Institutional review board community members: who are they, what do they do, and whom do they represent?

The roles of nonaffiliated and nonscientific institutional review board (IRB) members at academic medical centers have received some attention in the literature, but many questions about them remain. For instance, whom, if anyone, do they represent, how are they selected, and what do they do? This report describes how IRB chairs, directors, administrators, and members view a range of issues concerning nonaffiliated and nonscientific IRB members, and it examines a series of questions and decisions that IRBs confront regarding these individuals. Section 46.107 (a) of the federal regulations governing the protection of human subjects requires IRBs to “be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes.” Sections 46.107 (c) and (d) of the same regulations state that IRBs will include “at least one member whose primary concerns are in nonscientific areas” and “at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.”1 For review of research concerning prisoners, 45 CFR §46 specifically requires that this population be represented. Important principles underlie these mandates. The views of nonscientists and of those outside an academic medical center are valuable and, presumably, reflect the concerns of potential research subjects and the broader community. They also are less affected by the possibility of financial and nonfinancial conflicts of interest (COIs), which may arise with someone who works at an institution or is a close family member of an employee. Yet, the regulations do not address who exactly these nonscientific and nonaffiliated members should be, how they should be chosen, and what roles and functions they should fill. The National Institutes of Health (NIH) Office of Human Subjects Research (OHSR) determined that a single person could fit both these roles.2 Yet, such a determination may, arguably, counter the intent of the regulations. Surprisingly, prior studies of such members have usually combined the nonscientific and nonaffiliated IRB members. Anderson3 found that 16 “nonaffiliated/nonscientific” IRB members from 11 institutions were unclear whom they represented, and these members felt that they should receive more respect from the rest of the IRB. Porter,4,5 also not differentiating between the two groups, found that these individuals saw themselves playing a variety of roles and valuing several traits as ideals (e.g., assertiveness and communication). Allison and colleagues6 also combined the two groups, as “nonscientists,” in examining how they viewed their specific functions and found that they were also more likely than scientists to think that their major role was to review informed consent documents. In one question, however, Allison and colleagues compared affiliated and nonaffiliated nonscientific members and found that nonaffiliated members were more likely, in general, to see themselves as laypersons. Sengupta and Lo7 surveyed 32 nonaffiliated and nonscientific members from 11 IRBs. These participants had been on IRBs for a mean of 8.4 years, 71.9% held advanced degrees, 88% had occasionally felt intimidated and disrespected by the scientists on the IRB, and 78% wanted more education. Yet, it is not clear whether these members included those (e.g., nurses and social workers) who are clinicians even if they are not scientists per se. Affiliated clinicians may also vary markedly from nonaffiliated nonclinicians because of training. Additionally, nurses and social workers may have experience conducting research, raising questions about the definition of nonscientists. Rothstein and Phuong8 analyzed three groups (physicians, nurses, and nonaffiliated members) and found certain differences in what was very important to them personally, with nonaffiliated members being less likely to list protecting confidentiality and privacy and ensuring IRB oversight postapproval as concerns. It is unclear whether these nurses are scientific or not (i.e., they have clinical training but may not be researchers). Still, this study suggests that nonaffiliated and other IRB members differ. Critical questions thus remain about how IRB chairs and other members view the roles and functions of these nonscientific and nonaffiliated members. I conducted an in-depth, semistructured interview study of the views and approaches among IRB chairs, directors, administrators, and members toward research integrity (RI), which these participants define very broadly.9 Interviewees revealed how they viewed and addressed RI, how they responded to RI violations in various ways related to how they saw and approached their roles and responsibilities, and how they interpreted and applied federal regulations. IRBs were affected by their members’ personal views and psychological and personality issues and also by institutional factors. Issues frequently arose concerning differences between nonscientific, nonaffiliated, and other IRB members’ roles, functions, contributions, work, and identities. Because my study used qualitative methods, I was able to further explore these domains and shed light on these issues. I have reported elsewhere on other, distinct sets of issues regarding interviewees’ views and approaches concerning COIs,10 central IRBs,11 perceptions of variations between IRBs,12 and research conducted in the developing world.13 But other distinct and important sets of issues and decisions arose as well concerning nonscientific and nonaffiliated members, which I have analyzed and explored in this report.