Institutional Review Boards: Decision-making in Human Subjects Research

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 research.