Posted February 18, 2005 Atlanta
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University Research Ethics Committees: A Look from Behind Closed Doors
High-profile deaths in clinical trials at Johns Hopkins University in 2001 and the University of Pennsylvania in 1999 spotlighted the importance of human subjects review boards, also called institutional review boards (IRBs). Little is known about the decision-making process of these research ethics committees responsible for balancing ethical concerns with assessments of scientific methodology and the benefits of proposed research. A Georgia Tech researcher studies the composition of IRBs and how the IRB's makeup of scientists, non-scientists and community members affect decision making in a paper to be presented at the American Association for the Advancement of Science (AAAS) Annual Meeting on February 18.
Federal regulations require that all organizations that receive federal funding for research involving human participants establish an institutional review board to oversee such research. IRBs are formal committees that review and monitor research involving human subjects, and approximately 6,600 IRBs exist in the U.S.
Funded by a dissertation research grant from the National Science Foundation, Eliesh O'Neil Lane, who recently completed her Ph.D. at the School of Public Policy at the Georgia Institute of Technology, studied seven top-tier universities' IRBs. She conducted 37 in-depth interviews with IRB members and observed IRB meetings at all seven schools to examine their decision-making processes, the makeup of the board memberships, and the participation and roles of IRB members. In her paper, University IRBs: Decision-Making at the Intersection of Science and Society, which is part of a larger dissertation research study, Lane explores the rationale for involving nonaffiliated IRB members and lay participants in the IRB process and compares the roles of each type of member who serves on an IRB.
Of the seven IRBs Lane studied, two review all types of human subjects research proposals for their universities, three focus on social and behavioral research only, and two reviewed biomedical research only. In the U.S., federal guidelines require IRBs to evaluate the potential risks and benefits to research participants and to judge the scientific merits of a given study. In order to do this, IRBs must make judgments about four key areas of the research protocol: scientific merit, research design, risk-benefit ratio and the adequacy of informed consent. However, federal guidelines do not provide specific criteria for all these areas, so each committee must decide how to interpret the baseline regulations and is encouraged to use the flexibility of the regulations when deemed appropriate.
An example of this flexibility is in the Common Rule, which requires that IRBs not be composed entirely of members from one profession or entirely of one gender. This rule also requires that at least one IRB member, sometimes called a "community member," not be affiliated with the research institution. In Lane's study, all of the nonaffiliated members were also non-scientists.
Through qualitative analysis of member interviews and IRB meeting observations to explore IRB members' experiences and perceptions of the IRB process, Lane draws three major conclusions regarding the role of IRBs and how to improve them.
First, the composition of the IRB can greatly affect the types of issues that are discussed during an IRB review. The roles of the scientists, non-scientists and nonaffiliated members need to be more defined. Such phenomena as deference to expertise and the common knowledge effect may further influence the review process and the final decision outcome.
Second, in theory, the non-scientists and the nonaffiliated members who represent non-experts are presumed to have an equal voice in the IRB decision-making process. The IRB process allows any member, whether expert or not, to question other members about the proposed research, issues of risks and benefits and scientific merit. However, Lane concludes that it is questionable whether these non-experts actually choose to exercise equal participation in IRB meetings.
Third, without full participation by all members, IRB decisions cannot fully reflect all the relevant perspectives. So, what is the point of requiring certain types of members to serve on these committees?
The full paper is available by request.
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