Discussion 3
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Discussion3.docx
Discussion 3
This week, you will discuss the proper role of the IRB at a university. Regardless of whether you are carrying out an empirical capstone study or not, it is critical to understand the role of an IRB and to think critically about its purview.
Do IRB's have the potential to limit the academic freedom of researchers? Do IRB's have the potential to engage in needless censorship of potentially important research? Please read both articles - the "IRB as a mirror" goes over issues with IRBs, and the case study is essential - what would you do if you were an IRB reviewer for the study presented? Do you agree with the decisions? Do you agree with the student researchers? Why or why not? Read the attached articles on this subject.
racial_biascasestudyfromOER-week3.pdf
Studying Racial Bias: Too Hot to Handle?
by Jane Marantz Connor Psychology Department
State University of New York at Binghamton
Part I: A Research Proposal
In a Psychology of Racism class at State University in River City, New Jersey, during the fall of 1998, students were watching a video called "True Colors" that had been produced and shown on the television show Prime Time Live. In the video two young men, John and Glen, were shown pretending that they had just moved to St. Louis and were looking for an apartment and a job, ordinary activities of a person new to town. John and Glen appeared similar in every important way--dress, appearance, grooming, speech, etc., except that John was white and Glen was black.
The video camera caught major differences in how they were treated. At an employment agency, for example, John was given several job leads while Glen was questioned with suspicion. At a housing complex, John was given a key and invited to check out an apartment while Glen was told there were no vacancies. At a car dealership, Glen was quoted a higher price and less favorable financing for the same car. On and on it went.
At the end of the video, the students discussed their reactions to what they had seen. The African American and Latino students in the class indicated that they were not surprised by what had been shown. They thought it was an accurate reflection of the experiences of persons of color in the United States. The Asian American students agreed with them but were less strong in expressing their opinions. Most of the white students, however, reacted quite differently. While they thought that the discrepancies in how John and Glen were treated in the video were striking and deplorable, they did not believe that those discrepancies were typical of everyday interactions. They thought that racism was pretty much a thing of the past. They had questions about how many agencies, apartments, or stores John and Glen and the camera crew had visited in order to obtain the segments that were included in the video. Knowing that the video had been made almost 10 years earlier and in a different region in the country, they also felt that the observations in the video would be quite different from what would be found in River City in 1998. In sum, watching the video did little to bridge the gap between the perceptions of white students and students of color regarding the existence and magnitude of racism in River City today, as Dr. Barbara Jones, the instructor, had originally hoped it might when she decided to show the video.
After class was over, four concerned students spoke with Dr. Jones, whose research interests included prejudice and racism.
"The video we saw today was provocative and attention-getting but was not controlled research. Would it be possible for us to apply the research skills we have been learning as psychology majors and investigate racism in River City?" asked Greg.
"I would really like to know if the discrimination we saw in the video today is a common occurrence or a rare event," said Lourdes.
With much enthusiasm the students signed up for an independent study course with Dr. Jones the following semester and by February 1999 had designed an experiment to investigate the existence of racism locally. Following university guidelines, Dr. Jones and the students wrote a description of the research they wanted to do and how they would do it, and submitted the proposal to the IRB at State University.
Summary of the Proposal:
Black students and white students will visit nearby stores and apply for jobs. The conversations will be audio tape-recorded and the content of the tapes will be coded and scored by other students who will not know the race of the student in the tape or the store that was visited. After being scored, the tapes will be erased and the data from all of the stores will be analyzed and summarized as a group; no information about individual stores will be reported. From an analysis of the statements on the tapes and the number of phone calls, interviews, and job offers the students receive, it will be possible to evaluate whether the students' race affected their job opportunities.
Go to Part II
Originally posted: 1/28/00
Case copyright held by the National Center for Case Study Teaching in Science, University at Buffalo, State University of New York.
Studying Racial Bias: Too Hot to Handle?
by Jane Marantz Connor Psychology Department
State University of New York at Binghamton
Part II: Ethics and the Conduct of Research With Human Subjects
1. How does ethics relate to the conduct of research with human subjects?
Although scientific research has produced much of value to humankind, the rights of human participants in research have not always been protected by researchers. One infamous example is the heinous research done on prisoners in concentration camps by Nazi doctors during World War II. Another is the Tuskegee syphilis study with poor, rural black men, which was started in the 1940s before an effective treatment for syphilis was known. In order to study the untreated course of syphilis, the men were not made aware of penicillin, which could effectively treat their disease, even long after it was generally available.
To prevent such abuses, Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. This commission was charged with identifying the ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects, and to develop guidelines that should be followed to assure that such research is conducted in accordance with those principles. The Belmont Report, issued by the Commission in 1979, recommended three basic principles to serve as the foundation for the evaluation of the ethical conduct of research. (The full text of this report is available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm.)
Ethical Principles
1. Respect for Persons - Individuals are to be treated as autonomous persons "capable of deliberation about personal goals and acting under the direction of such deliberation."
2. Beneficence - Researchers have a responsibility to avoid harming research participants and to maximize possible benefits while minimizing possible harm.
3. Justice - Those who enjoy the benefits of research should also bear its burdens. It is not just, for example, that poor persons or minority people should be the subjects of research while the advantage of the knowledge gained is used to benefit people with money or positions of power in society.
The Belmont Report also identified three major applications of these principles.
Applications
1. Informed Consent - "Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied." Such consent must be based upon subjects having suitable information about the research presented in a comprehensible fashion, and subjects' participation being voluntary and free of coercion or undue influence.
2. Systematic Assessment of Risks and Benefits - "Benefits and risks must be 'balanced' and shown to be 'in a favorable ratio.'"
3. Selection of Subjects - On both an individual level and a social level, the burdens and benefits of research should be justly distributed, e.g., potentially beneficial research should not be conducted only with advantaged persons and "risky" research with disadvantaged ones.
2. How are these principles applied to specific research protocols?
The Belmont Report was adopted as a statement of policy by the U.S. Department of Health, Education and Welfare, and, in 1981, federal regulations were issued to implement this policy (Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects, known as 45 CFR 46.) All institutions receiving federal money are required to have an Institutional Review Board (IRB) to ensure that all research conducted at those institutions that involves human subjects, whether supported by federal money or not, is consistent with these guidelines. The Office of Protection from Research Risks (OPRR) within the National Institutes of Health oversees these IRBs and can impose severe sanctions, including the loss of all federal money, on institutions which do not comply with these regulations. The parts of these regulations most relevant to the present case are printed below. The full set of regulations can be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.
Guidelines from the Code of Federal Regulations, Protection of Human Subjects (45 CFR 46)
Definitions:
A. RESEARCH: A systematic investigation designed to develop or contribute to generalizable knowledge.
B. HUMAN SUBJECT: A living individual about whom an investigator (whether professional or student conducting research) obtains (1) data through intervention or interaction, or (2) identifiable private information.
C. MINIMAL RISK: The risks of harm anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.
It is the responsibility of the IRB to approve research based on the committee's determination that the following requirements are satisfied:
a. Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
b. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
c. No research is conducted without the informed consent of the participants, unless
the committee approves a waiver of the requirement of informed consent, as described below.
The IRB may waive the requirement for informed consent if it determines that
1. The research involves no more than minimal risk to the subjects; 2. The waiver will not adversely affect the rights and welfare of the subjects; 3. The research could not practicably be carried out without the waiver; and 4. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation.
3. Objectives of the present case study:
Although much of the work of IRBs is routine, there are times when difficult decisions must be made. It is the purpose of this case study to give you some experience applying federal regulations in such a difficult case. This case is fictionalized, but it is adapted from a case that really did occur.
Do you think the research proposal described in Part I is consistent with federal guidelines for the approval of research with human subjects and the ethical principles outlined in The Belmont Report?
Go to Part III
Case copyright held by the National Center for Case Study Teaching in Science, University at Buffalo, State University of New York.
Studying Racial Bias: Too Hot to Handle?
by Jane Marantz Connor Psychology Department
State University of New York at Binghamton
Part III: How did the IRB Evaluate the Proposal?
The IRB at State University consisted of a lawyer, a philosopher who specializes in medical ethics, a vice president for university relations, a psychology professor, a minister, and another administrator who chaired the committee. It included four white males and two white females. The committee voted unanimously to disapprove the study. A summary of their concerns follows.
Mary Cooper (the lawyer): To me the proposal smacks of entrapment. Since it is against the law to discriminate in hiring based on race, it seems to me that they are creating a situation where storeowners or employees could be charged with illegal behavior. All of this is to be done without either the consent of the owners or employees or their knowledge that they are even participating in a research project. You can't get much sneakier than that!
Patricia Barton (vice-president for university relations): Frankly, I am concerned about the potential harm of this research for town-gown relations and the local community in general. We have enough conflicts with the local community: out-of-control fraternity parties, differences in interactional style between our urban students and the more rural local residents, and economic, political and cultural differences between the two groups.
It's clear from the way the proposal is written that the students want to give the results of their supposed research to the local media. We really don't need local merchants and citizens seeing the university as trying to trick them and make them look bad. And if this research should get a wider audience, possibly being picked up by the Associated Press, how is that going to look? "River City, that racist city in New Jersey." It will hurt the university in so many ways--recruiting students, getting money from the legislature, keeping minority faculty. It could be a disaster.
Robert Blake (psychology professor): I just don't see how this research would add to scientific knowledge at all. Studies like this have already been done. We know racism exists. What new finding could they hope to obtain? It seems more like a stunt to me than an honest piece of scholarly inquiry. I also feel obliged to point out that Dr. Jones hasn't published in a scholarly journal for several years and I do have serious concerns about her motivation for this research. Where is the science here? Is she just trying to stir up trouble on campus? I wonder if she isn't just using the students for her own purposes.
Tom Delaney (minister): How could the research yield meaningful information anyway? The black and white students might speak to different employees, and maybe a store really isn't doing any hiring. The black student would think he was discriminated against when he really wasn't.
Frank Smith (university administrator): I am very concerned about the tape recorder. Isn't it against the law to tape record a conversation without a person's knowledge? They say that the conversation will be anonymously scored and erased, but who is to say that the students might not make an extra copy or talk with their friends about what happened in the different stores. I really don't see any way to guarantee the confidentiality of the data collected, and exposure, as we have seen with the Denny's and Texaco cases, could really hurt businesses.
Also, how do we know that the students won't make a scene if they are treated badly by a racist employee? It is our responsibility to protect all research participants, even racist ones. There could be name-calling, or even worse, if a student thought that he was the victim of an employee's or storeowner's racism. Maybe that is even what the students want. All of these risks without the informed consent of the potential subjects! It could be a legal and political nightmare.
Sam Fisk (the philosopher-ethicist): I hate deception experiments of any kind. When subjects are being deceived as to the nature of an interpersonal interaction, you are violating a fundamental principle of how people should relate to each other- -honestly. And they are not even proposing to do any debriefing of the subjects, to try to remove the negative effects of the deception afterwards. Not that I think that is really possible anyway. A lie is a lie. How do you remove the negative effects of being lied to?
But for me the lack of informed consent in this proposal is the most important thing. From the days of the Nuremberg trials, a fundamental principle that has emerged is that subjects must be aware of, and give their consent to, participating in research. This consent should be based upon an understanding of the potential risks and benefits to themselves and science for such participation. Federal guidelines allow the conduct of research without informed consent only under the most restrictive conditions. There is clearly more than "minimal risk" to the prospective participants here and, frankly, I just don't see the benefits.
Go to Part IV
Case copyright held by the National Center for Case Study Teaching in Science, University at Buffalo, State University of New York.
Studying Racial Bias: Too Hot to Handle?
by Jane Marantz Connor Psychology Department
State University of New York at Binghamton
Part IV: The Response of the Supporters of the Proposed Research
Supporters of the research included the students, Dr. Jones, and the local chapter of the NAACP. They were very upset with the decision of the IRB. A summary of their views follows.
Greg (undergrad): I can't believe they think the study is too risky. Some of the deception experiments I have seen conducted in the psychology department induce a lot more stress in the subjects and have greater possiblities for harm than what we are proposing. I have seen some students reduced to tears in "approved" experiments. It's obvious to anyone that this research cannot be conducted if we have to obtain the informed consent of the subjects. So what they are really saying is that we just can't study racism in the community. What happened to freedom of speech and academic freedom?
Leslie (undergrad): I am so angry and insulted that one of their reasons for disapproving the study is the concern that I and the other black students will not follow the research protocol, and deliberately violate the confidentiality of the responses we are collecting. Other students are entrusted with highly sensitive information in research projects, including information about suicidal tendencies, sexual orientation, and family problems. Has anyone ever heard of any other study being disapproved because the IRB thought the undergraduate assistants would not follow the research protocol?
And what are they thinking we would do in the store? Punch someone? Talk about stereotypical thinking! As a black man I encounter racism every day. How can the risks of harm to the employees in this experiment be greater than in everyday life, which is the definition of "minimal risk," when what we are proposing to do is an everyday behavior? If anything, the risks of harm to the employees should be lower than in everyday life since the other testers and I will be trained and committed to following the research protocol and not to respond violently no matter how provocatively an employee might behave.
Lourdes (undergrad): I looked up the definition of entrapment. It is when an enforcement agency entices the commission of an illegal behavior for the purpose of prosecution. We are not an enforcement agency, and the data we are collecting will be summarized and reported anonymously. We will not be prosecuting anyone! Further, we are simply applying for a job, an everyday behavior, and could hardly be said to be "enticing" anything. How could a lawyer say this is entrapment?
I also checked the law on tape recording. In New Jersey it is legal to record a conversation as long as one party to the conversation is aware it is being recorded. We could do the study without the tape recorder, if necessary, but it would
compromise the scientific rigor of the study.
Suzanne (undergrad): It's clear to me that all of this is just a bunch of excuses. What they're really trying to protect is white privilege. Black people only get the jobs that white people don't want. This has been going on for hundreds of years. Why should we expect it to stop now? And, to the extent that there is a risk of harm to the subjects, isn't it only just that the persons bearing the risk of harm are the ones who have profited all these years from racism and discrimination against black people?
How can they say the study has no merit? Don't they think it's important for us to know what's going on in River City? Haven't they heard of replication in science? It's obvious they're not concerned with the welfare of the human subjects, which is their responsibility, but the image of the university.
Dr. Jones (psychology professor): They say that they can't approve the research because of the lack of informed consent. But the IRB approves observational studies in the community every year that don't include informed consent. I know because many of them are studies done by my statistics students. Why is this different? If the identity of the stores sampled is not revealed, where is the potential for harm to the research participant?
I'm also pretty upset that some of the lay members of the committee don't understand the role of randomization in experimental design, and the persons on the committee who do took no steps to enlighten them.
The job of the IRB is to evaluate the relative risks and benefits of the research. Can you believe the head of the IRB told me he sees nothing wrong with having the risks and benefits of anti-racism research judged by an all-white committee?
Billie (president of the local NAACP): This is just one more instance of institutional racism--the system ensuring that black people are kept down. Either they don't know how badly my people are being hurt by unemployment and racism, or they don't care. Since the beginning of science there has been no shortage of experiments like the one done at Tuskegee, which obtained knowledge at the expense of black people. And then there are all the bogus studies that have been done in the name of science to prove that black people are inferior and we deserve the treatment we get.
But when we have a proposal whose purpose is to study how the powerful maintain their power, all we hear is ethics this and ethics that. My tax dollars support this university, too. Why shouldn't the university do something for us once in a while?
If your group were the IRB, would you approve the study as is, disapprove the study, or approve contingent on certain specific changes in the research protocol? In the latter case, what changes would you require?
Case copyright held by the National Center for Case Study Teaching in Science, University at Buffalo, State University of New York.
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