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
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Contact: Elizabeth Campell
elizabeth.campell@icpa.gatech.edu
404-894-4233
Georgia Institute of Technology
18-Feb-2005

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