Commentary

Abstract

Much of the academic medicine community's confusion over institutional review board (IRB) composition and representation stems from the federal regulations themselves. The intent of these regulations is twofold-to ensure that IRBs are properly composed to review research proposals and to garner respect from the community for the decisions that they make.Klitzman's research, presented in this issue of Academic Medicine, looks at the roles of nonaffiliated and nonscientific IRB members. He found that those whom he interviewed, primarily IRB chairs, directors, and administrators, were confused about the role of these nonaffiliated and nonscientific members, how to train them, and how to engage them when reviewing protocols.The authors recommend moving away from a system of labeling IRB members (as scientific, nonaffiliated, etc.) and returning to the intent of the federal regulations-ensuring that the composition of the IRB results in an ethical review of the research. Every IRB appointment and every member's qualifications should be evaluated in light of the intentions of the federal regulations and the requirement that the IRB meet them. For example, if an individual's primary concerns are in scientific areas, the IRB should identify the individual as such, doing the same for those whose primary concerns are nonscientific. If the IRB needs individuals whose primary concerns are in nonscientific areas to represent the perspectives of human subjects, then it should recruit current or former research subjects for these positions. These changes would strengthen both the review process and the quality of the research.