Decision-making in the human subjects review system

Abstract

Issues involving the use of human subjects converge at the intersection of research in engineering, science, ethics, medicine, and technology and society. Questions arise about risks and benefits to research participants and society and the governance of science. By law a group of individuals known as the institutional review board (IRB) must be established by research organizations to decide whether to approve research protocols with human participants. Approximately 6600 IRBs exist in the U.S. Previous research on IRBs, mostly quantitative, has not studied the relationship between member characteristics (such as role and gender) and member perceptions of the IRB process. In this research I draw primarily on participatory democratic theory to frame the central research questions and the resulting analysis. I examine IRB members roles, participation, and expertise on the IRB and how these relate to their perception of the IRB decision-making processes at seven leading U.S. research universities. Policymakers and researchers alike increasingly are focusing on the adequacy of the existing system that oversees research studies involving human participants. As tension continues to mount over the applicability of the current guidelines to all research involving human participants, federally funded or not, it is timely to examine this oversight system to increase our understanding of how these committees actually decide whether to approve or disapprove human subjects research in their organizations. In this study, data are collected from personal interviews with scientist, nonscientist and nonaffiliated members serving on IRBs at each of the participating universities and from observation of an IRB meeting in session at each site. The findings of this research provide a scientific assessment of the relationship between IRB member composition and members perceptions of the IRB process. This research contributes to our understanding of the decision-making process that takes place within IRBs. Furthermore it utilizes the IRB as a mechanism for expanding our understanding of larger questions about the interfaces of science and policy and science and society. By questioning who are the experts and how do 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.