Drug Testing

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© 2004 Massachusetts Institute of Technology

Eth ics of Research In volvi ng Mandat ory Dru g Test ing

Ethics of Research Involving Mandatory Drug Testing of High School Athletes in Oregon Adil E. Shamoo, University of Maryland

Jonathan D. Moreno, University of Virginia Health System

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named “SATURN” (Student Athletic Testing Using Random Noti� cation), each school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the in� uence of random drug testing and to validate the survey data through identi� cation of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for play- ing a school sport. In addition to the coercive nature of this study design, there were ethically ques- tionable practices in recruitment, informed consent, and con� dentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human- subjects research and speci� cally the participation of children in research.

Introduction

Since the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) three principles have guided the ethical conduct of research with human subjects: respect for persons, bene�cence, and justice. For adults the principle of respect for persons is embodied in research with human sub- jects in the practice of informed consent. In the case of children whose decisional capacity is still in question, a parent or a guardian must give permis- sion to enroll the child in a research study. Within the principle of respect for persons lies the concept of “freedom from duress and coercion.” The view that research participation must take place without duress and coercion was prominent in the Nurem- berg Code (1947) and is embodied in the federal regulations at 45 CFR 46a, known as the “Com- mon Rule.” Ethically questionable research pro- jects involving children include using children in high-risk, nonbene�cial research (Shamoo and Tauer 2002) and knowingly allowing children to remain in unsafe environments in order to carry

out a study (Shamoo 2002). This article concerns the question of whether research that includes a mandatory drug testing program in which Oregon high school students are enrolled can be conducted in accordance with prevailing ethical standards.

Mandatory Drug Testing for High School Athletes

Under a three-year, $3.6 million grant from the National Institute on Drug Abuse, a part of the National Institutes of Health (NIH), a project be- gan in 1999 to study drug testing on high school athletes (Denn 2000; Card 2000). The principal investigator was a professor at the Oregon Health and Science University in Portland, Oregon, which was the of�cial recipient of the grant. The program was named “SATURN” (Student Athletic Testing Using Random Noti�cation). Under the study design each school in the Oregon public-school system could have, if it chose, a mandatory drug- testing program (separate and independent of the research study) for high school student-athletes. A state district court decision upheld such manda-

Target Article

Keywords

drug testing

research

adolescents

students

athletes

children

coercion

duress

mandatory

Open Peer Commentaries

Thomas R. Kosten, p. 32

Greg Koski, p. 33

Donald Louria, p. 35

Angela Roddey Holder, p. 37

David B. Resnik, p. 38

Erik Luna, p. 41

Gary T. Chiodo, Linn Goldberg, and Esther L. Moe, p. 43

Gregg E. Gorton, p. 48

Loretta M. Kopelman, p. 50

Anjuli C. Verma, p. 52

Richard R. Albrecht, p. 54

Peter J. Cohen, p. 55

Trisha Buchanan, p. 57

Jonathan Eder, p. 59

Authors’ Response

Adil E. Shamoo and Jonathan D. Moreno, p. W29

tory drug testing, and the U.S. Supreme Court af�rmed it (Tallmadge 2001). Initially, 18 public high schools agreed to participate in the program.

The study was designed to identify drug use among student-athletes, evaluating the in�uence of random drug testing on high school athletes (Goldberg 2000). The drug testing was used to validate survey data and identify individuals who did not report drug use. As was mentioned, each school could opt to have mandatory drug testing or not. However, the study required that each partici- pating school agree to a mandatory drug testing program for athletes before the initiation of the study at their school. Moreover, any school that al- ready had a mandatory drug testing program in place was not eligible for the study, because the ex- isting drug testing program might contaminate the study outcome. When the drug testing pro- gram became the school’s policy, the school had to declare drug testing a “pre-requisite for playing sports” (Goldberg 2000).

The stated purpose of the study was to:

1) assess the use of drug and alcohol among high school athletes and non-athletes; 2) determine the in�uence of drug testing on risk of substance abuse and protective factors among adolescents; and 3) ex- amine whether drug and alcohol testing of high school athletes leads to reduced drug and alcohol use. (Goldberg 1999)

Even though alcohol is mentioned, the proposal emphasizes drugs.

The literature contains much discussion of mandatory drug testing in high schools, primarily regarding the issues of ef�cacy and privacy (Palmer 1992; Tymowski 2001). Although the issue is be- yond the scope of this paper, a recent study by Yamaguchi, Johnston, and O’Malley (2003) indi- cates that drug testing is not effective in reducing illicit drug use among school students. Goldberg and colleagues (2003) recently published a pilot study of the SATURN project from two schools us- ing what appears to be the same protocol discussed in this paper.

The SATURN research project has been criti- cized by students, parents, the American Civil Lib- erties Union, newspaper articles, and editorials ob- jecting to its overall conduct (Kimberling 2000; O’Donnell 2000; Sabo 2000a; 2000b; Tallmadge 2001; Lawrence-Turner 2002; Rozas-Burke 2002a; 2002b). The U.S. Of�ce for Human Research Pro- tections initiated an investigation of the SATURN

study in response to a complaint by an advocate in Oregon (Eder 2002). The principal investigator has been vocal in defending his study on the grounds that it might signi�cantly reduce drug use by the athletes and, in turn, among the student population in general (Goldberg 2000; 2001; The Oregonian 2001).

Design of the Protocol

The investigation was a “prospective, randomized study” targeted toward “selected risk groups” (Goldberg 2000). The proposal suggests that SATURN is school-based “prevention interven- tion” research. The proposal involves 11 sequen- tial, well-coordinated parts. The �rst two parts ex- plain drug testing procedures and how the study will follow established methods in schools. The third part indicates that drug testers and coaches will receive training in all of the necessary proce- dures. The fourth part is to rely on peer reinforce- ment and ostracism to ensure student adherence to the testing policy. The �fth part requires that the school’s administration adhere to a “drug-free” pol- icy as a prerequisite to athletic participation; it fur- ther enlists coaches and athletes to endorse the pol- icy. The sixth part requires researchers to ensure family involvement, adherence, and promotion of the drug-free policy. The seventh part envisions that involvement in a drug testing program is sim- ilar to “Olympic” athletics and will enhance self- esteem. In this manner the program will establish the accepted “norms” of the “drug climate.” Part ten states: “Testing and threat of immediate conse- quences (e.g., not being able to participate in school sports) provide the basis of a decision to not use drugs or alcohol.” Parts eight, nine, and ten re- late to norms, refusal skills, and decision-making and social skills. The �nal, eleventh part states: “Repeated surveillance during the entire school year (all three sport seasons), for all student- athletes; seasonal repetition of instructional session re: testing procedure; during each season (three/ year) and subsequent years.”

The protocol further stipulates that all schools involved in the study must agree to a mandatory drug testing policy for athletes (Goldberg 2000). The protocol envisions two separate subject sam- ples for athletes and two for nonathletes. It envi- sions the participation of 85% of the (on average) 425 athletes per school. A total of 19,200 athletes and nonathletes were expected to be asked to par-

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ticipate. They were to be divided into groups of ex- perimental schools and control schools. The experi- mental group was to be subject to all of the interventions, such as drug testing, whereas the control school was to receive only a survey. In order to capture the nonathletes, the protocol envisions conducting a “condensed” survey of all athletes and nonathletes. The surveys request information from all students, athletes and non-athletes, including detailed histories of drug use, behavior, and psy- chological issues such as depression, as well as stu- dents’ knowledge of and attitudes toward drugs. The surveys were to be conducted during school- mandated gatherings, with athletes in one large area (e.g., a classroom) and non-athletes in a differ- ent area. All student athletes in the experimental schools were subject to random drug testing once during the school year but not necessarily during the season for their particular sport. Those ran- domly selected to be drug tested had to inform the investigator of all medications or drugs taken in the previous two weeks. Well-trained medical per- sonnel of the same gender observed the collection of urine samples. The school was noti�ed of all pos- itive tests and was obligated to follow its declared policy on drug users. Efforts to ensure the accurate, valid collection of urine samples for random test- ing were to be strictly enforced. The tests looked for opiates, cocaine, amphetamines, phencyclidine, anabolic steroids, and cannabis. Testing was fol- lowed by a survey questionnaire with unique iden- tifying numbers for longitudinal tracking. A sec- ond informed consent was administered to all athletes and their parents or guardians but was not a prerequisite for study participation. The program proposal clearly states that student athletes in ex- perimental schools may be drug tested as a condi- tion for athletic participation, regardless of their consent: “These students will be eligible for drug testing, whether or not they sign the consent to participate in the study.”

The school districts’ policy pronouncements were the same as those adopted for regular manda- tory drug testing approved in 1995. A positive drug test would result in a meeting being sched- uled with the principal, parents, and student, and disciplinary actions could be imposed, including a two-week suspension and drug and alcohol testing at any time during the school year. Because any given test result might be a false positive, a second specimen test (at the parents’ expense) could be re- quested. If the second sample also tested positive,

another meeting would be scheduled with the par- ents, and further disciplinary action could be taken, including suspension for the remainder of the year; suspension the following year from the speci�c sport; and, if the student wanted to partici- pate in another sport, submission to random test- ing and a drug/alcohol assistance program. If the student tested positive a third time, then he or she would be suspended from sports participation for a total of three years.

Informed Consent Documents

SATURN used two nearly identical informed con- sent forms. One form was addressed to student- athletes in the experimental schools and one was addressed to athletes in the control schools. The control groups were told that they would not be involved in the drug testing. The informed con- sent forms were less than two pages, including a large section on procedure (how the urine sample would be obtained and how same-gender research staff would accompany the student to the bath- room).

The only risk mentioned in the informed consent form (Goldberg 1999) is the loss of con�dentiality if the drug test is positive. The form mentions as bene�ts the advancement of sci- ence and the potential for the prevention of drug abuse among high school athletes. The form does not list any alternatives to enrolling, except to mention, “You may choose to not participate.” However, it also states that “the school may not al- low you to participate in school-sponsored athlet- ics” if the student refuses to participate in the study or if the drug test is positive. The of�cial Or- egon Health and Science University Survey Infor- mation Sheet states that opting out of enrollment will have no effect on “your relationship with your teacher, school.” However, at least one school dis- trict document states that “No student shall be al- lowed to participate in athletics without such con- sent [i.e., signing an informed consent form to participate]” (Oakridge School District 76 2000). (The document also notes the penalty, suspension from participation, for refusing a drug test or for a positive test.) Each student athlete was asked to sign two serially administered informed consent forms. The �rst consent form was required under the grant proposal and included the following un- derlined statement: “Signing the �rst consent form will be a requirement for athletes to participate in sports” (Goldberg 2000). The second informed consent

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form was not required for athletic participation but only for study participation.

Recruitment

The study protocol did not require students’ re- cruitment per se. Once the school had agreed to be a part of the study, then all student athletes were automatically enrolled in the research study if they wanted to continue playing a sport. The student- athlete was informed of the time and place to begin the research study and had to show a student photo identi�cation or have a picture taken for identi- �cation purposes. The protocol claims that coer- cion is reduced because the students’ parents need not sign the consent form in order for their chil- dren to play sports. However, the protocol relies completely on the school’s compliance with man- datory drug-testing policy and thus with the stu- dent-athlete’s parent or guardian signing both in- formed-consent forms.

Ethical Criteria

Institutional review boards (IRBs) are, by federal regulation, the gatekeepers for the protection of human subjects in research. Usually an IRB must answer a series of questions (Shamoo and Resnik 2002), of which one is the most pertinent to the mandatory drug testing at issue in this paper– informed consent. We will describe how the study design might have contributed to coercion of the participants in light of our description of the study protocol, informed-consent document, and recruit- ment process.

Children are among the vulnerable groups rec- ognized by the National Commission for the Pro- tection of Human Subjects (1979) for additional protections. These additional protections are re�ected in 45 CFR 46d, which classi�es research into four risk-related categories. The SATURN re- search study presents either minimal risk to the subjects, a minor increment over minimal risk, or, given hindsight and given the risks posed by this study, “greater than minimal risk and no direct medical bene�ts” (45 CFR 46.106). We do not have a record of the SATURN IRB’s decision con- cerning the level of risk of the study. We presume it falls under either the �rst or second category. However, regardless of the risk category the SATURN study, like all protocols, must comply with the principle of respect for persons. When a subject becomes involved in a research study that might impose risks to subjects, respect for persons

requires an informed consent process free of duress and coercion and with a reasonable guarantee of con�dentiality.

Was Informed Consent Adequate?

The SATURN informed consent documents fail to include the following elements:

a detailed description of the project;

an explanation of randomization;

a statement that parents will be informed if their child tests positive; and

an indication to parents of whether the study entails both survey research and drug testing.

Finally, under the heading of “Alternatives,” the consent form correctly indicates that refusal to en- roll will result in not allowing the student to par- ticipate in sport. Moreover, the research study staff contacted a number of students prior to their sign- ing of the assent form (Of�ce of Human Research Protections 2002b). Researchers also lacked knowledge about the prevalence of drug use, and hence provided no such information in the in- formed consent form. Furthermore, neither the in- formed consent form nor any other study docu- ment seen by students or parents discusses the consequences if the �rst test result is a false posi- tive (punitive steps would be initiated). The �rst consent form appears to be coercive and unethical.

In its determination letter of 4 October 2002 the U.S. Of�ce of Human Research Protections (OHRP 2002a) found the Oregon Health and Sci- ence University in violation of numerous federal regulations for the protection of human subjects, but it stated that it was not yet prepared to address the SATURN study. In its subsequent 24 October 2002 determination letter OHRP (2002b) sus- pended the SATURN program (2002b). Among OHRP’s �ndings were that “the goal of mandatory drug testing of student-athletes and the scienti�c aims of the study are so closely interwoven as to be indistinguishable.” OHRP also found that the study failed to meet the requirement that informed consent should be obtained under circumstances that would minimize coercion and undue in�uence: OHRP cited the linkage of athletic par- ticipation and a drug-testing requirement, as well as the use of formal classrooms and coaches during the contact with students. In addition OHRP found that the study was initiated prior to obtain- ing IRB approval and that the informed-consent

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form lacked complete descriptions of elements such as randomization, parental noti�cation if a drug test was positive, and the longitudinal nature of the study. On 10 December 2002 OHRP (2002c) further elaborated on its �ndings concern- ing the general problems associated with the pro- tections of the human subjects and suggested rem- edies for the institution to follow.

Was the Design of the Study Coercive to Participants?

Informed consent is known to be a process that be- gins with recruitment and continues until the end of the study. According to published reports (O’Donnell 2000; The Oregonian 2001), from the outset of the study school systems maintained an atmosphere of “pushing” student-athletes to par- ticipate in the mandatory drug testing. The push is alleged to have come in the form of threats and community pressure. When originally approached by the principal investigator, most schools did not have mandatory drug testing. However, schools were obliged to require mandatory testing in order to participate in the study (OHRP 2002b). School administrators’ might therefore have been moti- vated to reduce illicit drug use without cost to their schools. The study protocol is literally inter- woven into the mandatory drug-testing program. The student-athletes saw the whole school admin- istration (principals and coaches) as involved in the recruitment of participants. In fact, investigators admitted to OHRP site visitors that the study was an integral part of the mandatory drug-testing pro- gram (OHRP 2002b). For example, the director of the drug-testing laboratory was listed as staff for the SATURN program. This listing therefore con�ates the regular nonresearch drug testing pro- gram with the SATURN program. The project paid for drug testing, a built-in incentive for schools to participate in the program.

Of course, the most important coercive aspect of the program to participants was the threat that athletes would be disquali�ed from their sports if they refused to participate. One honor student- athlete was suspended for refusing to sign the in- formed-consent/assent form (Kimberling 2000), and the involvement of the school administrators and coaches in corralling the students into special classroom settings gives the impression that they were involved in recruitment of the students into the study. In fact, the schools’ administrations were involved in project coordination in general. Fur- ther, the informed consent form contains no men-

tion of alternatives to participation in the study, and probably none existed. There were also no ad- ditional protections provided to this vulnerable group, such as the right to refuse, an essential con- dition for a truly voluntary program. The federal regulations clearly state, “When some or all of the subjects are likely to be vulnerable to coercion or undue in�uence, such as children . . . , additional safeguards have been included in the study to pro- tect the rights and welfare of these subjects” (45 CFR 46.111b).

The study appears to have adopted no addi- tional safeguards to protect these children. But students were threatened with loss of participation in student athletic programs and with suspension from school if they tested positive. One of the re- quired elements of informed consent in the federal regulations is the statement that “participation is voluntary, refusal to participate will involve no penalty or loss of bene�ts to which the subject is otherwise entitled, and the subject may discon- tinue participation at any time without penalty or loss of bene�ts to which the subject is otherwise entitled” (45 CFR 46.116a8). Unfortunately, the SATURN study violated every element of this statement, because refusal to participate resulted in loss of bene�ts (O’Donnell 2000; The Oregonian 2001).

With regard to the SATURN program, these high school students were also under the speci�c duress of the power differential between them and their coaches and school administrators. Besides the general lack of control experienced by persons obliged to participate in the research study or face punitive actions by those more powerful, the loss of the opportunity to participate in a highly-valued activity in their peer group is a nontrivial threat. Recruitment of medical students and college stu- dents by their professors for studies that present physical or social risk are viewed with increasing skepticism (Moreno 1998). It would be odd if stu- dents aged 18 and younger were not granted at least the equivalent consideration as their older counterparts.

It is of interest that the local IRB did not pro- vide basic protections for these subjects. A key ele- ment of IRB approval is that it allows input from members of the community at large (non- researchers). Unfortunately, the community mem- ber in this case appears not to have provided the needed input. An editorial in The Oregonian (2000) expressed the views of many: “The government is forcing kids to participate in invasive research in

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order to participate in an educational activity— which is what sports are. Even if it works, it isn’t educational. And it sure ain’t science.”

Finally, the investigators could have avoided coercion in the experimental design if they had en- sured that the student-athletes and their parents knew that SATURN was a research project not in any way linked to the mandatory drug-testing pro- gram. The study protocol could further have made clear that a student’s refusal to participate might result in adverse consequences to them or to their relationship to the school.

Was Con� dentiality Protected?

In this study con�dentiality is lost if an athlete tests positive for drug use. The loss of con�den- tiality occurs due to the suspension of the student- athlete, which is again in violation of the federal standard (45 CFR 46.11.7b). Considering the pro- found social and psychological importance of peer relationships among adolescents, the loss of con- �dentiality results in humiliation as well as the public airing of drug-using status, assuming that the test result is a true positive. Con�dentiality re- quires that the consequences of trial participation not be subject to publicity of any form in which in- dividuals are reasonably at risk of identi�cation.

Was the Selection of Subjects Equitable?

Federal regulations require that “selection of sub- jects is equitable” (45 CFR 46.111.3). This re- quirement is based on the principle of justice, which according to the National Commission (1979) seeks to ensure that no particular group bears an unfair burden of research participation. The SATURN study targets athletes for drug test- ing even though drug abuse is a school-wide con- cern. By targeting athletes, the study places an in- appropriate burden upon a particular group of students. In combination with the lack of con�- dentiality, this inappropriate burden also stigma- tizes the student-athletes.

Could This Study Have Been Conducted under Prevailing Ethical Standards?

A rarely noted implication of our prevailing re- search ethics principles is that mandatory public- health interventions can rarely be combined with research without con�icting with those ethical principles. Such activities are inherently incompat- ible with the requirements of freely given in- formed consent. To take another example, a re- search study connected to a routine, required

screening program for infectious disease agents in a nursing home would face similar dif�culties with regard to lack of voluntary informed consent, as many of the residents are likely to have impaired decision-making capacity, and their institutional- ized status makes them severely dependent upon the facility. In the SATURN protocol are still more elements that caused it to con�ict with conven- tional views of human research ethics, including the inadequate informed consent documents, the problems with con�dentiality, and the young age and social status-related vulnerabilities of the sub- jects.

There can be no disagreement that adolescent drug use is a serious problem, both in its magni- tude for society and in its consequences for the drug user. Nor can there be doubt that a program for the identi�cation and assistance of those young people who use drugs could provide great social bene�t. It is beyond the scope of this paper to en- gage in a discussion of the morality of mandatory drug testing for high school students per se. How- ever, we can all agree that what is legal is not nec- essarily ethical. Perhaps other study designs that are not inherently coercive could be developed, though they might be less ef�cient and provide somewhat less secure conclusions. However, a pro- spective study that provides answers to these ques- tions in connection with a mandatory drug-testing program cannot be executed without violation of core ethical values. This result should not be sur- prising. One of the essential lessons of medical eth- ics following the Nuremberg trials is that certain avenues to knowledge are forbidden to science. The subject matter of this study is no exception. n

Acknowledgment

The authors wish to thank Jonathan Eder of Port- land, Oregon, who brought the original complaint to OHRP. One of the authors (AES) counseled Mr. Eder on the subject.

Received 30 May 2003; accepted 7 August 2003; revised manuscript received 7 August 2003; posted for commentary 22 August 2003.

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