IRB: Ethics & Human Research

Nonscientist IRB Members at the NIH

The Code of Federal Regulations for the protection of human research subjects (45 CFR 46) stipulates that institutional review boards have a diverse membership that is sensitive to issues such as community attitudes. To that end, 45 CFR 46 requires that each IRB include at least one member whose primary concerns are in nonscientific areas. We conducted this study to learn more about the roles and experiences of the National Institutes of Health’s Intramural Research Program’s nonscientist IRB members. We surveyed 28 nonscientist and 135 scientist IRB members; 89% and 62% responded, respectively. Nearly three-quarters of nonscientists thought review of the informed consent document was their primary duty. Two-thirds of nonscientist and more than three-quarters of scientist IRB members agreed that nonscientists represent community views. Nearly all scientist and nonscientist members agreed that nonscientists have a responsibility to help make the conduct of research accountable to the public. Promoting the involvement of nonscientist members in all aspects of an IRB’s review process and fostering an environment in which their advice is respected and implemented are important aspects of protecting human research subjects.
Key words/concepts: 45 CFR 46, IRB membership, role of nonscientist IRB members, informed consent

Robert D. Allison, Lura J. Abbott, and Alison Wichman, “Nonscientist IRB Members at the NIH,” IRB: Ethics and Human Research 30, no. 5 (2008): 8-13.