i e f i n g
23-39
experiment in which it is necessary to kill or maim the subject to facili-
tate effective and efficient research, so he may not design an experiment
in which it is necessary to deceptively debrief a subject.
Concerning second order deception ( i . e . , deceptive de- debriefing),
Kelman (1967) states,
Such a procedure undermines the relationship between experimenter and subject even further than simple misinformation...deception does not merely take place within the experiment, but encompases the whole def- inition of the relationship between the parties involved. Deception that takes place while the person is within the role of subject for which he has contracted can, to some degree be isolated, but deception about the very nature of the contract itself is more likely to suffuse the experimenter- subject relationship as a whole and to remove the possibility of mutual trust. (p. 2)
Some, but not all, of the above objections to debriefing can be met
provided that the investigator takes seriously his responsibility to offer
subjects a reparational experience.
that debriefing requires considerably more than blatant exposure of the truth;
subjects' reactions are in part a function of the experimenter's tact and
consideration.
deception and explain in detail its necessity and the care that went into
making the procedure believable, thus reducing the subjects' concerns about
being found gullible.
work out the truth for themselves, these writers believe that they will feel
less victimized.
Mills (in press) emphasizes that the clarification procedure or debrief-
Aronson and Carlsmith (1968) point out
The experimenter can express his own discomfort at using
To the extent that subjects are permitted to gradually
ing may itself have harmful effects unless conducted with great sensitivity.
He presents in great detail a debriefing procedure, including a scenario,
which he developed over 20 years of debriefing and which he believes can be
adapted to explain any experiment using deception.
scenario are that the investigator is required to put a great deal of care
The advantages of the
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and thought into his presentation; he can proceed confidently, covering all
necessary points so that the participant is provided with an educational
experience as well as a truthful account of the experiment's actual nature.
The experiment is explained very gradually and every point reviewed until
the subject understands. The subject is then given time to reorganize his
perception of the experiment and his responses to it, from possible humili-
ation and discomfort to self- acceptance and hopefully sympathetic understanding
of the researcher's perspective. Certainly investigators, if they use decep-
tion, should be required to show subjects the respect inherent in Mills'
scenario. It should be noted, however, that the script leaves no room for
the subject to object to the morality of the deception and, indeed, makes it
difficult for him to do so by providing such an air- tight rationalization for
its use.
quite offensive. But in most instances I would agree that such extremely
careful and considerate debriefing could substantially reduce the costs of
deception and increase the benefits to the subject of his participation.
For reactive subjects concerned with personal agency this could be
Decreasing Costs by Polling the Public
Many social science investigators claim that most prospective subjects
would not in fact object to the use of deception were they given a chance to
vote on the issue.
There is an important sense in which polling the public does decrease the
societal costs of the use of deception.
polling actually promotes a sense of self- determination for the group as a
whole, if not for each individual.
By informing the public of the issues,
There are in fact a few studies which explore the question of how subjects
feel about deception. For example, Sullivan and Deiker (1973) surveyed a random
23-41
sample of 400 members of the APA and 357 undergraduate psychology students
to determine which group most harshly judged deception. Not surprisingly,
more of the psychologists felt that deceptive practices were unethical than
did the students. Given the greater maturity of adult judgment this would
be expected. (The moral to be drawn from this study, in my opinion, is not
that the use of deception is ethical but rather than undergraduate psychology
students are still in need of ethical guidance.) More studies with other popu-
lations are needed.
I recommend, therefore, that where investigators plan to use deceit or
where informed consent cannot be obtained, representative samples of people
be matched with the individuals to be investigated to serve as peer consul-
tants and to review the proposed experimental or observational procedures.
These peer consultants, selected in the same manner as public opinion poll
respondents, could assist investigators in identifying ethical problems and
serves as informants to evaluate the effects of deception.
The public should know the kinds of risks a volunteer subject may expect
to undergo. While in a general sense subjects would be less naive as a result
of a publicity campaign, their set might also be more standardized and their
behavior less suspicious in a given experimental situation. The cat and mouse
element is reduced when subjects are encouraged to act " as if" the experimental
instructions are straightforward.
subject is one who has agreed to suspend disbelief rather than one who presum-
ably has been fooled into believing duplicitous instructions.
Investigators would realize that a " naive"
Increasing Benefits to Subjects
The investigator's indebtedness to subjects should be expressed in materi-
al payment and in focussed attention to the subject as a human being. The
investigator seldom perceives in positive terms his indebtedness to the subject,
23-42
perhaps because the detachment which he thinks his function requires prevents
appreciation of the subject as a person.
the subject's reason for volunteering includes course credit or monetary gain.
Particularly where experimental conditions expose the subject to loss of dig-
nity or offer him nothing of intrinsic value, the experimenter is obliged to
reward the subject with something the subject values.
rewards, the experimenter should make time to express his appreciation to the
subject, answer his questions in detail, assure him that he did well, and ex-
change amenities.
from the project-- knowledge specifically about themselves and then about the
questions the research is designed to answer. If a subject is seeking an oppor-
tunity to have contact with and confide in a person with psychological training
these personal needs also should be met.
subjects should be actively involved as collaborators in ongoing research.
will quote Eisner's excellent treatment of the debt owed to the subject and
the way in which this debt can be repaid.
Yet a debt does exist, even when
In addition to material
Subjects should be the first recipients of knowledge gained
To the extent that it is possible,
I
The social status of each subject renders him powerless within the research setting. Furthermore, the fact that experiments are carried out, for the most part, in the experimenter's laboratory, with his equipment, according to his rules, combined with the prestige and recog- nized expertise of the experimenter, further contributes to the power deficiency of the subject (Kelman, 1972).
and procedures, reduces the discrepancy between the power of the subject and experimenter, and simultaneously can alleviate certain ethical problems (Kelman, 1972; Mead, 1969), particularly in terms of the costs/ benefits approach. First of all, potential subjects or their peers might be useful in pointing out the possible harmful effects of the research, in other words, in assessing costs. Secondly, input into goals affords the subject the opportunity to reap some of the benefits of the research. It may also make research intrinsically interesting for the subject, and possibly more relevant to his own life. This is particu-
Giving subjects input regarding the purposes and goals of research,
larly applicable in the case of action- oriented research (Chein, Cook & Harding, 1948). Involving the subject in a way which benefits him, gives validity to the application of a costs/benefits analysis of a given piece of research.
23-43
Among the social scientists who have advocated increased subject involvement are Kelman (1972), Parsons (1969), Mead (1969), Argyris (1968) and Wallwork (1975b). Granted, extending to subjects complete, or, perhaps even equal control over research would be impractical, if not impossible. Because of the investigator's specialized knowledge, he is far more competent in experimental design and methodology. that area he must have the bulk of the power (Kelman, 1972). Argyris (1968) compare; the relationship between subject and experimenter to that of employer and employee. Like employees, subjects do not want to take over, to run the whole project. They simply want greater influence and opportunity to participate in the planning. Actively involving sub- jects in research has methodological advantages as well. Subjects tend to be more cooperative if research is perceived to be relevant to their own lives (Argyris, 1968). (1975, pp. 68- 70.)
Developing New Methodologies
In order to appropriately assess the cost/benefit criteria it is essential
In
to identity worthy research objectives where investigators claim the use of
deceptive practices is mandatory. I would suggest that the commissioners
contract for at least one paper on this vital subject. However, the assumption
that certain phenomena of interest cannot be investigated otherwise must be
examined critically.
actually occur because investigators have come to rely on specific research
designs based on deceit (as for example the Asch situation in the study
of conformity) and because deception per se is viewed either as a prestigious
methodological device or as a simple solution to research- design problems.
will be made of new methodologies being developed as a
In many cases where this claim is made deception may
Brief mention
result of dissatisfaction with traditional experimental methods or in response
to ethical problems. This is not the place to assess in detail their scien-
tific merit although that question is relevant to a cost/benefit analysis.
Role- playing has been suggested (e.g., Kelman, 1967) as a way of avoiding
deceit. There is reason to believe that subjects frequently role- play naiveté
whether asked to do so or not. But the effect of actually asking them to do
so may introduce a different artifact; subjects may be able to role- play the
direction but not the magnitude of particular behavior. Where role- playing
23-44
has been used there is some evidence that subjects can simulate gross but
not suble intervention effects in conformity experiments (e.g., Geller, 1970;
Horowitz and Rothschild, 1970; Willis and Willis, 1970). Appealing as this
" solution" is, there are good theoretical reasons to doubt the efficacy of
role-playing as a substitute for the real thing.
ject does not know how he would react in a given situation he cannot role-
play realistic behavior; were such information available investigators could
merely use introspection rather than experimentation to determine reaction.
To the extent that a sub-
S i m u l a t i o n , which is a special kind of role-playing may have greater
potential as a substitute for deception. Perhaps the most famous experiment
using simulation is Zimbardo's simulation of prison life (1973) where 24 vol-
unteer subjects were randomly assigned to the role of jail guard or prisoner.
The experiment was sufficiently successful in simulating loss of autonomy in
" prisoners" and abuse of power in " guards" that it had to be terminated after
6 days.
Overt f i e l d r e s e a r c h , using either structured situations or naturalistic
observation followed by intensive interviews is, in my opinion, the method for
avoiding deception and obtaining valid, representative, sound psychological
data.
investigator may introduce stimuli intended to produce a range of scientifically
interesting responses. While covert observation and staged occurences create
serious ethical dilemmas, overt observation of representative behavior is pos-
sible when subjects are given the opportunity to become accustomed to the
observers, tape recorders and videotapes. My own research (Baumrind and Black,
1967; Baumrind, 1971) relies heavily upon field research supplemented by inten-
sive interviews which probe attitudes and values relevant to already observed
behavior. These interviews also allow for examination of subjects' feelings and
Subjects can be fully aware they are being observed and even that the
23-45
attitudes about research, the setting, their own reactions, and the rela-
tionships the investigator is studying.
been a participant observer provides a shared focus of attention for the
view and decreases the liklihood of intentional misrepresentation or uninten-
tional romancing by the subject.
Enforcement of Regulations Governing Protection of Human Subjects
The fact that the interviewer has
Most social scientists have granted the HEW sidelines with dismay and
Investigators, with some justification, are complaining of har- confusion.
assment by university committees composed largely of lawyers whose main con-
cern is with neither the scientific enterprise nor the protection of subjects,
but rather with the protection of the university from suit.
subjects to their rights and to the possibility of gain, these committees
increase the probability that such suits will be brought. Both committees
and investigators, for self- protective reasons, become overly cautious and
concerned with following the letter rather than the spirit of the regulations
and lose sight of the fact that the intention of the regulations is to protect
the s u b j e c t . " Major limitations upon scientific progress have been imposed by
an overly restrictive interpretation of rules for the protection of human
subjects. The integrity and privacy of the individual must be protected, but
the procedures for insuring the welfare of the individual need not be so cum-
By sensititizing
bersome and stultifying as currently practiced." 2
Many investigators (including myself) feel that in operation University
review committees fail to protect the welfare and rights of human subjects
because that is not their primary aim.
protection of the institution from civil suit by subjects and/or harassment by
Their primary aim often appears to be
Wayne H. Holtzman, Chairman, Final report of the President's Biomedical 2
Research Panel of the Social and Behavioral Development Interdisciplinary Cluster, October 1, 1975.
23-46
HEW officials. Adherence to enlightened ethical principles and/or concern
for the welfare of subjects are secondary concerns. As long as investigators
and University committees experience themselves as in dire threat, which at
present they do, these public servants will attend to their own survival needs
first, and the welfare of the community second.
The research enterprise is in fact threatened on many fronts. Funds for
all research, but particularly social and behavioral research, have been
sharply reduced. The respect scientists traditionally enjoyed in the community
has been undermined. In my view, some of the most fruitful investigations
and creative investigators are most threatened by loss of financial and
social support. In social and behavioral science, the major important recent
findings (as the President's Commission's final report of the Social and Behavi-
oral Development lnterdisciplinary Cluster concludes) are an outgrowth of longi-
tudinal studies. But studying the same individuals repeatedly requires con-
tinuity of support and dedicated application of research' skills for several
decades. Without advance commitment of long-range support, longitudinal
programs cannot be effectively pursued.
dedication to knowledge and by personal autonomy, are the real victims of
restrictive regulations and punitive sanctions. For it is they, more than
those for whom research is merely a means of attaining material and social
rewards, who suffer the Ioss of the intrinsic rewards of the research enter-
p r i s e i t s e l f .
Creative researchers, motivated by
Perhaps the most serious and legitimate concern behavioral scientists
have about pressure from Washington is that it is frequently political in form.
Pressure may be from the right or the left.
the liberal ideology of most social scientists has resulted in punitive action
from a conservative administration in the form
Many investigators believe that
of reduced funding and general
23-47
harassment. Other investigators are more concerned about pressure from the
left suppressing lines of investigation whose results may prove politically
embarrassing. Genetic research is a particularly sensitive area because of
its capacity for revealing differences between groups of people in socially
valued attributes. For example, in Boston last year, public pressure forced
cancellation of an investigation of an acknowledged reality, the " X Y Y syndrome" ;
there occurs in roughly one in 1000 males an extra sex chromosome, labeled
Y, which limited statistical evidence suggests may be associated with anti-
social behavior. A group known as Science for the People, aided by other
activist critics, was able to exert sufficient political pressure to force the
investigators (Walter and Gerald) to truncate their research program.
Similarly, a category called " social risk" was invoked by the Small Grants
Section of the NlMH to effectively block normal peer review of two separate
grants on the basis of " apparent failure to consider the probable social con-
sequences of the study." One of the censored studies (Littman) proposed to
study exploratory behavior in order to detect individual differences in social
and intellectual competence among mildly retarded children. The second (Horn),
proposed a secondary analysis of data on 624 white children and 209 black child-
ren in a study of " fluid" and " crystallized" intelligence. Here, two so- called
ethical principles were invoked to censor his proposal-- one, that consent for
the secondary analysis had not been obtained from the original subjects, and the
other, that a social risk to the class of which the subjects were members
existed.
as examples of harassment at best, serious violations of academic freedom at
worst.
the enforcement of these principles will continue to be used to create an atmos-
phere of vigilantism and scruplulosity. I strongly recommend to the Commission that
I regard these two " ethical" rules and the use to which they were put
Hopefully neither the principles governing protection of human subjects or
23-48
it take steps to see that effects of its actions are positive and do
not create a
innovative scientists.
new self- perpetuating bureaucracy whose immediate victims are
Yet, as I documented at the beginning of this essay, social scientists
have not given evidence that they can be trusted to regulate themselves to
safeguard the rights and welfare of human subjects (witness the attached code
of the American Sociological Association).
practices and failure to obtain informed consent constitute serious ethical
violations.
p. 697) that among the examples of ethical problems cited by the APA " there is
not a single instance of any individual suffering permanent damage as a result
of participation in 'psychological' research;" and furthermore that (referring
to APA guidelines) "it is difficult to justify such an elaborate set of prin-
ciples to guide research.''
Most do not believe that deceitful
Most would probably agree with the sociologist Paul Reynolds (1972,
Moreover, the guidelines (APA and HEW) themselves facilitate abuse of the
rights of human subjects by a) requiring informed consent and restricting the
protection of the rights and welfare of subjects o n l y to those likely to be at
risk, and b) permitting risks to an individual provided it can be shown that
those risks are outweighed e i t h e r by the potential benefit to the individual
o r by the importance of the knowledge to be gained.
Regretfully, I must conclude that effective external regulations and
sanctions are necessary. How can they be made less onorous and more acceptable?
I recommend that the same structure which imposes sanctions against un-
ethical practices also a s s i s t i n v e s t i g a t o r s i n a c c o m p l i s h i n g t h e i r l e g i t i m a t e
o b j e c t i v e s u s i n g e t h i c a l m e a n s . When an investigator encounters a problem he
believes requires the use of deceit, manipulations or noninformed consent, he
should be able to submit his predicament to a peer group for help in devising
23-49
more ethical procedures. If this is unsuccessful, an ombudsman should be
available to represent the investigator's position to the ethics committee.
A w i d e s p r e a d e d u c a t i o n a l c a m p a i g n t o i n f o r m t h e p u b l i c about the social
role and value of scientific enterprise as well as the ethical dilemmas sci-
entists face in conducting their work should be mounted via the media.
example, citizens can be invited
similar to the one successfully mounted by social policy planners
for the development of Yosemite National Park.
clamored to participate in the formation of a master plan for the park by com-
pleting a very lengthy questionnaire composed of a very specific set of
questions with action implications. A similar questionnaire- substitute for
the town forum could be used nationally both to educate the public and to de-
termine its present views on procedures and policy to be instituted for the
protection of human subjects.
For
to respond to a graphic public opinion survey
responsible
More than 40,000 Californians
The decision as to kinds of procedures to be prohibited, regardless of
the potential benefit to society, belongs to the lay public. As yet we do
not know whether the average citizen, if informed, would require informed con-
sent and prohibit deceit regardless of potential social benefits. It is past
time that we found out.
Equally important, a w i d e s p r e a d e d u c a t i o n a l c a m p a i g n a i m e d a t t h e p r o-
f e s s i o n , perhaps sponsored by the Commission, should be mounted to encourage
discussion of the ethical issues which the Commission itself is considering.
Few members of University committees for protection of human subjects are
ethicists by training or interest. While departmental chairpersons and gradu-
ate advisors are responsible for supervising students' research, few of them
understand the ethical issues involved. The most serious ethical violations
now occur in graduate students' research. These students are seldom offered
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a course in ethics. I recommend that all persons involved in research on
human subjects, or review of such research, be invited or required to attend
seminars taught by ethicists who examine these issues.
Perhaps the most effective pressure that could be put on investigators
is the knowledge that e d i t o r s w o u l d r e j e c t r e p o r t s b a s e d o n u n e t h i c a l r e s e a r c h
where informed consent is not obtained or deceit is used. At present there is
little evidence that editors or consulting editors include ethical considera-
tions among their criteria for publication.
T h e o p e r a t i o n o f i n s t i t u t i o n a l r e v i e w p a n e l s m u s t b e i m p r o v e d . On the
one hand, investigators must be protected from unwarranted interference with
the efficiency of their operation and de facto censorship.
the regulations themselves must effectively prohibit research activities that
violate subject's rights or their welfare.
Conclusion
On the other hand,
Perhaps the seminal problem in social and behavioral research is that
not all investigators do in fact respect their subjects as persons or appreci-
ate their contribution to the research endeavor. If respect could be assumed--
or if it could be taught as an integral part of the social scientist's pro-
fessional education-- then neither the Commission for whom this report has been
prepared nor the various ethical codes of the professional societies would
be necessary. However, the very existence of ethical codes indicates that
trust and respect have eroded to the extent that they have had to be replaced
by formal contractual agreements, and even these are far from satisfactory.
An examination of the Code of Ethics of the three major social science
organizations reveals their established attitudes toward ethical regulation.
The code of ethics of the American Sociological Association appears to me
cynical and self- protective; the organization tries to defend itself from
23-51
external regulation and issues a declaration of professional independence.
The American Psychological Association has produced a balanced, literate
and profusely illustrated document which reflects but does not seriously
attempt to resolve the fundamental differences that exist among psychologists.
The body of the document provides varied and exquisitely detailed rationali-
ations and procedures for violating the 10 clear-cut ethical principles ennuci-
ated initially. The statement of the American Anthropological Assoication is
an idealistic, ethically sensitive, and socially responsible document. It
asserts affirmatively the absolute obligation of its members to place the
interest of the subjects before their own and before those of science, and to
use their scientific findings in the service of all humanity. However, it
considers none of the intrinsic problems of anthropological research. (e.g.,
in obtaining informed consent does one abide by the code of an authoritarian
tribal society which places no intrinsic value on the individual, or by a
Western ethic that ostensibly does?)
many third world societies have rejected the attentions of anthropologists as
intrusive and invasive.
Nor does it explore the reasons why so
Alas, if only all men were of good will, the AAA code of ethics would
suffice to remind us of our higher values and common humanity.
subjects' motives for participating in research range from the prudential to
the principled, so do investigators'. Investigators' motivations may include
the desire to dominate and control interpersonal situations. Unless sublimated
appropriately, these motives can stimulate dehumanizing behavior toward sub-
jects and rationalize that behavior in terms of scientific detachment and
rigor.
But just as
In view, then, of the social, political, and scientific realities of
twentieth century America, it would seem that we have no choice but to
23-52
substitute some code or contractual agreement for the trust and respect which
should, but can no longer be assumed to exist among human beings. All human
activities are permissible in the proper time and place.
deceiving, as there is a time for hating and for killing. The question con-
cerns time and place. It is the special characteristics of the research set-
ting that put subjects " at risk" in ways they would not be in ordinary life.
The use of deception in research, precluding-- as it does--informed consent,
cannot be justified today.
tutional rights posed by computer technology and electronic surveillance devices
in the hands of government and industry executives is too grave in contemporary
American society to legitimize any justification of violations of constitu-
tional rights. Social, behavioral, and medical scientists have not demon-
strated that the legitimization of such violations in order to obtain informa-
tion and knowledge would produce benefits that outweigh the costs to society,
In fact, they have failed to demonstrate, as yet, that important scientific
objectives are precluded by an absolute prohibition against deceitful practices.
It is essential that they be given a chance to do so.
that in all probability a socially useful scientific objective could not be
attained without the use of deceitful practices, I believe that, given an oppor-
tunity to decide, most segments of the community would consent to the controlled
use of deceptive practices to obtain that particular objective. I personally
would not consent, nor would I intentionally use such practices even were the
community to consent. But neither would I prohibit their use, because
explicit collective consent by citizen groups substantially lowers the proba-
bility that individuals will lose trust as a result of deceptive practices or
that their right to liberty and self-determination would in fact be threatened
by such practices. Also I am concerned that stringent external regulations
There is a time for
The threat to privacy and to individual consti-
If it could be demonstrated
23-53
will drive many creative, intrinsically motivated scientists to abandon
their research endeavors.
However, proscriptions against social science methods which violate
ethical principles may be exactly the impetus required to induce a paradigm
shift in social psychology away from the study of subjects as objects to the
study of subjects as active agents.
on both sides of the Atlantic are already moving in that direction (Armistead,
1974; Smith, 1974). To the extent that investigators treat subjects as though
they are purposive, active, self- reflective persons trying to construct mean-
ingful experiences for themselves within as well as without the investigator's
small world,
standing men and women as active agents engaged with their social environment
can be developed in response to the ethical and methodological limitations
of our traditional methods.
There is evidence that psychologists
they may become so. New research designs better suited to under-
23-54
APPENDIX A
Examples of the Use of Deception Drawn Mostly from
the Family Socialization Project (Baumrind)
Here I will illustrate the kinds of ethical problems that have come to
my attention in the last few years, all of them but the first drawn from my
own research.
1 . An undergraduate student studying nonverbal communication. This
fairly typical example illustrates rather well how little attention is paid
to ethical issues by instructors in charge of training undergraduate and
graduate students.
University of California wished to study nonverbal communication. She devised
a gadget for recording instances of behavior which interested her; this
gadget could be operated without the knowledge of the subject.
student subjects on the pretext that she wished to interview them concerning
their social and political attitudes and then recorded secretly their nonverbal
reactions to the interview questions.
sponsor did not raise the ethical issue with her.
of her study several friends questioned the ethics of her procedures, which
led her to wonder how her subjects would feel if they d i s c o v e r e d that they had
been duped. Since it was a small campus, she was sure some subjects would make
that discovery.
the real harm to the subjects would come from the debriefing itself.
she never debriefed her subjects.
ficient to justify the use of deceit and failure to debrief?
raised the question, nor had any of her instructors; I was the first to do so.
The student learned to regard the use of deception as normative, and covert ob-
servation as acceptable. The methodological requirements of her study did in fact
In 1974 a competent undergraduate at the campus of the
She recruited
It should be noted that her faculty
However, during the course
The student, like many more mature investigators, felt that
Therefore,
Was the scientific value of her study suf-
She had never
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necessitate concealment.
could have been accomplished.
But there were ethical ways in which the concealment
For example:
a) Subjects could have been selected from amongst those who agreed
to accept the instructions as given, with the understanding that, as is true in
many experimental situations, the entire truth might be withheld and they would
receive a full explanation of the objectives of the investigation subsequent
to the study. S's given such instructions easily suspend disbelief since what
they are suspicious about has been admitted candidly from the beginning.
or b) Nonverbal cues could have been recorded in conjunction with
an actual social survey conducted for bonafide purposes by another investigator.
Debriefing would include acknowledgment that additional information had been
collected.
retained in the unlikely event that any S objected to having such complete
data about his or her behavior collected.
Consent after the fact would be obtained from all subjects who were
2 . A graduate student using a modified Prisoner's Dilemma Game in my
A second example is described by a graduate student whose research project.
dissertation I helped to supervise. His account is as follows:
I encountered an ethical problem in my doctoral research when I decided to use a modified Prisoner's Dilemma Game. played by two subjects at a time at computer terminals. The sub- jects were nine-year-old children. In order to establish a base- line for each child's level of cooperation, I planned to present each subject with a standard sequence of plays stored in the com- puter. Then, to measure the children's interactive play, I planned to present each child with his or her partner's actual choice. My initial plan was to deceive the children by telling them that they would always be playing with their real partner. Dr. Baumrind, one of my dissertation advisors, refused to go along with this on the grounds that to falsify the children's perceptions of their social interactions was wrong. We cast about for a solution that would preserve the experimental design and that would also be free from deception. The solution which was actually applied was to inform the children that as they played, part of the time their partners
The game was
would be real (i.e. human) and part of the time the computer would be their partner. I added that, since they would not know when they were playing with the computer and when they were playing with
23-56
their real partner, they should play as if they were playing with their real partner. Thus, although the children were left in doubt until the end of the experiment as to who their partner was, they were not deceived. In fact, for the first 125 of the total 200 tries, subjects were playing against a computer.
Questioning after the game indicated that all of the children understood the actual situation. The children's comments and the data that emerged from this experiment were consistent with those of colleagues who used deceptive instructions; so that in this instance deceitful instructions appear to have been unnecessary to accomplish my exper- imental objectives. when the child was engaged in truly interactive play yielded information interesting in its own right.
My concern here was that if the children were deceived from the beginning
The information obtained during the 75 trials
the experimenter would have an untenable choice during the debriefing process--
either he would have to tell the children they had been deceived in the first
place, thus positively sanctioning the practice of deception by an adult
authority, or he would have to forego debriefing altogether in which case the
children would leave the experimental situation misinformed concerning the
extent to which their peers used cooperative or competitive strategies.
judgment was that in either case the child's own ethical judgment would be
affected adversely, and that the risk no matter how small could not be justified
by any gain in knowledge accruing from the experiment to the subject.
3 . We routinely
collect information on each child in the school setting. The information we
collect might be more representative if the children did not know they were being
observed.
explicit permission to make school visits although we
full consent from their parents.
the first school visit, and at the end of the interview obtain his permission
to make a series of school visits. But incidental to our observations of the
subject child, we do take notes on other children who are part of his environ-
ment. These children not in our study on whom information is collected
My
My own research--observing children in the school setting.
However, for ethical reasons our practice is to obtain the children's
have already obtained
Therefore, we interview the child prior to
23-57
incidentally, are not told that they are being observed.
that to do so would burden the students.
consciously concerned that any visitor in the room was observing him, even
those he did not know or with whom he had not established a relationship.
Since our choice was to distress the children by asking their permission, to
not make school visits at all, or to fail to make full disclosure, we chose
the latter alternative.
deceived by our presence alone, we regard our " failure to make full disclosure"
as acceptable although not exemplary, and continue to observe the child subjects
in their school settings.
It is our judgment
The child might then become self-
Since the children are in no way distressed or
4 . My own research--active withholding of information. In order to
protect a sensitive and self- conscious child, we have had occasion to withhold
the whole truth from other children who asked about our purposes in the class-
room. The partial truth we tell them is that we are there to learn more about
how classrooms differ. This partial truth is intended to deceive and is,
therefore, a lie.
save him embarrassment, we acknowledged that we had done so for that purpose.
We do not regard telling a " white lie" (i.e., a lie intended to prevent dis-
comfort) to a child as setting a bad example.
in which the child was placed " at risk" , we felt we had the responsibility for
minimizing that risk although to do so involved deceit. The implicit contract
with the subject- child is that we will relate to him or her in a supportive
and partisan fashion and that is what we do.
telling of a partial truth to the other children did not place them at risk,
because it is understood by school children that adult strangers need not take
them into their confidence by revealing their full intentions.
When one child thanked the observer for lying in order to
Since we had created a situation
It was our judgment that the
5 . My own research--lying thoughtlessly and unnecessarily. On occasion
in our research, we find ourselves lying unthinkingly and for no good reason.
23-58
For example, one of Flavell's role- taking tasks is administered as follows-
and we followed the standard instructions until we thought more about it.
E 1 displays a series of seven pictures and asks S to tell the story which they
illustrate. Three specific pictures are then removed, E 2 enters the room, and
S is requested to predict the story which E 2 would probably tell from the
remaining four pictures. S is told that E 2 has never seen the whole series of
seven pictures. This is of course a lie and an unnecessary one at that.
Incidentally, it is not believed by most bright children.
brought to our attention that we were lying by saying " Aw, come on, how
long has [E 2 ] been working here?!" )
S to predict the story E 2 would probably tell if he had never seen the remain-
ing four pictures.
all S's is standardized.
(In fact, a child
It is sufficient for our puposes to instruct
The added advantage of this procedure is that the set for
6 . My own research-- lying by implication. It is our practice to film
a family discussion situation.
be filmed. However, prior to the full family discussion in which both parents
and the subject discuss the Kohlberg moral judgment stories, the parents have
fifteen minutes together in which they plan their approach. For months we
overlooked telling the parents that this portion of the interaction was being
filmed.
they assumed that we would have told them if they were being filmed.
that one of the videotapers was aware that the parents were being misled into
thinking that they were not being filmed.
obtained was particularly valuable because it appeared so informal-- the family
is in a living room setting and no observers are present-- and that to tell them
they were being filmed would reduce the informality.
The family is told explicitly that they will
Since we had been so honest with them about our procedures and intentions,
It happens
He felt that the information thus
He did not feel that by
73-59
saying nothing he was lying.
were from then on informed.
Once I became aware of the situation, parents
I present these rather trivial but typical instances of the use of deception
to illustrate how ubiquitous the use of intentional and non-intentional deceit
is even when the investigator Is sensitive to ethical issues, and also to
suggest that in most instances deceptive practices can be eliminated and the
objectives of the research nonetheless achieved. I also wish to illustrate that
it is not deception in a vacuum which is ethically unacceptable; it is the
violation of the subject's basic rights, particularly the right of self-
determination, which so often occurs with the use of deceptive practices that
cannot be accepted on ethical grounds.
P o s t s c r i p t
In my final re-rereading of this paper I note that despite my objections
to the implications of the term "subjects" I continue to use that term to refer
to participants. This is not only logically inconsistent and revealing, but
has the effect of reinforcing a public attitude towards participants which I
contend should be changed. In the event that this paper is published by the
Commission I request, therefore, that the word "subject" be changed to
"participant."
23-60
APPENDIX B
Procedures for Obtaining Informed Consent Used by
the Family Socialization Project (Baumrind)
Participation is solicited by telephone from prospective subjects.
who are willing to explore further the possiblity of participation are sent
a lengthy summary of procedures in which they would be expected to participate
were they to consent.
all family members are present.
further to the parents, and those that affect them are discussed with the
children. There are three separate consent forms, all appended. One consent
form, to be signed by both parents, signifies agreement with the procedures
described. The second consent form is in the form of a letter to the child's
principal and teacher requesting their cooperation. Willingness to sign this
letter signifies a high level of commitment to the project. There is a third
consent form for use of case history material.
Note that the child's written consent is not obtained at this age (ages
Those
This is followed up by a visit to their home in which
At that visit the procedures are explained
8 or 9) and that none of the consent forms specify possible benefits or costs.
These considerations are discussed during the home visit.
description of costs and benefits is provided the University Review Group.
Effects on Subjects
The following
B e n e f i c i a l . T h e r e l a t i o n s h i p w i t h s u b j e c t s i s c o l l a b o r a t i v e . I n
a d d i t i o n t o t h e i n f o r m a t i o n a b o u t f a m i l y p r o c e s s e s w h i c h s u b j e c t s p r o v i d e ,
t h e i r c r i t i c a l a b i l i t i e s a r e h a r n e s s e d t o o u r o w n i n r e v i s i n g m e a s u r e s .
P a r e n t s a r e g i v e n c o p i e s o f t h e s e l f- r e p o r t a n d o t h e r m e a s u r e s i n o r d e r
t h a t t h e y m a y c o n t i n u e t o e x p l o r e i n
value issues which these measures assess.
23-61
their own minds the child rearing and
Lengthy conferences are arranged
with each family to provide feedback.
is given to each family.
In addition, an honorarium of $150.00
Potential drawbacks.
1 . I n v a s i o n o f p r i v a c y . Our procedures include invasion of the privacy
of the homes. Protection of subjects is afforded by selection of observers
who are courteous, supportive, tactful, and professional in their demeanor.
In order to assure confidentiality, data are converted to IBM cards and data
tape. In this form the subjects are fully anonymous.
2 . D e c e i t . We avoid the use of procedures which require deceit or
covert observation, even where to use these procedures would provide us with
more valid data.
child p r i o r to school visits and to obtain the child's consent to these visits,
even though observation would be more " naturalistic" if the child were not
aware that he was being observed.
all family members take their turn observing behind the mirror so as to assure
their full awareness as to what can be seen and heard.
For example, observers are instructed to interview the
While we tape behind a one-way mirror,
3 . U n a n t i c i p a t e d s e l f- k n o w l e d g e . The intensive interviews concerning
moral judgment and child rearing practices will initiate in some parents a
re-examination of their own values.
initiate insights and changes which would be facilitated by discussion with a
psychologist.
Benefits To The Lay And Scientific Community
Characteristics of this program of research which contribute to its scientific
significance are a) in-depth collection of data using multiple settings and
measures over time; b) the use of an extensive battery of objectively scored
tests and videotape transcripts to supplement the ratings; c) the longitudinal
nature of the data collected; d) the fact that the sample studied is from the
For a few this self-examination may
We have a person on our staff to perform this function.
23-62
San Francisco Bay Area, an area of the country where secular changes are
first felt so that the relationships noted should have predictive significance
for the rest of the country: e) dimensions of child- rearing and of child
behavior are studied configurally rather than in isolation thus permitting
important distinctions between parents and between children to emerge.
The focus of the program of research is on patterns of parental authority,
an area of acknowledged social importance, particularly today. The way in
which authority has been conceived and exercised has been one of mankind's
constant concernes through the ages and assumes particular interest in a
period of rapid social change.
23-63
23-64
23-65
23-66
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24
SOME COMPLEXITIES AND UNCERTAINTIES REGARDING THE
ETHICALITY OF DECEPTION IN RESEARCH
WITH HUMAN SUBJECTS
Leonard Berkowitz, Ph.D.
Some Complexities and Uncertainties Regarding the Ethicality
of Deception in Research with Human Subjects
Leonard Berkowitz University of Wisconsin
One of the most complex methodological problems confronting the sciences
engaged in research with humans has to do with the ethicality of deception.
Yet recent cultural trends have made us more conscious of this problem than
ever before and press for a relatively quick solution. There has been a re-
newed emphasis on the value of human dignity and the right of the individual
to be free from arbitrary coercion in the past several years. Perhaps more
than at any time since the Great Depression we as a people insist on the
desirability of individual autonomy. Revenue sharing, suspicion of big
government, the mounting distrust of politicians, and the spreading popu-
larity of the economic notion that "small is beautiful," among other things,
testify to the growing belief that a person should have more control over
what happens to him.
I do not mean to question these ideas or argue that the contemporary
interest in them is only a passing fad.
that the current concern with individual dignity and autonomy has led some
people to be highly critical of behavioral science and especially of labora-
tory experimentation with humans.
and benefits of this research these critics tend to give relatively little
weight to the favorable consequences that might result. At the same time,
they stress and perhaps even exaggerate the risks to the research subjects.
However, it is all too apparent
In their estimates of the possible costs
24-1
From their perspective it is necessary to establish firm guidelines, if not
restrictive rules, for behavioral science investigators in order to protect
the rights of the subjects and minimize the injuries that might be done to
them.
set up a screening agency that will assess the relative costs and benefits
of a given experiment with any substantial degree of validity, and also,
that attempts to create a board of monitors which will closely scrutinize
all research for every conceivable threat to subjects will seriously impede
the development of behavioral science.
in support of experimental behavioral science,
tices that most laboratory-oriented behavioral scientists follow today, in-
cluding reasonable deceptions. Since other writers speaking to the Commis-
I will try to argue in this essay that it is virtually impossible to
In a sense, this paper is a brief
It would permit the prac-
sion will emphasize the risks and ethical difficulties inherent in the use
of ruses, partial truths, and downright misleading statements in experimental
research, my own argument, brief-like, will downplay these costs. As a con-
sequence, it may seem that I do not believe there are any problems or dangers
in stressing and deceiving research participants.
do feel, however, that some of the objections to the investigations being
carried out by contemporary experimental behavioral scientists are exagerated.
This is not the case. I
Several prominent social psychologists have voiced misgivings about the
widespread use of deceptions in laboratory studies. To sample just a few of
these objections, a generation ago Edgar Vinacke (1954) expressed concern
about experiments in which "the psychologist conceals the true purpose and
conditions of the experiment, or positively misinforms the subjects, or ex-
poses them to painful, embarrassing, or worse, experiences, without the sub-
24-2
ject's knowledge of what is going on." He wondered what "is the proper
balance between the interests of science and the thoughtful treatment of
the persons who, innocently, supply the data?" Vinacke seemed to imply
that social psychologists all too frequently treated their research sub-
jects in a non-thoughtful, perhaps even inhumane, fashion in their pursuit
of their scientific objectives. Some years later Herbert Kelman (1967)
raised the problem anew in a thoughtful and fairly moderate critique of the
"unquestioning acceptance" of the "routinization of deception" that exists
in experimental social psychology. Kelman recognized the necessity of mis-
leading subjects about the true nature of the research in some types of
studies.
vestigated without the use of deception," he noted. However, he wondered
whether social psychologists have the right "to add to life's little anxie-
"There are many significant problems that probably cannot be in-
ties and to risk the possibility of more extensive anxiety purely for the
purposes of our experiments." The explanation (debriefing) typically given
to the subjects at the end of each laboratory session might not, he thought,
adequately remove all of the harmful effects. Milgram's well-known experi-
ments on obedience to authority are an excellent case in point.
the obedient subjects were told afterwards that they had only been in an
experiment and had not actually shocked anyone, Kelman argued, "there is
good reason to believe that at least some of the obedient subjects came
away from this experience with a lower self-esteem, having to live with the
realization that they were willing to yield to destructive authority to the
point of inflicting extreme pain on a fellow human being." Even if the
experience provided these people with an opportunity to learn something of
Even though
24-3
importance about themselves, as Milgram maintained, do we (Kelman asked)
"have the right to provide such potentially disturbing insights to subjects
who do not know this is what they are coming for?" The same thing can ob-
viously be said about much less stressful research such as conformity ex-
periments. Is it proper for the investigator to affect his subjects' self-
esteem by showing them that they were easily swayed by the fictitious group
pressure?
Kelman's question about the ethicality of deception research rested
largely on the possibility of long-lasting adverse consequences. The sub-
jects might suffer a fairly persistent injury to their self-concepts or ex-
perience a continuing anxiety that is not remedied by the experimenter's
debriefing at the conclusion of the session. But in addition, he also won-
dered if the lies and tricks used in social psychological experiments did not
also color the subjects' views of the world around them. They learned that
they had been manipulated by the experimenter's deceptions and this lesson
could reinforce other demonstrations, all too prevalent today, that man is
an object to be manipulated at will by societal institutions. "In institu-
tionalizing the use of deception in psychological experiments," Kelman con-
tended, "we are, then, contributing to a historical trend that threatens
values most of us cherish." The Ad Hoc Committee on Ethical Standards esta-
blished by the American Psychological Associationtion (the Cook Committee) sum-
marized this type of argument in these words:
"One frequently hears it asserted that behavioral research is contributing directly to the moral ills of society. According to this argument, when an investigator invades the privacy of another person, employs pain or stress, he contributes nities, and therefore to their behavior."
deceit, or occasions to legitimizing these indig- prevalance in interpersonal
(Cook et al., 1973, p. 17).
24-4
This accusation is a very serious one, especially given the prevalence
of deception in personality and social psychological research. A good many
studies in these areas attempt to mislead subjects about important aspects of
the investigation they are in. One count of 390 published reports in per-
sonality and social psychology (Stricker, 1968, cited in Silverman et al.,
1970) found that participants were "intentionally misled" in 21% of the stu-
dies. This is probably a minimum estimate of the frequency with which sub-
jects are deceived. As Aronson and Carlsmith pointed out (
mild deceptions can be very subtle and common--such as misinforming people
about the true purpose of a personality test they are taking (for example,
by introducing the TAT as a test of creativity) or behaving in a pseudo-
friendly manner to the subjects in order to make them more cooperative. Can
these widespread practices be defended? Should the researchers employing
these procedures be subjected to stringent controls established by some out-
side agency?
, p. 30) ,
I would like to start this defense of the judicious use of deceptions in
behavioral experiments by taking up the last two concerns I mentioned: first,
whether subjects generalize from the experimental situation to other condi-
tions of life and then, second, whether the experimenter's debriefing can
alleviate many of the ill effects of the experiment. The discussion will
then turn more directly to the matter of informed consent and will consider
the kinds of information that should be given to the prospective participants
in soliciting their cooperation.
Kelman believed that social psychologists are shortsighted when they dif-
ferentiate between the laboratory and the surrounding world. "We tend to re-
24-5
gard the [laboratory setting] as a situation that is not quite real, that can
be isolated from the rest of life like a play performed on the stage, and to
which, therefore, the usual criteria for ethical interpersonal conduct become
irrelevant" (Kelman, 1967, p. 5). Kelman is quite right in one sense; social
psychologists are inconsistent if they view the laboratory situation as "not
quite real" and still extrapolate their findings to other social settings.
He is incorrect, nonetheless, in thinking that investigators defend their
practices on the grounds that the laboratory "can be isolated from the rest
of life." The laboratory does not really have its own rules of conduct. Most
subjects believe that an experimenter's actions are governed by overriding
standards, general rules that an investigator is expected to follow, much as
everyone else also follows rules. Thus, according to evidence gathered by
Epstein, Suedfeld and Silverstein (1973), research participants typically
feel that an experimenter is primarily obligated to provide clear instructions,
insure the subjects' safety and warn them of danger.
expected to be truthful in every detail. It may well be, as many researchers
believe, that subjects do regard the experimenter's statements to them as
morally appropriate. The rules of his scientific enterprise, which they
generally recognize, permit him to mislead them, and he is keeping to these
rules. For many of them, the larger context within which the study is car-
ried out serves to justify the deceptions, partial truths and stresses to
which they had been exposed.
He apparently is not
While I agree with the Cook Committee (1973, p. 17) that further research
is needed to determine what standards should govern the experimental proce-
dures, my own experience over more than two decades of laborary investigations
24-6
with university students is entirely consistent with the statement I have
just made. Many of my experiments in recent years have deliberately pro-
voked subjects so that we could study the conditions influencing their ag-
gressive responses. Other social psychologists have conducted similar
investigations. But despite all of the frustrations and insults adminis-
tered to thousands of subjects, I have not heard of any complaints about
these treatments being voiced to university authorities at Wisconsin or
elsewhere. There certainly have not been any protests sent in to our
fairly radical student newspaper about this type of research.
a few students might have resented the treatment they received, but I sus-
pect this was quite infrequent, perhaps surprisingly so from the point of
view of some critics, and even then was very mild. There are good reasons
for this, some having to do with the debriefing--and I will go into this
shortly--and others with the perceived legitimacy of the experimental treat-
ments.
done to them and why, the great majority undoubtedly readily grasped the
significance of the research.
as justified within the context of his scientific activity.
had not been directed against them personally, they realized, but was in keep-
ing with the implicit rules of a social-psychological experiment, and was
therefore "de-emotionalized." My firm belief is that for the preponderance
of university students the scientific context of the experiment similarly
"de-emotionalizes" many different kinds of stress that they might have ex-
perienced in the course of the study.
Of course,
When the subjects learned at the end of the session what had been
They also regarded the experimenter's behavior
The provocation
24-7
The subjects understand this scientific justification when they finish
participating in the study and the researcher explains his purposes and
methods. The debriefing places the experimental experience in the appro-
priate context. Contemporary theoretical analyses of emotions as well as
several recent investigations of the consequences of debriefings suggest
that these after-the-fact explanations can do much to lessen the unpleasant-
ness of whatever stresses and strains have been imposed on the subjects.
These results are not particularly surprising. But I think they parallel
what often happens in some kinds of psychological experiments when the experi-
menter debriefs the research participants.
vided with an explanation that changes the meaning of the threat to which
they had been exposed in the investigation. They now learn that they had not
really been confronted by a test of how well adjusted they are or an assess-
ment of their personal adequacy or a deliberate insult to their self-esteem.
Perhaps equally important, they find that what had seemed like an arbitrary
assault directed at them personally was actually an impersonal treatment ad-
ministered to all of the people in their experimental condition. The event
that had previously aroused anxiety or anger is now viewed in a very different
manner, is "de-emotionalized" as I said before, and the subjects' emotions
subside fairly quickly.
Here too, the subjects are pro-
The debriefing can also cause the subjects to reinterpret their own be-
havior in the experiment. Earlier in this paper I quoted an argument that
Milgram had employed to defend his research on obedience to authority: his
participants had learned something about themselves--they had a tendency to
24-8
submit to authority. However, as Kelman (1967) noted, the subjects might
not have wanted this kind of insight.
pointed out that the subjects could have suffered a blow to their self-
esteem on realizing the full significance of their action. While the self-
awareness arising from some expertmental
certain amount of unhappiness, my experience with experiments on aggression
suggests that it is possible to minimize this distress with an appropriate
explanation.
In the same vein, Baumrind (1964)
situations could well produce a
Instead of focusing on what the individual himself/herself had
done, our debriefings clearly indicate (quite
at all interested in the subject as a distinct person; we only want to know
accurately) that we are not
how students in general behave
over, the subject is also assured (and again, this is usually a fairly ac-
curate statement) that quite a few other people had acted in a similar way.
Perhaps this is a commentary on the state of ethical judgments in our own
society, but many persons are evidently not too unhappy about the impro-
prieties they have committed if they are told
common. I am not saying that this is good--or
very frequently. Our type of post-experimental debriefing might be criti-
cized on ethical grounds:
soning.
right to hurt another individual (or steal or lie) if lots of others do the
same thing. We obviously do not want to impart this lesson. What we are
trying to do, and I think with some success, is minimize the chances that the
research participants will experience a loss of self-esteem on being reminded
under the conditions of our experiment. More-
that their behavior is quite
bad--only that this occurs
it helps legitimate a very questionable moral rea-
For some subjects at least, the statement might imply that it is all
by the investigator that they had exhibited antisocial conduct.
24-9
All post-experimental explanations obviously are not alike. Yet several
studies of the effects of debriefings indicate that they can do a great deal
to alleviate the unpleasant tension that might have been produced in the
course of the study. Some observations recorded by Clark after his experi-
ment with Word (1972) are fairly typical. The subjects in this study were
led to hear a staged accident under various circumstances and then were
watched to see if they would aid the supposed victim. Although the exact
level varied somewhat with the experimental condition, about a third of the
participants reported either being "very" or "mildly" upset at the time of
the emergency if this emergency was unambiguous. However, when the experi-
mental ruse was explained to them at the end of the session, "80% reported
no longer being upset, 19% were still mildly upset and only 1 S indicated
he was still very upset." The investigators also assessed the views of all
their subjects regarding the value of this kind of research:
"The overwhelming majority of S s (95% and 94% respectively) either agreed or strongly agreed that this type of research is valuable and that the deception practiced was unavoida- ble. While there was a more diverse feeling expressed con- cerning the ethics involved, only 2% of the S s reported being opposed to the use of stress in psychological ex- periments. These findings provide evidence that the parti- cipants in these studies felt that the potential worth of the research outweighed the negative effects of the stress of deception inherent in the situation."
Berscheid and her colleagues (1973) have published similar observations. For
one thing, they tell us of a study by Ring and others which essentially repli-
cated Milgram's obedience experiment:
"After actually participating in the replication, the sub- jects completed a questionnaire in which their candid reactions to the experiment were solicited. subjects were given debriefing information before filling
Some of the
24-10
out the questionnaire; others were not. The questionnaire was presented to the subjects as an attempt to determine 'whether any experiments in which you've participated in any way violate the rights of subjects ... '
briefing information indicated that they regretted they had participated in the experiment; on a related dependent measure, 4% of the debriefed subjects indicated the experi- ment should not be permitted to continue. The correspond- ing percentages for subjects who had & received debrief- ing information were 43% and 57%, or, on the average, 50%. Debriefing, thus, had a substantial amelioration effect on the subjects who actually participated in this replica- tion of the Milgram paradigm" (cited in Berscheid et al., 1973, p. 922)."
... 4% of the Ring et al. subjects who had received de-
In their own investigation Berscheid and her associates provided university
students with detailed descriptions of several well -known social psychological
experiments, including the one by Milgram, asked them to imagine taking part
in each of the studies, and then gave some of these people information about
the true purpose of the described research as well as the deceptions that had
been practiced.
tions to the most stressful experiments in the series. Although the results
differed somewhat from one questionnaire measure to another, the explanation
given the subjects about the stressful experiments raised their reported hap-
piness and satisfaction with themselves to the level produced by the non-
stressful studies. The debriefing informtion had apparently countered much
of the felt tension created by the stressful procedures.
This debriefing significantly affected the students' reac-
These findings taken together probably reflect what post-experimental
explanations can do, and not
Some investigators obviously will present a more adequate account than will
others, and all of the participants will not find the explanation equally
necessarily what they will do in every instance.
24-11
beneficial.
lessen many of the psychological ill-effects that might have been created by
the experimental procedure, including the subterfuges practiced by the re-
searcher.
Still, both theory and research indicate that debriefing can
There is another point that should be raised here. As I mentioned
earlier, some of the objections leveled against psychological experimentation
have assumed that whatever adverse consequences result from the treatment
given the participants, whether anxiety, anger or a bruised ego, might well
last for a considerable period of time. An individual might not have only
a brief, trivial experience when he takes part in an experiment. This is
conceivable, certainly, but in the great majority of cases, I am convinced,
subjects do not give the laboratory happenings much thought when they are
over. The event is finished. What had taken place is usually quite unim-
portant to them, and they soon turn their minds to other things. The experi-
menter's account of the study probably helps them do this. Their behavior
is translated into something that might be of interest to the investigator
but is not particularly relevant to their own goals. And it does not matter
much to them that the experimenter had fooled them for his own purposes.
Despite all this, some people could be hurt by their participation in the
investigation.
chological injury will be? History and research say "not very well at all."
Experts have made very inaccurate forecasts when they were asked to anticipate
the outcome of two controversial social psychological
first of these, at the time he
Can we predict how many will suffer and how severe their psy-
experiments. In the
conducted his research on obedience to authority,
24-12
Milgram asked psychiatrists and others to estimate the proportion of subjects
who would yield to the authority's (i.e., the experimenter's) dictates and
severely punish the supposedly hapless victim. Although fully 65% of the
subjects obeyed their instructions and increased their punishment up to the
maximum, and ostensibly dangerous, level, most of the behavioral science
specialists had thought that only a small minority would do so. The members
of the Stanford University Committee on Human Experimentation also failed to
forecast the impact of social roles on subjects in Zimbardo's simulation of
prisons (Zimbardo, Banks et al., 1973).
students role-played being guards in a prison-like environment for eight
hours a day over three shifts, while other men acted as the prisoners for
24 hours a day. Close observation of the participants as well as their
self-reports indicated that "this simulated environment was sufficiently
realistic and forceful to elicit intense, personal and often pathological
reactions from the majority" (Zimbardo, 1973). As a result, the investiga-
tors terminated the experiment well before they originally intended. And
yet the Stanford Committee had previously approved the research proposal be-
cause the members had not expected these strong reactions.
In this latter study one group of
Let us look more closely at these two examples of the experts' failure
to predict people's responses to role demands.
been wrong because they had given the investigator the benefit of the doubt,
exhibiting a willingness to try out the experimental treatments.
their theory of human behavior was in error; they had not given sufficient
weight to the situational influences impinging on the participants, incor-
rectly assuming that the subjects would remain almost impervious to these
The outside observers had not
Rather,
24-13
external forces.
argued that some of the outcry against the Milgram and Zimbardo experiments
reflects dismay at the demonstration of the power of environmental condi-
tions over human behavior. Milgram's research probably would have been
criticized much less severely if his subjects had generally resisted the
authority's pressure. As Helmreich, Bakeman and Scherwitz (1973) put it:
In this regard I agree with several other writers who have
"The upset generated by a Milgram or Zimbardo, both from the public and from their colleagues, in part stems from ethical concerns. But another part of their power lies precisely in their demonstration of how strong situa- tional determinants are in shaping behavior . . . Milgram's and Zimbardo's studies evoke public outcry in part because, through shaming demonstrations, they remind us just how fragile our ethical independence and integrity really are."
Phrasing this type of error somewhat abstractly, it appears that in their
judgments the specialists had placed too much weight on internal determinants
of behavior and had unduly
affect conduct. Or to say this in another way, the observers had not ade-
quately recognized the substantial variability in human behavior, the extent
to which action changes from one environment to another. Walter Mischel
(1968), an eminent writer on psychological assessments, has noted that expert
psychologists frequently make this mistake.
minimized the degree to which situational factors
This slighting of situational variability also occurs, in a sense, when
people exaggerate the impact of a single event upon the individual.
altogether inappropriate, I believe, to regard a person as something like a
shoot of bamboo.
son) fairly easily and
another. Yet the basic structure of the bamboo (the individual's personality)
It is not
Winds (situational influences) affect the bamboo (the per-
move it about often, first in one direction and then
24-14
is not altered so readily.
tially deny the individual's flexibility , the degree to which he responds
frequently to environmental stimulation without undergoing a drastic and
persistent change. Observers also neglect this flexibility when, as I
commented earlier, they assume that one occurrence, such as a stressful
treatment in a psychology experiment, will modify the subject's personality
for a long time afterwards. There can be differences of opinion as to just
how flexible humans ordinarily are, but I think most people are more in-
clined to view the personality as relatively fixed and yet fragile than as
flexible and reactive but still not easily altered in any fundamental way.
In minimizing situational variability we essen-
The particular conception of the human personality that we employ guides
our thinking about the ethical issues in behavioral research. I'll highlight
what I have in mind here by referring to a research proposal that was recent-
ly made in England. A social psychologist wished to test his theoretical
analysis of illegal behavior by placing teenage boys in a laboratory setting
and then giving them an opportunity to steal money. The psychologist thought
he would drive a van to certain working class areas of a community, recruit
adolescents individually to work on an ostensible laboratory task inside the
van, and then leave each boy alone with a chance to steal some cash. The
youngsters would not know the actual purpose of the study or that they were
actually being watched from behind a screen to see what they would do.
the psychologist noted in his proposal, this type of laboratory experimenta-
tion would yield the clearest answers to the theoretical questions he was
posing and therefore might well have direct social benefits. The granting
agencies he approached, however, turned him down on ethical grounds.
As
They
24-15
seemed to be mainly afraid that the experimental experience would strengthen
the teenagers' antisocial tendencies, perhaps by reinforcing their inclina-
tion to steal again in other situations.
for concern, the psychologist who made the proposal believes the granting
agencies' fears were much too strong.
cents in his sample would have already done some stealing prior to the ex-
periment (because of the neighborhoods from which they were recruited) so
that their laboratory behavior would be, for them, just one more petty
theft.
effect on the subjects' habitual mode of conduct.
While this is a reasonable basis
He thinks that most of the adoles-
He doubts whether this-single experience would have had any real
I agree with him by and large. However, none of us can guarantee that
there definitely would not be any increase in the probability
social conduct as a result of the boys' participation in the study. The
granting agencies' anxiety might be excessive; maybe they assumed that, say,
10 boys in 100 would have been affected by this experience where, let us
suppose, only less than one percent of the subjects would actually exhibit
a heightened likelihood of more thievery.
too much, especially considering the possible consequences? Do the conceiva-
ble benefits outweigh these possible costs? Who can say with any certainty?
of further anti-
Is not that small increment still
Now let me get back to the matter of the inaccurate predictions of the
outcome of the research. I have been arguing that even experts are often
unable to foretell the results of many behavioral science experiments be-
cause of the uncertainties and complexities
their thinking about behavior frequently
in human behavior and because
disregards human flexibility and
24-16
the force of situational influence.
and Zimbardo studies, the specialists had not anticipated the controversial
aspects of the research (as seen by later observers), probably partly because
they had slighted situational determinants. This failure might be regarded
as an error in favor of the investigators; they were, or would have been,
permitted to carry out their experiments. However, human experimentation
review panels are also susceptible to other kinds of errors that could act
against the researcher being allowed to conduct his investigation.
In the two examples I cited, the Milgram
What are the members of such a committee asked to do when they judge a
research proposal? At times they have to assess an experimental procedure
in light of fairly definite knowledge: will the subject be required to do
something that is illegal (such as smoke marijuana) or that might get him
into difficulty with legal authorities (for example, by admitting that he
has smoked marijuana often) or that is very likely to produce physical in-
jury (maybe by keeping his hand in ice cold water for too long a period of
time)? The judgments the Committee makes on the basis of this kind of know-
ledge rarely produce strong objections. Quarrels are much more apt to re-
sult, of course, when the review panel tries to estimate the stressfulness
of a particular experimental treatment on the basis of very imperfect know-
ledge and little, if any, prior experience with this technique. Here the
committee members have to make
situation and the action are quite ambiguous to them.
a behavioral prediction when the stimulus
Various biases can affect the panelists' forecasts. What is most rele-
vant to us, I think, is the influence of the judges' set. To a very considera-
ble extent our interpretation of an uncertain occurrence is greatly shaped by
24-17
the ideas that we happen to have in mind at the time (Bruner, 1957). Thus,
if a person has been exposed to a great many threats in the past, at a later
time he will be quick to interpret an ambiguous event as also threatening.
If he has been insulted frequently, he will be inclined to think that an
ambiguous encounter is one more insult. Behavioral scientists are not im-
mune from these perception-distorting biases.
testing often exaggerate the signs of psychopathology in a test protocol
(Cronbach, 1970).
may at times be overly sensitive to indications of abnormality and are
too ready to interpret a strange response as a sign of serious illness.
They make too much of what might actually be only a small and fairly unim-
portant detail.
Specialists in personality
Psychopathology is so much in their thoughts that they
I suggest that a similar phenomenon is apt to occur as a consequence of
repeated considerations of the risks in experimental research.
people have to assess the possible dangers in an experimental procedure, the
greater is the likelihood that ideas of threat and risk will be in their minds
when they evaluate any given proposal. And as a result, they may be overly
inclined to interpret an ambiguous experimental technique as a stressful one.
Here too, they may make too much of something.
human experimentation review panels?
creasingly cautious as they carry out their duties, is this because they have
become more sensitive to the actual hazards in the proposed investigations--
or have they become excessively preoccupied with ideas of danger so that they
quickly interpret an ambiguous procedure as "probably risky" and then exag-
The more often
Has this indeed happened to
If these committees are becoming in-
gerate the possible costs to the subjects?
24-18
Most discussions of the ethicality of human research have noted that
the investigator might well be a biased judge of the risks inherent in his
proposed study. As the Cook Committee observed in its report to the American
Psychological Association:
"The investigator should not trust his own objectivity in balancing the pros and cons of going ahead with research that raises an ethical question for him. His personal in- volvement tends to lead him to exaggerate the scientific merit of what he is about to do and to underestimate the costs to the research participant" (Cook et al., 1973, p. 12).
Yet the investigator is by no means the only one whose judgment can be biased.
Review committees can also have a tendency to err but in the opposite direction.
They may not want to be unfair to the researcher and may try hard to be dis-
passionate in their evaluation of his planned study. They are not motivated
to block his endeavors.
possible risks and see hazards that do not actually occur to the research
participants simply as a result of their committee work.
But still, they could become overly sensitized to
Without much hard evidence, I suspect that professional ethicists are
also likely to exhibit this oversensitization.
use of deceptions in social psychological experiments with friends at Wisconsin
who are philosophers of ethics I have been impressed with the way their weigh-
ing of the costs of the research does not seem to parallel the weights em-
ployed by our student subjects.
ing statements and subterfuges in research somewhat more harshly than do most
of our subjects; as I noted earlier, the great majority of our subjects ap-
parently view these deceptions as appropriate within the context of a scien-
tific experiment.
In my discussions about the
For one thing, they tend to regard mislead-
These ethicists are also inclined to see a possibly stress-
24-19
ful experimental technique as being harder on the subjects than do the sub-
jects themselves. Once, when I made this observation to an ethicist, he sug-
gested that the participants might feel intimidated by us, much the way poor
blacks in the Deep South have resented their treatment at the hands of whites
but were afraid to speak up. This analogy is quite imperfect, of course.
Blacks might have been reluctant to complain directly to whites but they still
expressed their feelings to each other. Psychology students do talk to each
other about experiments but we have never heard that they were annoyed by the
ruses and deceptions practiced on them. They occasionally complain about
what they think is an excessively boring and trivial investigation, but I have
not heard of student muttering about a stressful procedure that was reasonably
explained to them. All in all, some aspects of social psychological experi-
ments are evidently much more unpleasant to these particular philosophers (at
least) than to the young men and women who actually serve in the studies. Ethi-
cists are adept at analyzing the ethical issues in controversial problem situa-
tions.
exaggerate the costs of a given experiment to the participants.
Nonetheless, their training and experience might also cause them to
Who is in the best position to predict these costs? I do not believe that
the investigator should be ruled out altogether.
biased, he is usually also the person with the greatest amount
with the research procedure in question. If he has carried
dies in the past with the same techniques, he is more likely than the members
of the review committee to know whether his procedures actually do disturb the
participants.
ledge. Yet his judgments of the costs and benefits can admittedly be distorted
While his judgment could be
of experience
out similar stu-
Serious consideration should obviously be given to this know-
24-20
by his personal and professional desires. The best solution, it seems to me,
is to obtain reactions from observers drawn from the same population as the
research participants .
Various writers have also advanced this notion. The Cook Committee of
the APA implicitly argued that research evaluations should be obtained from
judges who are similar to the subjects when it discussed the reason why the
investigator's bias had to be corrected: The researcher "may be hindered
from seeing costs from the subject's point of view, because of differences
in age, economic and social background, intellectual orientation, and rela-
tionship to the project itself" (Cook et al., 1973, p. 12). As a result of
his experience with his simulated prison study, Zimbardo (1973) also con-
cluded that "students or representatives of the population being studied"
should be part of the institutional committee passing on the ethics of human
experimentation.
the use of representative samples would even permit evaluation committees to
estimate the percentage of research participants who would object to serving
in a given study:
Berscheid, Baron, Dermer and Libman (1 973) believed that
" ... draw a sample from the proposed subject population, present it with the full procedure to be followed in the experiment along with the purpose of the experimentation and determine the extent to which these subjects would be willing to participate in the experiment described ... From this 'role-playing-sampling' procedure, consent rates could be projected (Berscheid et al., 1973, p. 914).
for the subject population"
I would not care to follow Berscheid's recommendation to the letter.
strategy had to be carried out for every proposed investigation, research
would become much more expensive in money, time and effort.
If this
Moreover, how can
24-21
we establish an amount and intensity of consent that would be consistent and
yet reasonable for every study? Should an experiment be halted if five per-
cent object or four percent? What if ten percent of the participant sample
express misgivings but only tentatively? Is this better or worse than five
percent objecting strongly? Only a rigid and expensive bureaucracy could
deal consistently with these questions and the other problems that inevita-
bly would arise if every research proposal had to be screened by a sample
representing the research participants. Then too, as Berscheid and her assoc-
iates recognized (1973, p. 914), their recommended procedure is open to the
criticisms that have been lodged against role-playing techniques generally.
Let me digress for a moment to take up this particular matter for we
have here an issue that is closely associated with the attacks on deception
in psychological research.
to fool subjects in an experiment, as some writers have charged, what kinds
of investigations should be conducted? Kelman (1967), among others, offered
an answer. The researcher should not attempt to arouse the actual attitudi-
nal or emotional state that he wishes to study; this probably would require
subterfuges.
participants in which this psychological state is likely to exist and ask
them how they would behave.
situation rather than being actually exposed to the relevant condition.
the Berscheid procedure the participant samples are asked to play the role
of someone receiving a particular treatment and then indicate how they think
they would respond.
If it is ethically wrong and methodologically bad
Instead, he should merely describe a situation to his research
The subjects play the role of a person in that
In
24-22
Freedman (1969) has pointed out the shortcomings in this role-playing
technique.
mit they would act in a socially disapproved fashion even though many of them
actually do so at times. When he describes the Milgram obedience setting to
his students, none of them say they would administer the extremely severe
punishment demanded by the authority and yet a majority of Milgram's subjects
had compiled with the authority's dictates.
subjects can guess
Any time subtle factors or interactions are involved, any time actual be-
havior runs counter to what is considered socially desirable or acceptable,
guesses will probably tend to be wrong. But, most important, one can never
know ahead of time whether the guess is right or wrong until the people are
observed in the real situation ... The argument comes down to the simple
truth that data from role-playing studies consist of what some group sub-
jects guesses would be their reaction to a particular stimulus. The sub-
jects are giving their estimates, their intuitions, their insights, and
introspections about themselves or others.
and values of a society, these data would be useful.
how people actually behave, they are, at best, suggestive.
terested in people's intuitions, fine; if we are interested in their beha-
vior (other than guessing behavior), we must ordinarily use the experimental
method" (Freedman, 1969, pp. 110-111).
He noted, for one thing, that relatively few people care to ad-
It amounts to this: "sometimes
accurately how they would behave; sometimes they cannot.
If we are studying the myths
If we want to know
If we are in-
Several direct comparisons of the results obtained by role playing and
deception procedures have generally confirmed Freedman's observations (e.g.,
Willis & Willis, 1970). Sometimes people's estimates of how they would react
24-23
to a hypothetical situation faithfully mirror the behavioral of those in
the actual situation; they are familiar with this type of condition, are
aware of how they had responded in the past, and are not motivated to distort
their reports. At other times, however, the role-playing subjects' guesses
do not parallel actual behavior because they lack the requisite experience
and/or awareness, or are trying to present themselves in a favorable light
and this is easier to do in the role-playing than in the more spontaneous
experimental situation. In sum, we cannot be sure when the guesses are
right. We could not always tell whether the participant samples'
to the described situation accurately reflected the actual subjects' feel-
ings.
reactions
Than chances are, nevertheless, that judges drawn from the same popu-
lation as the research participants would offer better estimates of the
latters' reaction to the expertmental treatments than would others of a
dissimilar age and background. An institutional human subjects review
panel would be well-advised to obtain "input" from representatives of the
population being studied. Here too, though, I would recommend a fairly
frequent replacement of the panel membership . Just as those who are repeat-
edly engaged in assessing the risks in behavioral research might become over-
ly inclined to see hazards in the ambiguous research settings, so might the
participant-representatives become overly sensitized. With continued ex-
perience on the committee their ability to mirror the participant popula-
tion faithfully therefore declines--because of
cation as well as the possible hypersensitivity to possible risks.
their increased sophisti-
24-24
The thrust of my argument so far is that most criticisms of the ethi-
cality of human experimentation in the behavioral sciences are based on exag-
gerated fears. This does not mean that it is not necessary to obtain the in-
formed consent of the research participants before they are exposed to the
investigation. Together with practically every other behavioral researcher,
I subscribe to the statement made by the Cook Committee:
"The psychologist's ethical obligation to use people as research participants only if they give their informed consent rests on well-established traditions of research ethics and on strong rational grounds. The individual's human right of free choice requires that his decision to participate may be made in the light of adequate and accurate information" (Cook et al., 1973, p. 27).
The question is, what kind of information should be provided? As the APA
committee observed, "Ethical problems arise because the requirements of effec-
tive psychological research often conflict with the simple fulfillment of this
obligation to obtain informed consent." How can this conflict be resolved?
Indeed, is there any definite solution?
Let us begin this discussion with the time the investigator first encoun-
ters the research participants.
is obligated to inform his subjects that he is studying them.
problem here (for our present purposes) when the participants are volunteers.
They know they are in an investigation.
The initial question is whether the researcher
There is little
However, what if the researcher wants
to observe peope in naturalistic settings? Does he have to tell them of his
interest and purposes? As the Cook Committee observed, "the boundary between
drawing legitimately on one's everyday experience and spying is a narrow one.
Some critics feel that the
false pretences or with concealed observation is entirely out of bounds; others
investigator who invades private situations under
24-25
feel that there are problems and circumstances in regard to which it may be
warranted" (p. 32). I am in this latter group.
Suppose a sociologist was interested in the interactions among guests at
Let us say that he simply recorded his general impressions cocktail parties.
after each party he attended and then pulled his observations together some-
time later in an overall report.
this report.
bound to announce his research intentions every time he goes to a party.
quiring him to declare his purposes would also mean that every writer should
proclaim his professional role whenever he met other people. The writer,
like our sociologist, stores his impressions in his memory and then employs
these recollections in one way or another in a later story, article or book.
A novelist is basically no different from a sociologist in this regard even
if the latter tallied the frequency of certain acts and the novelist only
formed vague judgments of how frequently something was done. Both seek to
portray an aspect of social reality.
their intentions were when they entered a social situation.
he makes up stories or conveys a group's ideas, sooner or later will use his
experiences in some fashion in his work.
moment if they strike his fancy or seem important to him.
in the same vein, I do not think we can differentiate
gist and the writer when the portraits they draw are unfavorable to a parti-
cular group. A novelist does not have to identify himself to those he meets
even if he will eventually satirize their way of life, and the sociologist
None of the guests can be identified in
In this case I would say that the investigator is not ethically
Re-
Nor does it matter, I believe, what
A writer, whether
It may be the experiences of the
And continuing
between the sociolo-
24-26
does not have to say what he is doing although his report may have negative
things to say about people who go to cocktail parties.
Neither the present sociologist or novelist manipulate any
course of their observations. The problem becomes somewhat mor
when the investigation produces a substantial variation in the lives of the
participants. Sometimes this is unintended, but at other times the a
tion may be deliberate, as when a field experiment is conducted. The book
"When Prophecy Fails," by Festinger, Schachter and Riecken illustrates the
complexities in the former type of research.
of what happens after a failure to confirm a strongly held belief, the in-
vestigators sent several participant observers to join a group of persons
in a nearby community who predicted that the city would soon be inundated
by a flood.
recorded the group reactions. When the report was published the research
was criticized by at least one behavioral scientist (Smith) on ethical grounds;
by introducing other persons into the group who pretended they believed the
flood prediction, the researchers might have helped support the group's be-
lief. They therefore presumably exposed the members to a somewhat greater
shock when the expectation was not confirmed. Well, I cannot say that I
share the critic’s misgivings in this case. The group members were in danger
of scorn and disapproval even without the extra support introduced by the re-
search team. Further, the critic's point could question a good many partici-
pant-observation studies.
from this kind of research often outweigh the slight increment in costs pro-
duced by this type of unintentional variation.
In order to test their analysis
Needless to say, the catastrophe did not occur and the observers
From my perspective the gains that might result
24-27
But what about deliberate manipulations of the attitudes and feelings
of people who do not know they are in an experiment? The experiment of
Piliavin, Rodin and Piliavin (1969) is a good example. These researchers
wanted to investigate some of the conditions affecting the willingness to
aid a person in distress. Pursuing this aim, they staged a series of acci-
dents in a New York subway car, varying the race of the victim (white or
black) and whether he appeared to be drunk or a cripple. Certain naturally
occuring variations were also examined, such as the number of onlookers in
the car. More and more field experiments such as this one are being con-
ducted in social psychology, covering an ever wider range of research quer-
tions and settings.
Although, it is true that the research participants are being manipulated
by the investigators, they (a) are confronted by the kind of situation that
could easily occur naturally in their environment, and do not realize that
their attitudes are being operated upon. Moreover, (b) the ultimate goals
of this research are socially quite defensible.
These two points are fairly important, I believe. The first one means
I view most of these studies as legitimate enterprises.
that the participants will not have a feeling of being pushed around and will
have no reason to believe that their individual autonomy and dignity have
been violated.
they might normally encounter and their habitual modes of adaptation can
readily deal with whatever happens. They therefore should not suffer any
loss of self-esteem. No matter what they do, whether they help or do not
aid the victim in a Piliavin-type situation, their customary ways of think-
ing will tend to justify their action, and there is little likelihood that
For them, they are only facing the kind of life situation
24-28
they will be substantially affected.
are actually being manipulated, of course, and my second point is that the
social benefits that derive from the accumulation and dissemination of
scientific knowledge about human behavior are greater than this relatively
small cost.
However, the research participants
My argument, then, is that the people involved in most field experi-
ments do not have to be told that they are taking part in a study. This
is also scientifically desirable.
ment is very likely to produce a Hawthorne Effect. Many persons alter their
conduct when they think they are being watched, even if the observers are
researchers. They want to look good, gain the approval of the onlookers,
and so they are particularly apt to do the "right thing." Consequently,
their behavior may not be representative of how they would normally act in
this "real world" setting.
therefore lost to the investigator.
Informing them beforehand of the experi-
The advantages of the field experiment are
This reasoning obviously has implications for the debriefing procedure.
I suggest that if the participants do not realize they are in an experiment,
it is ordinarily unnecessary --and may even be undesirable-- to let them know
afterwards what had actually happened . My contention is that the staged
event will probably have only a fleeting impact on the subjects because
their ordinary defenses and ways of thinking enable them to adopt readily
to the occurrence. These defenses are directly confronted when the experi-
menter reveals what he had done to the participants.
riders in the Piliavin et al. study. How would they feel if the investiga-
Consider the subway
24-29
tors had explained their purposes? Those subjects who had aided the "victim"
might be pleased, of course; they had behaved in a socially approved fashion.
But, on the other hand, what about those who had not been helpful? By talk-
ing about the experiment, the researchers essentially tell these persons that
they had not acted properly. Their self-esteem could then suffer.
The reader might ask at this time, what is the difference between these
particular research participants and the subjects in a university psychology
experiment? Suppose the main features of the Piliavin study had been esta-
blished under the laboratory conditions (and this has actually been done many
times), and a subject fails to assist the individual in need. Would he not
also experience a blow to his ego at learning afterwards that he had not acted
in a socially responsible manner? How can we justify the post-experimental
explanation for him, and even say that this explanation is obligatory, while
recommending no debriefing for those taking part in most field experiments?
The major difference, it seems to me, is that the laboratory subject
knows he has responded to some experimental treatment. He is owed at least
an account of the investigation in order to justify whatever coercion or pres-
sure he felt in taking part in the study and to lessen whatever stress he
might have experienced. The debriefing might not eliminate the ill-effects
of the experiment altogether. There might even be a small chance that the
researcher's revelation will wound the subject by pointing up his "bad" or
undesirable behavior.
his sense of autonomy.
ing of independence, it is not necessary to expose them to the possible hazards
Yet we should take this risk in order to help restore
If the research participants had not lost this feel-
24-30
of the post-experimental explanation. They do not have to regain something
they have not lost.
Of course, there are times when the participants in field experiments
should be given the same kind of careful debriefing provided to the laboratory
subjects.
participants had been upset, disturbed or otherwise emotionally aroused by
the experimental procedure. There are very complex considerations and I be-
lieve this section is best concluded with some comments made by the APA's
Cook Committee:
In general, this is when there is some kind of indication that the
"When the man in the street becomes an unwitting partici- pant in research, realism has been combined with experi- mental control, but sometimes at considerable ethical cost. Informed consent is impossible. In the least questionable cases neither the anonymity nor the personal dignity of the participant is violated, and patience is only trivially imposed upon. But offenses to human dignity are readily imaginable in this sort of experimentation. As such pro- cedures become more numerous in an effort to obtain infor- mation about important social issues, there is reason to fear their cumulative effect ... such research can be con- sidered only with misgivings ... ." (Cook et al., 1973, p. 33).
Moving on to consider another aspect of the investigator's dealings with
the research participants, we now come, finally, to the matter of information
about people's discomforts. Virtually everyone is agreed that it is desira-
ble to tell the potential subjects what will happen to them at the time their
cooperatton is being solicited. They should know what they will be getting
into.
of any attendant discomforts and risks reasonably to be expected," while the
HEW regulations stipulate that informed consent requires "a description
APA list of ethical principles includes this statement:
24-31
"Ethical practice requires the investigator to inform the participant of all features of the research that reasonably might be expected to influence willingness to participate ... " (Cook et al., 1973, p. 29).
Here too, however, a conflict can arise between this very reasonable, easily
understandable principle and the scientific requirements of the research.
One problem is that the potential participants might be frightened unduly.
In another background paper to the National Commission, Robert J. Levine cites
overdisclosure:
an experiment by Epstein and Lasagna which documents some of the perils of
"They presented consent forms of various lengths and thoroughness to prospective subjects of a drug study. They found that the more detail was included the more likely were the prospective subjects to be either con- fused or intimidated" (pp. 17-18).
Could it be that the great emphasis on the possible ill-effects of the drug
produced the same kind of overweighing of conceivable dangers that I discussed
earlier? Just as personality testers sometimes give excessive attention to
faint signs of psychopathology in a test protocol, the Epstein and Lasagna
subjects might have exaggerated the hazards in taking the drug because their
attention was focused almost exclusively on these possible risks. In much
the same way, a behavioral scientist could arouse much too much anxiety in
his potential subjects by over emphasizing the conceivable sources of discom-
fort in his investigation.
wrong, he causes them to "accentuate the negative."
By enumerating everything that might possibly go
Another problem (from the researcher’s perspective) is that complete in-
formation about every possible source of unhappiness could lessen the effec-
tiveness of the experimental treatment. If the prospective participant was
24-32
told about every feature of the research that might influence his willingness
to participate, it would be difficult (if not even impossible) to carry out
some kinds of experiments. Researchers would probably be unable to examine
experimentally the consequences of anger or anxiety arousal. Following the
APA's ethical principle to the letter, the potential subjects would have to
be informed that, say, they might be frightened (or upset or emotionally
aroused) in the course of the study. After all, this information could
"reasonably" affect their willingness to be in the investigation. But ob-
viously, if the subjects had this knowledge and agreed to participate, it
would be exceedingly difficult to create the appropriate feelings within
them.
ment.
Being forewarned, they are forearmed against the experimental treat-
In my view this particular principle should serve as a general guideline
rather than as a strict rule. The Cook Committee clearly recognized this.
After presenting the principle we are now discussing, this committee then
went on to say:
"When the methodological requirements of a study neces- sitate concealment or deception, the investigator is re- quired to ensure the participant's understanding of the reasons for this action ... " (p. 29).
In other words, the post-experimental debriefing could compensate considerably
for the lack of full disclosure at the time the subject's consent is obtained.
From where I stand an appropriate compromise is to explicitly mention
each possible source of physical discomfort (e.g., that electric shocks may
be employed in the study) when the pre-experimental information is given,
but not say anything at this time about the psychological manipulations
24-33
that will be carried out.
the investigator should also emphasize that the subject is free to withdraw
from the study at any time he wishes with full payment or credit and without
jeopardizing his relationship with the researcher or institution.
However, and I think this is exceedingly important,
The reader's values obviously will determine his reaction to this kind
of compromise or, for that matter, his response to the general trend of com-
ments in this paper. By and large, those with a strong humanistic orienta-
tion will be especially repelled by the idea that our research participants
are often exposed to psychological stresses or even that the subjects' atti-
tudes and feelings are being manipulated without their fully informed con-
sent. I do not mean to question the desire to preserve individual dignity
and autonomy,
science can contribute to the preservation and strengthening of these values.
People are being manipulated every day by forces outside of their control
and often to their personal detriment. The development and dissemination
of behavioral science knowledge can lead to a greater awareness of these
influences and the steps that might be taken to counteract them. A sound
behavioral science can help uncover the truth about determinants of human
conduct, and as in other domains of life, the truth can make us free.
I do believe, nevertheless, that the advance of behavioral
24-34
25
SELECTED ISSUES IN INFORMED CONSENT AND CONFIDENTIALITY
WITH SPECIAL REFERENCE TO BEHAVIORAL/SOCIAL
SCIENCE RESEARCH/INQUIRY
Albert Reiss, Jr., Ph.D.
February 1, 1976
I. INTRODUCTION
This essay explores what Edward Shils calls the confrontation of
autonomy and privacy by a free intellectual curiosity (1959:121). It
does so by examining how institutions of consent and confidentiality are
organized in behavioral science inquiry. Their role in regulating the ac-
quisition, processing, and dissemination of knowledge is its major concern.
Regulations instituted by the Federal Government for implementation by
agents who sponsor or undertake sponsored inquiry are reviewed for the
issues they present for behavioral science inquiry.
given to analyzing the Code of Federal Regulations for the protection of
Special attention is
human subjects in research, development, and related activities supported
by Department of Health, Education, and Welfare grants and contracts
(45 CFR 46), the proposed code of regulations governing the confidentiality
of individually identifiable research and statistical information collected
under. Law Enforcement Assistance grant program (28 CFR 22), and the proposed
code of regulations to protect the privacy of research subjects by with-
holding from all persons not connected with the research the names and other
identifying characteristics of such subjects in research on mental health
sponsored by the Department of Health, Education, and Welfare (42 CFR 2a).
The Problem Setting
The behavioral scientist's access to information is limited by important
proprietary rights in information and individual and collective rights to
secrecy and privacy. Governments assert rights to keep secret or confiden-
tial information to protect national security and the deliberative processes
of executive, legislative, and judicial agencies, and information on individ-
uals or collectivities to which it is privy to insure their privacy and
25-1
protect their proprietary rights.
as professions and voluntary bodies have legally guaranteed proprietary
rights to information to protect the autonomy of the organization and their
clients' right to privacy. There are, similarly, proprietary interests for
private persons and a right to security of private personal expression and
affairs (Warren and Brandeis, 1890; Pound, 1915:343).
Corporations and other collectivites such
In a free and open society, these proprietary interests and private
rights confront public rights and claims to information.
in the public interest, depends upon both law and custom, including the
customs of a scholarly community, and its interpretation in any given case
as to what is public and what is privileged.
and the Freedom of Information Act among others define rights and privileges
in information and access to information.
What is available
The federal Privacy Act
The behavioral scientist's access to information is normatively a matter
of right to information that is public and a matter of consent where it is
1 proprietary, private, or privileged. How to regulate the acquisition,
processing, and dissemination of information is especially problematic in
a free and open society. At the present time regulation is in a state of
flux. Some recent federal and state laws make the information of public
bodies more accessible to inquiry while at the same time information for
private organizations and persons is subject to more legal, ethical, and
organizational regulation to protect proprietary rights in information and
corporate and individual rights to privacy.
ship of scientific investigators and their sources of information is both
subject to growing regulation in the interest of protecting the rights and
integrity of those sources and jeopardy by the inability of investigators
to resist efforts to break confidences or to control their misuse. Tradi-
The customary fiducial relation-
25-2
tionally investigators guaranteed their sources of information the protection
of confidentiality but the growth of legal challenges to their right to
confidentiality threatens the foundation of their fiducial obligation.
what follows some issues and problems in obtaining information through a
fiducial relationship of consent and confidentiality are explored and
ethical, legal, and organizational forms of regulation to protect proprietary
rights in information, corporate and individual rights to privacy, and the
privileges of investigators in behavioral science research are examined.
Both trust and privilege are paradoxically elements in maintaining scientific
inquiry in a free and open society.
In
Right to Privacy
The "right to individual privacy" has its roots in the common law
(Warren and Brandeis, 1890) and it has gradually been extended to corporate
bodies in one form or another.
concept embracing several related concerns such as the right of individuals
(1) to be "left alone," (2) to be secure from intrusion into private affairs
by unwarranted means, and (3) to he secure against unauthorized entry into
one's domicile or private place. The right extends also to proprietary
interests in intellectual property such as trade secrets, original work
subject to patent or copyright, and the like. Each of these rights may be
intruded upon by behavioral science inquiry.
defined or recognized.
the entry of a research observer with a police officer into the domicile of
a private citizen a "lawful entry"?
including such 'private conversations' as may take place during the meeting,
an intrusion by unwarranted means?
The "right to privacy" is a complex legal
Transgressions are not easily
Worth pondering are questions such as these: (1) is
(2) is the recording of a public meeting,
(3) is privacy respected when one has
25-3
the consent of an employer to secure information from the personnel records
before information on identity of the employee is removed?
At law, the privacy of another is invaded when there is an unreasonable
interference in making public any affairs that a person wishes to remain
private. A social research investigator invades privacy when he is respon-
sible for public disclosure of private facts or when such public disclosure
puts another in a derogatory light before the public (Goldstein, 1969:423).
A proposed revision of the law of torts prepared by the American Law Institute
broadens considerably the concept of invasion of privacy to include " . . .
one who intentionally intrudes physically or otherwise, upon the solitude or
seclusion of another or his private affairs or concerns . . . if the intrusion
would be highly offensive to a reasonable man" (1969:418).
Lerman note (1971:1126) intrusion upon solitude may occur when social scientists
make unobtrusive observations and the identity of those observed becomes known.
Whenever consent is lacking as an element in securing information on private
matters, the investigator risks invading the privacy of others, even when
that information is secured in public settings.
on the capacity of investigators to keep private information from becoming
public knowledge.
As Nejelski and
Much may depend, of course,
In much, though not all, behavioral science research, there is some
intrusion upon the privacy of others, seem it ever so slight.
fact that research investigators have a legal liability to suit for invasion
of privacy, ethical values constrain the intrusion upon privacy without
recourse to consent or some appeal to a priority of values.
examine below some of the principal criteria invoked to justify intrusion into
private affairs.
Apart from the
We shall briefly
The typical criterion invoked is that intrusion on privacy is justified
25-4
in the interest of developing new knowledge or scientific knowledge.
criterion of "developing new knowledge" is of little utility since all knowl-
edge is in some sense "new."
voking the criterion of contribution to "scientific knowledge."
to qualify as scientific knowledge, the study design should meet at least
minimal criteria of scientific method. The criterion of scientific or
methodological merit of the research design may be unduly restrictive on
scientific exploration, however. Much exploratory social research, par-
ticularly that by participant observation, might fail by methodological
criteria.
is justifiable, absent a formal design of scientific merit, merits careful
consideration.
The
Perhaps one is on somewhat firmer grounds in-
Ordinarily
The issue as to whether exploratory research into private matters
Apart from the simple intrusion into the seclusion of others, intrusion
occurs in obtaining information on the private matters of specific identifiable
individuals. The degree to which the investigator designs instruments that
define in advance these private matters affects the extent to which one can
test whether the intrusion is warranted in the interest of new or scientific
knowledge.
the more one is likely to probe for additional information; and, the more one
searches for the "confidential," the more likely one is to intrude upon matters
that are purely personal and private and perhaps more potentially damaging
to subjects or corporate bodies. 2
search for the "hidden agenda," the "latent attitudes," the evidence for
deviance or corruption is clear from many studies.
utilizing techniques of investigation that deliberately search for these
intrusions is not commonly dealt with in reports of such intrusions; yet they
merit careful consideration.
The more unplanned and diffuse the intrusion into private matters,
That behavioral scientists may deliberately
The responsibility for
25-5
Where the intrusion is planned, careful consideration must be given to
the trade-offs between the relative degree and cost of intrusion into the
privacy of others and the gains from it.
questions about drug use, for whom one voted in the last election, or one's
income? What will happen to the response rate if just prior to asking the
question one advises the respondent of freedom not to answer the question?
How much of a "no response" or refusal rate, or of what is called error in
reporting, stems from the respondent's belief that it is a private matter
and of no concern to the investigator?
answering if one is to intrude upon the privacy of others.
time judgments about the relative privacy of matters cannot be scaled
precisely and compared with judgments about the net worth of gaining that
information.
to a "reasonable man" or an empirical criterion such as the percent of sub-
jects objecting to the asking of, or responding to, a particular question,
differences in the relative privacy of matters are determinable.
determination of the net worth of undertaking a particular investigation may
be a more difficult task, though such judgments are commonly made in rating
research proposals for financial support. What remains problematic, how-
ever, for those who advance this criterion, is what criteria shall govern
decisions to undertake research once the cost of intrusion into privacy and
the net worth of the knowledge have been established.
On what grounds does one justify
These seem like questions worth
At the present
Yet whether one uses the legal criterion of objectionable
The
Alternatively, some investigators invoke the criterion that intrusion
on privacy is justified when the knowledge is necessary to matters of public
importance or interest.
about birth control, abortions, and unwanted pregnancies as essential to the
formation of population policies.
One is justified, for example, in asking questions
A difficulty with this criterion is that
25-6
so long as an investigator determines what is in the public interest, there
can be obvious contamination of judgment.
clear decision criteria for making judgments based on relating the relative
public importance of matters to the relative costs of intruding into private
matters.
In any case, there again are no
Consent. The criterion most commonly invoked by scientists to intrude
upon privacy is that intrusion into private matters is justified for scientific
inquiry when consent is secured for access to these matters.
of this criterion raises questions about who shall secure consent from whom,
how, and with what anticipated consequences from participation. The institu-
tional doctrine that derives from an answer to these questions is that of
informed consent. Consent " . . . concerns the conditions under which informa-
tion is obtained from a person" (Ruebhausen and Brim, 1965:1197); it is an
affirmative agreement by free choice to provide information under stated or
agreed upon conditions.
senting must be able to predict reasonably well from a description of the
procedure to be used in acquiring information and from such other information
as is provided what information will be sought and what risks or benefits will
follow from participation, given only the information provided at the time
consent is initially requested. Formally, informed consent is an agreement
that satisfies the conditions of an enforcable contract. The definition of
informed consent currently operative in the regulations that are applicable
to all Department of Health, Education, and Welfare grants and contracts sup-
porting research, development, and related activities in which human subjects
are involved follows (45 CFR 46.3):
Clarification
For consent to be informed means that anyone con-
"Informed consent" means the knowing consent of an 'individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or any other form of con-
25-7
straint or coercion. to such consent are:
their purposes, including identification of any procedures which are experimental;
reasonably to be expected;
The basic elements of information necessary
(1) A fair explanation of the procedures to be followed, and
(2) a description of any attendant discomforts and risks
(3) a description of any benefits reasonably to be expected; (4) a disclosure of any appropriate alternative procedures
(5) an offer to answer any inquiries concerning the procedures;
(6) an instruction that the person is free to withdraw his
that might be advantageous for the subject;
and
consent and to discontinue participation in the project at any time without prejudice to the subject.
Each of these elements of informed consent is examined in Section II below,
particularly as each bears upon behavioral science research.
Confidentiality. Issues in informed consent in behavior science research
cannot be discussed fully without reference to the question of the private
or confidential nature of much information and its protection.
tiality refers to " . . . the conditions under which the information is used."
(Ruebhausen and Brim, 1965:1197); it involves an obligation to keep private
matters confidential and free from public disclosure unless there is consent
from the private party to do so or some overriding collective interest to
make such matters public.
of informed consent is inextricably interwoven with the confidentiality of
information and its protection.
Confiden-
There are other reasons, however, why the matter
First, an element in informed consent is to apprise the party from whom
consent is sought of any risks involved from participation in the research.
It is commonly the case in behavioral science inquiry that there is little
harm in the procedure for acquiring information but that when harm arises
it does so from the public disclosure of private or confidential matters
that were communicated as a confidence. A fiducial relationship is at stake.
Once an investigator acquires any information for social research that can
25-8
cause harm, as a party to that information, he is potentially an agent for
doing harm. Where protection of confidential information cannot reasonably
be guaranteed, an element in informed consent should be to advise that there
is some risk of disclosure provided there is no adequate legal protection.
It indeed can be argued that to provide adequate protection in behavioral
science inquiry where information is acquired on private matters and there
is no legal protection or sanctions against compelled or unauthorized dis-
closure, it should be mandatory to inform the person from whom information
is sought in a manner akin to that of a Miranda warning:
you that you have a right to refuse to participate or to answer any query
put to you since anything you say or do can cause you harm for I cannot
legally protect any of the information that you disclose to me, including
the fact that you were a participant in this study."
"I must advise
Second, there are risks even for the parties who refuse to participate
in a particular behavioral science or bio-medical study should the investigator
be legally compelled to publically disclose that fact of refusal or if it
otherwise becomes public knowledge. Consider making public a list of persons
who refused to participate in a study of "former patients in a drug addiction
center," a study of "homosexual networks," or a project studying "persons
discharged by their employer." Might not such disclosure cause considerable
damage to reputation and substantially risk future opportunities and benefits
as well for those who refused?
about approaching persons for their consent when even the knowledge of that
approach is potentially harmful.
A particularly thorny problem thus is raised
No Miranda type warning will suffice in such
protection of informed a situation. Where confidentiality is an issue, any
consent is insufficient when public disclosure of refusal is harmful.
Third, where confidentiality must be maintained to protect the parties
25-9
from whom information is obtained, the requirement that one advise of the
risks that might reasonably be expected may prove unusually burdensome.
This is so for a number of related reasons. Often one lacks sufficient
knowledge about subjects and what might prove damaging to them on disclosure.
Although persons have a right to refuse information, if they have not done
so, it may be a consequence of their difficulty in predicting the consequences
of that disclosure--particularly in the prototype situations for eliciting
information in behavioral science inquiry.
tion on how the information they seek might easily turn out to be harmful,
since there is no established knowledge in the matter and they are far from
omnipotent. Moreover, whether individuals or collectivities are the object
of inquiry, particular outcomes cannot be promised in many instances with
any high degree of validity and reliability.
an "informed guess."
Investigators often lack informa-
At best one often makes only
Finally, behavioral science research occurs in diverse settings that
are at best characterized as "uncontrolled" research settings.
or their agents often must enter settings over which they have little direct
control and usually limited indirect control.
a private place where others are present and the rounds of social life go
on.
consequence of a research procedure, information often is acquired that was
not-intended as part of the designed inquiry.
be potentially harmful to the person who granted consent for a particular
study is quite obvious.
become privy to the matter should be equally obvious.
all information that is inquired apart from the research design set forth in
securing informed consent is to increase the risk or harm to any participant
Investigators
Indeed, often they may enter
As a result of being admitted to private places or as an unintended
That such information could
That the investigator often may not have wanted to
Yet to leave unprotected
25-10
in a research project.
protected the private utterances of patients being observed for post-operative
procedure may similarly increase their risk.
to in a research role is, with few exceptions such as the commission of a
henious crime, protected, informed consent should include the advice that
anything that is unrelated to the research inquiry which is said or that
occurs in the presence of the (outside) investigator can be used against
them.
clear, but it is
Unable to either forecast what will be covered by the research design or to
fully comprehend that which is and is not in a particular instance covered
by the research mandate. the best advice one should give prospective
participants perhaps is to refuse to participate if for any reason the
participant expects that any confidential information will be secured that
may be harmful.
that others who are not connected with the research process may decide what
was not part of the inquiry and that all parties are unprotected in such
matters. Without protection for confidential or private matters that are
acquired apart from the intent of the research then, investigators should
not only make judgments about the likelihood potentially damaging informa-
tion might be acquired through their particular design or from the nature of
their research settings but in any case they should advise parties they are
so unprotected.
Parenthetically, one might note that to leave un-
Unless what one becomes party
The dilemma this creates for all parties to the research should be
particularly critical for the informants or participants.
But, in any case all parties should be aware of the fact
There is inevitably some risk that investigators may take undue ad-
vantage of any protection for all information secured from and about parties
to a research inquiry.
inquiry.
They may, for instance, use it for unauthorized
Such possibilities exist, but they seem hardly an argument for
25-11
leaving participants unprotected, particularly when they often do not
volunteer for research but are approached for their participation.
For these reasons then, we consider both separately and together
matters of consent and confidentiality and their regulation.
so we shall consider the main model that underlies the regulation of research
by the Department of Health, Education, and Welfare.
Before doing
The Human Subject Model. Much of the writing on regulating the ac-
quisition, processing, and dissemination of knowledge is based on an ele-
mentary model of a principal investigator--commonly referred to as PI--
acting upon or intervening in the life of a subject--commonly referred to
as S.
in regulating bio-medical research. Our interest in this model here lies in
the fact that it also underlies the Code of Federal Regulations for research
grants and contracts of the Department of Health, Education, and Welfare
that might be undertaken by behavioral scientists (45 CFR 46). Although
understanding this elementary model is useful in articulating other models
of inquiry, it oversimplifies problems and issues in informed consent and
confidentiality in behavioral science investigations and for that matter,
much bio-medical research as well.
an oversimplification for stating rules to protect human subjects and main-
tain free inquiry for a number of reasons.
We shall speak of this as the Human Subject Model; it is the prototype
The Human Subject model of research is
Much research is undertaken by a team or organization where a fairly
large number of employees as well as investigators acquire and have access
to information regarded as confidential. The principal investigator often
may acquire none of the data, relying upon others to do so, and often operates
primarily in the roles of administrator of the research and principal analyst.
Frequently in social research, moreover, the object of the inquiry is an
25-12
integral social group, organization, or collectivity rather than a person
as subject.
rather than direct inquiry or from confidential records (Goldstein, 1969:
417-37). Consent for access to confidential information may be sought from
administrators of records or from parties other than those who are the
original source of information.
systematic observation of natural social phenomena where the consent of the
observed is not regarded as problematic.
quiring and storing information and computer storage and processing both
facilitate and complicate problems of identification and access to informa-
tion.
Confidential information frequently is obtained by indirect
A growing number of studies depend upon
Visual and audio methods of ac-
Suffice it to say then, that the roles and parties to research do not
conform to the elementary model of a one-to-one investigator and subject
relationship.
is the sample survey. In the sample survey sampling statisticians select
addresses of respondents who are then approached for interview by persons
who are not subject to immediate supervision. The work product of inter-
viewers is reviewed by a supervisor who may also make direct inquiry of the
respondents to verify information and audit interviewer conduct.
information in turn is transmitted to a field office where confidential
information may be processed by coders and analysts before identification
is removed.
in a chain that ends with the preparation and dissemination of research
reports. Some, if not all, of these specialists may need to have access to
confidential information that identifies private parties.
in a survey who consent to participate by being interviewed could readily com-
prehend or become aware of this chain of accessibility to their confidence.
The prototype model for behavioral science research perhaps
This
Still others will prepare the data for computation and analysis
Few respondents
25-13
That principal investigators can guarantee confidentiality under these
circumstances is open to question. What is remarkable perhaps is how
little evidence there is that such trust and confidence is misused or
broken.
Other models exist in behavioral science research where the Human
Subject model is a gross oversimplification. Some of these are considered
later such as that for the systematic observation of behavior patterns and
interactions, the study of organizational behavior--including organizational
processes of regulation--, and the quasi-experiment in natural social settings.
Without explicating each of these models here, we simply ask the reader to
bear in mind that some of the issues and problems that arise in applying
current federal regulations of behavioral science research derive from their
conceptualization in terms of the elementary Human Subject model.
II. INFORMED CONSENT
Informed consent is said to involve " . . . the knowing consent of an
individual or his legally authorized representative, so situated as to be
able to exercise free power of choice without undue? inducement or any element
of force, fraud, deceit, duress, or other form of constraint or coercion"
(45 CFR 46.3).
Conditions of Consent. A strict construction of this definition would
make it mandatory for any Institutional Review Board "to decline approval for
any proposal where there is either any "undue inducement . . . or other form
of constraint . . ." or "any element (italics mine) of force, fraud, deceit,
duress, or other form of . . . coercion." From a behavioral science perspective,
many research studies could not qualify for approval under a strict construction.
25-14
We shall try to explain why this is so.
Criterion of Undue Inducements. At issue in the matter of undue in-
ducements is whether inducements have an effect on choice so as to make it
"not free." To a behavioral scientist, of course, this is in itself an
empirical question rather than a matter of "informed judgment" and it is
well recognized that each of the terms--undue, inducement, free, and choice--
can be operationalized in different ways for scientific investigation. Just
when inducements become an "undue" element influencing choice would probably
not be altogether evident in any empirical investigation of the relationships
between inducements and choice.
whether and when subject payments for participation in an experiment or
other scientific investigation constitute an "undue inducement."
expect that members of a population would vary considerably in whether a
given payment had a substantial effect on inducing them to participate.
Perhaps the poorer one is, the more likely one is to opt for a given payment
when one would otherwise have refused.
the unemployed may be more susceptible to any sum becoming a sufficient
inducement to bring participation.
ficult to measure.
people, most of the time, will participate when there is only a simple
request to do so and at the conclusion of the inquiry will express satisfac-
tion in having done so.
willingness to participate in a given kind of research without any inducement--
whatever that might be--and their willingness to participate only under a
given level of inducement. To substitute judgment for empirical inquiry in
such matters seems a dubious requirement since it will tend to lead to con-
ventions about inducements that are false, with errors in both directions.
Consider but one example, the question of
One would
The very young, the very old, and
Yet the matter is complicated and dif-
For a good many kinds of behavioral science studies most
It will take a complex design to ferret out the
25-15
That is, some inducements will be tabooed on grounds that they are "undue"
when in fact they are not while others will be approved as not being "undue,"
when in fact they are. Moreover, under a strict construction, one is barred
from examining the question of the effect of inducements on choice to
participate in a given kind of scientific study, since one is prohibited
from offering "undue inducements": they are mala prohibita if not mala in se.
Money is only one class of inducements that might have an effect on
There are many other forms of inducement or reward that vary in choice.
the extent to which their effects are definable and measurable.
offers of feedback concerning skills or personality, and opportunities to
develop skills or secure new information can be forms of inducement that at
least for some subjects may unduly influence their choice.
Prestige,
The form of inducements can be subtle and indirect, particularly when
peer or group interests and pressures combine in a consent procedure.
simple example may illustrate some dilemmas and contradictions in approving
a consent procedure. Consider the approval of an experiment of the effects
of inducements on the rate of learning.
individual and aggregate rewards for increments in the rate of learning.
The consent of parents must be secured for the student to participate in the
experiment. The school administration prefers that all students participate
in the experiment as does the investigator.
the parents directly than to do so via their children, so the latter mode of
contact for seeking consent is approved. Moreover, it is fairly well known
that the rate of return of consent forms is affected by factors other than
the willingness of the parent to grant consent.
whereby the parent is asked to sign the form only if they disapprove of
participation (an approved modification of the written consent provision).
A
The experiment provides for both
It is more costly to contact
Thus a procedure is approved
25-16
Apart from questions about whether this procedure balances consent
unduly in favor of the sponsors of the research, which it well might, other
indirect inducements may be operating.
participation in the study--even added to the proferred inducements, the
study, for example, provides an opportunity to be free of the daily routine.
Under the approved procedure, some students would never show the form to
their parents or, if the consent of both parents is not required, select the
parent who is most amenable to their persuasion. Moreover, most parents may
well sign without a careful reading; they succumb in the moment to the re-
quest for a signature--"you've got to sign this, so I can take this test."
Indeed, only empirical inquiry can shed light on how parent consent
procedures work. We know very little about them, if for no other reason than
that the behavioral science community, like any community, may opt for "func-
tional ignorance."
of inducements on consent and unless review boards are vigilant in searching
for indirect as well as direct forms of inducement, considerable "error"
will attend the decisions about inducements.
Suppose one's peers encourage
Unless approval is forthcoming for studying the effect
Criterion of Coercion: Force, Fraud, Deceit, Duress. Institutional
Review Boards are required under the strict construction to disapprove any
research project where there is any element of coercion by force, fraud,
deceit, duress, or other means. Except for research designs that require
deception in soliciting consent, the direct use of force, fraud, or duress
by investigators in soliciting consent is uncommon. There are, however, some-
what more studies where force or duress is an element that may affect the
continuing grant of consent during the inquiry by applying pressure against
withdrawal. Again such forms of force and duress are less likely to be direct
manipulations by investigators than consequences of the procedure or of the
25-17
very phenomenon that is under investigation.
Zimbardo (
operating before and during the inquiry because the elements of coercion
and duress were themselves objects of investigation.
The Milgram ( ) and
) experiments are but obvious examples of such elements
Yet it is the less obvious sources that pose difficulty for Institu-
tional Review Boards in behavioral science inquiry, particularly if one is
careful to insure that there is freedom not only to enter the research
relationship but to refuse to respond to specific inquiries for information
and to terminate at any time the relationship altogether.
well be stages in processes of social engagement and disengagement.
committed by the initial consent procedure, fiducial relationships are
not easily broken.
refusal to answer or termination of consent--an interesting moral dilemma--
or one may give truthful answers that would not be given were it not for the
"threshold
These may very
Once
A person may prefer deliberate deceit in reply over a
problems" in breaking a fiducial relationship.
It is reasonably well established that groups have considerable
power over their membership by legitimating foms of coercion or duress.
These very elements may be incorporated as features in a study design, either
procedurally or as objects of inquiry.
of decision problems that might arise for Institutional Review Boards:
A few examples may illustrate the kinds
(1) Using Group Techniques. Many forms of group therapy or change
depend upon group processes where force and duress are elements of group
process. Such techniques are also used simply to acquire information on
group processes.
of any member's wish to withdraw are particularly common.
evident, for example, in the use of Tavistock than NTL, group techniques but
often arise in group settings as a consequence of the procedural mode of
Coercive pressures from the group to continue in the face
They are more
25-18
inquiry or the study design.
advance, and consent is given, the experience
a substantial effect on the choice to withdraw.
Even where the procedure is described in
under group pressure may have
(2) Using Contract to Secure Information. While the elements of
contract may be present in many consent procedures, e.g., paying subjects
to participate or offering some other benefit directly to the participant,
under certain circumstances formal contract is an element in behavioral
science research. This is not uncommonly the case in evaluation research
of government programs where federal legislation and policy makes funding
contingent upon agreement to outside evaluation.
choice to withdraw is constrained by formal contract and indeed the cost of
doing so may be coercive in continuing participation.
being evaluated
as a condition of employment in the program.
requirements for participation, the element of free choice to participate
and withdraw may inevitably be compromised. The need to evaluate federal
programs given their costs and consequences may be deemed compelling in the
resort to contract. Perhaps some guidelines for the use of formal contract
for organizations and their agents is necessary to guide the discretionary
choices of Institutional Review Boards.
Under these conditions the
Employees of programs
may similarly contract for participation in the evaluation
Where formal contract governs
(3) Using Organizational Sponsorship and Participation. Parties
providing information on private matters or in their organizational roles--
as officials, clients,
that their failure to participate in no way jeopardizes them or their af-
filiative relationship. The condition is not easily satisfied. Is there
no element of coercion when
research? when anyone superior in a hierarchy of authority asks an inferior
agents, or employees--must be given to understand
students in courses are asked to participate in
25-19
to participate?
participate precedes the request for consent from individual participants?
Whenever an organization stands to benefit from feedback generated in a
behavioral science inquiry, it has an incentive to agree to and encourage
participation from its members. When is encouragement not coercion?
Equally important to the understanding of the effects of organizational power
on member participation, is the question of whether there are ways of
eliminating all effects of organizational power.
reduce such effects when present but their elimination, as the strict
construction implies, seems doubtful.
can minimize the effects of teacher power over students and still have them
participate in teacher sponsored research, in each case there is still the
possibility that residual elements of coercion exist.
when an organizational decision or formal agreement to
It seems possible to
Thus, while I know of ways that I
Apart from the direct effect of organizational sponsorship and participa-
tion on the consent of members, there may be indirect effects of organiza-
tional power in the form of legitimated authority or power.
been observed that surveys under government auspices and administration have
response rates well above those of private organizations.
common belief that this is partly owing to the incremental affect of govern-
ment authority as a prestigeful and legitimate source obligating, compliance
or to the effect of coercive anxiety that failure to comply might jeopardize
other relations with or benefits from government agencies, it is difficult
to disentagle any such effects from one another and from other possible
effects such as differences in the training of survey interviewers, of
organizational resources, and so on. Whether Institutional Review Boards
should approve all forms of legitimating auspices that may have coercive or
inducement effects is problematic; even its own institution may nave
It has often
While there is a
25-20
legitimating properties that affect participation.
(4) Using Particular Methods for Eliciting Information. Methods for
eliciting infomation must be free of all elements of coercion and any un-
due inducement if there is to be free choice in providing information.
There is considerable variation in techniques for eliciting information
and the conditions for complying with the task of providing information.
They must vary considerably in their coercive features; little is known
about this variation from past research. One wonders, for example, whether
there would be differences in responding to a typical survey question on
private matters if options were routinely given to respond that it is
a private matter.
about how much falsification there is in responses to interview or test
questions about private matters because respondents feel too embarassed or
constrained to say that it is "nobody's business" or that because the
information is requested, they wish to withdraw their consent to continue
in the survey.
Again, it should be noted that we know all too little
There are other and perhaps more subtle ways that procedures for
eliciting information coerce or constrain responses.
trained to induce "cooperation," develop "rapport," or lead into a sensitive
area of privacy.
of such information; ways of indirectly measuring such responses are not
uncommon.
udiced towards members of a particular minority or have discriminated against
them in the past; more indirect methods would be used.
Interviewers are
Instruments are designed to subtly lead up to the eliciting
Thus one would usually not ask respondents whether they are prej-
Inducement and subtle forms of coercion are not necessarily evident
even to investigators and only a careful examination of how respondents
perceive or interpret the procedure and other elements of the inquiry may
25-21
disclose them. Coercive techniques and inducements to cooperate in an
inquiry, moreover, are not equally operative for all members of a study
population.
are more likely to be induced into consent out of ignorance or misunder-
standing as to what they are free to do than are others. In general, the
more the power between the investigator and the sources of information is
balanced in favor of the sources of information, the less certain is any
investigator to gain information on private matters. It would seem, for
example, that it is easier to acquire information on theft and fraud
from low than high income respondents.
lifting may be more successfully completed with consent from respondents
than let us say a study of income tax evasion. One might ponder whether
many study designs should not be approved until the matter of the effect
of inducements on consent is itself investigated, but that of course
entails a relaxation of the strict construction.
There is some evidence that the less educated and underclasses
For that reason, a study of shop-
The fraudulent use of trust is protected at law but the more common
forms of deception that are practiced in social research may lie outside
legal protection.
paper for the Commission, a few additional observations are offered here
since they relate to the matter of explaining procedures and measurement
that must be communicated in obtaining informed consent.
aside for these purposes the question of whether they cause individual harm
and take those instances where the potential for harm is largely absent or
minimal, particularly if there are legal protections for confidentiality
and the possibility of social benefits is reasonably substantial.
While the matter of deception is explored in a separate
We shall set
It is a commonplace in behavioral science research that persons are
likely to give "expected" or "socially desirable" responses to questions
25-22
rather than their "true" response. There is, moreover, a strong tendency
for respondents to cloak socially undesirable responses or behavior or at
least not to disclose them to persons who are not known to them. Both of
these events pose problems for social measurement so that procedures are
designed to measure without subject awareness of the intent of the measure.
Thus there are techniques for determining whether a given respondent is
falsifying responses and ways of measuring socially undesirable attitudes or
conduct indirectly. Turning again to the study of prejudice and discrimina-
tion, it should be evident that both prejudice and discrimination are more
likely to be measured indirectly rather than directly and certainly not
directly if the identity of a subject is to be known to the inquirer.
The problem is further complicated by quasi-experiments in natural
social settings, particularly public settings where the observation of
behavior may be recorded.
about discrimination in employment, housing, and public accommodations or
facilities.
of minority and majority groups as paid participants in the experiment and
observing the responses that others make to their behavior.
Civil Rights Movement and subsequent legitimation in legislation, such
techniques can be practiced by operating organizations as a means of
gathering intelligence to enforce civil rights laws.
precluded in research because they involve an element of deception is moot.
Indeed, as we shall note later, the explicit obligation to disclose any
procedures that are experimental (45 CFR 46.3:c-1) when coupled with a
prohibition against deception could seriously jeopardize the status of
social experiments in social problems research.
A great deal was learned in just such experiments
Such experiments not uncommonly are conducted using members
Through the
Whether they should be
25-23
Who Must Consent?
The HEW Code of Federal regulations appears to stipulate that informed
consent must only be secured for research in which "subjects are at risk."
A "Subject at risk
of injury, including physical, psychological, or social injury, as a conse-
quence of participation as a subject in any research development, or related
activity which departs from the application of those established and accepted
methods necessary to meet his needs, or which increases the ordinary risks
of daily life, including the recognized risks inherent in a chosen occupa-
tion or field of service." (45 CFR 46.3:b).
behavioral science research is that relating to the research increasing
the ordinary risks of daily life.
deal in information processing rather than in manipulation of human subjects
and social groups, the risk of disclosure of elicited information presumably
increases the ordinary risks of daily life.
procedures that elicit information require informed consent.
means any individual who may be exposed to the possibility
The operable provision for much
Since behavioral scientists ordinarily
Under that interpretation most
The question arises, however, whether exemption can be granted whenever
a person is not exposed to risk as a consequence of "participation as a
subject in any research, development, or related activity." Put another way,
when is a person not a participant? This is not a simple matter in certain
kinds of research.
observation of natural social phenomena in public settings or public places
should be exempted from the requirement to secure informed consent. Apart
from procedural difficulties in securing that consent--a matter considered
below--when persons are simply observed without any other intervention by an
investigator, they are hardly participants in a research project. One might
think by way of analogy to the social role of newsmen and the standards
A reasonable argument may be made that systematic
25-24
applied as to whether consent must be obtained by a newsman to report on
public events or to record them in various ways including by video-tape.
One might consider also by way of illustration the research sponsored by
the National Advisory Commission on Civil Disorders into the events at
Kent State University.
of video-tapes, photographs, and observer accounts, including those of news-
men, to reconstruct the tragic events at Kent State. No effort was made to
secure consent from the participants in those events even though many could
be uniquely identified.
The Commission research staff utilized a large number
Frequently in social science research, a participant is a member of an
organization whose behavior is examined--the object of the inquiry is the
behavior of organizations or collectivities.
obtained from many persons within the organization, there is reason to
question whether their informed consent is required if consent has been
given by organizational representatives and the information elicited pertains
to their role within the organization.
result from the inquiry, e.g., that the number of positions in the organiza-
tion might be reduced and some people loose their jobs; yet it is not the
subject who is the participant but the organization and positions within it.
The organization, for example, may in fact require assessment of job performance
as a condition of employment and thereby obviate a specific requirement for
informed consent. There are very special problems when an organization re-
quires a given procedure to be followed that is both a method of organiza-
tional intelligence and assessment and an input into evaluation research.
While information might be
It is even possible that harm might
Whether employees should be permitted to decline participation in the research
project if the officials authorized to consent for the organization grant
consent for the research is problematic.
25-25
One might view this problem in another way. Where organizational
consent is required to undertake an inquiry, their consent is essential.
Whether or not that consent should be informed is unclear in some federal
regulations, but clear in others.
example, require organizational consent (28 CFR 22.2).
as "any individual, partnership, corporation, association, public or
private organization or governmental entity, or combination thereof" and
a private person means "any person as defined . . . other than an agency,
or department of Federal, State, or local government, or any component
or combination thereof." Under this proposed definition all 'individuals'
are 'private persons' (e.g., no distinction is made between an 'individual'
acting in a 'private' as opposed to 'official' capacity) (28 CFR 22.2:
Commentary).
tion be followed for all persons. They do however provide for an exception
when information is to be obtained by observation or when " . . . such dis-
closure would have a serious detrimental effect on subject participation or
purpose of research that would make conduct of the program impossible"
(28 CFR 22.27:c).
The proposed LEAA regulations, for
A person is defined
The proposed regulations require that the elements of notifica-
There are several criteria that can be considered in determining whether
the requirement to obtain informed consent may be waived or unnecessary.
Each of them is briefly considered:
1. The consent of persons need not be obtained when what is observed
is ordinarily open to observation by many others in the course of daily
life--i.e., it is public knowledge.
places open to the public as well as to public places.
consent need not be obtained for the observation of what is public behavior
in public places.
The exemption could extend to private
As a corrollary,
The question of whether private behavior in public places
25-26
is similarly exempt from the requirement of informed consent is more difficult
to defend, e.g., making a record of an overheard conversation in a public
place or during a public event with evidence of the identifying characteris-
tics of those engaged in conversation.
the matter of unique identifiers and the special conditions of consent
related to them.
We shall later consider separately
2. Within hierarchical organizations, the necessity to secure informed
consent may be restricted to the highest level of participant representing
the Organization provided that the object of the inquiry is organizational
behavior or aggregation across an organization or organizations rather than
the persons who are members of that organization.
3. Special problems arise as to whether organizational consent is
required when the object of inquiry is an organization but the information
on the organization is secured solely by obtaining the informed consent of
members of that organization. Should one, for example, require the consent
of teachers to test the learning increment of students in their classes, or
only that of the students, when teacher as well as student performance is
being evaluated? There would appear to be no simple answer to that ques-
tion, but it must be borne in mind that when there is substantial power to
block the objectives of inquiry due solely to the power persons are given
by virtue of their position, then their consent need not always be required,
provided they are not coerced into participation. Put another way, informa-
tion can be sought about individuals and organizations that is not strictly
a personal matter, i.e., it pertains to their organizational or public roles,
when their power to withhold consent blocks the objectives of an inquiry to
which others grant their informed consent.
This is but a special case of a more general problem of using social
25-27
power to block the objectives of legitimate scientific inquiry when those
in lesser positions of power grant their consent. Thus when a police
chief refuses to grant permission for interviewing police officers in the
police department regarding police work but the officers consent to being
interviewed about these matters when off duty, the consent of the police
chief need not be required.
power to grant consent should not ordinarily preclude obtaining the same
information from others who grant informed consent.
A refusal from persons in positions of social
4. When consent is obtained to investigate social relationships or
social settings from at least one of the participants to an event, the
consent of all participants need not be obtained if that requirement would
be burdensome and it is unlikely that any undue risk is occasioned by
their failure to do so.
is not necessary to obtain consent.
Suppose one wants to study the way teachers allocate time to various roles
in their classroom because one is interested in how much time is spent in
teaching and how much time in the role of principal disciplinarian.
observer will only sit and observe, never intervening in the process.
There may be difficulties in determining when it
Consider the following example.
The
The
purpose of the study is fully communicated to the Board of Education which
grants its consent.
been granted and are requested by the Board to participate in the study.
The principals in turn inform teachers that an observer will be present in
their classroom and have the Board's permission to be present and observe.
Teachers in turn may introduce the observer to pupils only as someone doing
research.
tained by the research investigator only from the Board of Education provided
that all individual identities are protected? The problem, as one can see,
School principals are made aware that consent has
Is it sufficient in this example that informed consent be ob-
25-28
is very much tied to the question of confidentiality.
can be protected so that no one within the organization is privy to any
information that uniquely identifies persons within the organization, only
organizational consent may be required if there is legal protection against
disclosure.
Where confidentiality
One reason why such a rule may be reasonable is that the procedure
itself entails no risk from the procedure to those who participate as
data sources in the inquiry--in brief, they are doing nothing they might
not otherwise do and in fact are free to alter their behavior in the
presence of an observer if they so wish.
such situations it arises from the disclosure of information, once ac-
quired, or from the knowledge that is applied following the research. Now
if there are formal contractual agreements with organizations guaranteeing
the protection of the identifying information from all, including members
of the organization, and there is legal protection against compulsory and
unauthorized disclosure, the need for informed consent seems altogether
obviated if generalizations apply to aggregates rather than individuals.
If there is any risk of harm in
There are difficult cases nevertheless. Consider, for example, a
study of police behavior in police and citizen encounters where one has
secured the consent of the police to observe their behavior.
cannot observe the behavior of the police without observing the behavior of
citizens in the encounter--a common problem in studying behavior in human
interactions or the interactions.
citizen be secured before one could study the behavior of the police in
the interaction is not only burdensome but might well endanger both the
police and citizens under some circumstances were it necessary to secure
the consent of the citizen before the police could intervene.
Clearly one
A requirement that the consent of the
Indeed, the
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most likely result would be to foreclose that kind of research altogether
since the police could hardly be expected to agree to allow an observer
to observe their behavior on the condition that the observer first be
allowed to secure the consent of the citizen before any police behavior could
take place.
behavior in natural social settings where the intervention to secure an
informed consent can itself fundamentally alter social situations and the
risks attached to them.
protection of confidentiality and strong sanctions for violation is critical
in considering the matter of informed consent.
science research the only risk that exists is the risk arising from the
failure of the society to grant legal protection for information. Thus
in many cases the question should shift to the question of when legal protec-
tion should be given, as by a confidentiality certificate, rather than
whether there should be informed consent. Informed consent is crucial when
something can happen to the person because of what the procedure of inquiry
does directly to the participant; it seems far less critical when the only
harm that can occur arises from the disclosure of private information--a
problem that is largely obviated by legal protection.
This example clearly points up a complication of studying
We shall have occasion to note later that the
In much behavioral social
Who May Grant Consent For Intrusion Into Private Matters?
Private matters may be those of individuals or corporate bodies.
Individuals generally have information about their own private matters, those
of others, and those of corporate bodies.
possesses information about the private matters of individuals and its own
affairs. Clearly at issue is what may each consent to or provide informa-
tion about without having secured the consent
A corporate body, similarly,
of others on whom they give
25-30
information. Correlatively, can an investigator obtain information where
in securing it information often is obtained that pertains to the private
affairs of others?
to consent to intrusion upon their private affairs poses questions of com-
petence and the form of inquiry.
consent may be given on direct inquiry.
to grant consent can rest in a legal age of adult status, but whether social
investigators should abide by that definition of age of consent is debatable.
The criteria for establishing mental or emotional competence to grant
consent are far more ambiguous.
direct inquiry, for example, automatically satisfy criteria for protecting
subjects? Absent competence to grant consent, is the criterion of consent
granted by the person or persons "responsible" for the incompetent adequate?
The principle that competent individuals have the right
Provided that an individual is competent,
The question of age of competence
Does the consent of a mental patient to
The question of who may grant consent is particularly troublesome when
information about private affairs is secured by indirect inquiry (from
others) or from the records of corporate bodies.
body has secured consent to disclose information for use by others, as
Goldstein notes, the agreement is generally so vague or incomplete as to
lack the basic elements of informed consent (Goldstein, 1969). A simple
agreement that the information will be used only for research or later
treatment, for example, lacks the basic elements of informed consent. The
absence of specific legal prohibitions against divulging information that
identifies individuals leads to much questionable use of files and dossiers
of corporate bodies.
Even where a corporate
One of the more difficult questions about consent for access to informa-
tion on private matters arises in securing consent on the private matters of
corporate bodies since the organization often has no clear procedures for
25-31
granting consent to gain access to such information. Employees, moreover,
may purport to give consent when they lack authority to do so or they make
disclosures inadvertently. Without written authorization for access to
specific information on corporate bodies, the legitimacy of acquiring such
information is highly questionable.
An important question for Institutional Review Boards to consider is
whether they can maintain a viable behavioral science while adhering to
the following principles for who may grant consent:
1. Information on the private affairs of individuals shall be obtained
only by informed consent on direct inquiry from the individual on his or
her private affairs.
2. There shall be no indirect inquiry on the private affairs of
others, or access to such information from corporate bodies when the individual
can be identified by the investigators.
3. Information on the private affairs of corporate bodies that identifies
the body may be obtained only on written authorization of an individual or
group of that body that has authority to grant that consent.
One need not reflect long to see that such principles seem to fly in
the face of social reality.
arise in interactions that involve the private affairs of all parties in
the interaction.
usually disclose private affairs of the wife.
about their relationships with parents frequently pry into the private
affairs of their parents.
often personal matters since they inquire into what sociologists call inter-
personal relationships.
bodies with their clients and with other bodies.
Many personal or seemingly private matters
Questions of the husband about the marriage relationship
Questions asked of children
In general, private matters are by definition
The same holds true for the relationships of corporate
Furthermore, on direct
25-32
inquiry few persons or agents of organizations separate their personal
view about others from disclosing facts about others.
indeed, can capitalize on the fact that informants do not make such separa-
tions. The willingness or persons to disclose information about others
often is used to reduce the cost of collecting information.
what these and many other examples can illustrate is that in the course of
social inquiry, one simply cannot avoid acquiring information that could
bring harm to others whose consent was not obtained.
altogether familiar with this problem in treating patients; social scientists
are altogether familiar with it in studying most aspects of social life.
Clearly what this points to again is that the problem arises as to how to
protect information from disclosure when the only alternative is to foreclose
the possibility of the inquiry altogether.
to what can an individual consent without risking disclosures that depend
upon the consent of others?
social life that involve the study of relationships or interrelationships
and for certain kinds of techniques such as sociometric and social network
analysis that are based on social exchanges or relationships, it is impossible
to investigate them without acquiring information on more than a single party
whose consent was obtained. There is no simple answer to that question. The
suggestion that the consent of all parties be obtained before that of a
single party is obtained is often unworkable since in many cases the other
parties are not known in advance.
except by first discovering the friendship network.
ship networks include participants in a form of deviant behavior, e.g.,
homosexual conduct. If one began by delineating the network and followed
this with queries to learn what it is that formed the basis of friendship
A research procedure,
In any case,
Psychiatrists are
Considered in yet another way,
For whole classes of problematic aspects of
Thus one cannot study friendship networks
Suppose that some friend-
25-33
only to learn then that it is a form of sex relationship, one is immediately
privy to information on all parties to the network. What seems required for
the study of "private" social relationships and exchanges then is adequate
protection for disclosure of the information secured by informed consent.
The consent process is further complicated by the question of who
grants consent given the ways that persons become accessible for behavioral
science investigations.
the research subject becomes accessible for reasons other than the particular
research inquiry.
settings that are controlled by persons who conduct the investigation.
Typically the bio-medical model refers to clients or patients who are re-
questing treatment of professionals who operate in offices, clinics, or
hospitals that are subject in some measure to the investigator's control.
Certainly all of these settings lie beyond the control of the research
subject.
they are at the same time in some other role relationship with the investigators,
such as patient and therapist, is also critical.
sible because they are the clients of other professionals, it, is well to
bear in mind that the
institutionally organized setting and a confraternity.
overlapping dependencies in role relationships such as the doctor-patient
with principal investigator-subject relationships, and where the subject is
in relatively unfamiliar or on alien and unfamiliar territory that lies
beyond their domain and control, and where it is further complicated by an
active procedural intervention on the subject, it seems essential that the
research subject be able to distinguish these separate roles and what is
open to choice.
The bio-medical model quite commonly assumes that
Moreover, they become accessible to investigation in
The fact that many subjects become accessible for research because
Even when they become acces-
accessibility of research subjects depends upon an
Where there are
25-34
There is a second model, that of subject research in total institutions,
where it seems that the right of subjects to informed consent is critical.
A closed institutional setting lies beyond the capacity of subjects to
control.
total institutional routines (Goffruan, 1961: ). Special attention must
be given to insure that their participation is voluntary, not only by
securing informed consent directly from subjects, but by insuring that the
prior processes of securing institutional consent have had no effect upon
subject consent. Both bio-medical and behavioral science research occurs
within total institutional settings and special consent and confidentiality
procedures are appropriately established for such settings.
Much of their activity, moreover, is constrained and coerced by
A third model is the one already alluded to where subjects become
available because they are members of organizations that make them accessible
to inquiry.
parties, a matter considered previously.
already noted, depends upon whether it is the behavior of organizations or
the behavior of persons that is under investigation.
Here the problems exist of securing consent from multiple
Much of the matter of consent, as
A fourth model is prototypical in social surveys and some systematic
social observation surveys of natural social phenomena or occurrences.
Typically, the social investigator or observer moves to the setting of the
participants and must accommodate to their rules.
entirely beyond the control of the investigator and largely subject to
control by the behavior of the participants, particularly in private places.
The investigator is there as a matter of privilege, if it is a private
place.
pected following the completion of the research task.
tion is therefore limited exclusively to the research investigator-respondent
The setting is almost
Moreover, typically there is no prior relationship and none is ex-
Contact and communca-
25-35
relationship.
of those of whom inquiry is made is more nearly equalized under these condi-
tions.
It would appear that the social power of those inquiring and
There is a fifth model, where if consent is required, an abbreviated
form may be all that is necessary.
phone or mail survey, assuming no method of data collection that provides
unique identification is employed. With the phone survey, the investigator
is quite limited in both verifying information and controlling the situation.
Lacking any prior role relationship, having only a short time and tenuous
grounds for establishing one, and lacking most criteria for establishing
identity, an abbreviated form of consent often not only is necessary if
the survey is to proceed but also in keeping with the balance of social
power in the subject-research relationship. There perhaps is no condition
under which it is easier for a subject to refuse access, refuse to respond
and withdraw from participation than by hanging up the telephone.
This is typically represented by the
Generalizing across these models, one might conclude that Institutional
Review Boards should pay particular attention to:
subject relationship grows out of a prior or continuing relationship; (2) the
balance of power between subject and investigator ranging from subject
dependent to investigator dependent; (3) whether the research setting is
subject to control by either of the parties to the inquiry or by other parties
who may create an imbalance in investigator-subject power; and (4) whether
the procedure of investigation alters the condition of the subject. Rules
of the following sort might guide decisions,
relative to investigator power, there should be considerably more attention
to their effects upon free choice by subjects.
investigator power is low relative to subject power, the requirement of
(1) whether the investigator-
Where subject power is low
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Correlatively, where
informed consent may be waived or abbreviated forms accepted.
Who May Secure Consent. Formal rules for certifying human subject
research typically do not confront the question of who is qualified to
secure consent.
are taken as the criteria for approving the solicitation of consent.
similar situation tends to prevail for Institutional Review Boards where the
reputation of field staffs, survey organizations, and other specialists in
eliciting information is taken as the criterion for approving the elicita-
tion of consent.
in scale has led to the training and development of specialists in eliciting
information--survey interviewers, for example, or trained social observers.
While matters of pretige and reputation are guides, they are far from
fallible in insuring that required procedures will be followed.
Generally the qualifications of the principal investigators
A
Typically the social organization of research and its growth
It is no simple matter to control the activities of persons whose task
it is to elicit information. Generally in social research there are part-
time as well as full-time white-collar employees, who have been trained in
a particular eliciting procedure.
in training are members of the research team.
specialists, such as clinicians, procedures for certification exist; despite
failings, certification provides reasonable grounds for deciding competence
and trust in a fiducial capacity.
Often student volunteers or assistants
When there are professional
Yet it remains true that much social research is conducted by a spatially
dispersed set of employees who are not subject to direct supervision and
often are not under the direct control of the principal investigator.
competence will vary considerably.
between investigator and task
Their
This makes the fiduciary relationship
specialist and of the latter with the subject
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precarious in two ways.
unauthorized misuse of information as well as fraud in failing to secure
informed consent.
misuse of procedure and information, thereby increasing both his legal
liability and the integrity of the research process.
tion from employee misuse of position and information and strong sanctions
against violation of the fiducial relationship, it is difficult to guarantee
and control confidentiality.
controlled if the principal investigator either monitors or seeks ways of
determining employee competence to undertake the task of eliciting informa-
tion.
organization is no more invulnerable to such failures than is any other
organization.
and poor practice generally have not crossed the threshold to be regarded
as problematic in behavioral science inquiry.
said that very little attention has been given to these matters.
confidentiality is essential to the design of an investigation, principal
investigators and Institutional Review Boards should seek information on
the competence of those who elicit information.
The subject is vulnerable to incompetence and
The principal investigator is vulnerable to the employee's
Lacking legal protec-
Procedural competence can at least be partially
Yet in all employing organizations there are failures, and a research
It is in fact quite remarkable that misuse of confidentiality
At the same time it must be
Where
The corporate nature of research and the size and scope of the inquiry
enlarges the circle of persons who elicit information.
therefore that attention be given to what forms of organizational control
are exerted over employees, what sanctions are available for misuse of
authority, and what procedures are followed to insure that they are properly
trained in the particular eliciting procedure.
may require assurances that such training procedures are actually carried
out.
It is essential
Institutional Review Boards
It is one among a number of matters that should be called for in
25-38
routine monitoring of behavioral research.
In behavioral science research procedures, generally those who elicit
consent are those who terminate the research relationship.
that they not only be sensitive to the right of subjects to terminate the
relationship at any time but that they fully inform them of any changes in
conditions related to the consent.
certificates obligate investigators to inform subjects when a certificate
is terminated (42 CFR 2a.4:8 and 2a.8). Institutional Review Boards should
request assurance and evidence that subjects are advised appropriately when
a confidentiality certificate is withdrawn.
It is important
The regulations governing confidentiality
Elements of Notice for Informed Consent
The Code of Federal Regulations for HEW sponsored research (45 CFR 46)
sets forth a number of basic elements of information for which notice must
be given in eliciting an informed consent. Each of these is considered in
terms of its special implications for behavioral science inquiry.
(1) A fair explanation of the procedures to be followed and their purposes , including identification of any procedures which are experimental. (45 CFR 46.3:c-1)
Although it seems appropriate in securing informed consent to explain
the procedures that are to be followed in eliciting information from persons,
it is generally correct to say that almost all of the procedures for eliciting
information have little effect on persons or organizations qua procedures.
Thus the procedure of interviewing that consists of asking questions and
getting answers has little if any effect on persons; indeed the elements
of the procedure occur in everyday life.
on subjects because of special experimental interventions or stimuli or for
other reasons, some explanation seems required. But routine eliciting
procedures would appear to require little by way of explanation.
Where the procedure has some effect
25-39
It is unclear whether more is intended by saying that the purpose of
any procedure must be described other than its intended procedural use.
If the purpose is to require some explanation as to the kind of informa-
tion that is to be elicited or task to be performed, matters of communicating
the substance of the inquiry and the goals of the investigation need to be
specified. Generally in behavioral science research, any detailed explana-
tion or description of these matters would prove burdensome and might have
a substantial effect on the rate of consent.
follow is that subjects should be advised on matters of substance if the
procedure will elicit information on confidential matters, matters that
are ordinarily anxiety provoking, or ones that a minority of respondents
find objectionable.
statement of what procedure is to be used--a poll, a survey, an interview,
watching or observing, filling out a questionnaire, completing a form--
will be sufficient.
Perhaps the best rule to
For many social science investigations, however, a simple
Earlier we made note of the fact that some social experiments, surveys,
and evaluation studies require a cloaking of purposes or measures if they are
to provide valid and reliable information.
that there are some indirect measures in the study about which feedback will
be given at the close of the procedure or whether other modes of communicating
must be followed is moot.
a consequence of using deceptive or indirect measures, it would seem un-
necessary to require that it be communicated in securing informed consent.
The full implication of this position bears scrutiny, however.
Whether persons must be advised
Where no particular harm will befall a person as
It should be clear that social scientists not infrequently seek to
acquire information that persons would not provide if directly and explicitly
informed of the intent by the investigator. To tell a parent that one is
25-40
interested in learning whether they are authoritarians or democrats, punitive
or permissive, racist, liberal or conservative, and sexist or egalitarian in
their child-rearing practices is not only unwise if one is interested in
valid and reliable measures but to risk securing consent for studies that
may have enormous social benefits.
What seems critical in informing persons or organizations about the
procedure to be followed is that they be informed about the procedures for
analyzing and reporting upon the information that is to be gathered.
Generally, social scientists are interested in analyzing and reporting data
for large aggregates in which it is not possible to identify individuals.
It should be sufficient in many instances to simply inform the person whose
consent is being sought that one is doing a statistical study where it will
not be possible to identify them with any of the information that becomes
public knowledge.
or collectivities is an important way of preventing disclosure of uniquely
identifiable information.
reporting data is to be followed where it may be possible to make inferences
about individual identities, persons should be apprised that is the procedure
to be followed. A statement, for instance, that the information is to be
presented as a case study and whether or how identity is to be cloaked in
reporting is a minimum of what must be communicated in such instances.
Analyzing and reporting information for social aggregates
When, for any reason, a procedure of analysis or
There are types of social research where it is especially difficult
to describe the procedures to be followed or where their full disclosure
imposes limits on the technique.
attention: exploratory studies, participant observation, and systematic
social observation.
Three of these are singled out for special
Exploratory Research. It is particularly difficult to satisfy the
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criterion of informing about procedures and goals of inquiry in research
that is essentially exploratory in nature and where no specific procedure
is to be followed, a situation that is not uncommon in behavioral science
research.
research and in case studies.
exploratory procedures including observation and interviews, group dis-
cussions, life history techniques, personal documents or records, participa-
tion in events, and even assuming social participant roles in everyday
life.
rather than a closed or fixed response.
the information that will enlighten, inform, or explain do not lend themselves
to predictable types of information that will be acquired.
may quite often obtain considerable material that is extraneous to the
problems under exploration and may be matters which the subject would not
otherwise disclose. Yet the acquisition of new knowledge must permit
reasonable exploration. While a simple statement that the investigator
wants to explore certain topics or matters will not suffice to inform the
subjects of participants from whom information is sought) their permission
to, quite frankly, "explore" or "look at in-depth" a number of matters
should be allowed if an Institutional Review Board and Peer Review Committees
consider the problem significant, if alternative ways of investigating
the matter are not as promising, and if the investigator can be trusted
to fulfill at least those conditions of notice which are applicable (such
as allowing persons to refuse answers or withdraw from participation).
This is often the case in solo-field or participant-observer
The investigator may utilize a host of
Questions in exploratory surveys more often seek an open-ended
The use of probes in exploring
Such techniques
Participant Observation poses special problems of satisfying the criterion
of "informed consent"
well as that of investigator to acquire information or to legitimate the
since the observer utilizes ordinary social roles as
25-42
observer role.
nature of participation and observation is not explicitly stated, participa-
tion itself may be utilized to gain an advantage before any information is
gathered.
which then might be exploited by seeking their consent to serve in a re-
search role. The participant observer role, as previously noted, poses
special problem of consent generated by the intersection of several dif-
ferent roles in the same person. There seems to be more rather than less
need to inform about the research role in participant-observer as compared
with observer studies since the role of observer is easily confused with
the role of participant.
Apart from questions of deception that arise when the dual
Thus participation may serve to develop a trust relationship
Systematic Social Observation is constrained, as previously noted,
by difficulties in determining whose consent is required. There are,
however, important limitations on securing consent from individuals who
are being observed, limitations imposed by practical considerations of
implementation, timing, and unpredictability about precisely who is to be
observed in particular settings.
secure the consent of all persons at a public meeting but certainly it
would be difficult to single out in advance all persons who might be
active participants on which the observation would concentrate.
one can follow the procedure of announcing that one is present as an
observer or one can secure the consent of persons in authority in the
setting, but where these are not feasible there are few substitutes for
securing the consent of those under observation. The extent to which one
will forego the requirement of informed consent in systematic observation
always will depend, of course, on an assessment of the risks involved in
observation and protection afforded against harm from disclosure.
It might not only be impractical to
At times
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(2) a disclosure of any appropriate alternative procedures that might be advantageous for the subject. (45 CFR 46.3:c-4)
This requirement of notice derives from a bio-medical model of research
where the role of investigator intersects with those of other roles such
as that of medical specialist who has diagnostic or treatment options to
that of the research procedure.
than one form of diagnosis or treatment, etc.
is merged with that of impartial investigator, alternative forms of experi-
mental procedures may be possible.
in studies that involve social intervention and evaluation of it or in
participant observation.
section of other roles with that of investigator.
Alternatives also exist when there is more
When the role of experimenter
Alternative procedures may also exist
In such cases there is likewise a merger or inter-
Most of the time, however, the question of advising about alternative
procedures that might be advantageous to the subject is inapplicable in
behavioral science research because the nature of any anticipated benefits
does not involve a calculus of alternative procedures. Ordinarily, behavioral
science inquiry does not promise benefits to research participants as a
consequence of participation.
procedures that might be advantageous to subjects.
prohibitions against using procedures that may be more advantageous to
subjects in behavioral science research on the grounds that such advantages
may bias the results of the inquiry.
Thus it is not germane to define alternative
Indeed, there are strong
That of course is an empirical question.
(3) an offer to answer any inquiries concerning the procedures. (45 CFR 46.2:c-5)
Quite obviously, any person in direct contact with a research subject
or participant should answer questions about any of the elements that are
stipulated as the elements in notice. There are certain other kinds of
information, nevertheless, that a social investigator often supplies by
25-44
way of notice and about which there must be direct answer if direct inquiry
is made. These include the following:
1. The person who seeks to elicit information or make any other
procedure operative must provide a unique identification of self on direct
inquiry.
informed consent.
given or who is performing research procedures; this might well be an
element of notice in informed consent.
or testimonial discussed later will provide documentation of persons who
secure informed consent and undertake any procedures directly on a person.
Ordinarily this should be done as a part of the procedure in securing
A subject has a right to know to whom information is
The complaint form and the warrant
2. Requested information on auspices and sources of financial support
should be answered on direct inquiry. Where promise is made to provide that
information in the event that a particular employee is not familiar with the
information requested, evidence must be provided that it was made and sup-
plied.
have a reasonable amount of information on auspices and sponsorship and
principal investigators should be held responsible for informing them.
Normally, however, every employee who interacts with subjects should
3. Any request for information about unique identifiers whether by
means of data collection or other modes of identification should be supplied.
Questions about modes of observation and recording and whether they carry
unique identifiers must be answered by an employee when questions are asked.
4. Any request for information about mechanical aids to information
recording should be answered, including information about how that or any
other kind of information is to be protected, for how long, etc.
We have had occasion to note that when procedures cloak some of the
objectives of the inquiry, investigators may be excused from making those
explicit if the result is to seriously damage the validity and reliability
25-45
of information and no particular harm attends most subjects who are involved
in the procedure. Despite this exemption from affirmative action, it
appears reasonable to stipulate that should any person explicitly inquire
whether there is deception in any form, one must not only offer to answer,
but to answer truthfully, so as not to deceive on direct inquiry.
In brief, remembering that employees are members of an organization,
all employees who have roles for eliciting informed consent or performing
any research procedures directly on persons should be given sufficient
information so that they may answer directly the questions stipulated
above and any others deemed essential to informed consent.
(4) an instruction that the person is free to withdraw consent and to discontinue participation in the project or activity at any time without prejudice to the subject. C-6).
The promise that the subject is free to withdraw consent and to
(45 CFR 46.3:
discontinue participation at any time poses special problems for both
subjects and investigators.
conditions is that promise compromised by the consent procedure or the
methods of inquiry undertaken by the investigator.
One question that can be raised is under what
First, whenever inducements have been offered to subjects to reward
them for their participation and they are so advised at the time to consent,
the inducements, particularly money, may affect any person's willingness
to withdraw.
inducements that are contingent upon completion of a particular task unless
it is a matter of formal contract.
a subject's wish to withdraw.
It should be apparent that investigators should not offer
Otherwise they can easily compromise
Second, any promise of withdrawal is operative only at the level at
which it is communicated. When consent is obtained for organizational
25-46
personnel to participate in an investigation, there should be explicit
agreement about whether such persons may voluntarily refuse to provide
information or withdraw from participation.
do so, it should be explicitly communicated to each participant.
illustrate, if a police command agrees that an observer may ride with the
police in his command to observe their behavior and that they have no right
to refuse to cooperate with the observer, it is his rather than the
observer's obligation to communicate that to officers and the observer has
no right or obligation to advise the officer that he has a right to refuse
or withdraw.
When it is agreed they may
To
Third, a promise of a right to withdraw or refuse to participate in
cooperating with some aspects of the procedure may lack force where there
are strong pressures from other sources to continue participation as
noted in the discussion of inducements.
the force of such pressures when they cannot be eliminated altogether by
virtue of the fact they are natural social phenomena.
Fourth, the promise of refusal or withdrawing may be an inadequate
Care should be taken to minimize
protection with some procedures and neither the person who elicits informa-
tion or controls participation nor the person who is advised of the right
to withdraw may be aware of the subtle ways that the decision to refuse or
withdraw is brought to a threshold of consciousness and therefore raises
the matter to a decision level of refusal or withdrawal.
responses to stimuli, including verbal stimuli, are sequenced, much informa-
tion may have been given that the subject may wish had not been given after
the threshold is reached.
is followed in intelligence gathering procedures; it may also occur in
research techniques of questioning.
Where behavior or
This is not an uncommon result when interrogation
A question arises whether persons who
25-47
consent to participate should have such control over the information provided
that they may demand that information already given now be withdrawn.
subject refusal or withdrawing may be inadequate when the person wishes to
withdraw matters that are already a matter of record.
Thus
Even were one to grant some right to expunge the record, there are
real limits on the capacity to do so.
return a questionnaire or test that was completed, or in other ways destroy
matters of record, including the record that consent was given!
such an option should apply to a right to expunge the record of consent is
problematic. Yet, there clearly are conditions under which a person might
wish to make that request such as when that record of consent or refusal
to consent is incriminating or damaging to the participant.
expungement arise, moreover, from the fact that one cannot obliterate the
memory or experience of others. The most that could be required in such
instances is an explicit prohibition against the use of such materials in
any form or for any purpose.
memory is at stake absent explicit evidence of use.
(5)
One can expunge a written record,
Whether
Limits to
That is not, however, an enforceable rule where
Any obligated to obtain and document legally effective informed consent. under an assurance provided pursuant to this part shall include any exculpatory language through which the subject is made to waive rights, including any release of the institution or its agents from liability or negligence.
institution promising to place any subject at risk is
No such informed consent, oral or written, obtained
or to appear to waive, any of his legal
One assumes that statements made to subjects holding that any assistance
given to the subject cannot be regarded as an acknowledgement of liability
or negligence by the institution or any of its agents are not exculpatory
since they do not represent a disclaimer of responsibility for conduct but
pertain to evidentiary questions at law.
25-48
It is unfortunate that the traditions of tort liability in American
law place such heavy emphasis on fault and negligence and fail to lay
stress upon affirmative duties or responsibilities.
research exposes subjects to risk and there is reason to believe harm
has 'occurred, tort doctrines might better stress affirmative responsi-
bilities--the moral and legal obligation to give help.
exceptions in American law of affirmative doctrines, such as the Good
Samaritan laws to protect heroic and other civic actions from tort
liability. In human subject research, special consideration might be given
to developing some exemptions from tort liability where the desirability
of affirmative actions outweighs protection provided by tort liability.
Where human subject
There are some
(6) a description of any attendant discomforts and risks reasonably to be expected. (45 CFR 46.3:c-2)
From the perspective of behavioral science, this requirement of notice
is unduly restricted by the bio-medical model of Human Subject research
unless one construes the reference of "attendant discomforts and risks" to
include any dicomforts or risks that follow both directly and indirectly
from participation in the research. It bears reminder that in behavioral
science inquiry major risk of harm attends primarily from the disclosure
of private matters rather than from specific procedures for eliciting informa-
tion or the performance of tasks during the eliciting procedures. We shall
assume that in behavioral science research the broader construction applies
and merits close attention from Institutional Review Boards.
Considerable difficulty attends the operationalization or interpreta-
tion of the constraint "reasonably to be expected."
applied on the basis of expectations for a population of all possible sub-
jects? For a particular subject whose consent is being secured? Or, for the
population at risk in the given research study--a population whose dimensions
Is that criterion to be
25-49
are only generally known, e.g., a random sample of the U.S. population?
Is one obligated to assess separately risks for subclasses of a population--
those identified by race, age and sex, for example? Or does one choose to
adopt the risk in using a given procedure--survey research, for example?
To have an exact probability for a population "at risk" is unlikely
not only because it is difficult to obtain such probabilities but also because
such information is at most available for some related population and one
would have to assume that risk applied.
does not provide a decision rule for an investigator or an Institutional
Review Board. Even a rule that the benefits must exceed the risks is un-
satisfactory in itself, not only because as already noted such ratios can-
not be applied to all behavioral science research but because both the
level of the risk and the ratio of risks to benefits are at issue. There
is a strong likelihood, in fact, that different Institutional Review Boards
will adopt different decision rules both for a given level of risk and for
cost/benefit ratio, thereby leading to inequities among investigators. The
problem, of course, of not unique to scientific research since it is
characteristic of all discretionary decision-making in systems where equity
is at stake.
Moreover, knowing the probability
There are also no clear guidelines in the regulations, for the choice
of a base to assess risk.
of probabilities of harm for a given population that is "at
actuarial base. Yet if choice of risk and base population are permitted,
one might opt for the risk element and the base that give the lowest risk.
Social scientists would ordinarily think in terms
risk" or of an
To illustrate, there is a fairly low probability that the survey method ever
leads to employee disclosure of confidential material; enough evidence, is
available to permit one to conclude that the use of the survey method cannot
25-50
reasonably be expected to produce unauthorized disclosure.
risk of using the survey method in all studies, one would conclude that
in the ordinary use of the survey, informed consent is not required.
Similarly the risk of compulsory disclosure from the use of subpoenas is
so low for all studies or even "sensitive ones" as to "obviate" the need of
informed consent. If, however, the relevant criteria are the population
at risk to a particular study where the population already is at risk for
harm from past behavior, e.g., a population which is asked to report
violations of law during the past year, the problem is not easily resolved
as to whether their informed consent is required.
might conclude that the risk of disclosure has been very low in such
studies, but on the other hand the potential harm is not inconsiderable
in a given case.
Based on the
On the one hand one
There is, of course, the additional matter that a guarantee of confi-
dentiality may be necessary to secure consent from the members of a popula-
tion that percieves its risk to be high, e.g., criminal offenders or drug
users. The relevant criterion here shifts to subject perceptions of risk
of harm rather than to actual assessment of risk from harm. Where confi-
dentiality is at stake, one perhaps must recognize that no simple rule of
whether or not informed consent is mandatory is easily formulated.
any case, adequate legal protection has the capacity to reduce many social
risks. It can be maintained, nevertheless, that in exchange for legal
protection one is compelled to follow rules of informed consent, a require-
ment that proposed regulations follow (43 CFR 2a.4 and 28 CFR 22.26).
But, in
The problem of risk assessment is, in any case, closely linked with the
necessity to guarantee the
disclosure if subject cooperation is to be secured.
unique identity of persons and information from
Where the procedure
25-51
guarantees anonymity in the form of data collection as in the anonymous
completion of questionnaires, the risk is close to zero. Yet the anonymity
procedure cannot be instituted without consent to participate, though the
extent to which consent must be informed to secure anonymous participation
is moot.
With some exceptions, to be discussed later, behavioral science
research when gathering information that has unique identifiers has no
interest in reporting information with unique identifiers. This follows
from the fact that most behavioral scientists have an interest in ag-
gregative levels of information. It is most easy to disaggregate data
gathered from persons, families, and households, and most difficult to
report it for certain kinds of corporate units such as multinational
corporations. Much depends, however, on the number of units in a defined
statistical universe and whether or not that universe is identified. Thus
one could do some disaggregation in reporting analyses for 200 teachers
but if they are all identified as coming from the same school, the level
of disaggregation possible before unique identification occurs is much
less than if the 200 teachers came from all schools in the United States.
It would be relatively easy, moreover, to identify the male physical educa-
tion teachers in a single school but more difficult if the sample were from
200 schools. Yet some possibility would exist even at that level of dis-
aggregation for the 200 national schools. Disaggregation must follow rules
of its own to prevent disclosure.
There are situations, however, where reasonable expectations are that
considerable risk may attend the securing of information because one is
unable to protect the data against disclosure should one be compelled to
do so. That condition arises whenever the State, at law or otherwise,
25-52
compels disclosure. At law within the United States, absent statutory
protection on disclosure, one may be compelled to disclose in response to
subpoena, for example. The risk of coerced disclosure is considerably
greater in comparative national research, however, since the capacity of
foreign nationals to protect their data is generally without legal guarantee.
The risk may be considerable in some societies for kinds of data that
ordinarily pose little or no risk in American society.
is to be undertaken in foreign countries, Institutional Review Boards must
give close attention to the capacity of investigators to protect their
information even when informed consent is elicited, lest one become an
Whenever research
agent of harm.
The necessity of notice, however, hinges in part upon the definition
The HEX requirements in the Code of "subject at risk" already discussed.
of Federal Regulations stipulate that a subject is at risk when he " . . .
may be exposed to the possibility of injury, including physical, psychological,
or social injury, as a consequence of participation as a subject in any re-
search, development, or related activities which departs from the applica-
tion of those established and accepted methods necessary to meet his needs,
or which increases the ordinary risks of daily life, including the recognized
risks inherent in a chosen occupation or field of service" (46 CFR 46.3-b).
It is hard to say that most behavioral science research in any way is neces-
sary to meet the needs of most subjects or that there is no possibility
research does not increase the ordinary risks of daily life or those inherent
in an occupation or career.
possibility of psychological harm always exists and an operable question is
whether a social research procedure has any more risk of psychological or
social harm than the ordinary risks of social life.
Possibilities always exist. I suppose that the
Think for a moment
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whether most behavioral science studies of pupils in schools are any more
likely to do psychological or social harm than that done each day to pupils
in many schools.
more harm to students than do most investigators.
that because research in schools ordinarily does no more harm than that
done every day by their teachers, one is justified in approving a proposal?
What criteria are to be applied? Or consider another example:
police ordinarily not do more harm to citizens than observers of police and
citizen transactions?
My impression is that research suggests many teachers do
Should one conclude then
may the
These examples are not offered to suggest that the risks of social
science research do no more harm than the risks of everyday life or, if
indeed that were true, that one should conclude that the criterion creates
a tolerable level of risk in the society.
show that we know very little about the nature of risks in everyday life
and that to know more is in itself an empirical question that would involve
research on human persons and their organizations. There is danger that
Institutional Review Boards will "create" risks that have little if any
empirical foundation.
satisfactory solution to the problem, particularly in the assessment of
risk.
for any phenomenon.
sample to create even reliable estimates of subjective probabilities.
any case the relationship between subjective and objective probabilities
can be positive or negative and they are often far from perfectly correlated.
They are intended rather to
The substitution of "informed guesses" is hardly a
There is ordinarily a considerable range to subjective probabilities
An Institutional Review Board is hardly a large enough
In
The Concept of Social Harm. It likewise is far from clear what is
intended in defining the concept of "social harm" since it is not defined
beyond the conception of "subject at risk."
that again what is intended flows from the elementary Human Subject model.
There is some implication
25-54
Social harm in the restricted sense would refer to the social consequences
for a subject. Such harm might range from a temporary experience of anxiety
or forms of social embarrassment to far more serious consequences if private
matters become public knowledge or are disclosed to persons who may wield
social power over individuals. This can include the imposition of penal
sanctions, loss of employment, social isolation or ostracism, and divorce,
to mention but a few possible consequences that befall some persons when some
private matters are privy to others.
harm in behavioral science research most usually would come about as a
consequence of these latter sources of social harm, i.e., private matters
become privy to others who then do harm. Investigators and their methods
are not ordinarily a source of serious harm to individuals apart from harm
through disclosure.
We have repeatedly noted that social
There is another type of social harm, however--that which may befall
corporate actors or collectivities when their behavior becomes public
knowledge. A few illustrations may suffice to make the point. Disclosure
of the financial condition of financial institutions might lead to a "run-
on-the-bank" ; disclosure of an impending stock transaction within an organiza-
tion might lead to the illegal act of "insider trading" (it is assumed the
principal investigators would not become "inside-traders"!).
that a particular employer discriminates against minority employees in
employment could lead to legal actions against the firm.
instances where the disclosure of information that an investigator may ac-
quire may do harm to corporate actors. If that information was acquired
with a promise of trust, as is often the case, the investigator becomes
an agent of social harm in this broader sense.
The disclosure
These are all
It is inevitable, however, that some forms of social research do harm
25-55
when results are published--literally made public.
ise that their inquiry will reach a predetermined conclusion and indeed, given
the nature of their fiduciary responsibility as scientists, they cannot offer
such promises. Results do not usually intend harm, but they may bring harm
to corporate actors and their individual members.
is undertaken, as already noted, both social harm in the restricted sense
of harm to persons and harm to corporate actors may occur with the disclosure
of the results from a given inquiry.
at least limited disclosure of identifying characteristics for the corporate
actor.
Investigators cannot prom-
Where evaluation research
Evaluation research often requires
An important and major ethical dilemma is created for behavioral
scientists when they enter a research relationship and extend a promise
of a guarantee, including a legal guarantee, of confidentiality. Any
promise of confidence prior to the disclosure of what must be held in
confidence can become a source of a moral dilemma. Disclosures in confi-
dence that acknowledge grievous social harm raise the question of whether
an investigator is obligated to disclose the harm despite the promise of
confidentiality.
fessional or counseling roles. In general the norms that apply to such
roles would appear to apply as well to the investigator's promise of
confidence. Yet it seems unethical to extend such a promise if there are
circumstances under which one cannot reasonably control unauthorized dis-
closure, as when legal protection against compulsory disclosure is absent.
For many types of private matters, approval perhaps should not be given when
disclosure would bring substantial social harm--benefits aside--and the
investigator has no formal legal sanctions or protection against disclosure.
This dilemma is commonly faced by professionals in con-
One other matter about social harm should be clarified. It is appropriate
25-56
for Institutional Review Boards to weigh the matter of harm both absolutely
and relatively.
its relationship to potential benefits.
certain research procedures may be ruled out on moral or legal grounds,
e.g., wire-tapping or electronic eavesdropping, with no reference to poten-
tial benefits. Most of the time, a calculus or cost-benefit is applied to
determine whether a project may be approved.
benefits outweigh social harm or costs, there are reasonable grounds for
granting approval by this criterion of notice.
Harm is weighed absolutely when there is no reference to
Certain kinds of research and
Generally if potential
Yet there are types of behavioral science research where a harm/benefits
ratio is inappropriate.
the study of corporate actors, as a consideration of examples may make
apparent. First, since in much evaluation research or in quasi-social
experiments the outcome is not predictable, neither the social harm nor the
social benefits to corporate actors can be calculated in advance of the
actual investigation. Moreover, as already noted, an investigator cannot
promise benefits from the results of the inquiry, though if some form of
compensation is given by way of inducement, in a trivial sense, that might
be thought of as a benefit.
may be simultaneously social benefit.
proportion of banks have high risk investments can bring harm to these banks
by bringing an an investigation of all banks during the course of which their
condition is discovered and sanctions applied.
closure may lead to increased control of the banking industry in the public
interest--a rather clear social benefit. It should be apparent that this
instance is rather different from the oft cited bio-medical example where
one must first do harm to cause wellness, or to say that the firt action
The harm/benefit ratio is often inappropriate in
Second, in yet other cases, what is social harm
A conclusion that a substantial
At the same time, the dis-
25-57
is not harm since its intent is wellness. Social scientists may well have
similar examples but in the type case just presented, the same information
causes both corporate harm and corporate benefits, albeit it to different
corporate actors. It follows, of course, that it can be simultaneous for
the same corporate actor and its members.
Mention already has been made of the need to protect persons and
corporate bodies from the disclosure of private matters whether or not
there have been promises of confidentiality.
obligation to maintain such confidence when there is a prior fiduciary
relationship and a moral obligation to do so when intruding upon the privacy
of others.
There is both a legal
The matter of protecting the integrity of corporate bodies is one that
is particularly troublesome for behavioral scientists. On the whole, less
attention is given to preserving the anonymity of private matters of corporate
bodies, yet the basis for doing so is not altogether clear.
evidence that the socially harmful consequences of such disclosure are examined
though in some kinds of research the investigator may actually "intend"
harm, as research undertaken in the spirit of muckraking sociologv or social
criticism (Marx, 1973).
evaluation or action research where the disclosure of identity is built into
the study design.
There is little
Social harm may flow also from the design of much
Risks of damage or harm exist as well for corporate bodies that are
the sponsors of behavioral science investigation. There is ample evidence
of the political risks occasioned by scientific research (Shils, 1956) and
behavioral science investigation (Sjoberg, 1967). Behavioral scientists and
their sponsors also assume political risks in competing with journalists
(Horowitz and Rainwater, 1970), lawyers, and other organized modes of inquiry
25-58
as they challenge more traditional and established modes of inquiry with
claims of "scientific truth." 3
Congressional investigations of private
foundation funding and of grants from public agencies for research into
controversial social issues and their ethical standards in research on
human subjects impose political risks and governmental control over inquiry.
On the whole, behavioral scientists have been given to view these investiga-
tions as attacks or threats to academic freedom and free inquiry.
are less commonly viewed as risks and moral dilemmas for such organizations,
which they often are as well.
such as that of Harvard University faced with a broad mandate to protect
students, academic freedom, and the reputation of the university in the
psilocybin research of Leary and Alpert (Benson and Smith, 1967) is given
much less attention. Yet in that case, as in many others, research sponsors
are moved to institute controls over investigation as a resolution to
political and moral dilemmas. The moral imperatives of protection with
their attendant risks become a central focus of any organized effort to
control bio-medical and behavioral science inquiry.
They
The moral dilemma of university sponsors
The question of how much social harm may result from a particular
inquiry is often closely linked to whether or not an investigator may
forestall potential harm or take steps to protect from social harm.
shall examine below some of the matters that raise problems of protection,
particularly those related to unique identifiers and the public disclosure
of matters that cause harmful reactions. At the same time we shall briefly
consider the matter of protection from harm, though that is treated more
We
extensively in the third section on confidentiality.
Unique Identifiers. A unique identifier is any information that will
25-59
permit someone other than the actor to whom the identification applies to
identify that actor, whether person, corporate, or collective.
other information can be attached to a unique identifier by ordinary
evidence, a disclosure problem exists.
When any
Unique identifiers will vary in terms of the evidence they provide for
exact identification according to rules of evidence and inference. Some
identifiers have a high degree of precision, e.g., fingerprints or voice-
prints.
their evidentiary value is substantial.
exact such as names and addresses. Still others require more inference
from the evidence such as the race, age, and sex of a person at a given
address.
evidentiary rules and the less inference that is necessary in making a
unique identification, the more protection that should be provided if harm
may result from disclosure.
Photographs are somewhat less precise means as are signatures but
Other identifiers are still less
It follows that the more exact or unique the identifier by
The unique identification problem in research must also be viewed in
terms of potential processes of disclosure: how the unique identification
is made to bring about the disclosure. We shall not review all such ways
but note that all ways relate to how access to unique identification and
other information is obtained and how one becomes accessible to physical
and testimonial evidence.
science research.
Both present substantial problems for behavioral
Access to Physical Evidence.
as voice-recordings, video-tapes, photographs, and fingerprints pose very
special problems for social research.
questions of whether they are necessary to the inquiry, what protection is
provided to access, and how long and how such records are retained. Not only
Clearly access to exact identifiers such
Such unique identifiers pose special
25-60
should considerable precaution and security attend their acquisition and
retention if they contain potentially harmful information, but some provi-
sion must be made concerning their retention and eventual destruction as forms
of evidence. Destruction should be guaranteed where applicable and under
some circumstances Institutional Review Boards should require stipulation
of these plans.
provided for at the conclusion of research, except under the most extra-
ordinary and compelling circumstances for their retention in subsequent
research. The earlier destruction can be feasibly undertaken, the more
security provided.
Destruction of exact identifiers should wholly be
It should be apparent to all involved in research that absent legal
protection for unique identifiers and the other information related to them,
they constitute damaging forms of evidence when there is potentially harm-
ful information. It should also be apparent that it is far more dificult
to erradicate testimonial than physical evidence.
considerations where serious damage may result from disclosure of informa-
tion with unique identification.
These are compelling
Access to Settings.
must occur in social settings.
their access to other than authorized research persons.
access to processing and storage, once information is acquired. Private
places are less accessible to both authorized and unauthorized intrusion,
for example, than are public places. Vulnerability, therefore, is greater
in systematic social observation in natural social settings than in contrived
ones in private places.
there must be reasonable means of protection against access during the data
acquisition, processing, and storage phases. Above all, Institutional
When physical or oral evidence is obtained, it
Social settings vary considerably in
The same holds for
Where potentially damaging information is obtained,
25-61
Review Boards should be mindful of the fact that access during acquisition
is often the most vulnerable of social settings in the research process, at
least from an evidentiary perspective.
settings are generally more vulnerable than domestic ones, that public
We would remind again that foreign
places more so than private places, that natural more so than contrived
settings, and that physically unprotected more than protected settings.
Where the possibility of testimonial evidence exists-as it usually does
unless the procedure is constructed so as to provide anonymity from all
persons involved in the research process--the problem deserves special atten-
tion.
Note should be taken here of a separate but related issue, that of
dangers to disclosure by the access given through didactic use and in
dissemination through agents other than those of scholarly publication.
Institutional Review Board may wish to grant approval subject to some con-
straints on either mode of access. Didactic use of confidential information
is common in teaching and training of research specialists and practitioners
or in other forms of training.
closure of information, it is doubtful that unique identification should
ever be allowed in behavioral science teaching and training.
is a more difficult and serious one in bio-medical research where living
subjects are used in training.
is generally afforded only to employees.
are not employees ordinarily are not qualified for protection unless specifi-
cally appointed as employees.
An
Where serious harm could result from dis-
The problem
The problem is a critical one since protection
Students, trainees, and others who
Similarly, the sharing of confidential information where unique
identification is possible with colleagues and its dissemination through
forums and media must be carefully protected. Sharing such information
25-62
with journalists is particularly risky and its sharing for any public
purpose such as law enforcement or regulation must be precluded and
legally protected.
Testimonial Evidence. Little need be added to the problem of
testimonial evidence than has already been said.
nerability of testimonial evidence, viz., that it cannot be totally er-
radicated except under the most extreme of measures taken against persons
(and means that must be morally repulsive to any scientific investigator,
e.g., homicide), it presents special problems.
Given the special vul-
The first problem is that of unauthorized disclosure and deliberate
misuse by members of the research team or others who obtain unauthorized
access.
criminal law to sanction persons who deliberately misuse or disclose
damaging confidential information, they are ordinarily weak remedies for
those harmed and they do not provide any means of preventive control for
those responsible for their protection in the research process. It is
unlikely that reasonably effective preventive control can be provided
institutional sponsors and principal investigators unless there are
and specific legal sanctions against unauthorized disclosure and misuse
that is inadequately protected by tort and criminal law.
is provided for in the LEAA proposed Code of Federal Regulations (28 CFR 22.29
and Commentary).
While there are some legal protections available in both tort and
strong
Such protection
The second problem is that of compulsory disclosure through trial pro-
ceedings and subpeona.
creasingly vulnerable to the threat of subpeona (Nejelski and Peyser, 1975:
B12-B24; Nejelski and Lerman, 1971). Adequate protection in this respect
would seem to be provided in the HEW provided Code of Federal Regulations
Behavioral science research has proved to be in-
25-63
that stipulates:
in any Federal, State, or local civil, criminal, administrative, legislative,
or other proceeding to identify the research subjects encompassed by the
Certificate except in those circumstances specified in paragraph b of this
section." I
make special note of the caveat "would seem" since these are complicated
legal matters and the Code of Federal Regulations is itself subject to
subordination by present and future Federal legislation on specific matters
and the constraints of the Privacy and Freedom of Information acts.
is and will be case law and there are related constitutional issues.
"Persons so authorized may not at any time be compelled
We shall have occasion to refer to those exceptions later.
There
Just how much of the information on risks should be communicated in
securing informed consent is problematic. A requirement of full disclosure
to secure consent could be burdensome and have consequences for the reli-
ability and validity of information.
protected and the more sanctions that are available to forestall disclosure,
the less specific information need be communicated. A simple statement
that states the form of protection that is available may often suffice,
particularly when there is strong protection as with legal protections for
It follows that the more one is legally
confidentiality and disclosure.
Potentially Chilling Effects of Full Information. Behavioral science
investigators may well overestimate the possibilities of the chilling ef-
fects that full disclosure of the information required by the elements of
notice may have upon cooperation and the reliability and validity of informa-
tion.
closure rule may not only create a greater possibility for free choice but
also raise unrealistic doubts and concerns that are damaging to free inquiry.
The problem is not a single one since compliance with a full dis-
We do not propose to discuss the problem fully here. We would simply
25-64
note that some matters would seem more important than others such as the
necessity to inform about unique and exact identifiers and what protections
are afforded for confidentiality.
There is, nonetheless, one special problem that deserves attention.
It is axiomatic that any form of regulation has possibilities for its
evasion and that any form of protection has possibilities for leaving one
vulnerable to harm. Both require brief comments. First, patterned evasion
will inevitably develop among Institutional Review Boards and among
Principal Investigators if requirements unduly constrain free inquiry or
prove unusually burdensome. Second, current regulations now provide a
possibility for leaving persons vulnerable and unprotected on evidentiary
grounds. The requirement
of a written and informed consent signed by subjects provides signature
evidence and ordinarily provides fingerprint evidence as well.
evidence to be either secured by compulsion or otherwise, and since such
evidence can be damaging to persons, that particular requirement has made
for greater possibility and perhaps likelihood of harm!
A single example may call attention to this.
Were such
We note one other related matter in passing since we shall have recourse
to consider it later.
burdensome and lead to patterned evasion as well.
example, that one keep a log of all persons who have had access to confi-
dential records may readily lead to evasive tactics and more rule-making
which in turn may generate evasion.
The bureaucratization of regulation may easily prove
A requirement, for
(7) a description of any benefits reasonably to be expected; 46.2:c-5)
The elementary Human Subjects model is predicated on the presumption
that ordinarily participants in research are subject to some other form of
(45 CFR
25-65
intervention that is designed to benefit the participant directly. The
research intervention is coupled with another form of intervention that
is designed to do good. That model is largely inapplicable to most behavioral
science research even when good may result from the research.
for a number of reasons.
This is so
First, and it hardly bears repeating, most participants in social
science research are related to investigators solely through the research
role; there are few if any direct side benefits.
Second, most behavioral science research has an interest in descrip-
rather than individual or corporate units and seeks tions for aggregates
generalizations at an aggregative level.
unique identification is rarely useful for the dissemination of knowledge.
Disaggregation to the point of
Third, where benefits are possible, they ordinarily arise from the
production of knowledge that will help an aggregate or class, of which the
participants are only representatives. They are thus class rather than
individual benefits. Benefits, moreover, often may not flow from a
particular inquiry, except to the scientific community, since a particular
benefit may flow only from the cumulation of knowledge.
Fourth, in many cases, the benefits, therefore, are not predictable
in advance and we would remind again that the same knowledge may bring both
harm and benefit.
Fifth, the benefits from behavioral science research often are expected
Most assuredly many federal dollars to redound to the sponsors of research.
are spent on behavioral science research not only because the government is
operating in its general role of public interest and welfare but in its more
special one of making policy and program decisions. Evaluation research and
program research is expected to bring pay-offs in practice and in decision-
making. 25-66
Put another way, the beneficiaries of behavioral science knowledge
are generally principals and third parties. Investigators may be rewarded
for discovery and additions to knowledge.
served collectively.
The public interest may be
The sponsors may make practical use of the knowledge.
Much behavioral science research has engineering, enlightenment and
intelligence benefits only (Crawford and Biderman, 197 ).
benefit is enlightenment for a scientific community and the public.
becomes an element on the basis of which they can more intelligently relate
to the problems before them, either as citizens, officials, or workers in
some other role. Behavioral science knowledge has a special relationship
to the making of social policies and serves therefore an intelligence
benefit.
problem and actions that may be taken.
elements in the formulation of public or private policy.
its engineering benefit, its utility in direct use of application.
example, a study of the use of a modus operandi file in police work may
result in immediate changes in the structure and use of that file.
The most usual
It
The policy-maker utilizes the special knowledge to sense the
But it is only one of a number of
A third use is
As an
There is, naturally, as in all science, a reasonable amount of what is
called basic science research, the acquisition of knowledge that will make
new knowledge or increase the production of knowledge.
benefits of a particular study to basic science is precarious at best.
To forecast the
25-67
FOOTNOTES
1. There are some statutory limitations on consent where proprietary interests prevail or when exchanges are privileged.
The more unplanned the intrusion into private matters, the more complicated are problems of "informed consent" and "protection of the sources of information," matters treated below.
Note that I do not argue that we have a more legitimate claim to "truth," whether or not it is made in the name of scientific inquiry, but simply that our claim to science opens us to political challenge.
2.
3.
25-68
These matters considered, cost-benefit decision rules in decisions
to grant or withold approval are both troublesome and inapplicable. A
few additional issues are raised however with reference to the element
of benefits in notice and these are now considered.
Participation in behavioral science research often may involve
benefits that are particularly difficult of measurement, viz., psychic
benefits. Studies of the old and retired, for example, often report the
pathos of the pleasure that their attention brought to those who are all
too often socially isolated and neglected.
prestige, satisfaction, and a sense of achievement are open to exploita-
tion in research but more often
benefits.
benefit calculus.
and prediction, that research ordinarily is not available and not obtain-
able without prior research on persons.
The psychic benefits of
than not participants regard them as
I do not know how they can enter in any precise way a cost-
Even were research to provide us evidence for inference
Protection Against Disclosure. There is no explicit provision in
the elements of notice to stipulate that participants be informed of the
nature of the protection offered against disclosure.
matter is included among the risks one might stipulate.
to maintain that it should be an explicit element of notice in securing
informed consent.
harmful. But there are other reasons. At least where confidentiality is
at issue, as it is in any research where unique identification is an element
in the design, there is a problem of special protection.
corporate bodies have a right to know to what extent they are protected
against disclosure whether or not the investigator defines the information
sought as a private matter; subjects may regard it so.
Presumably that
There is reason
The obvious reason is that it is potentially very
All persons and
If they
25-69
do, there is even a potential side-benefit for investigators if protection
is afforded:
validity and reliability of the information.
make representations about confidentiality.
ought to know what those representations will be.
to permit the extension of confidentiality when protection is weak or
unafforded.
against disclosure.
it may increase the participation rate and enhance the
Moreover, many studies must
Institutional Review Boards
It seems intolerable
Both Boards and participants should be informed of protection
The Extent to Which Notice is Explicit and Full. Apart from the
problem of potential chilling affects already alluded to, questions arise
as to how one will decide how explicit and how full notice shall be.
rules shall guide decisions about the form of notice. A criterion of
reasonableness, for example, must be guided.
What
The problem of information overload is a common one in information
processing and research participants are also subject to information over-
load. Overload may not only constrain free choice because it makes
matters "too clear" or unintelligible but it may also induce compliance
to unduly impressing some potential participants. When people do not
understand, they do not always withdraw; they may want to find out more
or believe that it is a good thing to go along with something which is that
impressive.
education and comprehension, a single form of notice must be intelligible
to those with the minimum education and comprehension
under study.
It is well established that given differences in levels of
for the population
Forms of Documenting Informed Consent
The elicitation of informed consent is primarily a matter of procedure
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or method. Our previous discussion focused on the requirement that regard-
less of specific modes of elicitation and procedure, they must permit "free
choice."
federal regulations for informed consent do not similarly permit the
participant to chose whether or not the agreement to participate is
documented by the participant in some form of unique identification. The
decision that the participant or his/her representative if they choose to
consent must give written consent, unless the investigator is exempted
from the requirement to obtain informed consent, is a restriction on the
participant as well as the investigator and is a constraint upon his/her
freedom to choose.
To some it may be surprising that both recommended and approved
The main reasons for requiring written consent are presumably
twofold
the conduct of investigators and as evidence they afford investigators
legal protection.
if also signed by the investigator or an authorized representative and
preferably attested to by a third party.
(though they are never mads explicit)--they are a means to audit
They may also afford participants similar legal protection
It appears that no consideration is given as to whether the legal
protection afforded by written consent should override a participant's
willingness of free choice to participate without giving written consent.
We note now, and shall discuss below, the fact that some other forms of
documentation, such as testifying to the fact that a given person or
corporate body gave informed consent, do not similarly constrain choice
while affording the participant as full protection.
The choice among options, e.g., written consent, testimonial/warrant,
and testimonial cum complainant notice discussed next, involve choices among
who deserves protection from what, who is to be regulated, and how is regula-
tion by consent to take place. Specifically we shall compare each of the
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three modes of documenting informed consent in terms of their grant of
freedom of choice, regulation by audit and complainant mobilization, and
protection through affording legal evidence.
Written Informed Consent. The HEW Code of Federal Regulations
(45 CFR 46.10) specifies the actual procedures to be utilized in obtaining
"legally effective informed consent" by documentation.
of informed consent must employ one of three forms:
The documentation
1). "Provision of a written consent document embodying all of the basic elements of informed consent. ject or to his legally authorized representative, but in any event he or his legally authorized representative must be given adequate opportunity to read it. This document is to be signed by the subject or his legally authorized representative. copies of the consent form as approved by the Board are to be retained in its records." (45 CFR 46.10: (a))
This may be read to the sub-
Sample
2). "Provision of a 'short form' written consent document indicating that the basic elements of informed consent have been presented orally to the subject or his legally authorized representative. Written summaries of what is to be said to the patient are to be approved by the Board. the subject or his legally authorized representative and by an auditor witness to the oral presentation and to the subject's signature. A copy of the approved summary, annotated to show any additions, is to be signed by the persons officially ob- taining the consent and by the auditor witness. Sample copies of the consent form and of the summaries as approved by the Board are to be retained in its records."
"Modification of either of the primary procedures outlined in paragraphs (a) and (b) of this section. Granting of permission to use modified procedures imposes additional responsibility upon the Board and the institution to establish: (1) that the risk to the subject is minimal, (2) that use of either of the primary procedures for obtaining informed consent would surely invalidate objectives of considerable immediate importance, and (3) that any reasonable alternative means for obtaining these objectives would be less advantageous to the subjects. The Board's reasons for permitting the use of the modified procedures must be individually and specifically documented in the minutes and in reports of the Board's actions to the files of the institu- tion. All such modifications should be regularly reconsidered as a function of continuing review and as required for annual review, with documentation of reaffirmation, revision, or dis- continuation, as appropriate." (45 CFR 46.10: (c))
The short form is to be signed by
(45 CFR 46.10: (b))
3).
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Setting aside the provision of a modified procedure, it should be
noted that there are several significant ommissions in the written informed
consent attested to by the research subject and/or others. Brief mention
is made of each of these since we shall wish to compare several modes of
subject and investigator protection later.
1). No provision is made for advising subjects or their representa-
tives as to who retains the signature document, for what purpose, and of
how it will he protected and used.
2). No provision is made for documentation of refusal to grant
written and informed consent and of how that is to be protected and used.
3). No provision is made for documentation of withdrawal of informed
consent once given and what rights, if any, the person has in information
provided prior to that point.
4). No provision is made for the document to be signed by the person
officially obtaining the informed consent in all options (altogether absent
except in the abbreviated form of consent) or for location, date, and time
that consent was obtained.
5). The provisions are silent on the matter of who retains the signed
informed consent document.
a copy to consenting persons and if only a single copy is refused, as
appears to be the case from the language of the regulations (e.g., 45 CFR
46.10: (a) "This document is to be signed by the subject or his legally
authorized representative.
as approved by the Board are to be retained in its records.") it apparently
is to be retained in the principal investigator's files for purposes of
audit.
The investigator is not obligated to provide
Sample copies of the consent form (italics mine)
6). No provision is made to advise persons who will have access to
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to the signature document and for what purposes.
auditors may have access to such documents for purposes of audit. Their
powers probably include a right to inquire of persons whose informed consent
was obtained or consent refused, i.e., whether or not specific procedures were
accomplished or specific information obtained, though not what a person said
or how he behaved.
consent for further clarification, however, and perhaps provision should be
made to limit it, should they appear to be overly broad powers that intrude
upon privacy and thereby fail to adequately protest both subjects and investi-
gators.
Under federal law, federal
The extent of auditor powers over information on informed is a matter
The proposed LEAA regulatory code stipulates that revelation of all
"research and statistical information identifiable to a private person may be
revealed on a need-to-know basis only to:
"a) Officers, employees and subcontractors of the recipient of
assistance;
"b) LEAA staff; and
"c) Persons or organizations for research or statistical purposes.
Information may only be transferred for such purposes upon a
clear demonstration that the standards of Section 22.26 have
been met, except that when information is transferred to persons
other than LEAA or project staff, that the transfers shall have
been conditioned on compliance
(28 CFR 22.21)
with a Section 22.24 agreement."
The above provision makes explicit that for all LEAA grants at least
three categories of persons or organizations may have access to information
provided by informed consent without the explicit consent of the participant
provided that there is a "need-to-know" w hile there are rules and precedents
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that govern "need-to-know" and the proposed LEAA code provides rather full and
explicit guarantees of protection of the information through the confiden-
tiality certificate, transfer agreement, and sanctions provisions, it seems
possible that since auditors or staff persons are not covered in the regula-
tions by the provision for immunity from legal process, some possibilities
for compulsory disclosure still exist. In any case, federal regulations
cannot preclude federal auditor powers, absent explicit legislative restric-
tion on such powers. There would seem to be good reason to seek to restrict
such powers, at least to protect any confidential identifiable information
so obtained from authorized or compulsory disclosure.
At the same time, any regulations should make explicit the classes of
persons, including those of the sponsoring institution, that shall have
access to confidential information and the conditions pertaining thereto.
Should Institutional Review Boards, for example, in connection with their
review and regulatory powers have the right to information on who did and did
not grant informed consent and whether the provisions of protection and con-
fidence were fulfilled by the principal investigators?
and responsibilities for approving projects and continuing review (45 CFR
46.6 and 46.7: (g)) they may have a right to such access; if so, it should be
clearly stipulated by regulation.
Given their powers
Special Features of Documenting Informed Consent by Signature. A number
of special problems arise in documenting informed consent by requiring all
consenting persons or their legally authorized representative to attest to
their consent by signature on the written consent form.
problems need not arise for some other forms of consent.
These special
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Documenting informed consent by participant signature (written consent)
makes the unique identity of each participant known to an investigator, even
when the object of all other procedures is to insure anonymity to all parti-
cipants.
ipso facto (ipso jure) a problem of protection where confidentiality char-
acterizes the information.
Having information on the unique identity of participants creates
There are three principle ways that investigators procedurally protect
from disclosure the identity of participants and the information they provide
by selecting different accessioning and eliciting procedures.
First, investigators can protect the identifiability of information by
the manner in which they procedurally accession participants. Procedures for
accessioning participants range from accessioning subjects by techniques that
make it impossible for anyone other than the subject to know he/she is a par-
ticipant--the anonymous participant--to procedures that provide for their
unique identification. Regardless of what accessioning procedure is used,
however, the requirement for documentation of informed consent by signature
makes it altogether impossible to have anonymous participants.
ment is a burdensome restriction since it forces investigators to protect the
anonymity of participants in research when disclosure of their identity as
The require-
participants is in itself potentially harmful and the investigator could
protect by anonymous participation.
Second, the procedure for eliciting information can be anonymous. Under
these conditions the documented informed consent by signature poses no problem
of uniquely identifiable information.
unique identity of participants should not be made public or when it is indeed
public knowledge, documentation by signature provides protection to investigators
Whenever there is no reason why the
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in accessioning participants and they may still protect anonymity by their
collection procedure. There are, however, distinct limitations to anonymous
data collection techniques since they preclude certain types of study design
and forms of analysis.
Third, when both the accessioning and elicitation procedures provide for
unique identification, protection can be afforded by separating both the docu-
mentation of informed consent by signature and any other identifiers that may
permit unique identification of information from the information itself.
Whenever consent is documented by signature, however, the evidentiary problems
in separation are compounded so long as one is required to maintain the docu-
mentation of consent.
It is unfortunately the case that modes of accessioning participants in
behavioral science research often must provide for knowledge of one or more
identifiers that can lead to unique identification.
to have a random selection of households or persons in the United States, one
must obtain information on certain identifiers such as an address and on
household characteristics to select a respondent, e.g., "head of household."
Since in a given unit at a given address, the head of household is often a
unique identifier, e.g., in one person households, a single identifier can
provide unique identification.
For example, if one wishes
Yet it is well to bear in mind that in much behavioral science research,
our interest does not lie in these identifiers as a means of identifying
unique individuals but in social aggregates.
incidental to the participant accessioning or data collection procedure.
return to our examples, we do not select an address or a phone number by
random means to know whom we are uniquely getting information from but to
The identifying information is
To
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insure that in the aggregate we are getting information from participants who
represent classes of participants or who in the aggregate will describe the
universe of participants in which we are interested within a given range of
error of estimation.
Although our procedures then may make it necessary to collect information
that falls in the class of identifiers that individually or collectively may
lead to unique identification, any procedure of securing consent should not
invariably coerce the collection of a unique identifier such as a signature.
Ordinarily unique identifiers should not be obtained in behavioral science
inquiry unless they are essential to the inquiry or its design. Since they
usually are not essential, documentary evidence of unique identity is burden-
some since it increases risk of disclosure and correlatively the need for
protection of confidentiality. That risk of course can be balanced by forms
of legal protection, but the only certain way to protect is not to document
accessioning participants and their informed consent with unique identification
procedures.
When an investigator seeks to protect participants by anonymous means of
accessioning participants or data collection, although informed consent should
be obtained, the requirement of documentation of that consent by participant
signature should be waived altogether.
consent, moreover, should be obviated, particularly the provision "of con-
siderable immediate importance," since that is rarely applicable in behavioral
science inquiry.
The written
The other requirements of abbreviated
techniques of data gathering.
duct an interview may be necessary before any written informed consent could
be obtained, for example.
The consent to enter a private place to con-
Such field setting difficulties should be sufficient
informed consent is not altogether practical in using some
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grounds for waiver of some requirements of consent.
As noted previously, organizational behavior research raises questions
about the obligation to secure written informed consent.
research is a matter of formal contract, the consent of employees may not be
required, e.g. observation of them at work.
poses special problems; particularly in matching records.
fact that it is impractical to obtain written and informed consent from the
deceased or from those who have moved or otherwise cannot be located, the
risk of disclosure or harm in their use ordinarily is no greater than that
arising from their retention by the original data source. With guarantees
of confidentiality, risk should ordinarily be so low as to preclude require-
ing any form of consent for the use of many kinds of records.
Where evaluation
Likewise documentary research
Apart from the
Informed consent that is written and documented by signature can serve
to constrain refusals to respond or withdraw from participation. There is
some evidence that signing any consent document makes it more difficult to
break a trust relationship or agreement.
any contract is not that easily broken--no matter how fragile it may seem
in a modern world--and some participants will find it harder to break the
relationship of commitment than others. It is well to remember that to bind
investigators to do right may also bind their subjects so that they are less
rather than more free.
The basic fiduciary element in
An informed and documented consent has such elements.
Subjects or participants, moreover, often are willing to consent but
not sign.
pate. Whenever a unique identifier is not essential to the research study,
it seems burdensome to require a signed or third party attestation proce-
dure since on the average it will reduce the participation rate (a source
of error) and may affect the validity and reliability of information (other
Signatures arouse suspicion and affect the willingness to partici-
25-79
sources of error). Above all, it becomes more. difficult to control and
measure error in estimation for aggregates.
Finally we shall discuss some problems that arise from the require-
ments for a modification of the written informed and signed consent
procedures. The requirements that an abbreviated procedure meet the test
of that "either of the primary procedures for obtaining informed consent
would surely invalidate objectives of considerable immediate importance,
and that any reasonable alternative means for attaining these objectives
would be less advantageous to the subjects" (45 CFR 46.10: (c)2(3)) derive,
it would seem, from the bio-medical Human Subject model (where they surely
may be appropriate) rather than from a behavioral science model.
attention here to their inappropriateness when one or more of these condi-
tions prevail, a condition of common occurrence in behavioral science in-
quiry.
invalidate the objectives of the study in the particular case of which the
application for approval is an example.
science research are only rarely of "considerable immediate importance."
And, third, since the means used often are of no particular advantage to
subjects, the consideration of alternatives is usually inapplicable.
Indeed, the only condition of the modification procedure that is ordinarily
applicable to behavioral science research is "that the risk of any subject
is minimal" (45 CFR 46.10:(c)-l). It should ordinarily, therefore, be
the only condition required for modification.
not stipulated seem more applicable in permitting modification of written informed
consent procedures in behavioral science, inquiry such as permission to
modify information on unique identifiers is absent or
they do not need to be retained after the participant is located for the
4
We call
First, often proof is lacking that the primary procedure would
Second, the objectives of behavioral
Other conditions that are
when the need for
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data collection phase of the inquiry.
Investigator's Signed Testimonial or Warrant of Informed Consent. We
have noted that the signed written informed consent procedure
governing HEW sponsored research lacks some protections for subjects or
participants in research.
dures but others cannot be added without changing its form to that of an
investigator testimonial or warrant.
currently
Some of these would be added to current proce-
It is to this form we now turn.
Both participants and investigators require some form of protection
in behavioral science research. In the matter of informed consent partici-
pants must be informed particularly of risks benefits so that they
may make a free choice about participation.
from being compelled to be agents of harm toward subjects as a consequence
of their participation in the research.
these things but on balance insure the rights of participants more than
those of investigators should choice among them be necessary.
less, a procedure which more nearly balances both participant and investi-
gator rights and their protection should be optimal.
testimonial or warrant of informed consent should be preferred to the signed
written informed consent on the following grounds.
and/or
Investigators must be protected
The consent form should do both
Neverthe-
The investigator's
In the investigator's written testimonial or warrant of informed
consent, the investigator or his/her agent warrants that a person or corporate
body or their representatives have been advised of the required elements in
securing their informed consent and it was granted. The basic elements are
these:
1) A written document that is approved by the Institutional Review
Board embodying all of the basic elements of informed consent;
A statement of whether the document was read by the named partici-
pant and/or his/her named legally authorized representative or
2)
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read to either party by the named investigator or a named auditor
witness;
The name and address of the consenting party or legally authorized
representative who consented or refused consent;
A statement of any additional conditions agreed upon and (at
option) any modifications agreed to during the elicitation of
informed consent;
A statement of whether any record is made providing unique
identification as a matter of record as in visual or voice re-
cording;
A statement of how the information is to be analyzed and
disseminated and the information stored (perhaps optional if
there is aggregative reporting and full protection for confiden-
tiality of information--though the Institutional Review Board
must grant such exemption);
If the principal investigator is not the person soliciting the
form of the consent he/she shall be named as well as the institu-
tional sponsor who also signs as the authorized representative
(the authorized representative should have reasonable proof of
his/her authorization and provide this identification in securing
informed consent, but in any case shall be obligated to furnish
reasonable proof in the course of eliciting informed consent if
it is requested by any party to consent);
A statement of whether any legal protection is afforded the
participant by the study such as a confidentiality certificate
or by sanctions against misuse of information. Where no such
protection is afforded the participant and is concluded that
3)
4)
5)
6)
7)
8)
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"more than ordinary" risk of harm is involved should confidence
become public information, the participant must be advised that
the investigator is not able to afford protection against compul-
sory disclosure; since tort remedies are possible for misuse of
information, it is perhaps not necessary that the participant
be advised of them;
Whether consent was granted or refused and whether there was with-
drawal following consent (the participant permitting) should be
recorded;
A copy signed and dated by the principal investigator (either as
the party eliciting information or performing procedures or as
granting a particular agent authority to do so) and by, the
representative authorized to secure consent or perform other
procedures and by the participant or his/her legally authorized
representative when
consent is elicited including those who refuse to grant consent as
well as those who grant it.
address of the institutional sponsor and of an authorized represen-
tative for the institution;
The investigator shall keep no record with unique or other identifiers
when a subject refuses to grant consent or later withdraws it unless
there is full legal protection against compulsory disclosure and
misuse of information.
investigator shall not refuse subjects to provide their signature
of consent unless the participant has been advised there are
specific risks of harm of which he/she is advised in securing
informed consent.
9)
10)
consent is granted shall be given to all whose
The form shall include the name and
11)
Where informed consent is granted the
When an investigator retains a signed written informed
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consent document there must be reasonable protection against dis-
closure of that evidence;
Where any procedure in the research intervention other than the
elicitation of information is performed on the subject by other
than the person eliciting information, there shall be a stipulation
that the principal investigator agrees to provide full information
on who performed such procedures at any time that the participant
or his legally authorized representative requests. Moreover, the
participant is entitled to information of the name and address
of any person who had authorized access to confidential informa-
tion and of unauthorized access, if known to the investigators.
The investigator therefore is obligated to keep a record of all such
interventions and who performed them insofar as they are specifi-
cally for purposes of the research only (some investigators are
legally compelled to keep such records in any case);
No member of an Institutional Review Board shall have access to
unique identifiers or uniquely identified information unless they
enter an explicit agreement with the principal investigator to
protect the confidentiality of such information and where ap-
plicable become subject to any provisions for sanctions against
misuse or disclosure (28 CFR 22.29, for example);
12)
13)
14) When specifically requested, the principal investigator must
provide information on the specific government agency sponsoring
the research, its address, and the designated officer signing on
its behalf.
The Investigator Written Testimonial or Warrant With Provision for
Complaint. Although one may regard the testimonial or warrant form as
25-84
providing sufficient information and a legal document for formal litiga-
tion, provision may and perhaps should, be made to provide for less formal
modes of adjudication of complaint.
involves actual or potential risk of harm, participants should be specifi-
cally advised of that "right" or "possibility" including the following:
In any case, whenever the procedure
1) A statement that if they wish to lodge a complaint or secure
further information on the particular inquiry (e.g., pending
further participation) they are given the following information:
The identity of the investigator and/or the legally authorized
representative who secured consent and of the institutional sponsor
and its representative as the agents who should be contacted un-
less the Institutional Review Board chooses to designate it-
self or other agent to secure such complaints.
are more fully protected when the complaint is lodged with a dis-
interested party. Principal investigators and their agents are
not disinterested parties. Therefore, unless it is unduly bur-
densome, an Institutional Review Board or its agents should
receive such complaints and provide for some means of their review
and adjudication (including, of course, involving principal in-
vestigators).
interested party and for some special kinds of research, the
government sponsor of the research may chose to require that it
be designated the agent to whom such complaints should be directed.
In any case, all investigators or their agents must provide such
information on specific request as required in the testimonial form.
We would note parenthetically that in all cases there should be
some means provided for dealing with complaints whether of principal
2)
Complainant rights
The institutional sponsor is not always a dis-
25-85
investigators, institutional sponsors or government sponsors of
research.
There shall be a record made and retained for a reasonable period
of time following the conclusion of the inquiry of all such com-
plaints received and any actions taken thereon. Such records
when kept by principal investigators, shall be accessible to the
Institutional Review Board and at least some record of them and
actions taken on them kept in its files.
3)
If one intends to protect a subject's right to protection in research
inquiry, it seems essential that the complaint procedure be followed whether
or not consent is documented by the written and participant signed informed
consent of the testimonial or warrant signed consent form. Moreover, written
notice of when complaint can be lodged should be the minimum provided when-
ever The reason for this seems obvious
enough.
about whom they are dealing with in the consent procedure or fail to retain
or recall the requisite information essential to lodging a complaint.
obligation in all cases should fall on investigators to provide information
documenting how complaint can be lodged in the form:
you wish to know more about this study or complain to others about what was
done to you, call or write to
in all cases be intelligible to all literate persons.
informed consent must be secured.
Most participants may either err in this acquisition of information
The
"if for any reason
." The form of notice should
Should only the complaint form be required, provision should also be
made within the written form to advise the participant that information on
the name and address of any person who had contact with the participant in
performing any procedure connected with the research intervention or had
authorized access to any confidential information pertaining thereto or
25-86
of unauthorized access, if known, will be provided on request.
likewise should be an obligation to provide information identifying the
government sponsor on specific request
There
Comparison of Modes for Documenting Informed Consent. We turn now
to compare the relative advantages and disadvantages of the presently
authorized mode of documenting informed consent and the proposed model.
Chart I summarizes these comparisons.
since the comparisons should be obvious to the reader.
some summary observations and conclusions derived from the comparisons in
Chart I, we return to review the prototypical bio-medical Human Subject
model and the prototypical behavioral science model as they bear upon these
comparisons.
Little comment seems called for
Before turning to
In the choice of models for securing informed consent it is well to
bear in mind that the prototypical bio-medical model and the prototypical
behavioral science model have both different "harm" probabilities and
different harm points in the research process. Quite typically the bio-
medical model involves some risk of harm both from administering the ex-
perimental or treatment procedure or by delayed effect and such effects
are ordinarily mentioned throughout the period of research inquiry.
though similar conditions prevail in some behavioral science inquiry (more
likely so in research by psychologists than others) and they are more likely
to arise in the use of some techniques (e.g., social or psychological ex-
periments or longitudinal studies), the prototypical behavioral science
model involves virtually no risk of harm from or during the data collection
phase and minimal risk from the data processing and analysis phase.
behavioral science model, moreover, incorporates corporate as well as
person actors.
Al-
The
Risk to person or corporate actors in a research inquiry
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25-88
25-89
25-90
ordinarily attends the disclosure of confidential information, particularly
the risk from compulsory disclosure.
usually follows publication or the dissemination of information when all
contact with the subject is terminated.
mobility of participants in much behavioral science inquiry, participants
are not easily followed nor located.
This form of harm, should it arise,
Indeed, given the high residential
The comparisons provided in the preceding discussion and in Chart I
call attention to forms of documentation and protection that would seemingly
be essential to documenting informed consent yet are not provided in current
federal regulations (45 CFR 46).
the present form of "written informed consent" others when added would trans-
form it into either a testimonial or warrant document or to a formal agree-
ment signed by both parties.
different combinations possible of the elements in Chart I and the elements
of information necessary to being informed.
applied to the form of documentation is of the barest consequences.
Although some of these could be added to
Moreover, it should be clear that there are many
The specific concept to be
Comparison also will make apparent that the currently approved regula-
tions for documentation are balanced in favor of providing protection for
investigators rather than for participants. They also leave both partici-
pants and investigators vulnerable and unprotected in matters of confiden-
tiality of information.
fuller guarantees for both participants and investigators, though on
balance it may protect more the rights of participants. Without more ade-
quate legal protection against misuse and explicit provision for provision
against compulsory disclosure, however, all forms of documented consent make
both participants and investigators vulnerable to harm through the disclosure
of information.
The investigator testimonial form moves toward
It is to this matter--the legal protection of confiden-
25-91
tiality--that we shall turn in Sections III and IV.
Feedback on Procedure and Participant Satisfaction.
Some bio-medical and behavioral science inquiries make provision for
feedback from participants on the procedures used and their satisfaction
or dissatisfaction with being a participant either during the procedures
or at their termination. The question should be asked whether feedback
should ordinarily be required as part of any research procedure. There
are persuasive arguments in its favor but some to the contrary as well.
Feedback can be of considerable utility to both participants and
investigators.
or how to increase participants' benefits by systematically eliciting feed-
back. The more exploratory the procedure or the greater the risk of harm
from its use, the more Institutional Review Boards should consider making
feedback an essential element of "procedure."
refused whenever there is reason to believe that knowledge of it will make
corrective action possible to protect the participant from further harm or
to "undo" harm.
Yet, there are reasons why it should not be required or even to
Investigators may well learn how to reduce risk from harm
Such feedback should be
prohibit its use.
participants from legitimate complaint or they may use it in other deceptive
ways. Even though investigators do not intend these effects, whenever
feedback has a reasonable likelihood of doing so for a reasonable number of
persons "at risk," its use should be prohibited or circumscribed so as to
avoid effects that are not in the interest of the participant.
Investigators, for example, may seek feedback to "cool"
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Participant Rights to Information
There are important and largely unexplored issues about the rights of
participants to confidential or other information that has been secured from
them by informed consent for purposes of scientific inquiry.
rights as Federal law provides--e.g., were information given to a govern-
ment sponsor of research, a participant has the right to review all informa-
tion that retains unique identification and to correct the record--the
issues are far from clearly formulated, much less resolved. There are many
difficult questions that will arise in discussing the matter of participant
rights to information and we shall not review them here.
the right to review information that is uniquely identified and to correct
that record, is it reasonable to conclude that subjects can correct many
matters of observation and recording that refer to their behavior, attitudes,
or other research investigator recorded information, or does it apply only
to those items of information that can be validated independently of the
subject's correction?
Apart from such
For example, given
Matters of correcting research records apart, participants should have
a right to request a copy of all information where unique identification is
retained so long as its disclosure does not invade the privacy of other rights
of any others referred to in that record.
protecting the identity of human subjects of DHEW (42 CFR 2a7:(b)) and of
LEAA (28 CFR 22.23: (4)) provide for the release of confidential information
with the consent of the participant, but they do not unequivocally grant
the participant the right to review or request a record of all information
Both the proposed procedures for
that is retained with unique identification. There perhaps are some limits
on the extent to which participants may request information that remains
uniquely identifiable as, for instance, were there a strong presumption
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that knowing it would cause the person considerable harm.
question, however, is whether the participant is entitled only to that
information given with the participant's informed consent or to all informa-
tion on the participant in the records in a uniquely identifiable form.
in behavioral science studies, information is secured on transactions among
persons or corporate actors.
involved in securing the information, a participant's rights are less
clear. On the one hand, any confidential information, regardless of its
original source, is potentially damaging on disclosure and any participant
should have a right to know what is in the record, but on the other hand,
persons who gave such information with a promise of confidentiality have
a right to have the information kept confidential.
information on pupils or the wife who provides information on the husband
(and vice versa in the above illustration) create a special case where
rights to information are hopelessly intertwined and where the knowledge
that each would have access to all information provided by the others
obviates all forms of research except that of the public forum.
without limits on the right of participants to information that is uniquely
identified, a right to request all of the information that is a matter of
record could well have a chilling effect on all research where confidential
information is secured about a participant from anyone other than the
participant.
A more difficult
Often
Where the informed consent of others was
The teacher who provides
In short,
The Rights of Investigators to Information Secured on Promise of Confidentiality.
Whether and what rights investigators have to information that has been
secured by informed consent without explicit forms of legal protection is far
from clear. They obviously possess those rights in the information that are
25-94
matters of informed consent and contract--to use it for the explicitly stated
purposes of research and all related interventions explicitly provided for
as matters of agreement.
noted to rights of those who provide the information. Where a promise of
confidentiality is explicitly provided for in obtaining informed consent,
investigators should have the exclusive right and duty to protect the informa-
tion subject only to the rights of those who consented to give the informa-
tion.
as they intend no harm in using it.
But that right is not exclusive, subject as already
They, of course, have a right to use that information only so long
Transfer of Confidential Information to Other Investigators. Among the
many other matters at issue in subject and investigator rights is the ques-
tion of whether an investigator may share information that has unique
identifiers with other investigators to whom consent was not originally
given.
and where there was no prior agreement to use them for a given inquiry.
Indeed, any more or less general provision giving an investigator the right
to permit access to the confidential information for purposes of research,
other than that for which informed consent is being secured, will generally
be so vague and incomplete as to lack the very elements considered basic
to informed consent (Goldstein, 1969). Should this mean then that except
where informed consent is originally secured for one or more specific
projects, or where a subject is subsequently contacted and informed consent
secured for each subsequent project using the information, no other research
access should be permitted? That rule would seem to be unusually burdensome,
given the high cost of much behavioral science inquiry and the cost attendant
upon building up time series from individual data.
This matter arises where confidential records have been obtained
Where the risk from subsequent use of the information provided by informed
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consent can arise solely from its public disclosure, and where there is
legal protection against compulsory disclosure and strong sanctions against
its misuse, investigators should have rights to transfer confidential
information provided the same protection is afforded on transfer.
right should extend to its use not only for similar and related projects
but to unrelated ones that in the judgment of the investigator or/and
institutional or government sponsors are in the public interest of free
scientific inquiry.
entirely to custom, however, and should be protected through federal regula-
tion. The proposed regulations by LEAA set forth the major elements for any
information transfer agreement (28 CFR 22.23 & 22.26).
That
The transfer of such infornation should not be left
The major elements of a request for transfer of information should
include the following (28 CFR 22.26:(b)):
. . . the general objectives of the project for which informa- tion is specifically requested, and specifically justify the need for such information in identifiable form. The request shall also indicate and provide justification for the conclu- sion:
or indirectly, cause legal, economic, physical, or social harm to individuals whose identification is revealed in the transfer of information.
expected to have a detrimental effect on overall future research or statistical efforts of the Federal or State government.
The information transfer agreement should be formally executed and
(1) That conduct of the project will not, either directly
(2) That conduct of the project as designed would not be
should make provision for at least the following minimum information
stipulated in the proposed LEAA regulations (28 CFR 22.24):
(a) used only for the purposes stated in the transfer agreement.
(b) be revealed to any person for any purpose except where
Information identifiable to a private individual will be
Information identifiable to a private individual will not
(1) The information has been included in research findings (and/or data bases) and is revealed on a need-to-know basis
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for research or statistical purposes, provided that such transfer is approved by the person providing information under the agreement, or
(2) is authorized under 22.24(e).
Knowingly or willfully using or disseminating information (c) contrary to the provisions of the agreement, shall constitute a violation of these regulations punishable in accordance with the Act.
(d) taken to assure security of information obtained for such pur- pose.
(e) Access to information will be limited to those employees or subcontractors having a need therefore in connection with performance of the activity for which obtained, and that such persons shall be advised of, and agree to comply with these regulations.
(f) private persons to whom information relates, including, where appropriate, required name-stripping and/or coding of data or other similar procedures.
(g) will not contain infornation which can reasonably be expected to be identifiable to a private individual.
(h) Information identifiable to a private individual (obtained in accordance with this agreement) will, unless otherwise agreed upon, be returned upon completion of the project for which ob- tained.
Adequate administrative and physical precautions will be
Project plans will be designed to preserve anonimity of
Project findings and reports prepared for dissemination,
These proposed regulations clearly provide that all sanctions, including
fines, obtain for all investigators and their employees who have access to
information by transfer agreement.
from compulsory disclosure also apply is not altogether clear in the LEAA
regulations but were a transfer agreement to be legally authorized under
the proposed HEW regulations for protecting the identity of subjects (42
CFR 2a), such protection would seemingly apply to the transfer agreement
as well since: "The protection afforded by a Confidentiality Certificate
is permanent with respect to subjects who participated in research during
Whether the provisions of protection
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any time the authorization was in effect" (42 CFR 2a8:(c)).
Cooperative Activities to Develop Confidential Information. The DHEW
regulations currently in effect make provision for cooperative activities
" . . . which involve institutions in addition to the grantee or prime
contractor (such as a contractor under a grantee or a subcontractor under
a prime contractor)." (45 CFR 46.16). They further provide that: "If
in such instances, the grantee or prime contractor obtains access to all
or some of the subjects involved through one or more cooperating institu-
tions, the basic DHEW policy applies and the grantee or prime contractor
remains responsible for safeguarding the rights and welfare of the sub-
jects" (45 CFR 46.16).
The obligation which falls on the grantee or prime contractor to
safeguard the rights and welfare of subjects will hardly guarantee subjects
protection when, as is now the case, there are no stringent sanctions against
unauthorized disclosure or misuse of the information. Prime contractors
now have no specific sanctions available to deter misuse nor are there
provisions against compulsory disclosure.
surprising that despite considerable subcontracting in behavioral science
research, few situations have arisen where sanctions are appropriate. Yet
there have been somewhat more situations where protection against compulsory
disclosure seemed essential, as in the negative income tax experiments in
New Jersey.
One must grant that it is
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III. CONFIDENTIALITY
Confidentiality is the communication in confidence of private matters.
It involves a fiduciary responsibility--a pledge or promise to hold privi-
leged or otherwise keep secret communications about private matters.
also involves a promise of protection and implies the capacity to keep mat-
ters communicated in confidence from disclosure by the confidant or others.
It
Both fiduciary and protection obligations came into question when in-
vestigators pledge confidentiality in behavioral science research.
gators often are caught in a dilemma that a pledge of confidence is necessary
to secure valid and reliable information but they lack the legal right of
privileged communication and the sanctions of tort law are inadequate pro-
tection against misuse or disclosure by others to whom the responsibility
for confidentiality must necessarily be entrusted.
investigators are well aware of the fact that organized behavioral science
inquiry involves a chain of confidence and they are personally and morally
committed to maintaining that confidentiality even at the risk of loss to
themselves. They lack, however, sufficient knowledge about their vulner-
ability to disclosure and the weakness of the protection afforded them in
promising confidentiality. Many behavioral science investigators, therefore,
enter into a pledge of confidence in good faith but their faith rests on a
weak societal foundation whose dimensions they know not.
Investi-
Viewed another way, many
Requirements for Pledge of Confidentiality. On its face, pledges of
confidentiality should not be extended by investigators for information
provided them except when it concerns private matters.
is defined at law; yet it hardly bears noting that most people are unaware
of what are private, privileged and public matters at law; ultimately the
What is a private matter
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courts will decide if a particular matter at issue is private, privileged
or public.
participants whose informed consent is being elicited.
ably strong basis for argument that communication between investigators
and subjects should be privileged whether or not there was an express or
implied promise by the investigator to the participant that the information
provided will be treated as confidential.
cessible to inquiry because investigators approach them to seek their coop-
eration; while confidentiality may be promised, when it is not, unless they
are expressly advised that what they say can be told to anyone, they invari-
ably assume confidentiality. Moreover, even when they volunteer to partici-
pate, they ordinarily assume that implies confidentiality as well. Most
participants, moreover, are unaware of what is implied in confidentiality
even when they are advised of some risks.
quire information may not make it easy to promise confidentiality since
others may be privy to the same matters.
cular instance from protection, however.
ticipant may disclose the same information to a friend, a journalist, and a
behavioral scientist with the expectation that all will regard it as confi-
dential and without any explicit promise of confidentiality, a complicating
feature in much behavioral science inquiry.
where a particular piece of information is unlikely to become available ex-
cept as a consequence of the research intervention, behavioral scientists
seek to acquire information to which many others are privy but in the ex-
pectation that it will be regarded as confidential.
protection of information on participants by investigators is possible when,
And that is of little help either to investigators or their
There is a reason-
First, most subjects become ac-
Likewise, the method used to ac-
That should not leave the parti-
I note parenthetically that a par-
Unlike much biomedical inquiry,
Needless to say, full
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and only when, the investigator and the participant uniquely share a given
matter as "private".
pants are not fully protected against disclosure of information they share
with investigators but protected only from disclosure by that source.
the perspective of private persons (both person and corporate actors) in
our society, whatever they regard as private matters in giving confidence
should be treated as a confidential matter in research regardless of the
status of law, i.e., there should be an absolute privilege. Yet it is un-
likely that the society will grant an absolute privilege since that would
cover a confidence that one was about to commit a heinous crime such as an
assassination of a public official. While at law such relationships may
need to be conditionally privileged the conditions should be relatively few
if one is to recognize that most people respond to a guarantee of confi-
dentiality with their definition of what is confidential and we should or-
dinarily be prepared to protect those matters as well since they are im-
portant to them.
That is, we suspect, rarely the case so that partici-
From
Yet, from the perspective of the public interest, there may be other
reasons why investigators should not be given a simple license to promise
confidentiality in exchange for information or compliance with an interven-
tion in research.
investigators, may wish to categorically prohibit or circumscribe the in-
vestigator's right to pledge confidentiality for public behavior.
there is no reason why they should not.
must he obtained or the behavior of public officials or employees is being
investigated and these become possible only through a promise of confiden-
tiality.
The government and institutional sponsors, as well as
Seemingly
Yet often access to public behavior
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Conditionally, it might be argued that investigators have no right to
Were that so, promise confidentiality for information on illegal conduct.
much behavioral science inquiry that leads to an understanding of illegality
and its regulation by law and custom would not be possible.
might be argued that conditions on confidence or privileged communication
in research should generally restrict neither substance nor procedure in
inquiry unless it is so clearly and substantially damaging to the public
interest as to be stiplated by specific exclusion.
Indeed, it
Given full protection of confidentiality in research, questions of its
use might well be left unregulated by other than the investigator were it
not for two matters.
never absolute and therefore damage may result.
sessment of potential harm and its seriousness and the capacity to protect
confidentiality must come into consideration in permitting investigators
to promise it. Second, the privilege of communication opens the door to
abuse of privilege.
than is necessary to the particular inquiry to meet their own needs or re-
quirements rather than those of the participants or the larger public in-
terest in research. Some regulation is necessary to protect both private
persons and the public interest against unnecessary intrusion into private
matters. In practice, it will be difficult to regulate investigators ex-
cept by prohibition of a pledge of confidence given the difficulty of de-
ciding what information is essential to the inquiry on the one hand and the
fact that extraneous confidential information is offered by participants
on the other.
as extraneous information seems arbitrary and not in their interest, given
First, the capacity to protect confidentiality is
For that reason some as-
Investigators may seek to acquire more information
To refuse to protect participants who offer what is regarded
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what for many must be a very limited understanding of what lies within and
what lies without the approved domain.
The major means for regulating the promise of confidentiality is to
require that it not be utilized when there is some alternate means that
will permit the acquisition of information while protecting the anonymity
of participants from everyone, including the investigators. Absent that
possibility, whenever possible, restriction should be imposed on the number
of persons that may be privy to private matters and the length of time
that uniquely identified information is accessible for disclosure.
these matters are vulnerable as we have already noted, e.g., to testimony
when physical evidence is destroyed but testimonial evidence remains viable.
Yet even
In brief, then, a pledge of Confidentiality seems essential whenever
participants regard it as a condition of providing essential information, (1)
whether or not at law it is a private matter;
cannot he elicited and usefully analyzed with the participants remaining
anonymous;
the collective or public interest.
tiality should be given or required when there is no possibility for personal
harm on disclosure of information or when the objectives of the study can
be accomplished by strictly anonymous procedures. Whenever one restricts
the chain of information, however, a promise of confidentiality must be
given if there is, risk of harm, though in the interest of protection from
disclosure one may want to impose restrictions on acquisition of uniquely
identifiable information by members of the chain.
Risks in Protection of Confidentiality.
(2) whenever the information
and whenever the pledge is not clearly substantially damaging
Correlatively, no promise of confiden-
We have noted on numerous oc-
casions that the major harm from behavioral science inquiry follows from
the fact that information is socially powerful and damaging. When information
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is used on private matters it may damage the interests or welfare of those to
whom the imformation obtains. Now since the major risk from disclosure comes
either from unauthorized or illegal misuse or from compulsory disclosure,
harm will rarely occur if one is protected from these sources of disclosure.
We turn to guaranteed forms of protection from these forms of disclosure in
Section IV.
There are, nevertheless, some other problems related to protection from
Some of these arise from the nature of analysis and publication
For the most part, the analysis of data and publication of re-
disclosure.
of results.
sults in behavioral science inquiry is interested in aggregative information.
There is thus little risk from disclosure apart from the eliciting and early
processing of information unless for some reason the data are to be retained
There are conditions under with unique identifiers for subsequent analysis.
which one may do so apart from an interest in longitudinal or panel studies
where uniquely identified individual or corporate actors are followed for
extended periods of time. Some behavioral scientists have an interest in
deviant case analysis. Correlation is always far from perfect and explana-
tion is often incomplete and unsatisfactory.
tifiable information with the opportunity to either add information to it
or undertake a different form of analysis is extremely useful in trying to
understand one's failures at explanation and in seeking leads for future in-
quiry. For these reasons the simple notion that one should eliminate unique
identifiers as early as possible and not retain them so that information can
be recaptured a terms of them seems often unwise.
By returning to uniquely iden-
The case history and case study techniques of inquiry and reporting are
perhaps more vulnerable to disclosure of information than other forms of
25-104
analysis since they rely very much on retaining at least minimal unique iden-
tification for the information--separation of identifiers from the informa-
tion but a capability for matching them.
identities are at stake in such inquiry and in much evaluative research.
Since often considerable information is published on a case basis, efforts
are made to protect confidentiality by alteration of identifying character-
istics, etc., but unless the investigator has been able to keep confidential
the identities of all participants, alteration of identifiers may be a weak
form of protection, given the limited knowledge one may have about what in-
formation others possess that might permit then to make a unique identifica-
tion.
case information, the greater the risk of disclosure.
to be true for corporate than individual actors as previously noted.
Both individual and corporate actor
Thus the more one disaggregates information or publishes particular
This is more likely
Types of Information to be Protected. There are four principal types
of information that must be protected where a promise of confidentiality
has been extended.
against breach of confidentiality and both informant and investigator types
of information must be protected if confidentiality is to be protected.
The four types of information requiring protection are: (Nejelski and Peyser, 1975:
B-37-41):
tions with a subject; (3) direct observations of subjects; and (4) work
product.
Both participants and investigators must be protected
(1) identity of the research subject; (2) contents of communica-
(1) Identity of the research subject. The identity of individual and
corporate actors depends both upon unique identifiers or a combination of
identifiers that result in a unique identification. We have already dis-
cussed the status of unique identifiers such as fingerprints, voiceprints,
25-105
and photographs in behavioral science research and others may arise in bio-
medical inquiry.
identified information is that a number of identifiers permit unique identi-
fication. There is, for example, in a given instance only one person who
is of a given race, sex, age, income, and first name at a given apartment
at a given address.
essary for a given unique identification in a given case, e.g., when there
is a one person household at a given address that is the only household at
that address.
is problematic in the law of evidence so that what is uniquely identifiable
information for behavioral scientists would not be regarded as meeting a
sufficiency test for conclusion beyond a reasonable doubt at law.
social world is not built on proof beyond a reasonable doubt, and much harm
is done from the use of identifiers to converge toward unique identification.
A formal system of law exists to protect against the doing of harm based on
these forms of unique identification.
sibility either because of unique identifiers or through the convergence of
identifiers, and a promise or need for its protection exists, that informa-
tion must be protected whether for an individual or a corporate actor.
But an equally likely possibility for obtaining uniquely
I note that even fewer of these may be all that is nec-
The problem of unique identification from a set of identifiers
Yet the
Where unique identification is a pos-
(2) Contents of communications with a participant. Identifiers do
not exist simply in the form of characteristics of individual or corporate
actors but in the contents of their communications.
what specifically was disclosed to the investigator can lead to a unique
identification, since that person, and that person only, was privy to that
information or is responsible for it. As Nejelski notes, one reason for
protecting the contents of communications from a source is the practical
Not uncommonly, knowing
25-106
difficulty "...in distinguishing between the information per se and informa-
tion that would reasonably reveal the identity of the sources" (Nejelski
and Peyser, 1975:B-39).
of communications might be more important for corporate than individual
actors, but in the aggregate more individual than corporate actors might be
so protected given their relative numbers in a population of participants.
We would think that the protection of the contents
(3) Direct observation of participants. Access to individual and
corporate actors to observe their behavior, including illegal behavior, is
essential to some kinds of inquiry.
even when it has not been possible to obtain prior consent.
some circumstances, as previously noted, one does not obtain consent for
the observations but nevertheless records them.
be directed to record the race and sex of a person without direct inquiry or
to record whether or not the subject appeared to be truthful or cooperative,
and so on.
reliability of behavioral science studies and should be protected.
Those observations must be protected
Indeed, under
Thus the interviewer may
Such observations are essential to improving the validity and
(4) Investigator's work product. During the course of a research in-
quiry, much work product is produced that potentially would permit the dis-
closure of confidential information.
and every effort will be made to insure that any final work product is free
of the possibility of disclosure. Yet during the inquiry some work product
may inevitably permit disclosure. We might, for example, have a computer
output prepared that disaggregated information to a given level on the pre-
sumption that there is sufficient numbers of cases to do so and provide con-
fidentiality.
tification is possible.
mediately since there are ways to protect for that particular case (by simple
Such product will never be disseminated
Yet when the output is examined, it is clear that unique iden-
One might not necessarily destroy that output im-
25-107
recombination, for example).
in advance against the generation of work product that would permit dis-
closure of confidential information, it requires protection.
Quite obviously since one cannot always guard
Types of Matters Where Disclosure Is Harmful. Social harm is a conse-
quence of the actions of persons or collectivities against those who are
harmed.
intended, the disclosure of information results in harm whether or not it
is intended whenever its consequences are harmful. At times the same in-
formation causes both harm and benefit. Unfortunately, one cannot always
predict harmful or beneficial consequences and social prediction in many
areas is at best subject to considerable error. What we must rely upon,
therefore, is some notion of the potential for harm resulting from the dis-
closure of any piece of information, while recognizing that the disclosure
of any information on private matters may be both harmful and beneficial.
We shall concern ourselves here only with those kinds of matters for
While harm my occur when it is not intended as well as when it is
which confidentiality must be promised because of their high potential for
harm and low potential for benefit on disclosure. These are all matters
on which behavioral science inquiry seems justified on grounds of public
interest in the inquiry.
ment should be clear from their ennumeration:
They are only briefly ennumerated since the argu-
1. Legal matters where the disclosure of information leads to a legal
proceeding that is harmful to individual or corporate actors, including in-
formation from legally privileged communications and on violations of law
leading to criminal, civil or administrative proceedings and sanctions.
2. Violations of organizational rules and regulations for which there
are organizational sanctions against members.
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3. Conduct that is stigmatized within the larger society or any group
therein who have power to stigmatize conduct.
zation may range from social exclusion and isolation to subtle forms of re-
jection and discrimination.
considerable since stigma can affect the life-chances of individuals.
The consequences of stigmati-
Their potential for harm in any case may be
4. Performance and achievement measures or any related item that or-
dinarily is considered a private matter and its disclosure is regarded as
violating the privacy of the actor.
5. Official or organizational secrets whose disclosure harms the parti-
cipant by altering advantages or reducing benefits; their disclosure can be
the cause of considerable damage.
These are but some of the major types of matters to which behavioral
scientists can and do become privy in the course of inquiry and confidential-
ity must ordinarily be extended and protected if research on them is to con-
tinue. One must take note of the fact that considerable behavioral science
inquiry has occurred on all of these matters without disclosure having be-
come problematic. This is in large measure due to the integrity to all mem-
bers and employees of the research community respecting fully any confidence
given and to the openness and tolerance of the larger society toward that
research community in withholding strong support for compulsory disclosure
of such matters.
Exclusion of Protection for Information Acquired in Research. Both to
constrain investigators from unduly intruding upon the privacy of persons
whose confidence is obtained and to sustain the public interest in and right
to information, some types of information, it is maintained, should be ex-
cluded from a promise of confidentiality and from protection if acquired.
We have already dealt with the question of what might be excluded from a
25-109
promise of confidentiality and deal here with the question of whether there
should be specific exclusion of any matters from legal forms of protection.
The following matters that have been suggested for exemption from legal pro-
tection we shall maintain should be covered.
First, it is argued that information that lies outside the scope of the
project should not be protected if the investigator elicits it and it is
supplied by the participant.
gest, is to punish participants for investigator misdoing.
To leave that information unprotected, we sug-
Second, it is argued that the information participants provide that lies
outside the investigator's promise of confidentiality should be left unpro-
tected.
maintain those distinctions or even to perceive them.
not altogether in control of the activity which takes place when the investi-
gator is present, particularly when consent has been given to enter a pri-
vate place.
sociation" or mere presence in a situation; the disclosure of such matters
is unwarranted.
in providing information once consent is given though investigators should
be obligated to constrain them from offering any information that may be
damaging to either party and that is not essential to the inquiry.
Elsewhere we have suggested that it is difficult for participants to
Moreover, they are
Finally, persons may be damaged by such means as "guilt by as-
We would suggest that particpiants should be fully protected
Third, any investigator acquires information even when subjects refuse
or for some reason fail to participate or comply with what it is that the
investigator seeks by inquiry, including a refusal to grant informed consent.
We have already noted that even a refusal to grant informed consent may be
damaging if known such as the disclosure of refusal of a member of a stigma-
tized group. Within total institutions or any institution that provides for
25-110
the compliance of their members with the inquiry, knowledge of failure to
comply may be damaging and should be protected. Even within a total insti-
tutional setting when informed consent is obtained, such as in a prison, if
the prisoner is released to appear for interview, for example, and fails to
appear as agreed upon, should such information be protected on inquiry from
the warden? These are no simple matters, but there should be no categorical
exclusion of them from protection since in many, if not most, instances such
protection should be afforded if behavioral science inquiry is to be sustained.
Indeed, one might make a reasonably compelling case that all information
except that relating to potentially great harm at some future time should be
protected from disclosure whether or not it was made a matter of confidence
in securing informed consent. The reasons for this argument are several.
1. It is difficult to prove matters of what both subjects and investi-
gators intended and understood and what and what not are the specific matters
to be protected by agreement. More harm may be done from just such misunder-
standing than would be done by full protection.
2. Where information is acquired because investigators exceeded their
authority, participants should not be punished for their failures.
3. Since there is considerable variability among the participants in
many studies in their levels of education and other skills, it is unreason-
able that they will be able to specifically monitor what can and cannot be
said or done with a given agreement.
4. Finally, absence of protection would likely generate patterned eva-
sion on the part of investigators; much more attention would be given to ex-
cluding from the record information that was acquired lest it be considered
extraneous and jeopardize the collection and retention of other information.
25-111
While such evasion might well be desirable in that it protects such informa-
tion from disclosure, as a matter of record, it is still unprotected testi-
monial evidence.
cularly since such screening must often be delegated to employees whose train-
ing in what to include and exclude is far from ideal.
It may well affect the quality of information also, parti-
There are conditions under which investigators should have full protec-
tion to keep information confidential that was acquired through explicit
agreement in eliciting informed consent and that which was not even though
the investigator is not in a position to protect against its disclosure.
That is investigator warrant only that they keep confidential the information
as they acquire it but not to guarantee anything other than that they will
not be the source of disclosure.
upon the investigator to remind participants that others than the investiga-
tor may be the source of disclosure.
At the same time, some obligation falls
There is likely to be misunderstanding about what it is that investiga-
tors agree to and can protect.
tion they acquire from their being an agent of disclosure.
reasonably adequate guarantees of that protection only when they have legal
protection against its compulsory disclosure and strong sanctions to protect
it from illegal or unauthorized misuse.
all to quick to conclude that what is being guaranteed is protection from
its becoming public knowledge, forgetting that the only protection afforded
is that the investigative agent agrees not to be an agent for its disclosure,
This is no simple matter in securing and protecting informed consent since
participants are all too easily confused in such matters and some protection
must be afforded in the face of their possible confusion.
Investigators can protect only the informa-
They can offer
Yet participants and others are
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Let us return again to our elementary Human Subject model of a single
investigator and single subject.
formation can be such that if it
anyone else, or if in fact only the
tervention on the subject, protection against disclosure is a likely event.
Yet if both subject and investigator share the information, either may be
the agent of disclosure.
modes of confidence including other agents who have and can afford protec-
tion.
dentiality promised, it can apply only to the agent and disclosure from
others is problematic.
science research where the information derives from group settings or corporate
actions. Whenever
case in behavioral science inquiry, disclosure is possible without involving
the agent investigator as the source of that harm.
perceived to be the source of that disclosure when in fact he has been a pro-
tector and has no way of demonstrating that he has not been the agent of dis-
closure.
there are no compelling or other reasons why he should have been its agent.
Given the fact that disclosure is possible from more than one source in many
kinds of behavioral science inquiry, it is incumbent upon investigators to
advise persons from whom potentially harmful information is sought that the
protection they offer--if legal or other protections are afforded--provides
no guarantee against its disclosure by others.
acquire confidential information in group settings or when third parties are
There the acquisition of confidential in-
never has been or will be communicated to
investigator acquires it through his in-
The subject may even do so by sharing it in other
Yet in many situations where informed consent is elicited and confi-
This is particularly true in some kinds of behavioral
there is a third party to confidence, as is often the
Paradoxically, he may be
The most that tan be done in such instances is to demonstrate that
Clearly when investigators
present, they have an obligation to inform that anyone present other than the
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investigator is a potential source of disclosure (unless they are covered
by the investigator's privilege, e.g., as employees).
Types of Methods Presenting Special Problems for Protecting Confiden-
tiality.
their capacity to provide anonymity in the eliciting process and analysis
phases of inquiry. Here we shall focus on some special problems that be-
havioral science methods present in eliciting and protecting confidential
information.
We have observed many times that methods vary considerably in
1. Techniques for the self-reporting of behavior. These techniques
include a wide range of tests (e.g., achievement or performance measures)
questionnaires and scales (e.g., items in a masculinity-femininity scale or
personality test), and interviews, among others.
is whether and how the technique is linked to unique identification. Where
unique identification is possible, protection is especially critical, since
self-reports of behavior have considerable evidentiary value, more so than
might ordinarily be the case when they derive from an impartial inquiry such
as research.
havior are elicited, the government is obligated to provide legal protection
if it sponsors the inquiry.
government assumes certain obligations if it sponsors inquiry for eliciting
confidenttal information, not the least of which is an obligation to provide
legal protection for that which is confidential and potentially harmful.
The critical matter here
Where self-reports of illegal or other damaging forms of be-
Parenthetically, we might note here that the
2. Direct observation and recording of behavior. Again the evidentiary
value of such information is considerable, particularly when it has unique
identifiers such as in audio-visual recording.
from direct observation and from direct recording (e.g., tape-recording or
Both information obtained
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video-tapes) require special protection and special obligations to insure
its protection.
nique since the participant observer acquires information by virtue of posi-
tion that might otherwise be disclosed as confidence but at the same time
has a special status in providing testimonial evidence--as observer and as
scientific observer. Direct observation poses especially difficult problems
where entire groups rather than individuals are under observation since they
are especially vulnerable, as previously noted to the disclosure of informa-
tion from a large number of potential sources.
The participant observer is an especially vulnerable tech-
3. Investigator intervention in social situations. When investigators
intervene in situations and that intervention itself gives rise to confiden-
tial information that is shared by all persons in the group (as in guided-
group interaction techniques of intervention), the investigation has a special
burden:
quate to forestall disclosure of information, particularly since group pro-
cesses of sharing information--rumor, gossip, e.g.,--have their own dynamic
elements.
these circumstances the confidential information is created by the research
intervention and others become party to it because of the nature of that in-
tervention.
privy to the information.
using guided-group interaction techniques with a group made up of alcoholics;
under both interventions from the investigator or his agent or other members
of the group, confidential information is disclosed and necessarily shared
by all.
group techniques pose but simply note that they have enormous power to induce
whatever legal protection is afforded an investigator may be inade-
The problem poses a special moral or ethical dilemma since in
Indeed, but for the intervention, other parties might not be
By way of illustration, imagine an experiment
We shall not review in depth here the special problems that such
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confidential information that persons would not otherwise disclose; at the
same time such processes have a potential for doing harm to participants
that cannot be predicted.
elicit information as well as to produce a separate result--such as group
therapeutic or interview techniques--require special examination because
they are both a potential for harm and a potential for harmful disclosure.
Interventions that are particularly designed to
4. Informant and relational techniques. A surprising number of be-
havioral science techniques are based on a model not only of self-reporting
but of informant reporting.
directly, e.g., what did your mother do then? or to describe relationships
that necessarily supply information on others indirectly, e.g., did your
father and mother have a quarrel over that?
The subjects are asked to report on another
We call special attention to
the fact that any technique which elicits information on social relationships
not only poses problems of eliciting informed consent as noted earlier, but
special problems of protecting confidences that were not secured by informed
consent.
tained but they most qualify the extent to which anyone who supplies the
information has a right to request its disclosure.
formation about relationships when they become implicated in a research in-
quiry that developed it as an item of information is that it involves rela-
tionships between the parties to it and the investigator who structured it
as "relational information".
"was your father working at this time?"; "how much education does your mother
have?" and many more intimate questions than these provide information on
persons related to the participants being studied or on their relationships.
whenever such information is elicited, investigators have a special obligation
They pose special problems not only because consent was not ob-
The very nature of in-
Thus questions like: "do you hate your mother?";
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to protect that information from harming the other parties as well as the par-
ticipant who gave informed consent from disclosure.
We note in passing that behavioral science research can provide complex
problems of protection of informant information. Suppose, for example, one
wished to study an informing process by investigating police use of inform-
ants in law enforcement, securing the confidence of both the police and their
informants. Without legal protection for confidentiality the study would be
impossible, yet it must rank as a rather high priority in understanding an
important problem in the study of police practises and their effect on in-
stitutions of privacy.
5. Sociometric techniques. Sociometric techniques, as noted earlier,
pose special problems in securing informed consent; they also pose problems
of special protection since disclosure of information on any person in the
network is potentially harmful to all others. Thus studies of delinquent
gangs, gay bars, a military squadron, and similar phenomena pose problems
of special protection of confidence.
6. A case history of technique. Any study employing a case history
technique that requires the retention of information that is uniquely iden-
tifiable over a long period of data collection and analysis must be specially
protected since it is more vulnerable to both unauthorized and compulsory
disclosure.
destruction of identifying information require both that special precautions
be taken to protect the processing and storage of information and that special
forms of legal protection be available if disclosure of the information is
The use of techniques that preclude the complete and early
potentially harmful.
The Need for Formal Punitive Sanctions as Protection. The more biomedical
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and behavioral science inquiry is organized to include investigators and
employees, each of whom undertakes one or more specialized tasks, the more
administrative control that must be exercised and the less likely profes-
sional ethics, commitment, and self-regulation can be counted upon to pro-
tect confidentiality.
tect the confidentiality of information from those outside the research or-
ganization who might seek access to it but its unauthorized or illegal use
by employees. A typical survey research study, for example, might involve
more than a hundred different employees who could have access to confidential
information. Others may also have access to it who are not employees, such
as student trainees and assistants who volunteer their services in exchange
for training.
The more
Not only must greater precaution be taken to pro-
potentially harmful the disclosure of confidential information,
the greater the obligation for its protection. Where serious harm could re-
sult from its disclosure, investigators or sponsors must have access to for-
mal sanctions for any unauthorized disclosure or misuse.
regulations for the protection of confidentiality of identifiable research
and statistical information make provision for sanctions.
vides (28 CFR):
The proposed LEAA
Section 22.29 pro-
"Where LEAA believes that a violation has occurred of Section 524a, these regulations, or any grant or contract conditions entered into thereunder, it may initiate administrative actions leading to the termination of a grant or contract, commence ap- propriate personnel and/or other procedures in cases involving Federal employees, and/or undertake appropriate legal actions leading to imposition of a fine not to exceed $10,000 against any person responsible for violation."
Any employee of any investigator hence is subject to a fine of $10,000
if he/she in any way knowingly violates the protections provided for confiden-
tiality of identifiable research and statistical information. Should
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investigators seek to safeguard confidentiality of identifiable information
where persons who are not ordinarily employees might be given access to it,
such protection is easily afforded by nominal appointment ($ a year appoint-
ment, for example) as an employee.
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IV. MINIMIZING RISK FROM DISCLOSURE OF CONFIDENTIAL MATTERS
The main risk of harm in much behavioral science inquiry stems from the
disclosure of private matters to which socially harmful responses are then
made.
sent and its documentation can pose risks to participants when that simple
fact is disclosed.
able information results from the procedures required to accession subjects--
they ordinarily are not volunteers--and from the procedures for acquiring,
and processing information.
possible not only if there is risk of harm but if the participants desire
its protection for any reason whatsoever.
often become privy to private matters that are not intended by the mode of
accessioning participants or by eliciting procedures; acquiring information
often is an unintended consequence of the necessity for gathering data in
social situations that have a dynamic life of their own.
these unintended matters may also harm individual and corporate actors and
the risk of their disclosure must be minimized if behavioral science inquiry
is to continue as a vital form of scientific inquiry in the public interest--
an interest that is minimally presumed whenever government sponsors research.
We shall examine briefly some modes for minimizing risk from disclosure,
focusing particularly, however, on forms of legal protection that government
sponsors may provide for inquiry involving individual and corporate actors.
Protection by Anonymity in Accessioning Participants and Eliciting In-
We have pointed out that even the mere refusal to grant informed con-
For many kinds of inquiry, moreover, uniquely identifi-
Such information should be protected insofar as
Finally, we noted that investigators
The disclosure of
formation.
and eliciting information that minimize risk because they ipso facto insure
anonymity. These have been discussed briefly in general terms.
There are many different techniques for accessioning participants
No specific
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catalogue of them is presented here. We Previously indicated that two rules
might well apply when there is risk of harm from disclosure of information-
provided that disclosure is not a matter of formal contract, as it may well
be in much evaluation research. These rules may be stated:
1. Information that may cause harm if disclosed should not be collected
unless it is necessary to the particular inquiry;
When the objectives of a particular inquiry will not be undermined
by either accessioning participants anonymously or by anonymous
procedures for eliciting information (or both), they should be
required over any other procedure of accessioning or elicitation.
2.
Yet, as we have noted, there are distinct limits to the use of such
anonymous procedures. Among those we have mentioned are these:
fying information is necessary to increase the validity and reliability of
information and to estimate error in information;
tion is necessary for many designs that measure changes in the behavior of
individual or corporate actors; (3) identifying information, and even its
disclosure, may be necessary in evaluation research;
formation is necessary to some eliciting and data gathering procedures that
are essential to a particular form of inquiry; and
tion is necessary when information from independently derived sources must
be collated, e.g., information derived from interviews and records of past
behavior are brought together for the same individual or corporate actor.
The last is not exhaustive but uniquely identified. Several rules may be
stated with respect to safeguarding uniquely identified information from
disclosure:
(2) identifying informa-
(4) identifying in-
(5) identifying informa-
not be collected unless they can be demon-
strated to be essential to the particular inquiry.
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(1) identi-
1. Unique identifiers should
2. Similarly, identifiers that, when taken collectively, provide unique
identification should not be collected unless they are essential
to a particular inquiry.
Any identifiers should be separated from any information sources
as soon as they no longer are essential to an inquiry; identifiers
should then be destroyed unless it is demonstrated that they are
necessary to some later stage of inquiry.
All information on identifiers that may be linked to information
and all information that has a potential for unique identification
should be physically protected from access by anyone other than
authorized personnel.
gators should be legally obligated to provide such physical pro-
tection when there is risk of harm from disclosure.
3.
4.
Institutional sponsors and principal investi-
(28 CFR 22.23;
(5); 42 CFR 2a4:(C)).
5. Access to uniquely identifiable data "shall be limited to those em-
ployees having a need therefore, and that such persons shall be ad-
vised of, and agree to comply with these regulations" (28 CFR 22.23:
(2)).
6. Provision shall be made for the final disposition of any identifiable
materials either by their complete destruction upon completion of a
research inquiry or by separation and destruction of any identifiers
or by provision for maintaining their security to make possible
longgitudinal or continuing studies (28 CFR 22.25).
is called to the fact that unique identifiers pose special problems
for retention, particularly when each bit of information has unique
identification as it does in tape or video-tape recordings.
Special attention
More
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stringent criteria for protection retention must apply to the retention of
unique identifiers.
sponsors have responsibilities under the Freedom of Information Act to notify
and make accessible records that are uniquely identifiable, including re-
search records they may acquire from sponsored research. Any transfer of
records with uniquely identifiable information to a government sponsor thus
poses enormous administrative burdens of notification, problems of correct-
ing a record, etc.
Legal Protection for Compulsory Disclosure.
Attention is called also to the fact that, government
The growth of behavioral science inquiry has brought with it the recog-
nition that the information acquired has uses for other than scientific in-
quiry.
journalists often is useful to others as well.
islative, executive, and judicial bodies often find useful information that
is uniquely identifiable and may seek to compel its disclosure to accomplish
their own ends. It goes, almost without saying, that the ends of such bodies
at times not only conflict with those of behavioral science inquiry but taken
collectively they threaten the very foundations of that inquiry by the ways
in which information is used.
Information gathered by behavioral scientists like that gathered by
Law enforcement agents, leg-
The need to protect information gathered in behavioral science inquiry
from use by others is considerable.
research participants have "a paramount interest in keeping the invasion of
their privacy to a minimum and making sure that the information will not be
the basis for prosecution or reprisal." Moreover, investigators have an
interest in maintaining that privacy to insure the continuing participation
of participants and to insure the quality of the information they acquire.
As Nejelski and Peyser (l975:B-1) note,
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Sponsors of research have a similar interest.
there may be conflicting interests--to protect the integrity of the scienti-
fic inquiry by protecting confidentiality but also to compel its disclosure
for its other ends.
terest, The State as Society would seem to have an overriding interest in
protecting behavioral science inquiry from compulsory disclosure both in its
general role of protecting free scientific inquiry and in its more special
one as sponsor of specific research investigations.
When the State is the sponsor,
Yet in the broad rather than in the narrow public in-
There are two major forms of legal protection proposed to protect be-
The first form, that havioral sctence inquiry from compulsory disclosure.
of a statutory privilege, protects from compulsory processes all information
gathered in the course of an individual's research. These statutes are com-
monly referred to as "shield laws".
the State in terms of its general interest in protecting all behavioral
science inquiry from compulsory processes of disclosure.
that of a confidentiality certificate, protects from compulsory processes all
individually identifiable information that is gathered in a particular re-
search study sponsored and funded by the federal agency issuing the certifi-
cate.
sponsor and leaves unprotected any investigation where the government is not
directly implicated as sponsor. It is obvious that a statutory privilege,
since it offers general protection, has more far-reaching implications for
the development of behavioral science than does the confidentiality certifi-
cate.
They are designed to meet the needs of
The second form,
This form of protection meets the needs of a particular research
Each is now considered in somewhat greater detail.
Statutory Protection.
There are at the present time few federal and state statutes that are
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specifically designed to protect research investigators or research informa-
tion and activity.
1975: B-20-21) concludes that these statutes provide protection for only a
small minority of all behavioral science investigators and investigations.
They conclude, moreover, that there are major drawbacks to the limited and
specific protection offered by current statutes, including those that provide
a limited privilege for a given kind of research, such as drug research.
Apart from the fact
the community in
discretion of officials for extension of the protection. As Nejelski and
Peyser observe (1975:B-21):
that researchers be "licensed" before they receive protection, could severely
threaten the freedom of researchers
quiry".
inquiry is much less well protected by statutes granting privilege for a
A recent review of these statutes (Nejelski and Peyser,
that they afford protection for only a small segment of
need of protection of confidentiality, some depend u on the
"Such discretion, as well as the requirement
to pursue controversial avenues of in-
The point is that the general interest of society in free scientific
specific inquiry than by one that extends it to all qualified investigators
We do not propose to discuss here in my detail proposals for a behav-
ioral science investigators shield law.
statute proposed by Nejelski and Peyser (1975:B-9-11).
examine some of the issues that are
resolution of these
behavioral science investigators,
thereto. With them, we define the major issues to be those of who is to be
covered by the statutory privilege, to what matters shall the privilege ex-
tend, what is the scope of the protection, including possible limitations,
An example is provided in the model
Rather, we shall
raised by statutory protection and the
Nejelski and Peyser provide in a model shield law for
together with some of the reasons pertaining
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and their research activity.
who may invoke the privilege, and right of waiver.
Who is to be covered? Nejelski and Peyser (1975:B-31-32) observe that
there are four principal ways of defining who is to be covered.
is to simply name a category such as behavioral scientists, leaving undefined
who is a behavioral scientist.
that must need be settled by litigation.
privilege to certain kinds of information, such as particular kinds of re-
cords. This is the least ambiguous of all definitions of coverage but un-
fortunately leaves many kinds of legitimate inquiry without protection.
might add that statutes that grant discretion to officials to decide what
is to be covered by limiting it to a specific inquiry have a similar limita-
tion.
protected and a specific type of research activity, such as might be the
case in granting protection to all persons who are engaged in research on
the use and effect of drugs (be it noted as is the case now with federal
legislation limiting that privilege to investigations under federal sponsor-
ship). The advantage of this approach will depend upon the extent to which
it can effectively cover a sufficiently large number of categories of re-
search so as not to unduly restrict inquiry. The fourth approach is what
Nejelski and Peyser identify as the functional approach and the one they
use for their model statute.
all individuals who perform a particular role in a specified way.
proach, they note, has the advantage of covering all individuals in all fields
of inquiry including biological and natural as well as behavioral sciences
if their activities conform to a specified pattern of behavior. Moreover,
a functional approach extends the protection to all individuals involved in
The first
Such an approach involves serious ambiguity
A second approach is to extend the
One
The third major way is to specify a relationship between the person
The functional approach confers protection on
This ap-
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the research process, not simply to those who actually elicit information
from individuals.
is followed in some of the proposed federal regulations for confidentiality
certificates, the alternative approach discussed later.
I note parenthetically that a limited functional approach
In considering the matter of what role, is to be covered in what speci-
fied way, a number of issues arise. The problem of who is a behavioral
scientist investigator is an especially difficult one since any mode of
resolution by statute has limitations.
licensing authorities who may serve as gatekeepers. To require particular
affiliations has similar limitations. To resolve the matter, Nejelski and
Peyser propose to sacrifice specificity and precision "...to accommodate
all those who have a bona fide involvement with research activity".
extend coverage to all individuals who in some way deal with information
"obtained employing principles recognized or standards accepted in the field
of inquiry" (1975:B-33).
Licensing poses problems of creating
They
A statutory protection must conform, of course, to the requirement that
the research activity have a public benefit, to square the statute, as
Nejelski and Peyser note, (1975:B-34) with the First Amendment.
To What Matters Shall the Privilege Extend? A general statutory privil-
ege protecting research investigators from compelled discolsure of informa-
tion would exempt investigators from their civic obligation to provide evi-
dence in civil and criminal proceedings only when the information sought was
obtained from research activity.
information handled 'in the course of' research activity" (Nejelski and Peyser,
1975;B-35) to make certain that investigators are not covered for material
obtained in their other roles.
The statute should restrict coverage "to
There will, of course, be grey areas in the
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use of some behavioral science techniques with this provision, such as in
participant observation where the research investigator has difficulty de-
termining when research activity begins and ends as, for example, when a
participant observer lives in a community to investigate compliance and
conformity in it.
Any general statute should extend protection from compelled disclosure
to all information that is obtained in the course of the research inquiry
whether or not it is specifically covered by the research design and whether
or not it is a matter of implicit or explicit promise in securing informed
consent by promising confidentiality. This is a critical provision in all
forms of protection from compelled disclosure.
broadly this provision might apply and why it is essential. Suppose one is
doing a sample survey of people's attitudes toward child abuse and has con-
sent to enter a private place to conduct the interview and the informed
consent of the participant to interview about these attitudes. Now suppose
that during the course of the interview the respondent punishes the child
in such a way that it might well constitute child abuse.
suppose that in a judicial proceeding information in sought from the inter-
viewer on that incident of "child abuse".
disclosure? Our answer is that it should be for a number of reasons shared
also by Nejelski and Peyser (1975:B-35-36).
An example may show how
Let us further
Should it be exempt from compelled
First, any participant's interest in keeping the invasion of their
privacy to a minimum and in insuring that any information they provide either
orally or otherwise will not open them to prosecution or other possible
harm from disclosure can be fostered only when the protection of the statute
does not rest in a promise of confidentiality.
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Second, while serious ethical issues can be raised in particular in-
stances about granting such protection, the protection of any person should
not depend upon the fortuitious circumstance of whether or not the investi-
gator explicitly promised confidentiality for given information.
had occasion to note previously, any extension of confidentiality often is
regarded by participants as a trust relationship--they come to have confi-
dence in the interviewer as the relationship proceeds and even any explicit
statements of exemption made in securing informed consent may come to be
"forgotten" as trust develops. Such risks are generally less where the
relationship is of short duration as with some research techniques, but
as in others, e.g., prolonged observation or treatment, the trust relation-
ship may become considerable. It is difficult for research investigators
and participants to avoid those elements of trust and participants should
not be placed in jeopardy because they either disclose or behave in ways
that provide information that is potentially harmful to them.
As we have
Third, there are a number of modes of inquiry that often preclude ex-
plicit or implicit promises of confidentiality because of what they are
measuring, as we have noted before in tests of personality or of qualities
such as prejudice and discrimination, as will occur in direct observation
of human behavior, and as in the study of social relationships.
as noted before, study social relationships without becoming privy to informa-
tion about others whose consent was not obtained and who deserve the protec-
tion of confidentiality.
husband is not the only party subject to protection; her husband is as well
if that information is also potentially harmful to him.
One cannot,
A wife who talks about her relationship with her
Finally, it should he noted that if any statute were to be open to
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considerable litigation as might well be the case when what is at stake
was what is and what is not covered by the privilege, it will lose its
protection and the benefits to scientific research that it is designed
to provide.
formation that was not a specific matter of consent will open the protection
to just such damage.
We would maintain that an exclusion from protection of all in-
We shall simply note here that matters we have previously discussed
must also lie covered by any viable shield law: (1) the identity of the sub-
ject, whether by unique identifiers or other means of unique identification,
including the specific knowledge that they were approached and refused in-
formed consent since that may be damaging;
cations with any participant, any information acquired through direct or
indirect modes of observation, and the work product of investigators.
reasons for being sure these are protected have already been provided.
(2) the contents of all communi-
The
What Shall Be the Scope of the Protection and any Limitations? There
are a number of reasons, as Nejelski and Peyser note (1975:B41-42), why it
is not quite appropriate to regard a research investigator privilege as
either absolute or qualified.
provide the maximum possible protection, given the ever present problem that
the "law is what the courts decide". The question of maximum possible pro-
tection perhaps is best approached by answering the question of the circum-
stances under which the privilege will be divested while seeking the maximum
possible coverage.
Those matters aside, ideally one wants to
There are many types of proceedings to which the privilege might apply,
including legislative, executive and judicial proceedings.
investigative and adjudicatory proceedings.
They include
While it can be maintained that
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investigative proceedings are potentially more damaging than adjudicatory
proceedings and the privilege should extend only to the former, particularly
if the identity of the participant or source of information is specifically
excluded in adjudicatory proceedings--in short, that a qualified privilege
extend to the contents of communication. There is considerable risk in
trying to maintain that distinction and a simple example may show why.
one to report that all of the participants in a given inquiry were, say,
drug users and were it known from some independent source that a given person
was a participant in the study, identity remains unprotected.
qualified statements about subgroups can similarly lead to disclosure.
note, parenthetically, that investigators have an obligation to protect iden-
tity in the manner they report research results and that if statements are
made of the sort above, they risk exposure of identity.
Were
Even more
I
Quite clearly, all compulsory proceedings, whether legislative, execu-
tive, or judicial, should be covered if maximum protection is desired. The
language of the proposed protection of identity in human subject research
of DHEW might well apply to a general statutory privilege:
ized may not, at any time, be compelled in a Federal, State or local civil,
criminal, administrative, legislative, or other proceeding to identify the
research subjects encompassed by the Certificate, except in those circum-
stances specified..." (matters of waiver) (42 CFR2a7:(a)). Note that the
scope extends here to all levels of jurisdiction, a matter that clearly re-
quires separate legislative authority.
"Persons...author-
The matter of whether there should be further qualification dependent
upon other overriding interests is also at stake in a statutory privilege
whether general or specific. Among the major overriding interests often
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considered are those of national security, law enforcement, prior crimes
and future crimes.
inclusion or exclusion.
arguments against qualification for information relating to national security,
law enforcement, and prior crimes, arguments that appear to this research
investigator as compelling. There is agreement, however, that information
on further crimes should be subject to compulsory disclosure, particularly
for the more serious or heinous crimes.
We shall not review the arguments for and against their
The reader is referred to Nejelski and Peyser for
There are, finally, some issues of a statutory privilege for research
investigatory interests conflicting with constitutional interests and other federal
or state statutes.
some of which is given by Nejelski and Peyser (1975:B-48-55).
note here only of the real possibility that a criminal defendant should not
be violated by any statuatory privilege.
contents of communications as well as specific identity of sources are ex-
cluded by statute it violates a defendant's Sixth Amendment interest--the
right of the accused in criminal prosecutions to have compulsory processes
for obtaining witnesses in his favor. The researcher privilege previously
mentioned covering the content of communications in criminal prosecutions is
therefore potentially in conflict with the Sixth Amendment rights of persons.
Because the research investigator's privilege status tests in the First
Amendment interest in providing the public with information, the statute
provides the possibility of conflict between two constitutionally protected
interests. A defense subpoena permitting the defence an exception "...opera-
tive only if the defendant is acting in good faith in requesting the contents
of communications or observations of the researcher"
These matters would require an extended discussion,
We would make
There is some risk that if the
(Najelski and Peyser,
1975:B-49) may therefore be necessary in balancing First and Sixth Amendment
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rights. There should, however, be no exception to the provision that the
identity of all research participants be protected and if, therefore, the
effect of disclosure of contents is to disclose the identity of participants,
the protection of identity of subjects should be overriding.
We make simple note in passing that both the Federal Reports Act and
the Freedom of Information Act are federal acts that would need to be ac-
comodated to the kind of proposed federal statute as described in any
federal statute.
Who May Invoke the Privilege? A central issue in invoking the privilege
is who assumes the burden of proof for qualification.
upon the person asserting the privilege or upon the party requesting the in-
formation.
would require some form of proof that the information sought is research
data as defined by the statute while placing it upon the party requesting the
information requires proof that what is sought are not research data. Any
failure by the requesting party to sustain this burden means the privilege
is automatically effective.
should perhaps fall upon the party asserting the privilege, the most compelling
being that if the privilege confers the broad coverage deemed necessary for
effective protection, it should be relatively easy for investigator's to in-
voke the privilege and the burden should therefore fall upon the investigator.
It can be placed either
Placing the burden of proof on the person asserting the privilege
There are a number of reasons why the burden
Nejelskli and Peyser (1975:B-56) also note that the research investiga-
tor's privilege can be further strengthened if the situations in which a sub-
poena can be issued are carefully circumscribed by statute.
Who May Waiver Privilege, When and How? The proposed statute is designed
to provide maximum possible protection against compulsory processes of
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disclosure of the identity of participants in research and any information
connected with research activity.
there should be any power to divest the privilege by voluntarily disclosing
privileged information.
that the person who provided the information should have the right to divest
the privilege.
when it is kept in mind that the power to waive any privilege is to provide
substantial control over its exercise.
however, both participants and investigators acquire some right in the in-
formation and its disclosure.
the greater stake in the information, that of the investigator is not insub-
stantial. The investigator has obligations to protect information that per-
tains, at the same time, to others as well as to the participant and to pro-
tect the integrity of the specific inquiry which might well be damaged were
disclosure to take place, e.g., while the investigation is still in progress.
The question arises, however, whether
On the face of it, there is compelling argument
Yet the matter of divesture is more complex, particularly
Whenever information is provided,
While the research participant clearly has
One way of balancing these rights is to require that both the partici-
pant and the investigator must voluntarily divest themselves of privilege,
a resolution opted for by Nejelski and Peyser (1975:B-60). There could be
some qualification on the investigator's right, however, by providing that
he has the right to withhold consent only on proper showing of its potential
damage to the investigator or others if disclosed.
Lest considerable damage be done to the statutory privilege on compul-
sory disclosure by an absolute right of the research participant to voluntary
waiver, provision should be made to limit waiver to only certain situations,
The one obvious condition is to when waiver should apply is that when the
party or parties who are empowered to waive the privilege can do so only in
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response to a subpoena or other legal process.
information, whether by the parties to the research activity or by others,
should not dissolve the privilege.
government agencies, for example, would not have access to specifically iden-
tifiable information or the identity of participants, including access for
audit or as a research sponsor.
respects is not unimportant, and, as we shall later note, those powers are
reserved in granting a confidentiality certificate.
Any other disclosure of the
Unless specifically exempted, then,
The role of the government in these latter
Earlier we noted that the presence of third parties makes it difficult
to protect confidentiality, since they are always potentially a source of
disclosure of confidential information.
science inquiry there are third parties present.
should not divest the privilege of confidentiality, however, as Nejelski
and Peyser conclude (1975;B-60-61): "Logically, the presence of a disinter-
ested third party would destroy confidentiality at the outset."
researcher's privilege as provided in the proposed statute...is not based on
confidentiality.
formation revealed in the course of a direct conversation between the pro-
fessional and client. The researcher's privilege protects information ob-
tained by the researcher employing techniques that involve methods other
than direct communication...If the privilege were automatically waived when
a third disinterested party was present, the protection given in the men-
tioned situations would be meaningless."
Yet inevitably in some behavioral
Their presence, however,
But, "The
In addition, the professional privileges protect only in-
These, then, cover the main elements and reasons for them in a general
statutory privilege protecting research investigators and their participants.
There are good reasons to maintain that such protection should be afforded
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all inquiry where human life is involved, whether as individuals or col-
lectively.
might not be taken.
legislative activity by the Federal government and the States.
be far from uniformity in the enacted statutes adopted by states and such
protection might be long in coming. While it might be commended as a long-
run strategy for protection since it provides protection for all legitimate
scientific inquiry on human beings and their social life, in the meantime
there also is a need for protection. The role of government in fostering
the right of the public to information, moreover, is clear and unmistakable
when it is the research sponsor. We turn, therefore, to the ways that the
federal government may protect confidentiality in its role as research
sponsor, dealing specifically with protection through the discretionary
granting of confidentiality certificates. Before doing so, we simply note
that the federal government can do so in other ways. It may, for example,
provide protection for a given kind of research categorically specified at
law. This is done, for example, at the present time, for some research on
drug use.
interplead in a given proceeding, and so on. We shall focus on the confi-
dentiality certificate, however, because of its special status in proposed
federal regulations by DHEW (42CFR2a) and LEAA (28CFR22) and note particu-
larly that the LEAA proposed regulations have some advantages for investiga-
tors and participants not now included in the proposed DHEW regulations.
Yet there are both practical and other reasons why this course
Practically, such protection requires considerable
There will
Some protection also is provided if the government choses to
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Confidentiality Certificates.
Privacy Certificate while those of DHEW refer to a Confidentiality
Certificate.
of individuals by requiring that information identifiable to a private
person obtained in a research or statistical program funded by LEAA may
only be used and/or revealed for the purpose for which it was obtained"
(28 CFR22) and "The proposed amendment sets forth procedures under which
persons engaged in research on mental health, including research on the use
and effect of alcohol and other psychoactive drugs, may apply for an
authorization under section 303 (a) of the Public Health Service Act
(42 U.S.C. 242a (a)) as amended by Pub. L. 93-282, to protect the privacy
of the research subjects by withholding from all persons not connected
with the conduct of the research the names and other identifying charac-
teristics of such research subjects." (42 CFR 2a). The certificate, in
both cases, is granted to the institutional sponsor for a proposed study
by a designated principal investigator(s). We make note of the fact that
the LEAA protection has somewhat less scope than that of DHEW, since LEAA
extends the protection to "information identifiable to a private person"
where a private person includes "any individual, partnership, corporation,
association, public or private organization . . . or combination thereof
. . . other than an agency, or department, of Federal, State, or local
government, or any component or combination, thereof" (28 CFR 22.2 (a),
(b)) making it inapplicable to government agencies while DHEW includes
them: "Person means any individual, corporation, government, or govern-
mental subdivision or agency, business trust partnership, association, or
other legal entity" (42 CFR 2a.2(b)).
The LEAA proposed regulations refer to a
The purpose of these certificates is "to protect the privacy
We note in passing that statutory authority, of course, is essential
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to make the issuance of a confidentiality certificate possible.
authority is now provided by the Congress for only a limited number of federal
agencies for their behavioral science research.
Such statutory
Degree of Protection Afforded. In describing the protection afforded
the introduction to the DHEW regulations note (Federal Register 40:234:
56693):
The proposed regulations provide that persons receiving an authorization of confidentiality may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding to identify the research subjects encompassed by the authorization (2a.7 (a)), but that such persons are not authorized to refuse to reveal identifying information where (1) the subject (or, if legally incompetent his guardian) consents, in writing, to the disclosure of identifying information, (2) the medical welfare of the subject would be threatened by a failure to reveal such information, or (3) release of such information is required by the Federal Food, Drug, and Cosmetic Act or the regula- tions promulgated thereunder (2a.7(b)). The purpose of these exceptions is to prevent the protection against compulsory disclosure of identifying information from being invoked the detriment of the research subject.
The regulations also set forth procedures on termination of Confidentiality Certificates. a confidentiality certificate is, however, permanent with re- spect to subjects who participated in research during any time the authorization was in effect.
to
The protection afforded by
In the proposed DHEW regulations research means " . . . any activity
that is intended and designed to establish, discover, develop, elucidate,
demonstrate, or confirm information or procedures.
is not limited to, behavioral science studies, surveys, evaluations, and
clinical investigations " (42 CFR 2a.1(c)).
broad definition to encompass what we have previously addressed as behavioral
science inquiry.
to decide whether a particular inquiry qualifies is left to the Secretary
or other persons to whom that authority is legitimately delegated.
have a somewhat broader definition, providing that "Research or Statistical
The term includes, but
Clearly this is a sufficiently
Yet, it must also be clear, that the discretionary authority
LEAA may
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information--means any information which is collected during the conduct of
a research or statistical project or derived from such information, and
which is intended to be utilized for research or statistical purposes.
The term includes information which is collected directly from the individual
or obtained from any agency or individual having possession, knowledge, or
control thereof" (28 CFR22). Despite this somewhat broader definition,
the published proposed LEAA regulations specifically excluded from re-
search " . . . information which is unrelated to project research and
statistical objectives" (28 CFR 22.23(4) & 22.27(4)). However at recent
hearings on the proposed regulations there was apparent agreement to
eliminate this latter restriction for reasons already discussed in our
protection of confidentiality section.
that much would depend upon how the research clause is construed.
DHEW is silent on the matter so
Both DHEW and LEAA provide explicit protection relating to "identifying
characteristics."
protection as identifying characteristics as " . . . refers to any data
collected on an individual by a researcher that contains his name, or
the identifying number, symbol, or other identifying particular assigned
to the individual which could reasonably distinguish that individual from
The DHEW regulations may have a somewhat more limited
all others in the study, including but not limited to fingerprints, voice-
prints, or photographs" (42 CFR 2a2:(g)); though the definition of person
as already noted includes all individual and corporate actors.
explicit that "information identifiable to a private person--means informa-
tion which either (1) is labelled by name or other identification, or (2)
can by virtue of sample size or other factors, be reasonably interpreted as
referring to a particular private person" (28 CFR 22.2:(e)), though as
noted, the definition of a private person specifically excludes government.
LEAA makes
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Regardless of which is more limited in what respects, the definition of
private person in proposed DHEW regulations and of identifying characteristics
in LEAA proposed regulations may afford the maximum possible protection.
The question of who is to be afforded protection and how to be eligible
for a certificate likewise differs among proposed regulations. DHEW stipu-
lates that any person engaged in the applicable research described above
". . . who desires authorization to withhold the names, and other identifying
characteristics of individuals who are the subject of such research from any
person or authority not connected with the conduct of such research may apply
to the Office of the Director of the National Institute on Drug Abuse . . . ,
National Institute of Mental Health, or . . . National Institute on Alcohol
Abuse and Alcoholism . . . for an authorization of confidentiality. Such an
application may accompany the submission of an application for grant or con-
tract assistance" (42 CFR 2a3:(a)).
only to some DHEW sponsored research.
that "Each applicant for LEAA support either directly or under a State plan
shall submit, as a condition of approval of any grant application or contract
proposal, a Privacy Certificate" (28 CFR 22.23:(a)).
range of kinds of research can be sponsored by LEAA and none is excluded,
there are no restrictions by specific kind of research sponsored by the
agency--though it might be argued that all DHEW sponsored research would be
comparable to all Department of Justice sponsored research.
far as the issues confronting the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research are concerned, it should
be apparent that only the behavioral science research under the above
sponsors could be protected by a Confidentiality Certificate.
The proposed regulations thus applies
The LEAA proposed regulations stipulate
Since a considerable
In any case, so
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All such research should be protected where confidentiality and its protec-
tion is at stake.
Requirements for Certification. We shall not review in detail the
specific requirements that institutional sponsors and investigators must
meet to be eligible for a Certificate of Confidentiality in both proposed
DHEW and LEAA regulations. We shall simply make note of some, since these
requirements are discussed in many sections of this paper, while reserving
comments for others.
CFR 2a4):
The following are the major requirements (DHEW 42
1. The Secretary may require any pertinent information other than that specified below;
2. "The name and address of the individual primarily responsible for the conduct of the research and the sponsor or institution with which he is affiliate, if any;
"The location of the research project and a description of the facilities available for conducting the research, including the name and address of any hospital, institution, or clinical laboratory facility to be utilized in connection with the research";
We note that for much behavioral science inquiry while the location of the
project can be specified in the application, the specific location of sites
where procedures will be performed is not generally available.
one may be able to specify is the kind of site, e.g., a stratified
probability sample of U. S. households.
"The names, addresses, and summaries of the scientific or other appropriate training and experience of all personnel having major responsibilities in the research project";
3.
The most
4.
We would only make note of the fact that some of these persons may be
known only after funding and employment so that provision should be made
to supply them at some later point, if that is deemed essential; otherwise
a statement of their qualifications when employed should suffice.
5. "(i) An outline of the research protocol for the project including, where applicable, the following information: (ii) A statement of
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the methodology to be followed including: subjects (e.g., age, sex, education) who will be used in the research project; (B) The type of information which is to be collected and the instruments and methods for such collection; and (C) The procedures for safeguarding of data on the research subjects, which shall include as a minimum an assurance that records containing any information pertaining to a research subject shall be kept in a locked file cabinet, safe, or other similar container when not in use; and (iii) A statement: (A) From applicants who receive DHEW grant or contract support for the research project with respect to which a Confidentiality Certificate is requested assuring that they will comply with all the requirements of 45 CFR Part 46, "Protection of Human Subjects," or
determined by the Secretary, on the basis of information submitted by the applicant, that (1) the subjects will be placed at risk and (2) a decision to allow the subjects to accept the risks is warranted, comply with the informed consent requirements of 45 CFR 46.3(c) and document legally effective informed consent in a manner consistent with the principles stated in 45 CFR 46.10. If a modification of paragraphs (a) or (b) of 45 CFR 46.10 is to be used, as permitted under paragraph (c) of this section, the applicant will describe the proposed modification and submit it for approval by the Secretary.
(A) The number and types of
(B) From all other applicants assuring that they will, if it is
(5) The estimated date for completion of the project; (6) A specific request for authority to withhold the names and
other identifying characteristics of the research subjects and the reasons supporting such request;
given it will not be represented as a general endorsement of the research project by the Secretary or used to coerce individuals to participate in the research project; and
(8) An assurance that the research subjects will be immediately advised of any termination of the authorization of confidentiality. (See 2a.8(c)). We make specific note of only two provisions here that may raise some
(7) An assurance that if an authorization of confidentiality is
questions.
Requirement 8 states that one must grant assurance that "an authoriza-
tion of confidentiality . . . will not be represented as a general endorse-
ment of the research project by the Secretary or used to coerce individuals
to participate in the research project."
one, only if certain matters are explicit.
potential participants that one can afford the protection provided by the
confidentiality certificate one must be able to make representations that
such protection is afforded by Federal regulations and on request furnish
The requirement seems a reasonable
To effectively represent to
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proof that such a Certificate of Confidentiality has been issued.
when matters of potential harm from disclosure of confidential information
are at stake, one may have an affirmative obligation to provide a copy of
the certificate to all potential participants to fully inform them of the
nature of that protection so that one meets the requirement of an "informed
consent." That in doing so, one risks the possibility, even the likeli-
hood, that some participants will on having that information change their
minds and become participants should not be interpreted as "coercive" of
participation.
mind when provided with a copy of the Confidentiality Certificate.
Indeed
A "reasonable and informed man" might well change his/her
Since the LEAA Privacy Certificate is applied for in connection with a
regular research application, no special provisions of the foregoing are
stipulated.
sponsored research, including the requisite assurances, must be made when
they occur in conjunction with a regular application, an option that is
provided.
The Certificate of Confidentiality or Privacy certificate and Its Limits
It is assumed that the obligation to provide then in DHEW
The proposed DHEW regulations provide some general guidelines for the
Secretary to take into account in issuing a Confidentiality Certificate
(42 CFR 2a6) while they are only implied in the statement of purpose for
the Privacy Certificate in LEAA proposed regulations (28 CFR 22.1).
The discretion of the Secretary is constrained to take into account:
(1)
(2)
(3)
(4)
The soundness of the purposes and methods of the research
The scientific or other appropriate training and experience
The suitability for use in the research project of the proposed
Such other factors as he may consider necessary and appropriate.
project;
of all personnel having major responsibilities in the research project;
subject population and the protections to be afforded to subjects; and
All applications for confidentiality ceritificates shall be evaluated by the Secretary through such officers and employees of the Department
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and such experts or consultants engaged for this purpose as he determines to be appropriate.
authorization of confidentiality, the Secretary will either issue a Confidentiality Certificate or a letter denying a Confidentiality Certificate, which will set forth the reasons for such denial, or will request additional information from the applicant.
(b) After consideration and evaluation of an application for an
The LEAA implied guidelines refer to matters of protecting privacy
and clarifying the purposes for which identifiable information may be used
or revealed.
tion on application
certification.
It likewise seems apparent that the requirements for informa-
are addressed to the major criteria governing privacy
Elements in the Confidentiality Certificate. The proposed DHEW regula-
tions stipulate the elements in the Confidentiality Certificate and major
limitations on its protection and use (42 CFR 2a.6(b), (c), (d)).
The Confidentiality Certificate will include: (1) The applicant's name and address; (2) The name and address of the individual primarily responsible
(3) The location of the research project; (4) A brief description of the research project; (5) The Drug Enforcement Administration registration number for
(6) The date of expiration of the Confidentiality certificate. (c) A Confidentiality certificate is not transferable and is
effective only with respect to the names and other identifying characteristics of those individuals who are the subjects of the single research project specified in the Confidentiality Certificate. The recipient of a Confidentiality Certificate shall, within 15 days of any completion or discontinuance of the research project which occurs prior to the expiration date set forth in the Certificate, provide written notification to the Secretary. If the recipient determines that the research project will not be completed by the expiration date set forth in the confidentiality Certificate he may submit a written request for an extension of the expiration date which shall include a justification for such extension and a revised estimate of the date for completion of the project. of such a request, the Secretary will issue an amended Confidentiality Certificate.
(d) The protection afforded by a Confidentiality Certificate does not extend to significant changes in the research project as it is described in the application for such Certificate (i.e., changes in the personnel having major responsibilities in the research project, or changes in the research protocol affecting the number and types of
for conducting the research, if such individual is not the applicant;
the project, if any; and
Upon approval
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research subjects or the nature of their participation in the project). The recipient of a Confidentiality Certificate shall notify the Secre- tary of any proposal for such a significant change by submitting an amended application for a Confidentiality Certificate in the same form and manner os an original application. tion and other pertinent information the Secretary will either:
fidentiality Certificate together with a Notice of Cancellation terminating the original Confidentiality. Certificate in accordance with 2a.8; or
in writing that adoption of the proposed significant changes will result in the issuance of a Notice of Cancellation terminating the original Confidentiality Certificate in accordance with 2a.8.
On the basis of such applica-
(1) Approve the amended application and issue an amended Con-
(2) Disapprove the amended application and notify the applicant
We note especially the provisions stating that "The Confidentiality
certificate does not extend to significant changes in the research project
as it is described in the application for such Certificate" and that " . . .
the recipient of a Confidentiality Certificate shall notify the Secretary
of any proposal for such a significant change by submitting an amended
application for a Confidentiality Certificate in the same form and manner
as an original application."
reasonable on grounds of holding investigators accountable so that they
do not extend the range of inquiry unduly to cover matters that invade the
privacy of participants and that might not otherwise be approved by sponsors
of the Confidentiality Certificate as well as to constrain against altering
substantially risks of participants. Yet, given the relative lack of
guidelines (provided only by a few examples) as to what constitute "sig-
nificant changes," it can lead both to improper regulation of scientific
inquiry and to burdensome administration and decision-making. Many
behavioral science studies undergo a large number of small changes as they
proceed; it is more likely to occur with some designs than others.
small changes might be regarded by others to cumulate into a "significant
change."
This provision to be sure appears quite
Such
Experimental designs are less likely to involve such modifications
25-145
than other designs.
dures used, the fewer the modifications called for.
the inquiry, the less likely it is to utilize more systematic methods.
Exploratory investigations and the less experimental methods might be
burdened unnecessarily if no provision is made for approving modifications
within limits that construe significant in a broad rather than a narrow
sense.
to pose a questionable standard for regulation.
The power of the Secretary, moreover, to disapprove such proposed
In general, the more systematic the design and proce-
But the more exploratory
As it stands, the term "significant" is perhaps so ambiguous as
changes can pose problems of serious interference in scientific inquiry
since there are virtually no guidelines in the proposed regulations to
constrain his discretion.
will automatically entail the issuance of a Notice of Cancellation terminat-
ing the original Confidentiality Certificate could be tantamount to cancelling
any further inquiry deemed appropriate by an investigator and approved by an
Institutional Review Board. While it may be necessary to utilize such
sanctions to effectively control project alterations by investigators, it
would appear that unless constraints are imposed on how judgment is to be
made regarding "significant changes in the research project," any investigator
is open to arbitrary control of the research design.
Moreover, the notification that any such changes
Perhaps it would be more reasonable to leave changes in design to in-
vestigators and their institutional sponsors, setting guidelines that any
changes not alter the basic objectives set forth in the original inquiry
provided they do not increase the risks from harm that participants assume.
The research sponsor might then be expected to approve the changes and they
would be covered by the Confidentiality Certificate unless when the Secretary
is notified of these changes, he is obliged to set forth specific reasons
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why the proposed changes do not meet criteria for approval.
would place the burden of proof upon the institutional sponsor and on the
Secretary issuing the Confidentiality Certificate. Both should be obliged
to set forth explicitly the reasons supporting any adverse decision before
an amended application can be rejected for protection by a Confidentiality
Certificate. When an Institutional Review Board rejects an investigator's
modifications that are to be covered by a Confidentiality Certificate, the
investigator should have a right to "appeal" that decision to the Secretary.
Both the Institutional Review Board's explicit statement of reasons for
rejection and the investigator's rejoinder should be forwarded in that case
to the Secretary for a final decision.
spectre of unwarranted inference in scientific inquiry.
This procedure
To do otherwise is to raise the
Protection Afforded with Waiver and Other Exceptions. The DHEW
proposed regulations set forth the following provisions regarding the effect
of a Confidentiality Certificate and exceptions to those effects (42 CFR
2a.7):
2a.7 Effect of Confidentiality Certificate: exceptions. Subject to the exceptions set forth in paragraph (b) of
this section, a confidentiality Certificate authorizes the with- holding of the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while the Certificate is in effect. The authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of the research. Persons so authorized may not at any time, be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding to identify the research subjects encompassed by the Certificate, except in those circumstances specified in paragraph (b) of this section.
part does not authorize any person to refuse to reveal information which would identify a research subject where (1) the subject (or if he is legally incompetent, his guardian) consents, in writing, to the disclosure of such information, (2) the medical welfare of the research subject would be threatened by a failure to reveal such information, or (3) release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regula-
(a)
(b) Exceptions. A Confidentiality Certificate granted under this
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tions promulgated thereunder (Title 21, Code of Federal Regulations).
The proposed DREW regulations basically provide protection against
compulsory disclosure of identifying information. As noted earlier this
provision offers considerable protection to both participants and inves-
tigators.
which includes the data so identified, provides sufficient protection in
a large proportion of behavioral science studies.
the power to compel disclosure of all other information, including the
materials of investigators, could expose certain individual and corporate
actors to harm simply because at times it is difficult to determine what
is an identifying characteristic that might bring disclosure and what
information others have that would make identification possible.
well to bear in mind that the behavioral scientist is not the only one who
may possess information with identifying characteristics; others may also
have possession of some information.
sets of information, each can become privy to the information of the other--
a technique of expanding the amount of intelligence not unknown to intel-
ligence and law enforcement agencies.
characteristics does not guarantee that given some overlap in information by
others, they cannot become privy to the confidential information the inves-
tigator seeks to protect.
protect all the information at an individual level if there is any risk of
harm on disclosure and, correlatively, that protection should be afforded
against compulsory disclosure of all information.
then is that set forth in our discussion of shield laws--to protect all
information that is gathered by research activity.
information related to a criterion of research activity provides greater
The limitation of the protection to identifying characteristics,
Yet, as noted earlier,
It is
Where there is overlap in the two
Thus the simple removal of identifying
For that reason alone, one should be obligated to
The appropriate standard
Protection of all
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protection than does one based on a criterion of identifiable information.
The LEAA proposed regulations provide (28 CFR 22.28): "(a) Research
or statistical information identifiable to an individual and/or copies there-
Of shall be immune from legal process and shall only be admitted as evidence
or used for any purpose in any action, suit, or other judicial or adminis-
trative proceeding with consent of the individual providing such information,
or, in any case in which information is obtained through means other than
direct inquiry of the individual to whom the data pertains."
to the DHEW provision, it omits reference to legislative proceedings and
while providing, as noted earlier, a somewhat broader definition of what is
meant by "information identifiable to a private person," it still does not
provide protection for other information connected in the course of research
activity. Both regulations, as now proposed, offer no protection for
information that is collected by inadvertence or as a consequence of natural
occurrence in social situations to which investigators become privy, an
omission we noted earlier that should be corrected in the interest of be-
havioral science inquiry.
Quits similar
The DHEW regulations make no provision for protection of the informa-
tion against unauthorized or illegal use and sanctions therefore are not
provided for in the case of misuse.
in aiding investigators to protect information from employee misuse or
unauthorized access; special statutory and regulatory sanctions are required
to provide investigators such effective control. Protection of this kind is
provided for in the proposed LEAA regulations (28 CFR 22.29) where LEAA
is authorized to take legal actions leading to imposition of a fine of not
to exceed $10,000 against any person who violates the provisions of confiden-
tiality.
Tort remedies are unlikely to be useful
The Commentary on the proposed regulations makes clear:
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This would include the grantee organization, as well as particular individuals (including grantee employees) committing violations. (Federal Register 40, 186:44037)
The Commentary also makes clear that violations under transfer agreements
are similarly covered by these sanctions.
The exceptions to the privilege accorded by the DHEW Confidentiality
Certificate include both an individual's right to waiver and exceptions that
seem applicable only to bio-medical research sponsored by the DHEW agencies
covered by the proposed regulations.
privilege.
privilege for a consideration of qualifications on the participant power
to waiver l
LEAA provides for the same waiver of
The reader is referred to our earlier discussion of waiver of
Apart from waiver of privilege, the question can be raised as to whether
there are specific exceptions that should be provided for in any Confiden-
tiality or Privacy Certificate. We previously discussed the obligation to
disclose information on future crimes, at least those of a henious nature.
There are other matters that merit consideration as well:
1. Investigators should be permitted to transfer information identi-
fiable to private persons to other persons or organizations for research
or statistical purposes, provided they are covered by and legally bound by
the same provisions governing confidentiality and the disclosure of informa-
tion.
2. The Federal Government has a right and a duty to audit sponsored
research.
as confidential to insure that at least research subjects were indeed sub-
jects and were at least dealt with by certain procedures. The LEAA regula-
tions provide for the sanction of government employees (28 CFR 22.29) if in
any way they violate the provisions of section 524a of Pub. L. 93-83 Stat. 197,
This probably means they must have access to information regarded
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the statutory authority for the regulations.
3. Provision is made in the LEAA regulations for staff access to
confidential data (28 CFR 22.21:(b)), and they are similarly subject to
federal employee sanctions as well as the specific sanction provisions of
the regulations. Absent some guidelines governing when staff shall have
access to confidential information, there is a risk that such monitoring
might be used for other than the legitimate purposes of protection and audit.
If the sponsor's interest lies in utilizing the information for research or
statistical objectives, that should be made a matter of contractual agree-
ment on the grant or contract award rather than as a blanket authority
granted all staff in the regulations. If this form of protection from
staff is not provided, other modes should be considered, e.g., that such
information can be obtained only with the specific authorization of the
Director and then only with a statement of the reasons why the information
is requested.
staff access to the confidential information in a research project.
This latter provision should be a minimum requirement for any
Institutional Control. The procedures for approving research and
applying for a Confidentiality Certificate in the proposed DHEW regulations
fail to make clear what role the Institutional Review Board or Institutional
sponsor has with respect to approving or disapproving the request for a
Confidentiality Certificate. LEAA provisions provide only for approval
of the research by the institutional sponsor.
not an investigator should apply for a Certificate of Confidentiality however
is germane to the considerations of the Board.
withhold approval from a research project because a Certificate of Confi-
dentiality is requested while it may do so when it regards a Certificate
of Confidentiality essential to protect subjects "at risk."
The question of whether or
Yet a Board should never
The reasoning
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behind this proposed guideline for Institutional Review Boards is that
investigators should be permitted to request protection whenever they regard
it as essential to their own as well as to participant protection. At the
same time both investigators and Institutional Review Boards have a re-
sponsibility to protect the participants at risk and the IRB should have
the power to require that one be requested if in their judgment it is
essential for protection from harm.
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V. SOME THOUGHTS ON THE REGULATION OF BEHAVIORAL SCIENCE INQUIRY
The Role of Government Sponsor.
To a growing degree, government has become the sponsor of biomedical
and behavioral science inquiry. Support from both the private sector and
from voluntary associations or foundations comprises an ever smaller part
of the investment in research undertaken by employees of non-profit organi-
zations.
sponsibilities for harm done are far from clearly defined.
The obligations of government in regulating research and its re-
Current DHEW models of regulating biomedical and behavioral science
inquiry on their face place the federal government in several protection
roles: (1) those of protecting the government's general interest in the
public's right to information and its particular interest in deriving
specific benefits for its many functions (legislative, executive, and judi-
cial) by setting program standards and objectives for research to qualify
for funding; (2) that of protecting the rights of investigators from too
much government interference by providing for institutional and peer re-
view and making public the grounds on which applications are denied by
the government agency; (3) that of protecting the rights of participants
in research by establishing regulations requiring investigators to secure
informed consent, protect subjects, etc. as a condition of their sponsor-
ship. There are other ways that government research sponsors assume the
legitimate mantle of protector, but the right to protect carries with it
more than a responsibility to see that protection is adequate and in the
public interest.
Some of that "something more" is the responsibility it perhaps might
assume in its role as specific sponsor. The use of experiments, the growth
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of evaluation research, and the creation of many other interventions com-
bining research and social action objectives originate at least as often
perhaps with the government sector than with the "voluntary" community of
scientists.
stantial degree by government needs, government inducements, and government
requirements.
social ills and it shapes its programs and funding to do research on them--
a proper role, to be sure.
programs provides inducements that shape what investigators do, the more it
must pay attention to its responsibility for the consequences of research.
The more a government induces research that requires experiment, eval-
Many research proposals and some procedures are shaped to a sub-
The government wants "cures" to physical, psychological and
Yet the more a government by its policies and
uation and action research, or other types of research that include inter-
ventions in social life, other than the interventions required by research
procedures, per se, the more likely it is to do harm as well as good.
is so, if for no other reason than that even with a low probability of harm,
the more of that kind of research, the more harm that is done by research.
But since risks from some kinds of research are greater than others, the
more the government induces investigators into high participant risk re-
search, the more burden it should also assume for failures and liabilities.
Such burdens should not fall exclusively on investigators and their insti-
tutional sponsors. If the government wants a cure to drug use and encour-
ages research on drug use in human subjects, it has not only a strong obli-
gation to protect those subjects, but it should incur some of the liabili-
ties that may result from any harm done.
do harm by disclosing confidential information or other means without over-
riding public interest.
This
Moreover, it should not readily
Matters of tort liability not altogether aside in
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American law, government must increasingly recognize its responsibilities
for the actions of its agents--directly or indirectly--as well as a need to
protect participant and investigator interests.
parties to government sponsored research, including the government as spon-
sor, must come to recognize there may be affirmative responsibilities as
well as liabilities when harm is done--responsibility to help that may over-
ride liabilities that might otherwise obtain--and a responsibility to share
in the costs from tort actions or other forms of settlement.
This may mean that all
It may not be
enough to encourage protection by "informed consent", leaving the risks to
fall to those who consent and the liabilities to those who are the immediate
principal in securing it.
that harm will not be done.
insure that whatever risk is taken will not fall upon the chooser for it
must fall upon some!
tions or the burden being borne by those who "freely chose" to consent?
Perhaps that is not enough in a society where government encourages and ac-
cepts legal affirmative duties in matters of harm.
Individual and Corporate Actor Informed Consent.
To know risks and to consent is no protection
Knowledge affects choice, but knowledge cannot
How is such harm to be dealt with? Only by tort ac-
Attention has been called to the strong likelihood that when research
is undertaken that involves corporate actors, information often must be
obtained not only on corporate behavior, per se, but from those who are
members of the corporate actor (corporate actors include all forms of col-
lectivities from families and other small groups to bureaucratic organiza-
tions).
corporate actor (provided by some 'officially' recognized or legally author-
ized person) and
This necessity raises the problem that when the consent of the
of all members who must be involved in the research, each
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has the power to control the actions of others and subvert the research
goals by refusal to participate.
in this respect. The first occurs when the corporate actor grants consent
but its employees have a right to refuse consent to participate in their
role as employee.
ment requires that a prison security program be evaluated but the guards
refuse to grant their consent. We have suggested that this might be re-
solved by formal contract in making a grant that involves the corporate
actor; the corporate actor then exercises an "employer right".
might well be questions of limits to employer rights where research is
involved and those matters must be explored.
There are two principal types of dilemmas
This might occur, for example, when the federal govern-
Yet there
A second dilemma occurs when employees grant their consent but the
corporate actor refuses to do so for matters that involve the corporate
actor.
grant their consent to investigate styles of school administration and
their effects on learning, but the school administration would refuse to
grant their consent. What is at issue here is the right of employees to
disclose matters that involve the corporate actor.
a
We noted that this could arise when, for example, teachers might
There likewise is not
simple answer to that question.
Both of the above dilemmas can occur for inquiry in private as well
as well as public organizations.
LEAA might have in studying policing and security by both private and public
organizations (it provides funding for both types of research). Studying
policing in either the private or the public sector raises these dilemmas
for requiring informed consent by all or only some parties of the corporate
actor.
Consider, for example, the interest that
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Without some reasonable balancing of rights to informed consent and
rights to give and obtain certain kinds of information, much behavioral
science inquiry on corporate actors becomes impossible.
in a modern complex society information on corporate actors may be of greater
consequence than that sought on individuals apart from their roles for
corporate actors?
Journalists, Behavioral Scientists and the First Amendment.
Need one add that
Both journalists and behavioral scientists seek to lay claim to First
Amendment rights to protect their right to inquiry and to disclose informa-
tion in the public interest.
their confidential sources of information by laying claim to a privilege
from compelled disclosure of confidential information based on the First
Amendment, though there is little argument that Congress "presumably has
the power to fashion legislative such as a testimonial researcher's privilege
to insure that the First Amendment rights of researchers are not infringed.
Such legislation would apply both on the federal and state levels"
(Nejelski and Peyser, 1975:B-28).
Both face serious difficulties in protecting
There are, however, substantial differences between them in their ob-
jectives, modes of acquiring information, and of dissemination of informa-
tion. These must be kept in mind lest one assume their needs and require-
ments for protection are similar.
First, behavioral scientists always seek to protect any individual from
any effect of public information while the journalist often seeks to do
exactly the opposite.
aggregates, not individuals, and while journalists at times have a similar
objective, often they do not. While both want to protect their sources of
Generally, behavioral scientists seek to characterize
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information, their objective in doing so stems from quite different grounds.
Journalists, not unlike some law enforcement agents, seek to protect the
source of the information that is disclosed about some other individual or
corporate actor.
that presumably benefits the public interest in information.
are almost always absent in behavioral science research, though there are
exceptions, since behaviorists seek to protect all individual level data,
both its source and any to whom the information applies.
Their object may well be to do harm by disclosure, a harm
Those grounds
Second, journalists are not now regulated by a requirement of informed
consent much as is the case for behavioral scientists who do research in any
public or private organization that lies outside the domain of government
sponsored research.
provided by whom, how, when and where.
constraining for government sponsored research, that kind of inquiry might
well shift to the private sector of behavioral science research and to the
domain of journalists. Both shifts may have undesirable consequences. Were
it to shift primarily to journalists, one would pay the cost that public
information on many aspects of social life fall to their methods and proce-
dures that lack the constraints of science. Were it to shift to the private
sector, it might in the long-run jeopardize at least the study of government.
One can think of other unintended and dysfunctional consequences as well.
This leads to an imbalance in what information can be
Were regulation to become unduly
Third, behavioral scientists have more of a stake in sharing confiden-
tial information for purpose; of research than do journalists. Journalists
do not ordinarily wish to share identifiable data; their sharing is done in
the public press.
transfer of identifiable data and its protection.
Behavioral scientists thus have special problems of the
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Need for Research on Informed Consent, Protection of Confidential Information,
and their Regulation.
It is axiomatic that intelligent and enlightened regulation of biomedical
and behavioral science research depends upon careful research on matters that
are to be regulated.
of regulation without knowing a great deal about their consequences for free
scientific inquiry--knowledge that must come, in part, from research. Now,
it is paradoxical that once legal regulation is introduced it necessarily
makes choices that constrain what investigators can do.
cipation carries with it its own form of enslavement.
regulation of behavioral science inquiry can be particularly destructive
when they preclude or constrain unduly inquiry on processes of regulation
and their effects on scientific inquiry.
several examples how this might easily be the case.
We cannot, for example, reasonably choose among modes
Every form of eman-
The consequences of
We shall briefly illustrate by
1. Were regulation to prohibit some forms of what is called "deception"
in behavioral science inquiry, it would also preclude studying whether decep-
tion has the effects it is presumed to have and why, therefore, it was con-
strained. We very much need more knowledge on the effects of withholding
certain kinds of information in securing consent from participants and of
ways that such effects, if they may harm, can be altered to reduce substan-
tially risk from harm. There are no other animals on which many features
of social life can first be investigated.
2. Were regulation to preclude research on regulatory processes for
behavioral research in any way, it will deny us that knowledge which we may
need for intelligent regulation. A requirement that regulators grant their
informed consent to be studied could well do just that.
that institutional sponsors and principal investigators perhaps have the
I note in passing
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same rights to informed consent as all other participants in research.
they be permitted to preclude many kinds of research on self-regulation be-
cause their informed consent is required?
Should
3. It is axiomatic that any system of regulation or control generates
its own forms of deviance.
scientific inquiry.
scientists will require their protection as participants if valid and reli-
able information is to be obtained on the "knowledge establishment".
Knowledge of patterned evasion and other forms of deviation from the rules
of regulation must be acquired for enlightened regulation.
It must be so also with the regulation of
The proper study of those forms of deviance among
I note in passing that much remains to be known about the organization
of the production and dissemination of knowledge, about the role of govern-
ment in research, including its regulatory processes, and about the effects
of scientific inquiry on the participants in research.
knowledge should not be constrained by regulation so as to subvert the very
goals of enlightened regulation.
Acquiring that
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VI. EPILOGUE
A long dissertation--and this one perhaps needlessly so--has an end
as well as a beginning.
altogether lacking in value.
there a cautionary tale?
The medium is the message; yet redundancy is not
What is it that we have tried to say? Is
This paper has treated of matters of regulating behavioral science
inquiry by a requirement of informed consent.
informed consent is inextricably bound in behavioral science inquiry with
the risks that attend disclosure or confidential information and stated
the case for a need for the maximum possible legal protection for confiden-
tiality.
model of scientific inquiry is of ten inapplicable when applied to behavioral
science inquiry; it perhaps often is so as well for bio-medical inquiry,
depending upon how the line is drawn among disciplines.
We have emphasized that
We likewise have emphasized that an elementary Human Subjects
Along the way, we have tried to maintain that some elements are more
or less distinctive of behavioral science inquiry and how exceptions to
these must be treated separately.
1. Behavioral scientists are interested in aggregative data for
individuals, whether individual or corporate actors, not in individual
level data. Exceptions arise for evaluation or assessment research, and
their requirements may be different.
2. Behavioral scientists generally intervene in the life of partici-
pants only to acquire information from and about them; it is much less
common that some form of intervention other than the research procedure
is undertaken. Where it does occur, such as in experiments with human
subjects and their collective life, separate consideration should be given
to the problems that arise when a research role intersects with an inter-
25-161
vention role and to the consequences for research of deliberate interven-
tion for purposes other than research.
3. Behavioral science inquiry is generally low risk inquiry so that
for much of it a requirement of informed consent seems unnecessary and
burdensome. The main risk from harm in behavioral science inquiry arises
solely from the disclosure of confidential information, the disclosure
being the source of harm. There is an obligation to protect participants
from that risk of harm by disclosure, one that can be obviated by a legal
privilege against compelled disclosure and by legal penalties for un-
authorized disclosure, misuse, or illegal use.
Finally, we make note of the fact that legal regulation carries with
it its own consequences that must be investigated by behavioral science
inquiry if regulation is to be both enlightened and in keeping with constitutional
imperatives.
possible in the study of the effects of regulation on free scientific
inquiry, if in no other way than by making special provision for that kind
of inquiry as an exception (and with due care for protection of all interests).
Regulatory constraints should make for as few constraints as
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FOOTNOTES
1. There are some statutory limitations on consent where proprietary interests prevail or when exchanges are privileged.
The more unplanned the intrusion into private matters, the more complicated are problems of "informed consent" and "protection of the sources of information," matters treated below.
Note that I do not argue that we have a more legitimate claim to "truth," whether or not it is made in the name of scientific inquiry, but simply that our claim to science opens us to political challenge.
2.
3.
4. The concept "written consent" applies to more than that it be written (one has an option to read it). a signed consent to a written statement that is read either by par- ticipants and/or their representative(s) or by the investigator/ agent. In this sense "signed written consent" is a more meaningful designation of these procedures for obtaining informed consent.
The operable condition is that it be
25-163
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Washington, D.C.: National Academy of
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193-220.
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26
THREE THEORIES OF INFORMED CONSENT: PHILOSOPHICAL
FOUNDATIONS AND POLICY IMPLICATIONS
Robert Veatch, Ph.D.
February 2, 1976
Abstract
To understand the nature and definition of informed consent it is essential to understand the reason why we get consent in the first place. sent. medical profession, informed consent may serve the purpose of protecting subjects from harm. That current DHEW regulations require assuring informed consent only when subjects are at risk implies that this may be the foundation. However, if the objective is to protect subjects from harm this could be accomplished more efficiently by simply banning all non-therapeutic research. Furthermore, one must understand why this would be committed to protecting individuals from harm. It is suggested that it is because individuals are the possessors of individual rights including the right to self-determination.
This paper outlines three alternative theories of informed con- First, consistent with the traditional Hippocratic ethic of
A second theoretical foundation for informed consent might be the the greatest good for the greatest number. classical utilitarian one:
If the research enterprise depends on continued trust and confidence from the public, then consent might, in the long run, produce the great- est good by helping maintain the public trust in the medical research community. justifies too much. would be done if no consent were obtained and the rights of the individual were subordinated to the good of society. Once again a commitment to the rights of the individual requires that limits be placed on arguments based solely on consequences.
The difficulty with the second theory, however, is that it Often it might be the case that even greater good
The third theoretical foundation for informed consent we believe to be the most plausible one: the individual's right to self-determination. This right, basic to Western society and American political philosophy in particular, implies that invasion of the individual's body or privacy re- quires an informed consent. The consent cannot be dependent upon the claim that good consequences can come for the individual or society if the consent is obtained.
Next the implications of the self-determination theory of consent for the standard of consent--for determining how much information must be transmitted for consent to be adequately informed--are examined. It is suggested that while if consequences were the foundation of consent professional standards might (but not necessarily would) be acceptable the principle of self-determination requires the reasonable person stan- dard now being incorporated into informed consent court cases in many jurisdictions. This standard must be modified, however, when there is evidence the subject wants more information than the reasonable person. The practical implication is that for purposes of approval of the ade- quacy of the consent (and for judging whether the risks to the subject are justified by the potential benefits to the subject and/or others an all lay committee of "reasonable people" is the only reliable basis of judgment. An advocacy system for introducing technical information to such a lay committee is proposed.
26-1
The implications of the self-determination theory of informed consent for Group I (competent, noninstitutionalized adults receiving medical care through private sources) are traced. It is suggested that only research protocols which would themselves compromise the subject's future capacity to consent should be prohibited by a re- view committee. For Group II subjects (those whose capacity or opportunity to consent is more problematic), however, self-determin- ation may be impossible (small children, the comatose), compromised (older children, the mentally incompetent), or de facto restrained (prisoners, clinic patients, and subjects of experiments where con- sent would destroy the research). be used only when it is impossible to use Group I subjects.
Group II subjects should normally
The question of overriding the principle of self -determination in cases where consent would destroy the experiment is considered concluding that only the principle of self-determination itself pro- vides a workable ground for waiving consent. ethical grounding- -a non-utilitarian theory of just ice--may eventually provide an additional basis, but only when the application of the theory to medical experimentation is further developed. A national level re- view is proposed for any use of Group II subjects.
The only other possible
Specific Recommendations
1. The individual's right to self-determination should be recognized as the foundation of the requirement for informed consent.
The present DHEW policy of requiring legally effective informed con- sent only if risk is involved should be abandoned.
The "reasonable person" standard for judging the adequacy of consent should be formally recognized, except in cases where there is evidence that the individual subject would require a different level of infor- mation in order to exercise what he or she considers self-determination.
4. An advocacy system of IRB consideration of protocols including adequacy of proposed consent forms should be adopted.
2.
3.
5. The following additional items should be included in the current list of "basic elements" of an informed consent:
a. A specific disclosure of the presence of a control group within the research design.
b. A statement of the inconveniences as well as the risks and discomforts.
Names of review and patient protection agents at the local and national level.
c.
26-2
d.
e. An explanation of who, if anyone, will be responsible
A statement of the basic rights of the subject.
for harms done.
f. An explanation of the right, if any, to continue receiving treatments found helpful.
6. The words "for negligence" should be deleted from the exculpatory lan- guage prohibition.
7. The "short form" of written informed consent in which a subject signs a statement that the information has been transmitted orally should be abandoned.
The researcher or their staffs should never be expected or permitted to obtain the consent themselves. A specially trained individual not directly involved in the research should have that task.
Experiments on Group I subjects with free and informed consent should not be disapproved unless they would compromise the subject's future ability to exercise self-determination.
The term "proxy consent" should be abandoned. Parent or guardian "selection" or "approval" should be required for therapeutic research on children. Parents should have discretion within the limits of reasonableness to decide what should be counted as potentially thera- peutic for their wards.
Parents or guardians should be permitted to approve non-therapeutic research on their wards whenever the research meets rigid criteria including no or minimal risk to the subject.
Children and formerly competent patients should be able to exercise self-determination to rejecting non-therapeutic experiments.
The formerly competent patient's wishes clearly expressed while competent should be determinative when the patient is no longer competent.
Children and formerly competent patients should be able to exercise self-determination in accepting or rejecting therapeutic experiments and accepting non-therapeutic experiments if they are judged by a court to understand sufficiently the nature of the choice.
Prisoners should not be treated as in any way having lost their capacity for self-determination.
In cases where the de facto opportunity for prisoners to exercise self-determination is diminished because of the nature of the in- stitutional structure, this should be seen as a fault of the prison system, not of the prisoner.
8.
9.
10.
11.
12.
13.
14.
15.
16.
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17. A scheme should be considered whereby prisoners are compensated for research at rates comparable to other prison wages proportionate to time and risk while those doing research pay at a rate comparable to costs to obtain similar subjects outside the prison. ference should be made available to the prison population for edu- cational and recreational activities.
Clinic patients should be treated as Group II subjects. be required that at least half of all subjects be recruited from other than clinic patient sources.
In experiments where informed consent would destroy the research informed consent should nevertheless be required unless it can reasonably be presumed with at least a 95 percent level of certainty on the basis of specific empirical evidence obtained from mock- subjects drawn from the same subject population that the real sub- jects would not consider their uninformed participation a violation of their right to self-determination.
More research should be undertaken on the adequacy of a non-utilitarian theory of justice for providing a criterion for overriding consent in specific cases where those less well off than the subject would bene- fit greatly.
A special, second review at the national level of the quality of the consent (and the acceptability of the risk) should be required for all use of Group II subjects to assure that self-determination is preserved to the extent possible and that only reasonable risks are taken when self-determination is not possible.
The dif-
18. It should
19.
20.
21.
26-4
Current government regulations require local review of all biomedical
and behavioral research on human subjects supported under grants and con-
tracts from the Department of Health, Education, and Welfare to determine
whether subjects will be placed at risk and, "if risk is involved," whether
"legally effective informed consent will be obtained by adequate and appro-
priate methods." 1 The logical implication is that informed consent of human
subjects, insofar as it is mandated by DHEW regulations, is subordinated to
and derivative from the goal of protecting human subjects from risk. If
that is the case I believe the current requirement of informed consent
rests on an inadequate bade.
My objective is to analyze the philosophical foundations of informed
consent articulating three theories of informed consent and the implications
of those theories for public policy.
in its essence cannot be related to and derived from the notion of avoiding
risks and/or producing good consequences, but must have an independent
philosophical foundation. That foundation, so I shall argue, is the prin-
ciple of autonomy--of self-determination.
peting theories of informed consent, I shall then examine the implications
for deciding how much information ought to be transmitted for consent to
be informed.
for informed consent from competent, non-institutionalized subjects and
then for subjects who are legally incompetent, institutionalized, or
both.
I shall argue that informed consent
After exploring the three com-
Finally I shall trace some of the policy implications first
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I. THREE THEORIES OF INFORMED CONSENT
My assigned task is to discuss the nature and definition of informed
consent. Although I am to focus on informed consent in various research
settings, I am convinced that the same standards apply to clinical medicine.
Thus some reference to cases and argument dealing with routine clinical
care will be made. 2 Also it might be appropriate to broaden that task
slightly to discuss free and informed consent. That consent be both free
and informed within certain limits seems necessary to make a consent ade-
quate. 3
whether or not it is qualified by the requirements that it be free and
informed.
is essential to place the concept in a historical context.
It is important to realize how modern any notion of consent is
In order to develop a theory of the foundations of consent it
A. The Patient Benefit Theory of Informed Consent
Traditionally experimentation in medicine was an integral part of the
treatment of the patient.
naturalistic footing. In works such as The Sacred Disease the Hippocratic
corpus demystifies diseases such as epilepsy. 4 The author argues with re-
gard to epilepsy, which had at the time been interpreted as being caused
by sacred powers, that "It is not, in my opinion, any more divine or more
sacred than other diseases, but has a natural cause, and its supposed divine
origin is due to men's inexperience, and their wonder at its peculiar char-
acter." 5
The Hippocratic authors placed medicine on a more
In spite of the fact that Hippocratic and Galenic medicine viewed
medical problems as natural phenomena, these traditions did not rationalize
26-6
and systematize medical experimentation as we know it.
happen until modern times--the end of the eighteenth century.
Hippocratic physician would try out new remedies, but always in the con-
text of treating a patient when routine therapies were not successful.
It was not until well into the modern period that medical experimentation
was undertaken in the sense of systematically designed research for the
purpose of gaining medical knowledge.
consent is absent from the Hippocratic tradition.
This did not
The
It is in part for this reason that
The ethic of the Hippocratic physician was (and to some extent still
is) rooted in a special set of norms. According to Ludwig Edelstein the
deontological (ethical) writings of the Hippocratic corpus reflect the
philosophical, religious, and scientific view, of the Pythagorean cult. 6
The dominating ethical norm is that the physician's duty is to do what will
benefit the patient according to his ability and judgment. 7
Although the modern physician may not have read the Hippocratic Oath
recently, the ethical norms are ones with which he is comfortable.
World Medical Association in 1949 adopted an International Code of Medical
Ethics which includes an updated version of the patient-benefitting principle:
"Under no circumstances is a doctor permitted to do anything that would weaken
the physical or mental resistance of a human being except from strictly ther-
apeutic or prophylactic indications imposed in the interest of his patient."
It is generally thought that the Hippocratic Oath may be rather platitudinous.
It is usually not recognized how controversial the principle itself is. 8
For our purposes the primary implication is that all physician activity in-
The
26-7
of the patient ought to be forbidden.
cluding medical experimentation which is not undertaken for the benefit
9
Although the requirement of informed consent is not traditional in
Hippocratic medicine, it is possible to justify such a requirement on
petient-benefitting grounds. Indeed, if we recognize that judgments about
what is beneficial to a particular patient will vary from patient to patient
depending upon the particular norms and values of that person, a strong
case can be made that informing patients of treatment alternatives so that
they can participate in or even control the decision-making process will in-
crease the likelihood that patient-benefits will be maximized. Especially
in cases of what might be called therapeutic research, 10 that is research
which simultaneously has two objectives, pursuit of knowledge and potential
benefit to the patient, patients might plausibly maximize benefits by
choosing between more conservative, standard therapies and experimental
therapies on the basis of their own inclination to take chances and their
faith in technological innovation. 11 Thus even in classical Hippocratic
ethics informed consent may have an importance place.
The decisive case for testing the relationship between patient-benefit
and informed consent ought to be the special situation where someone (usually
the physician) believes that getting patient consent will do harm to the
patient rather than produce benefit.
the treatment of schizophrenia is an example.
cancer drug on a terminally ill patient who does not know his or his diag-
Testing a psychoactive compound for
Testing an experimental
nosis or prognosis is another. If informed consent is a derivative princi-
26-8
ple designed to insure patient benefit, then whenever getting consent
would do more harm then good it ought to be waived.
explicit in the 1971 FDA regulations for consent for use of an investi-
gational new drug. Consent is to be obtained except where the investi-
gators "deem it not feasible or, in their professional judgment, contrary
to the best interest of such human beings" (i.e. the subjects). 12
implied in the December 1, 1971, version of the DHEW Guidelines.
the important Halushka vs. University of Saskatchewan case, the guidelines
specify that:
This exemption is
It is
Citing
Where an activity involves therapy, diagnosis, or management, and a professional/patient re- lationship exists, it is necessary "to recognize that each patient's mental and emotional condi- tion is important...and that in discussing the element of risk, a certain amount of discretion must be employed consistent with full disclosure of fact necessary to any informed consent. 13
The draft regulations as revised and published in the Federal Register
October 9, 1973, 14 and the final regulations as published May 30, 1974, 15
also have no such exclusion.
the drafters of the regulations may have continued in their commitment to
patient benefit, but held that consent will, on balance, be a practice
which is patient-benefitting in the sense of protecting them from risk even
in those cases where researchers believe that the patient would be benefit-
ted more by not being told. 16 If physicians were not capable of perceiving
what would benefit the patient--in terms of the patient's own values--or
what the patient's response to the request for consent would be, then the
consent should be obtained even if, in the physician's judgment, it might
There are two possible explanations. First,
26-9
do harm. 17 Alternatively they may have held that informed consent is
so fundamental to the subject's rights in the therapeutic experiment
that it must be retained even in cases where the
perceives that it might do more harm than good. 18
physician (rightly)
We are left with a confusion in the current guidelines. Consent is
only required in cases where subjects have been found to be at risk im-
plying that consent is somehow inherently linked with and subordinated to
the primary goal of protecting patients from harm. On the other hand the
researcher and the local committee are not permitted to waive consent on
grounds of net patient-benefit.
More doubt is cast on the adequacy of the patient-benefit grounds for
informed consent when one realizes that the patient-benefit principle tra-
ditional in medicine would rule out entirely all non-therapeutic experiments,
that is experiments designed to gain knowledge useful to society, but with
risks not justified on patient-benefitting grounds alone.
any physician who holds to the principles of the Hippocratic Oath cannot
participate in any non-therapeutic research.
other than strictly for the benefit of his patient.
It is clear that
To do so would be to act
The standard of the Hippocratic ethic, however, is the standard of a
private, professional group.
cluding medical groups ought to be of minimal importance to the National
Commission for the Protection of Human Subjects.
Commission to determine an ethically acceptable basis for human experi-
mentation whether or not that basis is consistent with the ethical view of
The ethical principles of private groups in-
It is the purpose of the
26-10
any such private groups. Nevertheless it is of interest that the medical
profession itself has abandoned its sole commitment to patient-benefit
when it considers non-therapeutic experimentation. In 1954, five years
after its general reaffirmation of the patient-benefitting principle as
the old grounds under which a physician could do anything to weaken the
physical or mental resistance of a human being, the World Medical Associ-
ation adopted its "Principles for Those in Research and Experimentation"
which clearly approves research on healthy subjects.
Declaration of Helsinki the World Medical Association explicitly adopts a
principle approving of non-therapeutic experiments "because it is essential
that the results of laboratory experiments be applied to human beings to
further scientific knowledge and to help suffering humanity." The American
Medical Association has similarly approved of non-therapeutic research im-
plying that it too has abandoned the Hippocratic or patient-benefitting
ethic as its decisive norm.
By 1962 in the
Of primary importance to the National Commission, however, is not the
norms of private groups including professional groups, but publicly legiti-
mated and accepted ethical standards.
is the protection of human subjects.
human subjects would be to ban all non-therapeutic research. Consent
might be justified for therapeutic experiments on patient-benefitting
grounds, but it is not clear that consent should always be required even
in those experiments.
would be more likely to benefit by giving consent.
In one sense the Commission's task
Clearly the easiest way to protect
It would be required when, and only when, patients
26-11
I take it as accepted by the Commission and by most reasonable people
in our society that at least some non-therapeutic experimentation is ac-
ceptable. If that is the case, however, the sole task of the Commission
cannot be the protection of human subjects.
of informed consent cannot be patient-benefit. In fact when patients con-
sent for non-therapeutic experimentation, and for much therapeutic experi-
mentation as well, consent seems to function more to cancel the implicit
obligation of the physician that he will strive only to benefit the patient
and protect him from harm. Logically, if consent functions to waive the-
obligations of the norm of patient-benefit, it cannot itself be grounded
in patient-benefit.
Likewise the sole foundation
Since the logical implication of the patient-benefitting principle--
that research can be done only for the benefit of the individual patient/
subject--is strongly counter-intuitive, that awareness may be sufficient
to reject the patient-benefitting principle as the foundation of informed
consent. The principle itself, however, implies even better reason. One
should ask why it is that physicians or others would feel a duty to act
only so as to benefit the patient and protect him or her from harm. It
seems the most plausible answer is that the individual human being (who is
sometimes in the patient role) is seen as an autonomous entity with special
claims against the rest of us--claims normally called rights.
ness that the individual human is uniquely endowed with rights is variously
expressed in the Western tradition by saying that humans were created in
the image of God (Genesis), are to be treated as an end and never only as
a means (Kant), or simply that they are endowed by their Creator with
This aware-
26-12
certain inalienable rights. If, however, the individual person is always
to be treated as an end and never only as a means, it must mean more than
that simply others must avoid taking risks with that individual.
a person is to be a autonomous individual, the possessor of rights.
To be
This notion of the human as an autonomous individual who is the pos-
sessor of rights is not explicit in the patient-benefitting Hippocratic
tradition. In fact, the explicit notion of individual rights is, like
the principle of informed consent, uniquely modern.
that modern medical professionals who remain Hippocratic in their ethic
would tend to link consent to risks and benefits for the patient. For
those more explicitly committed to individual rights, however, that Hippo-
cratic view limited to benefits and risks to the patient will be an in-
adequate foundation for the patient-physician relationship. It will be
even less adequate for the relationship between researcher and subject.
It is understandable
B. The Social Benefit Theory of Informed Consent
If it seems implausible that the primary purpose of informed consent
is to protect patients against risk--although it may in some instances
function in this way--some may find its purpose in the more generally ac-
cepted ethical theory of utilitarianism. According to this view, as artic-
ulated by Bentham, Mill, and others, 20 that course of action is right which
produces the greatest good for the greatest number.
be justified according to this view if, all things considered, more good
than harm came from the experiment and more net good came from the experi-
ment than any other plausible course of action.
Experimentation would
Holders of this view are
26-13
sophisticated in recognizing that good cannot be limited to economic
considerations.
goods and harms would have to be taken into account.
of liberty to a small group of subjects would not necessarily be justified
by great goods to a great number of others provided that one counted the
deprivation as a very grave harm.
Aesthetic, cultural, religious, and psychological
The deprivation
If non-therapeutic experiments are to be justified at all, there
almost has to be some element of social benefit included in the justifi-
cation.
care, that is when experiments were therapeutic in intent, social benefits
of the research were ancillary.
rational design of research in the pursuit of knowledge gave independent
grounds for experimenting, benefits to others became significant and at
the same time introduced a potential conflict with the benef it-to-patient
norm.
As long as experimenting in medicine was in the context of patient
With the modern period, however, when
It is often not realized how modern a phenomenon systematically designed
experimentation is.
Harvey's publication of his studies of animal circulation in 1628. 21
While this work exemplifies research for the pursuit of knowledge, even
this did not involve systematically controlled research exposing human
subjects to such risks as double blind placebo administration.
investigation of this kind is a nineteenth and even more a twentieth cen-
tury phenomenon.
Experimental medicine is often dated from William
Systematic
26-14
By the beginning of the nineteenth century research for the good of
Thomas society rather than the individual patient began to be defended.
Percival was asked by the trustees of the Manchester Infirmary to prepare
a code of ethical conduct for physicians to help them overcome an internal
dispute. The Code, which was published in 1803, has become the foundation
of Anglo-American physician ethics.
in justifying medical experimentation on broader public benefit grounds:
Whenever cases occur, attended with circumstances not heretofore observed, or in which the ordinary modes of practice have been attempted without success, it is for the public good, and in especial degree advantage- ous to the poor (who, being the most numerous class of society, are the greatest beneficiaries of the healing art) that new remedies and new methods of chirurgical treatment should be devised. But in the accomplish- ment of the salutary purpose, the gentlemen of the faculty should be scrupulously and conscientiously gov- erned by sound reason, just analogy, or well authenti- cated facts. And no such trials should be instituted without a previous consultation of the physicians or surgeons according to the nature of the case. 22
In the document Percival is explicit:
There is not any hint of a patient consent requirement, but there must
be previous consultation with "the gentlemen of the faculty." Given the
context of the tensions at the Manchester infirmary at the time it is plausi-
ble to see this consultation as serving more general social purposes includ-
ing protection of the hospital's image as well as making sure that the ex-
perimentation is "for the public good, and in especial degree advantageous
for the poor."
In Claude Bernard, the father of modern medical experimentation, the
justification of experimentation in terms of the general good it will do
26-15
goes even further.
Medicine in 1865 he boldly claims that "Christian morals forbid only one
thing, doing ill to one's neighbor. So, among the experiments that may
be tried on man, those that can only harm are forbidden, those that are
innocent are permissible, and those that may do good are obligatory." 23
In his famous Introduction to the Study of Experimental
The question remains, if the underlying justification of medical
experimentation is that it will produce good social consequences on
balance, what is the place of informed consent?
appear that more research could be done more efficiently to produce more
good consequences if the consent requirement were eliminated.
justification for the consent requirement, however, even on social benefit
grounds.
out patient or subject consent would soon create public suspicion and
severe handicap for the research enterprise.
ations where experiment was likely.
give consent would assure lay people that they would not be unknowing
subjects of medical research.
clever way of promoting long run social utility. 24 The fact that social
usefulness of information per se is sufficient to make consent expendable
requires some commitment to a social utility theory.
For the most part it would
There is one
It may be that a general policy of research for social good with-
Subjects would resist situ-
A requirement that all subjects must
The general consent rule might simply be a
A test case would be an experiment which, by its very nature could
not be done with consent, for example psychological studies of perception.
Under these circumstances no good could come if consent were obtained,
while some good might come if the research were permitted under controlled
26-16
non-consent circumstances.
ported by the fact that current DHEW guidelines permit waiving of the
consent requirement when "that use of either of the primary procedures
for obtaining informed consent would surely invalidate objectives of
considerable immediate importance." 25
The social utility theory of consent is sup-
There is some evidence that the original introduction of consent
for research in the nineteenth century had as one of its purposes the
preservation of the research for the social good which could come.
1822 William Beaumont began his famous experiments on gastric physiology.
His work was made possible because one Alexis St. Martin suffered an acci-
dental shotgun wound leaving a fistula (a direct opening) to the stomach.
St. Martin signed a written contract with Beaumont agreeing to be his
"covenant servant" for one year. 26
to be deported as an alien unless he could find some way to support himself.
His agreement with Beaumont was the solution.
late twentieth century standards.
part designed to guarantee that once Dr. Beaumont had invested in the sub-
ject, St. Martin would continue with him until the results could be demon-
strated to his colleagues.
In
St. Martin was destitute and destined
Its quality is primitive by
Being a binding agreement it seems in
27
While there are instances where the consent seems to function to
serve the general social welfare rather than protect the patient, for the
most part that does not seem
in contrast to the patient-benefitting principle, the principle of social
benefit legitimates non-therapeutic research, it seems to legitimate too
to be its primary purpose. In fact while,
26-17
much.
the general welfare must be done.
itates the research would it be necessary.
According to the principle, research which will on balance serve
Only in cases where the consent facil-
It is the social benefits principle which, together with some strangely
ethnocentric values, led to the Nazi experiments and the decisive challenge
to the bonum commune defense of medical experimentation. 28 It became clear
at Nuremberg as never before that fundamental human rights were at stake
in non-therapeutic research justified on the grounds of the greater good
for society.
C. The Self-determination Theory of Informed Consent
If maximizing social benefits leads to unacceptable violation of the
rights of the individual subject, the drafters of the Nuremberg Code had
two options. They could return to the older Hippocratic formula insisting
the research be undertaken only when it is justifiable in terms of benefit
to the patient/subject.
of research for the good of the community and control against excesses by
articulating some limiting principle.
The second principle of Nuremberg makes clear that social benefit has not
been abandoned. 29
clearly not to facilitate social benefits, but as a check against them. 30
We are led to an inescapable conclusion.
consent requirement on medical research for a reason other than the instru-
mental value that consent might have in furthering research for the common
good must recognize that individual subjects have claims against the society,
Alternatively they could hold to the legitimacy
The authors chose the latter course.
But informed consent is introduced as the first principle
Anyone who imposes an informed
26-18
claims so strong we call them "rights." There must be rights of the in-
dividual which have standing even against the claim that the greater good
would be served if those rights were compromised.
This should not sound strange at least for one steeped in Anglo-
American political philosophy. Americans have learned that all are en-
dowed by their Creator with certain inalienable rights including life,
liberty, and the pursuit of happiness.
due process before deprivation of liberty cannot be sacrificed simply be-
cause the good of the community would be served.
The Constitutional guarantee to
Although informed consent may, upon occasion, promote benefits to the
patient and/or benefits to society, it is clear that its primary purpose
stands over against these consequentialist objectives. Informed consent
functions as a waiver of certain individual rights for the good of self
(patient/subject benefit) or others (social benefit). In particular it is
the individual's right to self-determination which makes informed consent
necessary for all invasions of the body or even invasions of one's privacy.
The principle of autonomy--the right to self-determination--provides an
independent foundation for the informed consent requirement, a foundation
much more solid than the justifications of informed consent which occasion-
ally can be derived from concern over protection of the individual against
risk or protection of the society by protecting the larger research enter-
prise.
giving can be seen as a negotiation of a contract.
It is because of this self-determination foundation that consent
26-19
There is strong legal evidence that this self-determination theory
of informed consent is the philosophical foundation of the consent re-
quirement.
As late as 1871 32
and again in 1895 33 major court opinions dealing with
experimentation omitted any requirement for consent.
Cardozo articulated forcefully the patient's right to self-determination
as the basis for surgery:
It was not always the case in American jurisprudence, however.
But in 1914 Justice
...Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages.... This is true except in cases of emergency where the patient is unconscious and where it is neces- sary to operate before consent can be obtained.... 34
The self-determination principle was reaffirmed as the foundation of that
consent clearly in the famous Natanson v. Kline in 1960 where Justice
Schroeder argued:
Anglo-American law starts with the premise of thoroughgoing self-determination. It follows that each man is considered to be master of his own body, and he may, if he be of sound mind,
35 expressly prohibit the performance of life- saving surgery, or other medical treatment.
The principle of consent was applied to experimentation as opposed
to routine treatment in Fortner v. Koch 36 in 1935.
There is some evidence that the authors of the DHEW guidelines recog-
nize that informed consent as well as other rights are independent of the
question of risks and benefits to subject and society. Whenever review is
26-20
mandated, review committees have three substantive tasks:
that (a) the risks to the subject are so outweighed by the sum of the
benefit to the subject and the importance of the knowledge to be gained
as to warrant a decision to allow the subject to accept these risks; (b)
the rights and welfare of any such subjects will be adequately protected;
and (c) legally effective informed consent will be obtained by adequate
and appropriate methods. 37 That there are three co-equal requirements of
review makes clear that the right to consent as well as the other "rights
and welfare" mentioned in clauses (b) and (c) are not derived from the
notion of risk to the subject.
to say that the review committee must see that the risks to the subject
including violations of rights are so outweighed.... The DHEW guidelines
follow traditional theories of rights in American political philosophy by
recognizing that rights of individuals including the right to consent are
independent of consideration of risks..
to determine
If they were it would be more appropriate
Yet if that is so it is paradoxical that (b) and (c), that is the
protection of rights including the right to consent, are to be assured by
review only in cases where the subject is at risk.
sense to require that a determination of risks is sufficiently outweighed
by potential benefits only in cases where subjects are at risk, but it is
fundamentally illogical to require that the rights of the subject are to
be protected only in cases where the subject is at risk.
Logically it would make
If it is correct that the principle of self-determination is the pro-
per foundation of a theory of informed consent and that rights of subjects
26-21
exist independent of consideration of risks and benefit, then there seems
to me to be only one possible explanation of the subordination of deter-
mination of protection of subject rights to the determination that the
subject is at risk.
of self-determination might take as a basis for informed consent.
To make this clear let me suggest two forms the notion
The first I would call the weak theory of self-determination. Ac-
cording to this view an individual has the right to self-determination re-
garding invasion of his body or his privacy only when exercising that self-
determination will materially affect his welfare.
right to self-determination is limited to the area of risk-taking.
other hand we might speak of a "full theory of self-determination."
individual is always to be treated as an end and never only as a means,
that individual is the possessor of autonomy in all areas of his life, not
simply in cases where material risks and benefits are at stake. In fact
at least within limits we shall consider below he possesses the right to
self-determination to make choices which are contrary to his own interests.
Put in these terms it seems most implausible that the rights of life,
liberty, and the pursuit of happiness would carry the proviso "only in
circumstances when risks and benefits are involved." Many of the cases
where one exercises the right to self-determination are cases where risks
and benefits as we normally think of them are not at stake.
tutional rights to liberty and privacy cannot be so limited that they only
apply in cases where a committee has determined that the subject is at risk.
The right to confidentiality for instance, which is normally subsumed
under (b) can not be conditional on the subject's being at risk.
In this case an individual's
On the
If an
The consti-
26-22
If one examines the list of basic elements of informed consent
one discovers that some of the items included are not directly linked
to subject's calculation of risks and benefits.
human blood were needed to develop a test for sickle cell anemia and
trait in fetuses. Blood samples are to be obtained from adults with
and without sickle cell disease or trait for purposes of developing the
test.
in time so that all fetuses with disease or trait could be aborted thus
improving the gene pool. If the blood were obtained as remainder blood
from routine diagnostic work, it is difficult to conceive of any risk to
the subject in having it used in the study.
be aborted as a fetus and, if he already has reason to believe he and his
spouse do not have the disease or carrier status, his offspring could not
even be affected in any direct manner. 38 Yet it seems that some people
might object to the purposes of this research. Still more might object
to having their blood used for this study without their consent. That
presumably is why the first basic element of informed consent includes
For instance, suppose
The eventual objective of the research is to develop the diagnosis
He will never be at risk to
a fair explanation of the purposes of the research. 39
A second example of a piece of research where no plausible risk to
the subject is at stake and yet subjects might plausibly want the oppor-
tunity to consent to the research involves a study using human placentas
for basic physiological study.
the delivery room would be salvaged for research purposes.
bly be argued that the women from whom the placentas were taken were not
at any risk from the study.
Placentas normally routinely discarded in
It could plausi-
They were not being asked to modify the
26-23
delivery procedure at all.
want to be told that the placenta was to be used in this manner.
may object; others would gladly consent--if they are given the opportunity.
Yet it seems plausible that many women would
Some
A third example is the patient studies with medical instructions
Even if one had no reason to fear direct risk of mentioned by Levine. 39
ridicule, one might plausibly object to the concept of "compliance" on
the grounds such research is often built on the unstated hypothesis
patients are wrong in their judgment not to follow medical advice (or
doctor's orders).
rational given the value system and world view of the patient, but also
that those studying "compliance" did not share that belief, then one might
want to refuse to participate in such compliance studies on the grounds
that they were misguided, had the potential of leading to erroneous con-
clusions, and, if nothing more, paternalistic in their conception. Such
a patient might reasonably want the opportunity to participate in such
studies because he or she objects to the purpose of the study rather than
the risks.
If one believed that such patient judgments were often
Even the use of autopsy material and severed organs and limbs for
research raises questions which certain individuals would find potentially
meaningful or useful.
cal grounds to autopsy and subsequent research use unless they were directly
linked to the saving of a particular life. 40
of the research as well as idiosyncratic objections based on unique systems
of belief and value can be made independent of risk/benefit considerations.
For instance Orthodox Jews might object on theologi-
Objections to the purpose
26-24
The point is a logical one: if the right to self-determination is the
proper basis of the consent, it is illogical to make the exercise of
that right dependent upon the subject's being at risk.
II. THE STANDARD OF REASONABLY INFORMED CONSENT
If the proper theoretical foundation for informed consent is the
principle of self-determination or autonomy, this ought to have impli-
cations for our understanding of informed consent in various research
settings.
want to connect this self-determination theory to a question which has
received much attention recently in the legal literature: the question
of the standard to be used in deciding how much information ought to be
transmitted for a consent to be informed.
Before looking at those implications for specific settings I
Before looking at some plausible alternative answers it is necessary
to put aside one red herring, the standard of "fully informed and free
consent."
subject enough information for consent to be "fully" informed. 41
so would require an infinite amount of information--or at least a full
medical education. Since consent cannot be fully informed, they argue,
the physician should select particularly important items to transmit, but
not strive for an impossible standard.
Researchers sometimes argue that it is impossible to give the
To do
I claim this is a red herring because no one, or at least no one
who has thought about it, really demands "fully" informed consent.
not only impossible, but would be terribly tedious.
It is
It is more plausible
26-25
to require that all potentially useful or meaningful information be trans-
mitted. I say meaningful as well as useful since, as in the case of the
placentas, some information might be seen as meaningful even if no con-
crete use can be made of it.
We are still left with the question of how much information ought
to be transmitted if the standard is that which is potentially useful or
meaningful? Most believe that the traditional standard was some variant
on the standard of the profession: what the reasonable physician would,
have disclosed under the circumstances. 42
cited is Natanson v. Kline, especially the qualification that:
The court case which is often
The duty of the physician to disclose, however, is limited to those disclosures which a reasonable medi- cal practitioner would make under the same or similar circumstances. his obligation to the patient in this difficult situa- tion involves primarily a question of medical judgment... the physician's choice of plausible courses should not be called into question if it appears, all circumstances considered, that the physician was motivated only by the patient's best therapeutic interests and he pro- ceeded as competent medical men would have done in similar circumstances. 43
How the physician may best discharge
The standard of the profession has been challenged widely in court
cases in ten states 44 and in many articles in legal journals. 45
that this legal development, which I take to be the most exciting theoretical
conceptual shift in the ethical and legal dimensions of medicine in the
twentieth century, will be thoroughly discussed in the legal documents on
informed consent being prepared for the Commission.
out the philosophical implications and the connection of this shift to the
I presume
My task is to point
26-26
three theories of consent I have developed.
From Justice Schroeder's opinion in Natanson v. Kline it appears
that patient-benefit is an underlying concern for setting the standard of
how much information is to be transmitted.
vated only by the patient's best therapeutic interests.
sumes that patient-benefit is the primary foundation of informed consent--
an assumption which we have challenged and which would rule out all non-
therapeutic experiments--it would still be necessary to make further as-
The physician is to be moti-
Even if one as-
sumptions in order for the standard of the profession to be used in deter-
mining how much information must be transmitted.
to assume that the physician or physician/researcher was the proper person
to determine what is in the patient's best interest.
It would be necessary
This presumption appears to rest on an old model of medical decision-
making, one which sees medical choices as essentially technical matters
based on the scientific skills of the physician. If we can presume that
the values underlying the decision are agreed upon and the only question
is which course would promote the desired end, then those with technical
competency would appropriately be able to decide what would be in the
patient's interest.
It seems clear, however, especially in cases where the patient is to
choose between a conservative approach using an established therapy and a
more innovative course with an experimental therapy, that we cannot agree
on the values underlying the decision.
26-27
If consent for experiments were based upon either subject-benefit
or broader societal-benefit and we can assume there is some expert in
deciding what is beneficial other than the subject himself, then it would
be plausible to limit the information transmitted to those items which
the expert considered necessary in deciding what would be beneficial.
Thus, apparently beginning from a patient-benefitting motive, Garnham
proposes substitution of a physician's informed judgment for that of the
patient's. 46
Even if this were the theoretical underpinning of the consent, how-
ever, it is unlikely that the medical professional would be the appropriate
expert at least unless he had sufficient psychological skills to decide
what would benefit and what would harm.
mentation the subject-benefitting consideration which might require getting
consent or place limits on getting that consent is primarily the psychologi-
cal benefits to the patient/subject.
tressed at not knowing what was being done then consent should be obtained.
If the patient/subject would be distressed at hearing the details of the
research or its purposes then it should not be--according to this theory.
But it would normally be psychological experts who could most appropriately
make that judgment.
commune defense, then the appropriate expert would be someone such as a
sociologist skilled at judging community sentiment about the research
enterprise. In neither case would the (non-psychiatric) physician have
the relevant skills.
In cases of consent for experi-
If the patient/subject would be dis-
If, on the other hand, consent is rooted in a bonum
26-28
If the theory behind informed consent is the individual's right
to autonomy or self-determination, however, then the appropriate standard
for how much information should be transmitted should not be related to
any of these professional skills.
of information necessary for the subject to exercise self-determination,
that is the amount of information the subject would find useful or mean-
ingful, independent of whether the researcher or the research community
would find that information useful or meaningful. 46a If the objective of
the consent is to promote self-determination, then it is the subject pop-
ulation itself which must provide the standard for determining how much
information is to be transmitted in order to exercise self-determination.
The standard ought to be the amount
Earlier I said, with regard to the Natanson v. Kline case that most
believe that this case puts forward the traditional standard of the pro-
fession. In fact a close reading of it reveals it is much closer to the
reasonable person standard than most realize.
a key phrase was omitted, one which is often overlooked.
standard of the profession is to be used in judging the adequacy of in-
formation "So long as the disclosure is sufficient to assure an informed
consent."
of the profession are specifically qualified in this way suggests that
Judge
In the earlier quotation
It says the
The fact that the patient benefitting criterion and the standard
Schroeder must have had something more in mind.
This shift to lay standards--determining what the reasonable person
would want to know before consenting to research or therapy--is now be-
26-29
coming the basis for judging whether a consent is informed.
able man" (or "reasonable person") standard is now explicit in court
cases in many jurisdictions beginning with Berkey v. Anderson in California
in 1969 in which it was argued that:
The "reason-
We cannot agree that the matter of informed consent must be determined on the basis of medical testimony any more than that expert testimony of the standard practice is determinative in any other case involving a fiduciary relationship. We agree with appellant that a physician's duty to disclose is not governed by the standard practice of the physicians' community, but is a duty imposed by law which governs his conduct in the same manner as others in a similar fiduciary relationship. To hold otherwise would permit the medical profession to determine its own responsibilities... 47
There are radical implications for local experimentation committees of the
reasonable person standard for determining how much information is necessary
for consent to be informed.
implications, the
use. 48 Here I shall summarize the conclusions.
is to determine if legally effective informed consent will be obtained.
If, however, self-determination is the foundation for making that decision
and therefore the reasonable lay person's judgment is necessary for deciding
how much information that is, then a committee which is skewed in its com-
position away from that representative reasonable lay person will not be
capable of deciding whether the consent proposed is adequate.
include research scientists in greater proporation than in the general public
and those research scientists predictably give atypical answers to such
questions as whether they would want to know certain information and whether
I have recently completed a study of those
full text of which is available for the Commission's
One task of such committees
If committees
26-30
the risk is "worth it" given the potential benefits of the knowledge, then
such committees will give predictably unreliable answers to such questions.
It is not just that the committee must include some lay representation.
Rather in order to adequately carry out this one particular function of
deciding what the reasonable lay person would want to know, the committee
must be made up entirely of lay people (or alternatively composed in such
a way that special professional biases are neutralized). Of course, for
other functions, such as establishing the risks, professional skills are
needed. This remains a fundamental dilemma which, as I see it, can only
be resolved by having two committees, (one lay, the other professional)
or by reducing professionals to a strictly technical advisory capacity.
The capacity of lay people to make such judgments and the fact that those
judgments differ from professionally staffed IRB's is documented by Norman
Fost's study of a "surrogate system" for informed consent. 49 His proposal
differs from mine in that the lay people would not actually function as a
committee.
Even if those with special medical skills and the unique value commit-
ments which accompany those skills are limited to the role of technical
advisors to an all lay committee, there is reason to doubt that it is even
theoretically possible much less practical to transmit information to the
committee in a "neutral" manner.
the advocacy system for such review of protocols.
technical staff selected purposefully because of their inclination for and
against the research enterprise would be charged with the tasks of pre-
senting the best technical cases for and against the protocol under consid-
Perhaps we should consider shifting to
Under such a system
26-31
eration.
portunity to request further information and explanation, exercise their
judgments as reasonable people about the adequacy of the consent (and pre-
sumably also whether the risk to the subject was justified by the poten-
tial benefit to subject and/or others).
The lay committee, having heard the cases would, after an op-
There is one additional problem with the use of the reasonable person
for assuring that subjects will receive the information they consider use-
ful or meaningful.
cal sense the term "reasonable" is used in the law?
who desires more or less information than the reasonable person?
goal is providing enough information for adequate self-determination;
surely the reasonable person standard is not adequate for such subjects.
If there is any reason to believe that the particular patient or subject
wants more information than the reasonable citizen, then the patient or
subject's own standard of certainty must apply. If a subject communicates
to researchers that he wants more information of a particular sort than
the reasonable person would, there is an obligation of the researcher to
give that additional information, if the subject is to continue to be
part of the experiment. 50 At least for non-therapeutic experiments, it
ought to be sufficient for the researcher to drop such a subject from the
research. For potentially therapeutic experiments the abandonment of the
patient/subject by the physician/researcher when he or she has a treatment
potentially beneficial to the patient/subject would raise the same problems
of any physician abandonment.
reference of another physician willing to provide the treatment might be
What of the subject who is "unreasonable" in the techni-
What of the subject
If the
The obligation to give ample notice and
26-32
required--at least within the limits of reasonableness.
physicians may be capable of giving the experimental treatment makes the
case even more difficult than the normal therapeutic situation.
That few other
The case of the patient/subject who communicates that he or she wants
less information than the reasonable person would be a more difficult prob-
lem.
the one which ought to be used in requiring informed consent, it might be
possible to argue that the patient/subject should have the right to deter-
mine that there is some information he or she would rather not have. That,
of course, does not make the patient/subject's request for less information
an ethical request.
about his or her own medical future, it can be seriously questioned at the
ethical level whether one is justified in waiving information necessary to
make a consent informed. Nevertheless in cases of routine patient care
such a waiver might be taken as sufficient to relieve the physician of an
obligation to disclose.
Since I am contending that the principle of self-determination is
If the human is ethically responsible for decisions
In case of experimentation, however, I am not convinced that conclusion
can be reached.
ject against explicit instructions from the subject.
another option, however.
That would seem to me to be the preferable course.
I would still oppose imposition of information on the sub-
The researcher has
The investigator can turn to other subjects.
If the standard for an adequately informed consent is the standard of
the reasonable person (modified in cases when there is evidence the subject
differs from that standard), we are still left with the question of substance:
26-33
what information must be transmitted?
mined by reasonable representatives of the public on a case by case basis.
Some basic elements of informed consent, however, spell out the kinds of
information necessary.
in DHEW guidelines,51
able person would want to know before giving an adequately informed consent. 52
These include:
The exact content must be deter-
In addition to the six elements currently included
there are some additional elements I believe a reason-
1. A specific disclosure of the presence of a con- trol group within the research design. 53
A statement of the "inconveniences" as well as the risks and discomforts. 54
Names of review and patient protection agents including the person in the institution and the person at the federal level who should be contacted if the subject has further questions about the experiment.
A statement of the basic rights of the subject. This should include not only the presently re- quired statement of the right to withdraw with- out prejudice, but the right to access to the alternative treatments, mention of which is now presently required.
Explanation of who, if anyone, will be respon- sible for harms done to the subject. include an explanation of who, if anyone, will be responsible for both anticipated harms the risk of which was included in the consent, and negligent and non-negligent, but unanticipated harms.
2.
3.
4.
5. This should
6. An explanation of the right, if any, to continue receiving treatment found helpful to patient/ subject.
In addition the current DHEW regulations prohibit "exculpatory language
through which the subject is made to waive, or appear to waive, any of his
26-34
legal rights, including any release of the organization or its agents
from liability for negligence." 55
should be limited to liability for negligence.
the "for negligence" so that exculpatory language waiving or appearing to
waive liability is prohibited whether it is liability for negligence or
some other liability.
I see no reason why the prohibition
I would propose dropping
These new elements which I believe are necessary for a consent to be
adequately informed should be added to those currently in the list of six
elements in the DHEW guidelines.
posed by Robert J. Levine 56 including especially the requirement that there
should be a clear invitation rather than a request or demand, that the sub-
ject be informed why he has been asked to participate in the study, and
that there be a suggestion to the prospective subject that he or she might
wish to discuss the proposed research with another before consenting.
believe I disagree with Levine's final element--consent to non-disclosure--
but only in that he does not specify the limits of the non-disclosure.
shall discuss below such limits when considering research which could be
destroyed if informed consent were obtained.
I also endorse many of the elements pro-
I
I
I also share Levine's skepticism with the "short form" of the written
The use of a short written form which has the subject consent document. 57
affirm that items have been explained orally serves no useful purpose es-
pecially since a written version must be on file with the IRB.
cases it leads to suspicion about what is actually communicated not neces-
sarily because the researcher is not trusted, but because staff actually
obtaining the consent may accidently omit certain items.
In some
I also share
26-35
Levine's doubts about general consent forms for categorically related
research.
litigation arise.
should be excluded as not assuring legally effective consent.
thus favor deletion of paragraph 46.10(b) from the May 30, 1974, version
of the DHEW policy.
It also fails to provide evidence of the actual consent should
I believe both short forms and general consent forms
I would
Finally, there is one procedural problem in the mechanism of getting
consent which I think needs correction.
written form is used, it seems to me to be too much to ask of a researcher
that he negotiate the consent with the subject himself.
of the researcher to the worthiness of the project and the justification
of the risk on grounds of benefit to the subject and/or others is, or ought
to be very high--or he ought not to undertake the project in the first
place.
I would favor the use of those with no direct involvement in the protocol
to negotiate the consent with the potential subject.
be the negotiation first with the researcher and then with one hired as an
advocate for the opposition to the subject's participation.)
Whether a regular or a short
The commitment
The conflict of interest is too great for a normal person to bear. 58
(An alternative might
III. THE IMPLICATIONS OF THE SELF-DETERMINATION THEORY OF CONSENT
What then are the implications of the self-determination theory of in-
formed consent for subjects in different research settings? The implications
will depend upon the setting. In this final section I shall take up, first,
subjects which I would call Group I subjects, competent non-institutionalized
adult subjects receiving private medical care. Then I will turn to the
implications of the self-determination Principle for Group II subjects,
26-36
subjects whose capacity to consent is compromised in some way.
A. Group I Subjects
The theory that consent for participation in research is rooted in the
principle of self-determination has implications first for those subjects
ideally placed to give consent which is relatively free and informed. If
we limit ourselves to Group I subjects for non-therapeutic research, i.e.
subjects who are mentally competent, non-institutionalized, adults who
receive health care through private channels, we have probably limited our-
selves to the group most capable of exercising self-determination.
implications are apparent even for this group.
Some
First, if self-determination is the objective, then consent is neces-
sary for research independent of the risk involved. Second, recognizing
that self-determination is always a relative phenomenon, determining has
much information will be necessary for autonomous decision-making insofar
as the goal is promoting self-determination will have to be based on standards
as close as possible to the subject's own.
sensus of reasonable lay persons, but modified as necessary to bring the
standard in line with ways in which the subject may be known to differ from
the reasonable lay person.
Normally this will mean the con-
Third, there may be limits to that to which the lay person may accep-
This is a problem which I have not taken up because it tably consent.
takes us beyond the nature and definition of informed consent. Even though
informed consent may be rooted in a theory of self-determination, there may
be other constraints on participation in research beyond the right to self-
26-37
determination.
as ours is, those limits may be very broad, but there may nevertheless be
limits.
In a society as thoroughly committed to individual liberty
Even John Stuart Mill in On Liberty recognized at least two limits
to liberty.
ments could be banned when subjects give free and informed consent on the
grounds that they would do harm to others, but such objections are con-
ceivable, as for instance, a viral transduction experiment attemption to
manipulate the human genetic code where both researcher and subject are
adequately informed and willingly agree to participate in the study.
The first is harm to others. 59 It is unlikely that experi-
Although it is not generally recognized Mill also places a second
Limit on liberty: the limit of prohibiting surrender of one's own liberty. 60
It is possible that some free and informed consents by subjects of Group I
would be seen as surrendering too much liberty, in volunteering to take
great risk of death for marginally valuable results or volunteering for
experimental brain manipulation, for instance. Such consents could be at-
tacked as not truly free or not adequately informed, but the mandate of
local review committees would permit
were considered free and informed. The committee must determine not only
if there is informed consent, but independently, whether the risks to the
subjects are adequately outweighed by the potential benefits to subject and/
or others.
institutionalized adult is taken seriously, the instances where that right
should be compromised on paternalistic grounds will be extremely limited
such prohibitions even if the consent
If the right of self-determination for the competent, non-
26-38
if not non-existent.
consent might be rejected on the grounds that the subject's liberty cannot
voluntarily be surrendered.
would have to be based on the state's role as protector of the welfare
of its citizens.
cently men could be drafted to risk life and limb--but in even those cases
the conscription was done in the name of protecting liberty itself,
ing of experiments in which there is free and informed consent solely on-
the independent grounds of paternalism seems rarely, if ever, justified.
Occasionally experimentation with free and informed
For the most part, however, such rejection
There are limits to liberty in our society--until re-
Block-
B. Group II Subjects
Although I recognize the dangers of overgeneralization, I would like
to call all groups of subjects where the capacity to consent is problematic
Group II subjects.
considered for human experimentation only in cases where research on the
first group is impossible. For the most part I mean impossible; not merely
inconvenient. If the foundation of informed consent is self-determination,
then consent is impossible in cases where self-determination is impossible.
In all cases of Group II subjects self-determination is either impossible
or constrained.
I call them Group II because I believe they should be
1. Children
The clearest example of the impossibility to exercise self-determin-
ation is the very young child. In the small child consent has a very limited
applicability because self-determination is very limited. I believe, for
the most part, it is a mistake to speak of "proxy consent" for experiments in
children. Rather we should make clear precisely what is at stake:
26-39
research without subject consent justified if at all on some other grounds.
For therapeutic research on young children we must fall back on a principle
which we have seen is highly suspect: the principle of patient-benefit.
Because, by definition, therapeutic research proposes experimental treatments
about which there is no consensus as to the benefits, it is never possible
to justify such experiments on general patient-benefit grounds.
Parental "approval" or "selection" 61 of subjects for such therapeutic
research is essential for two reasons:
benefit parents in their guardian role are obligated to serve the best
interests of their children. They are in the best position to protect
their interests.
first, under the norm of patient-
Second, since in cases of therapeutic experiment there is no consensus
about what would be in the child's best interest, parents are given very
limited discretion to choose values upon which decisions may be made for
their children.
on the aura of a consent. Parents in our society are given limited authority
to exercise their own self-determination about the values of their offspring.
They are permitted to select religious training, parochial education not
valued by the majority, vegetarian or "organic" diet, and other values not
generally shared by the ordinary person. In this one sense parental "con-
sent" is the appropriate term.
apparent from the willingness of courts to intervene if parental determination
of values deviates very far from the social consensus, if, for instance,
Amish parents were to choose no school rather than, as in the case of parents
It is in this second role that parental approval takes
That parental consent is very limited is
26-40
choosing parochial education, a minority school.
One of the areas in which parents are permitted to exercise some
discretion is in encouraging the child to make minor contributions to the
general welfare or the welfare of specific others. Parents may encourage
the child to contribute a small portion of his allowance to the Red Cross,
for instance.
The child is not the property of the parent.
be one area where parental self-determination is to be tolerated within
these narrow limits.
The limits of parental discretion are quite narrow, however.
Non-therapeutic research may
One main line of opinion holds that no child or other non-consentable
can ever be the subject of non-therapeutic research because he cannot consent,
and a human should never be treated as a means rather than an end unless
consent is obtained. 62 This, however, is a highly individualistic under-
standing of individual responsibility. If in addition to being an end in
himself with inalienable rights, the individual is seen as a member of a
social community, then certain obligations to the common welfare may be
presupposed even in cases where consent is not obtained. The dangers of
balancing individual rights with obligations to serve the common welfare
are great especially in cases where consent cannot be used as a mechanism
to judiciously waive those rights. In very special cases, however, where
truly no risk or minimal risk to the subject is envisioned and when infor-
mation to be obtained from non-therapeutic experiments on children would be
of great value which can be obtained in no other way, there must be some
contribution to the general welfare which can be expected without consent
26-41
which the reasonable person would find required. This is not to say that
social benefits can cancel individual rights, that patient benefit can be
traded interchangeably for social benefit. It is rather to say that it is
reasonable to treat the individual, nonconsenting subject as a means to an
end under very limited and circumscribed conditions.
Even if it is emphasized that this is not the same as making the utili-
tarian trade off, there are great dangers in such a proposal.
reason, parental approval of non-therapeutic research in such special cases
should be required first, as the beat check to make sure that individual
rights are not unduly compromised and, second, to permit parental self-
determination to be decisive in deciding whether their offspring will make
a justifiable, but nonconsenting contribution to the general welfare. 63
For this
All of this is said with regard to consent and parental approval for
It seems to very young children where no self-determination is possible.
me to be valid also for older children when potentially therapeutic experi-
menting is contemplated. There are two special problems, however. For
children old enough to communicate when non-therapeutic experimenting is
contemplated consent is possible although consent which may be neither free
nor informed.
his uninformed refusal should nevertheless be determinative. In addition
to free and informed parental approval and the constraints on that approval
(for the reasons given above) uninformed consent of the child should also
be required in non-therapeutic experiments.
Since the child has nothing to gain, it seems reasonable that
26-42
Finally for therapeutic experiments for older youth, some real self-
determination may be possible. 64 If a youth could exercise self-determin-
ation, I see no reason why that should not take precedence over parental
judgment. The problem, of course, is determining that the youth's judg-
ment is free and informed.
the age of majority so that youth can consent on their own or making such
judgments on a case by case basis.
the age of consent for the particular treatment (such as venereal disease
and birth control services) may be justified.
think it is wiser to keep the age of consent for medical treatment high--
at least 18.
might mean substituting the persuasion of the medical profession or others
with influence, for the authority of the parent. For therapeutic experi-
menting and for treatments not covered by a specific statute lowering the
age for consent, case by case adjudication of the judgment of the youth
disagreeing with parental judgment seems appropriate.
Two solutions seem possible: generally lowering
For some medical treatments lowering
In general, however, I
To adopt a general lower age for consent for medical treatment
2. Formerly Competent Adults
Formerly competent adults--mental patients, the comatose, and the
senile--are, for purposes of consent very similar to children in that they
lack the capacity to exercise self-determination. They differ, however,
in several important regards. First, since they are formerly competent,
at one time in the In some
instances fomerly competent individuals may have expressed disapproval
of experimental cancer treatments or expressed a desire to contribute to
scientific knowledge of their particular disease. While in children the
past they could exercise self-determination.
26-43
parental judgment about what is in the child's interest would be taken
as decisive within limits, in the case of the formerly competent adult
the situation is more complex.
whether statements about medical treatments written while competent
ought to remain valid when one is no longer competent. 65
that if the incompetent patient were able to have an opinion now when
he is incompetent, his opinion would have changed; that it is impossible
for the healthy individual to anticipate the experience of terminal illness
or chronic mental incapacity. On the other hand, what judgment could be
more reliable about the wishes of the now incompetent one? I take it to
be an assault on the right to self-determination of the competent one to
hold statements made while competent as unacceptable expressions of the
best estimate of what one would want when and if incompetent.
There is currently great debate about
Some argue
There is a second problem with incompetents lacking in the case of
While statute normally specifies when a child is a minor in- children.
capable of giving consent for medical treatment and research, the defin-
ition of incompetency in adults is much more tenuous.
those who are incompetent is shrinking rapidly. Many patients including
some committed to mental institutions formerly considered incompetent to
accept or refuse medical treatments are now being permitted to do so.
The circle defining
An institutionalized woman in depression was permitted to refuse the
continuation of electroshock therapy. 66 A 60-year-old committed schizo-
phrenic was permitted to refuse a breast biopsy for diagnosis of a possible
malignancy on the grounds that she might die, that it would interrupt her
26-44
movie career, and prohibit her from having further children. 67
York the state Health Code explicitly specifies that mental patients
are permitted to refuse experimental treatments. 68
experiments on mental patients should be under the same restrictions
as for youth.
formation cannot be gained in any other manner, when there is no risk or
minimal risk, when there has been informed approval by a guardian, and
uninformed pro forma consent by the subject.
to be conducted under consent conditions similar to those on a youth.
Guardian approval or judicial determination that the patient is exercising
adequate self-determination ought to be required.
competent, however, should be taken as evidence of the patient/subject's
wishes.
over against guardian approval as is required in New York I find a difficult
question. In general, though, the New York policy seems acceptable since
by definition the benefits are problematic.
In New
Non-therapeutic
In rare cases where they might be justified when the in-
Therapeutic experiments ought
Expressions made while
Whether to permit pro forma refusal by the patient to be decisive
C. Prisoners
Although prisoners are frequently grouped with children and mental
patients as difficult cases when discussing consent, the problems created
in the case of prisoners are radically different. It is frequently noted
that prisoners may not be free psychologically because of the coercive nature
of the choices offered in the prison setting.
tion to that constraint on the prisoner exercising self-determination in
consenting to participate in experiments is the restructuring of the insti-
tution so that the choice to participate in experiments is more on a par
with other options.
It seems to me the only solu-
This might require increasing income opportunities from
26-45
other forms of prison employment.
within the present prison structure is that those wanting to do prison re-
search pay to the prisoners--as a group--fees comparable to what it would
cost to obtain subjects outside of prison while the individual subject
would receive an amount determined to be proportionate to other income
producing opportunities considering risk and time involved. The difference
could then be used by the prison population for educational or recreational
purposes of their own choosing. 69
The only proposal which I find plausible
The larger problem for consent prison research from the perspective
of a self-determination theory of consent seems to me to be in a different
area.
there is no reason to presume that prisoners lack the capacity for self-
determination.
then we should be very cautious in infringing upon that right even in the
name of protecting the individual's welfare. While prisoners do not lack
the capacity to consent, however, a social judgment has been made that
their right to self-determination should be greatly constrained.
upon one's theory of imprisonment infringing upon self-determination is
thought justified either for protection of the public interest, for rehabil-
itation, or for punishment for previous wrongs done.
general presumptive right to self-determination has been compromised.
In contrast with children, the senile, and the mentally incompetent,
If self-determination is a fundamental right in our society,
Depending
Thus the prisoners
The implication for prisoner consent depends upon the theory of im-
prisonment.
to get the criminal off the streets--then it is hard to see why the prisoner's
If the sole purpose of imprisonment is to protect the public--
26-46
right to consent to research should in any way be compromised in principle.
For rehabilitation exercise of the right ought to be encouraged.
however, retribution is the basis of the imprisonment conceivably that
right could be limited.
give the prisoner an opportunity to make amends for previous wrong to
society and to regain his sense of personal worth, then some might argue
that such a “privilege” should not be given.
American Medical Association in their statement in 1952 in which they
state:
If,
If one of the functions of prison research is to
That may be the view of the
...Whereas, some of the inmates who have participated have not only received citations, but have in some in- stances been granted parole much sooner than would otherwise have occurred, including several individuals convicted of murder and sentenced to life imprisonment... Resolved, that the House of Delegates of the American Medical Association express its disapproval of the participation in scientific experiments of persons convicted of murder, rape, arson, kidnapping, treason, or other heinous crimes, and also urges that individuals who have lost their citizenship by due process of law be considered ineligible for meritorious or commendatory citation.... 70
Regardless of whether human beings are imprisoned for purposes of
protection or retribution, I cannot accept this argument for depriving
them of self-determination in consenting to experimentation.
constraints on self-determination may be necessary, those constraints must
be carefully circumscribed.
rights.
death," the loss of all rights.
been abandoned, however, in favor of a much more limited deprivation of
rights.
While some
There can be no general loss of basic human
Until recently being a prisoner brought what was called "civil
That radical infringement of rights has
Self-determination in choices about medical treatment--including
26-47
experimental treatment--and about making humanitarian acts ought not
to be limited any more than it would be for other competent adults.
constraints are necessary because prisoner consent is feared to be de
facto coerced--even when the economic incentive is removed--that is a
failure of the system which ought not to be attributed to any deprivation
of the prisoner's right to self-determination in this area.
larly serious if prisoners are deprived of their right to potentially
therapeutic experimental treatments for this reason.
If
It is particu-
4. Clinic Patients
Like prisoners, clinic patients do not in principle lack the capacity
to consent, but may be coerced into consenting because of serious con-
straints on their options for receiving health care. I believe that clinic
patients--patients whose opportunities to self-determination may be limited
although their capacity should not be--should be treated as Group II sub-
jects just as children, the mentally incompetent, and prisoners are.
ever, since they do not lack the capacity to consent and their rights would
especially be jeopardized if they are deprived of any opportunity to parti-
cipate in therapeutic research, I reject what at first seems plausible:
banning of all research on clinic patients. Rather I would favor as a
check on de facto coercion a general requirement that at least half of
all subjects be drawn from sources other than clinic patients.
How-
5. Subjects in Experiments Where Consent Would Destroy the Research
There is a final group of subject's whose right to self-determination
is potentially compromised:
consent would necessarily destroy the experiment.
subjects in experiments where getting informed
Research in psychology
26-48
of perception where the design requires deceiving the subject as to
the purpose or procedures would be an example.
the difference in response between subjects receiving a placebo in a
drug study who are told there is a placebo in the design and those who
are not told would be another.
An experiment to test
First, it is important to distinguish between cases where consent
would necessarily destroy the experiment and cases where it would simply
make the experiment more. difficult.
of the researcher seems to me to be never tolerable.
cases it may be possible to be clever in designing protocols so that de-
ception or other lack of informed consent would not be necessary. In some
cases it is believed that consent would destroy the experiment without any
adequate grounds for that belief. For instance, I know of no evidence
that telling subjects there is a placebo in the design of a drug study
(never, of course, telling them whether they are receiving the placebo)
would harm the experiment.
jects would be different--they may be more cautious in their reporting;
but I know of no convincing argument that the results obtained would be
any less valuable.
valuable, because the subjects would generally be on guard to make accurate
reports.
be a requirement of informed consent to state that there is a placebo in
the design.
Omitting consent for the convenience
Further, in some
It is possible that the reports from the sub-
In fact it could be argued that they would be more
I believe that in all designs where a placebo is used, it should
There will still, however, be research which cannot be done without
deception of the subject. We have seen that current DHEW requirements
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justify such missions of informed consent. 71 We deduced that a principle
of social-benefits was necessary to omit consent in such cases.
just any social benefit would justify the consent omission.
in the DHEW guidelines.
sent would "surely invalidate objectives of considerable immediate impor-
tance," when "reasonable alternative means for attaining these objectives
would be less advantageous for the subjects,
subject is minimal." Thus there is already a clear recognition that not
just any social benefit is sufficient to waive the consent. In fact the
requirement that reasonable alternative means for attaining these objectives
would be less advantageous for the subject is a requirement which would
possibly permit some therapeutic research deception, but would apparently
prohibit all psychological studies using deception in normal subjects
since the deception study is of no advantage to the subject whatsoever.
But not
That is clear
First, missions are justified only when the con-
and when the risk to any
I think simultaneously we need to go further and have gone too far.
I believe we may have gone too far if we rule out all deceptive experiments
where only the good of society is at stake.
gone far enough in specifying what principles and what tests would justify
waiving of the consent. Hans Jonas, in discussing non-disclosure in cases
where disclosure would destroy the research, also takes a position that the
subject's rights may be violated even though no harm is done:
importance of the objective can exonerate it, without making it less of a
transgression.
Jonas seems to limit his argument to non-disclosure in cases of research
on patients (which he calls "an outright betrayal of trust"). It seems,
At the same time we have not
"Only supreme
The patient is definitely wronged even when not harmed." 72
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however, that the argument works equally for the non-patient subject.
Jonas also does not develop the argument about what would be sufficient
to justify such a non-disclosure.
where such non-disclosure would be justified, the one principle which would
justify violating the right to self-determination, must be rooted in the
concepts of self-determination and trust themselves.
there is good empirical evidence that the subject would not consider the
deceptive withholding of information a violation of that trust, would I
find the non-disclosure acceptable. 73
presume on the basis of specific empirical evidence that reasonable sub-
jects would not have objected to participating in the experiment without
It seems to me that the one instance
If, and only if,
If, and only if, we can reasonably
their consent, would such omission be justified. 74 I believe that is an
empirically testable proposition. I would suggest that for any experiment
which would be destroyed if informed consent were obtained, researchers
should be required to draw a sample from the subject population proposed
in the protocol, explain to these mock-subjects the research in mind in-
cluding the benefits as well as the deception involved. Subjects should
then be asked whether they would have considered their right to self-
determination violated--whether they would have objected to being an un-
informed participant, had the research actually been done on them without
their informed consent. If we can predict, based on that sample, using a
reasonable confidence limit such as 95 percent that other subjects drawn
from the same population would not object, then it seems to be a justifiable
compromise of the real subjects' right to self-determination.
a compromise because even at that level of certainty one subject in twenty
It is indeed
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predictably would object to being made part of the experiment.
this seems to me to be a reasonable compromise. If a lesser number of
mock-subjects, say only a majority, approved, that could hardly justify a
presumption that all or virtually all of the uninformed subjects would have
approved of the deception.
Nevertheless
The Need for Special Review of Consent in Group II Subjects
Because consent with all group II subjects is problematic procedures
are needed to assure that these subjects' right to self-determination is
not violated--insofar as such capacity exists.
second level review of all research involving Group II subjects, a national
board charged with reviewing all protocols using the same criteria as local
boards. There is good reason to suppose that Group II subjects, especially
clinic patients, are now used as subjects because their use is the path of
least resistence. Establishment of an additional level of review would
provide additional incentive to use subjects whose capacity and/or opportun-
ities to consent is not as problematic.
local committees vary tremendously in their standards for approving consents,
that such precaution seems necessary to protect the rights and welfare of
these special groups of subjects whose ability to give effective informed
consent is so problematic.
I would favor a special
There is sufficient evidence that
The August 23, 1974, draft of proposed regulations for protection of
human subjects includes an alternative to a national level review of con-
sent.
fetuses, abortuses, pregnant women, and in vitro fertilization.
proposed that a local "consent committee" be established to monitor consents.
75 That draft proposed additional protection for research involving
It was
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The proposal could be expanded to cover all of what I have called Group
II subjects.
dropped from the policy adopted August 8, 1975. 76
against such committees--that it would cost too much in time, money,
and social benefits--cannot be a definitive argument for jeopardizing the
rights of subjects unless one is committed to a utilitarian calculus of
social costs and benefits. 77
group of researchers should at least not be taken as definitive by the
representatives of the public since researchers are legitimately expected
by society to have a unique value commitment to the social benefits of the
research enterprise.
I favor such a committee and am disappointed that it was
The argument given
This argument, put forward by a distinguished
My own position, however, is not that the consent committees would
impede social progress;
way of well designed and executed research.
a second group completely independent of the special characteristics
institutionalized into the local IRB and exposed sufficiently to the
special problems of consent in problematic cases be given an opportunity
to review the quality of the consent as well as the judgment that the jeo-
pardy to the subject's interests, rights and welfare is justified by the
potential benefit to the subject and/or others.
effectively done by a national committee.
promise preferable to the well articulated and often reasonable demands
that research be banned entirely on children, prisoners and other Group II
subjects.
I am not convinced that they would stand in the
Rather I am concerned that
I would see this most
This seems to me to be a com-
----------
In principle I see one ground other than the principle of self-
26-53
determination which would justify experiments on human subjects.
would apply to all experiments including experiments requiring non-
disclosure.
prima facie obligation to promote justice independent of the consequences.
This has led to an exciting contemporary debate about the meaning of
justice.
variants of that theory
right which might deprive individuals of their right to self-determination.
The justification, however, is not in the production of good social con-
sequences on balance, but in promoting justice.
informed consent could be derived from this theoretical work which would
provide a very limited basis for sacrificing the rights and interests of
the individual for the benefit of certain others who are less well off
(but not society in general). 80 I have purposely not developed such a
formulation for this paper, relying instead on a theory of self-determination
because I am not convinced that the theoretical work on the theory of jus-
tice is sufficiently advanced that it could be incorporated into practical
public policy making by the National Commission without the risk of errors
which would jeopardize the rights of individual subjects.
ment of the implications of this theory for informed consent an important
research problem for the next few years.
This
It is often held, I believe correctly, that humans have a
78 The theory developed by John Rawls and the more egalitarian
79 would consider some practices fair and even
I believe a theory of
I see the develop-
I am convinced that biomedical and behavioral research, both thera-
peutic and non-therapeutic, is of tremendous importance to the individual
and to society.
right to such research.
fundamental rights, especially the individual's right to autonomy or self-
In fact, we might reasonably speak of the individual's
To do so, however, involves a recognition that
26-54
determination, which must provide the basis for free and informed consent.
To fail to get such consent will do far more than jeopardize important
benefits to the individual and to society, it will jeopardize those funda-
mental rights themselves.
26-55
1 Department of Health, Education and Welfare, Office of the Secretary, "Protection of Human Subjects," Federal Register 39 (number 105) Part II, May 30, 1974, pp. 18914-18920. See especially paragraph 46.2, p. 18917.
2 In fact I would stand with those who favor even more caution in getting consent for clinical care and so-called therapeutic experi- ments than non-therapeutic research because of the strong, sometimes coercive, interest a sick person has in maintaining the approval of medical professionals. See Robert J. Levine, "The Nature and Definition of Informed Consent in Various Research Settings," December 1, 1975, paper prepared for the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter cited as "Na- ture and Definition").
3 The alternative is to pack the requirements that consent be free and informed into the definition of consent. dictionary has as its first definition "voluntary agreement to or acquiescence in what another proposes or desires; compliance, con- currence, permission." The ambiguity is apparently within the word itself. voluntariness while the latter synonyms do not. consent as the naked permission leaving to the adjectives to specify that adequate consent must be free and informed. clarity and functionally leads reviewers to the proper questions to ask about a particular consent.
The Oxford English
The first part of the definition includes the requirement of I prefer defining
I believe that adds
4 Hippocrates, The Sacred Disease, in W.H.S. Jones, ed.,
5 Ibid.
6 Ludwig Edelstein, "The Hippocratic Oath: Text, Translation, and
7 The oath states the patient-benefitting principle twice, first
English edition Hippocrates II, p. 134.
Interpretation" in Ancient Medicine (Johns Hopkins Press, 1976), pp. 3-63.
with regard to dietic measures (one of the three elements of Pythagorean medicine): according to my ability and judgment." Later a more general form of the patient benefit-principle is repeated, this time without the explicit statement that the standard is to be the physician's own judgment, al- though this time the notion of intention is introduced: Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice..." See text in Edelstein, ibid., p. 6.
"I will apply dietetic measures for the benefit of the sick
26-56
8 In addition to the fact that the patient-benefitting principle, if taken seriously, excludes all experimentation not done in the inter- ests of the patient, it can also be criticized as being excessively in- dividualistic (concentrating only on benefit to the individual, isolated patient) and paternalistic (using the physician's own judgment as the standard of reference). That it focuses exclusively on benefits and harms to the exclusion of other ethical questions such as right and obligations inherent in action, is a problem we shall discuss below.
9 It has been recognized that in special circumstances so-called
If an individual were at high risk to a par- non-therapeutic research might be undertaken on healthy subjects in the name of patient-benefit. ticular disease testing a vaccine on that person in the face of an epi- demic might be justified on the grounds that the risk to the patient him- self was less in conducting the trial of the vaccine than in letting the patient go unprotected. Haven: Yale University Press, pp. 15-16.) Here, however, the principle of patient-benefit remains the norm. in the test is made on strictly patient-benefitting grounds without con- sideration of benefit to others which might come from the knowledge gained.
10 See Robert J. Levine's paper for the National Commission for the Protection of Human Subjects for a more extensive discussion of the dis- tinction between therapeutic and non-therapeutic research.
(See Paul Ramsey, The Patient as Person (New
The judgment to include the patient
11 Here I must explicitly reject the argument that some procedures undertaken where the two objectives of benefitting the patient and gain- ing knowledge both are present should not be seen as experimental. Ber- nard M. Dickens, for instance, argues that "If no orthodox treatment exists for the patient's condition (either because of the condition's novelty or because the orthodox treatment has become discredited by advances in medi- cal knowledge) the physician's innovation will be nonexperimental." (Ber- nard M. Dickens, "What is a Medical Experiment?", Canadian Medical Associ- ation Journal 113 (Oct. 4, 1975), pp. 635-639, quotation from p. 636.) That seems to me to simply be a flagrant corruption of the term "experi- ment." It is one thing to say that under these circumstances there is no known better alternative; it is another to say that the trial of an unproved treatment is not experimental. Especially since he believes that a lower standard of consent may be required when a treatment is not experimental (a position which I reject in any case), much is at stake in the definitional debate. Certainly the patient ought to have the option of doing nothing in these circumstances, an option which by definition has not been shown to be any worse than the novel therapy.
12 "Food and Drug Administration: Consent for Use of Investigational New Drugs (IND) on Humans--Statement of Policy," text in Jay Katz, Experi- mentation with Human Beings (New York: Russell Sage Foundation, 1972) p. 573. Drugs for Human Use: Reorganization and Republication," Federal Register, (March 29, 1974), pp. 11684-11685 and 11712-11718.
The same wording is reaffirmed in "Food and Drug Administration:
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13 Department of Health, Education and Welfare, The Institutional Guide to DHEW Policy on Protection of Human Subjects (Washington: U.S. Government Printing Office, 1971), p. 8.
14 "Protection of Human Subjects: Proposed Policy," Federal Regis-
15 "Protection of Human Subjects," Federal Register 39 (Part II,
ter 38 (Part II, October 9, 1973.
May 30, 1974.
16 It has long been recognized that it may be reasonable to persist in requiring that a rule such as the informed consent rule be followed even in individual cases where it appears that more good would come if the rule is violated. human being is sufficiently fallible that the rule is more likely to produce good on balance than individual judgment is or on the grounds that it is the nature of rules that they specify practices, practices which in turn might be chosen because they will produce more good than any other social practice. See John Rawls, "Two Concepts of Rules," Philosophical Review 64 (1955), pp. 3-32.
This is justified either on the grounds that the
17 See Ralph J. Alfidi, "Informed Consent: A Study of Patient Re- action," Journal of the American Medical Association 216 (May 24, 1971), pp. 1325-29, for empirical evidence.
18 I recognize that the argument about consent in cases where the consent would do more harm than good implies that there may in fact be such cases. nizes that lack of consent per se may do harm--the patient may have un- allayed fears, confusion about what behaviors are appropriate, etc.-- then a case might be made that consent is always necessary on patient- benefitting grounds. that consent might be contraindicated in some therapeutic experiment on patient-benefitting grounds.
Charles Fried in his important new discussion of the ethical foundations of experimentation develops the theme of "personal care" as the duty of the physician. Personal Integrity and Social Policy (New York: American Elsevier Pub- lishing Co., Inc., 1974). At one point he uses a qualified argument of "therapeutic privilege," that is the argument that information could be withheld on grounds of patient benefit (p. 22). Later, however, when he develops the theme of "personal care" he makes the claim that personal care involves a notion of rights which belong to the patient which seem to be independent of consequences. know all relevant details" (p. 101), autonomy, trust, and "the right to be treated without deceit or violence (p. 103). If, however, Fried per- ceives these to be rights inherent in personal care, it is hard to see how the physician has the "privilege" of overriding them when he believes (rightly or wrongly) that the overriding would be therapeutic. Thera- peutic "privilege," if it exists at all, must be precisely that, a pri- vilege the physician acquires because the patient has ceded the rights Fried has outlined.
I am not prepared to concede that there are. If one recog-
For this discussion I presume, hypothetically,
(Charles Fried, Medical Experimentation:
These rights include "a right to
26-58
19 American Medical Association Judicial Council, Opinions and Reports of the Judicial Council (Chicago: A.M.A., 1971), pp. 11-12. Also see in addition to section 2 which commits the physician to im- prove medical knowledge, sections 1, 4, 9, and 10 where the physician is explicitly committed to serving society or other collective groups as well as the individual patient.
20 See Jeremy Bentham, An Introduction to the Principles of Morals and Legislation; John Stuart Mill, Utilitarianism; G.E. Moore, Principia Ethica, London: Cambridge University Press, 1903; and Henry Sidgwick, The Methods of Ethics, London: Macmillan and Co., Ltd., 1907.
21 William Harvey, Exercitatio Anatomica de Motu Cordis et Sanguinis in Animalibus, 1628. Also see Henry E. Sigerist, "William Harvey's Posi- tion in the History of European Thought," in On the History of Medicine (New York: MD Publications, 1960), pp. 184-192.
22 Chauncey D. Leake, ed., Percival's Medical Ethics (Huntington,
23 Claude Bernard, An Introduction to the Study of Experimental
further than even the classical utilitarians in claiming that experiments which may do good are obligatory. utilitarians unless all things considered they would be likely to do more good than any other courses of action. Bernard, contrary to some inter- pretations of the negative formulation of the physician's duty primum non nocere (first, do no harm) seems to treat harms and benefits on the same scale.
New York: Robert E. Krieger Publishing Co., 1975), p. 76.
Medicine, (New York: Dover, 1957), p. 102. Bernard certainly has gone
They would not be according to the
24 This function corresponds to the point made by Katz and Capron that one purpose of informed consent is "to involve the public." Katz and Alexander Morgan Capron, Catastrophic Diseases: Who Decides What? (New York: Russell Sage Foundation, 1975) p. 90; cf Levine, "The Nature and Definition," p. 3.
Jay
25 "Protection of Human Subjects," Federal Register 39 (Part II, May 30, 1974), p. 18919.
26 See Carl J. Wiggers, "Human Experimentation as Exemplified by the Career of Dr. William Beaumont," in Clinical Investigation in Medi- cine: Legal, Ethical and Moral Aspects edited by Irving Ladimer and Roger W. Newman (Boston: Law-Medicine Research Institute, Boston University, 1963), pp. 119-125.
27 St. Martin bound himself to "Serve, abide and continue with the said William Beaumont, wherever he shall go or travel or reside in any part of the world his covenant servant and diligently and faithfully... submit to assist and promote by all means in his power such philosophical or medical experiments as the said William shall direct or cause to be made on or in the stomach of him, the said Alexis, either through and by
26-59
means of the aperture or opening thereto in the side of him, the said Alexis, or otherwise, and will obey, suffer and comply with all rea- sonable and proper orders of or experiments of the said William in re- lation thereto and in relation to the exhibiting and showing of his said stomach and the powers and properties thereto and of the appur- tenances and the powers, properties and situation and state of the contents thereof." Text from William Beaumont, Experiments and Obser- vations on the Gastric Juice and the physiology of Digestion, 1833, cited in Henry Beecher, Research and the Individual: Human Studies (Boston: Little Brown, 1970), p. 219.
28 See Michael R. LaChat, "Utilitarian Reasoning in Nazi Medical Policy: Some Preliminary Investigations," Linacre Quarterly 42 (Feb. 1975), pp. 14-37; for an important discussion of the general problems of utilitarian justification of human experimentation see Ruth Macklin and Susan Sherwin "Experimenting with Human Subjects: Philosophical Perspectives," Case Western Reserve Law Review 25 (1975), pp. 434-471.
29 "The experiment is to be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature."
30 "1. The voluntary consent of the human subject is absolutely essential.
to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. that before the acceptance of an affirmative decision by the experi- mental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or en- gages in the experiment. may not be delegated to another with impunity." tation with Human Beings, op. cit., p. 305.
Aspects of Human Medical Experimentation," University of Toronto Law Journal 25 (1975), pp. 406-438.
This means that the person involved should have legal capacity
This latter element requires
It is a personal duty and responsibility which In Jay Katz, Experimen-
31 See the interesting discussion in Bernard M. Dickens, "Contractual
32 Carpenter v. Blake 60 Barb. 488 (N.Y. Sup. Ct. 1871).
33 Jackson v. Burnham 20 Colo. 532 Pac. 577 (1895).
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34 Schloendorff v. New York Hospital 211 N.Y. 127, 129, 105 N.E.
35 Natanson v. Kline 186 Kan. 393 P2d 1093 (1960) text cited in
92, 93 (1914), text in Jay Katz, op. cit., p. 526.
Jay Katz, op. cit., p. 533.
36 Fortner v. Koch 272 Mich. 272 N.W. 762 (1935).
37 "Protection of Human Subjects," Federal Register 39 (Part II, May 30, 1974), p. 18917.
38 I concede that someone with imagination might argue that there are indirect, but serious risks--that mankind's respect for the genetically abnormal would change and that, in turn, would have a psychological impact on the subject. If those risks are included, however, it seems that any research would have risks and the proviso "if risk is involved" is mean- ingless.
at risk in the normal sense of the term, but that the rights and welfare of others are and that that is sufficient reason why some might want to refuse to consent to participate in the study.
It seems more plausible to say that the subject is not really
39 I endorse Robert J. Levine's emphasis on explaining the "larger ultimate purpose" as well as the immediate one. See Levine, "The Nature and Definition," p. 10.
40 See Immanuel Jakobovits, Jewish Medical Ethics (New York: Bloch Publishing Co., 1959), pp. 132-152; Fred Rosner, Modern Medicine and Jewish Law (New York: Yeshiva University Press, 1972), pp. 132-154; and David Bleich, "Medical Experimentation Upon Severed Organs," in his "Sur- vey of Recent Halakhic Periodical Literature," Tradition 12 (Summer 1971), pp. 89-90.
41 See L.C. Epstein and L. Lasagna, "Obtaining Informed Consent: Form or Substance," Archives of Internal Medicine 123 (1969), pp. 682-688.
42 There are a number of variants on the professional standard: what is customary for physicians in the community to disclose, what phy- sicians more generally in society or in a specialty group would disclose, or what the "reasonable physician" would disclose. All rely on a profes- sional standard. See Leonard L. Riskin, "Informed Consent: Looking for the Action," University of Illinois Law Forum 1975 (number 4, 1975), pp. 580-611, especially pp. 585-586.
43 Natanson v. Kline 186 Kan. 393 P. 2d 1093 (1960), cited in Jay
44 California, Idaho, New York, Ohio, Oregon, Pennsylvania, Rhode
Katz, op. cit., p. 534.
Island, Washington, Wisconsin, and Tennessee, but cf. Karp v. Cooley, 349 F. Supp. 827 (S.D. Tex. 1972, affirmed 493 F. 2d 408 (5th Cir. 1974).
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45 Riskin, op. cit. Also see Don Harper Mills, "Whither In- formed Consent?" Journal of the American Medical Association 229 (July 15, 1974), pp. 305-309, where Mills concludes (p. 305) that "the 'standard of practice' basis for judging the extent of disclosure will probably give way to a new rule of reasonableness; though what the courts believe to be reasonable disclosure may not necessarily be consistent with what physicians believe should be disclosed."
46 Garnham, op. cit., pp. 143-44. Many, including Garnham, still maintain that although informed consent of patient or subject is impos- sible, some consent should still be obtained. There seems to be an in- consistency in this position.
46a Of course, the same point can be made on patient- or subject-
The benefitting grounds if one holds that determining what is beneficial to the patient/subject is dependent upon the subject's own values. fact that the researcher or the research community would find some piece of information irrevelant given the researcher's values or the values of the research community as a whole, cannot be taken to imply that it would be irrelevant in another value context.
47 Berkey v. Anderson, 1 Cal. App. 3d 790, 805, 82 Cal. Rptr. 67,
48 The implications of the reasonable person court decisions for the composition of human experimentation committees and the questions they must answer is explored in greater detail in Robert M. Veatch, "Human Experimental Committees: Professional or Representative?" Hast- ings Center Report 5 (October 1975), pp. 31-40.
78 (1969).
49 Norman Fost, "A Surrogate System for Informed Consent," Journal
50 This Interpretation differs slightly from that of Robert J. Levine,
of the American Medical Association 233 (Aug. 18, 1975), pp. 800-803.
"The Nature and Definition," p. 19. standard " puts the particular physician or investigator in the precarious position of having to know in advance what harms a particular patient or subject might consider material after they occur." I agree that the phy- sician is placed in a precarious position, but I do not think it is quite that precarious. simply disclose what the reasonable person would find meaningful or use- ful. This should be modified when the physician has reason to believe that the individual patient or subject differs from that reasonable per- son view, but, unless the physician has negligently or maliciously avoided the discovery that the individual patient differs from the reasonable person, I do not see that he would be held to the standard of that (deviant) patient or subject. Of course, the physician is still in a precarious position because this series of cases makes clear that the physician's own judgment or even the consensus of medical professionals cannot be
He says that the reasonable person
My reading of the case law is that the physician must
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taken to adequately predict what the reasonable person would want to know. This does mean, however, that an all lay committee made up of individuals reasonably presumed to be reasonable would be a plausible test of the adequacy of the information, unless there was information to the contrary about the individual subject. Levine goes on (p. 20) to introduce the reasonable person standard, but without qualifying it for the case when the researcher knows or should know that the subject differs from that reasonable person.
51 "Protection of Human Subjects," Federal Register 39 (Part II,
52 For a fuller discussion of these elements see the author's
May 30, 1974), p. 18917.
"Ethical Principles of Medical Experimentation," in Ethical and Legal Issues of Social Experimentation edited by Alice M. Rivlin and P. Michael Timpane (Washington: The Brookings Institution, 1975), pp. 21-59, especially pp. 52-57.
53 See a fuller discussion of this issue below.
54 The specific mention of "inconveniences" occurs in the Nurem- berg Code. of inconveniences by some review committee members although "incon- veniences" could be taken to be subsumed in "risks." is listed as separate from "risks" can be cited to support the claim that "inconveniences" are not to be taken as risks.
Its omission has been taken as justifying non-disclosure
That "discomforts"
55 "Protection of Human Subjects," Federal Register 39 (Part II, May 30, 1974), p. 18918, paragraph 46.9.
56 Robert J. Levine, "The Nature and Definition," pp. 10, 11, 25.
57 Levine, ibid.
58 See Louis Lasagna, The Conflict of Interest Between Physician
, p. 57. Cf. "The Protection of Human Subjects," Federal Register 39 (Part II, May 30, 1974), p. 18919.
as Therapist and as Experimenter, (Philadelphia: Society for Health and Human Values, 1975).
59 John Stuart Mill, On Liberty (New York: Liberal Arts Press, 1956), p. 114, where he argues "for such actions as are prejudicial to the in- terests of others, the individual is accountable and may be subjected either to social or to legal punishment if society is of opinion that the one or the other is requisite for its protection."
60 Ibid., p. 125.
61 This is the term preferred by Alexander Morgan Capron, "Legal Considerations Affecting Clinical Pharmacological Studies in Children," Clinical Research 21 (1972), pp. 141-150.
62 Paul Ramsey, op. cit., chapter 1.
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63 The argument here is related to Richard McCormick's in "Proxy Consent in the Experimentation Situation," Perspectives in Biology and Medicine 18 (Autumn 1974), pp. 2-20.
64 G. Emmett Raitt, "The Minor's Right to Consent to Medical Treat- ment: A Corollary of the Constitutional Right of Privacy," Southern California Law Review 48 (1975), pp. 1417-1456.
65 In Re the matter of Karen Quinlan: an alleged incompetent: Superior Court of New Jersey, Chancery Division, Morris County, Docket No. C-201-75; Winters v. Miller, 446 F. 2d 65 (C.A.2, May 26, 1971).
66 New York City Health and Hospitals Corporation and Edward A. Stolzenberg, Associate Director, Bellevue Hospital, Petitioners, v. Paula Stein, a patient, respondent, 335 N.Y.S. 2d 461.
67 In re appointment of a guardian of the person of Maida Yetter, Docket No. 1973-533 (Pa. Ct. of Common Pleas, Northampton Co. Orphan's Ct., June 6, 1973).
68 N.Y. State Mental Hygiene Law, Article 15, "Rights of Patients,"
69 I have heard this suggested in personal communication with Karen
Section 15.03, Point (b)4.
Lebacqz and, independently, by Roy Branson. Whether the system would work I do not know. gain control of the funds in some cases leading to their inequitable use. Also it is not clear why drug companies and others wanting to do research would choose prisoners as subjects under these conditions. get subjects in a controlled environment for long periods of time they might recruit students who would agree to spend weeks in a controlled institution in exchange for offerings of summer school courses, room and board at the researchers' expense. Whether an offer to an economically deprived group such as students would be seen as less coercive than for prisoners, I do not know, but at least institutional review and control might be more dependable and the danger of use of research for retribution would be eliminated.
Possibly prison officials or dominant prisoners would
In order to
70 American Medical Association House of Delegates, "Resolution on Disapproval of Participation in Scientific Experiments by Inmates of Penal Institutions," text in Henry Beecher, op. cit., p. 225. This position may also be rooted in the concern for protecting the public interest insofar as research participation leads to earlier release from prison. It would not directly justify opposition to meritorious or commendatory citation, however.
71 We have already argued that the positions of private groups of professionals should not be persuasive in setting public policy. They are often committed to special value stances not shared by the general public. Thus the acceptance of the American Psychological Association
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of deception and even lying--presumably on the justification of the social benefits to be obtained--should not be terribly relevant to the Commission. The Association's unique commitment to the social value of the particular type of knowledge gained should not influence com- missioners who have a public obligation to protect constitutionally guaranteed rights. See American Psychological Association, Ethical Principles in the Conduct of Research With Human Participants (Wash- ington, A.P.A., 1973), pp. 29-35; Cf. Code of Ethics, American Socio- logical Association, which says obliquely, "Just as sociologists must not distort or manipulate truth to serve untruthful ends, so too they must not manipulate persons to serve their quest for truth."
72 Hans Jonas, Philosophical Essays (Englewood Cliffs, New Jersey: Prentice Hall, 1974), p. 126.
73 See the qualification of this statement related to a possible theory of justice below.
74 I believe this a more explicit principle and more precise re- quirement than Levine advocates. p. 30.
See Levine, "The Nature and Definition,"
75 "Protection of Human Subjects: Proposed Policy," Federal Register,
76 "Protection of Human Subjects: Fetuses, Pregnant Women, and In
August 23, 1974, pp. 30653-30654.
Vitro Fertilization," Federal Register, August 8, 1975, pp. 33526-33552. I also support third party scrutiny proposals as set forth by Levine, op. cit., pp. 46-52. However I feel such third parties should be used only with the consent of the subject. with the next of kin and/or a physician not connected with the research is certainly a violation of the individual's right to confidentiality. It should be clear, however, that third parties must be independent of the researcher and his or her staff. Thus the debate between Don Harper Mills and Alan Meisel over whether the physician or nurses and physician assistants associated with them would be better witnesses of the consent may be misplaced. While certainly the physician or researcher cannot be an adequate witness of a consent contract between himself and the patient or subject, those working under his supervision would not be adequate either. See Alan Meisel, "Informed Consent--The Rebuttal," Journal of the American Medical Association 234 (Nov. 10, 1975), p. 615; and Don Harper Mills, "Informed Consent--The Rejoinder," Journal of the American Medical Association 234 (Nov. 10, 1975), p. 616.
77 "Position Statement of the American Federation for Clinical
Discussing the proposed research first
Research on the DHEW Proposed Rules on Protection of Human Subjects," Clinical Research 23 (1975), pp. 53-60.
78 John Rawls, A Theory of Justice, (Cambridge, Mass.:Harvard University Press, 1971).
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79 See Brian Barry, The Liberal Theory of Justice (New York: Oxford University Press, 1973); and Robert M. Veatch, What Is a Just Health Care Delivery?," in Ethics and Health Policy edited by Robert M. Veatch and Ray Branson (Cambridge, Mass.: Ballinger Press, forthcoming).
80 See Macklin and Sherwin, op. cit.
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