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.

Beyond Research Ethics: Novel Approaches of 3 Major Public Health Institutions to Provide Ethics Input on Public Health Practice Activities

“…Given the numerous variables that may form the basis of a community in relation to a public health activity, such as ethnicity, geography, use of a common service, or other type of social relatedness, as well as the heterogeneity of values and perspectives that are usually present within a community, there will always be a limitation to the degree to which one or a few individuals will be able to be “community representatives.” A similar challenge is faced by research ethics committees. 40,41 To address this limitation, the PHO ERB, for example, also includes members from several public health units across the province, who bring understanding of the local context for the populations they serve. In addition, where there is concern that a project may pose particular risks to specific communities, additional engagement with the affected communities is undertaken, either by the project team or occasionally by inviting the input of an ad hoc community member.…”