Issues involving the risks and benefits of human subjects research
converge at the intersection of research in engineering, science,
ethics, medicine, and technology and society. By law, research
organizations must establish an institutional review board (IRB) to
decide whether to approve research with human participants. With
over 6500 IRBs in the US, IRB decision-making can vary beyond the
basic federal guidelines. Both policymakers and researchers
increasingly are focusing on the adequacy of the existing oversight
system. As tension mounts over applicability of the guidelines to
all human subjects research, examination of the system is needed to
increase understanding of how committees actually decide whether to
approve or disapprove such research in their organizations. IRB
members' roles, participation, expertise on the IRB and
relationship to perception of IRB decision- making processes at
seven leading U.S. research universities are discussed. By
questioning who the experts are and how different members attribute
value to a research protocol on an IRB, we can begin to address
broader issues of expertise and public understanding of science and
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