Robert Klitzman, "Institutional Review Board Community Members," Academic Medicine 87 (July 2012), doi: 10.1097/ACM.0b013e3182578b54, post author corrections version, 22 May 2012.]
Klitzman notes that "prior research has suggested that [nonaffiliated and nonscientific IRB] members frequently feel unempowered and disrespected." [He doesn't provide citations to such research, but one can consult Patricia E. Bauer, "A Few Simple Truths about Your Community IRB Members," IRB: Ethics and Human Research 23 (January-February 2001), 7-8; or Eliesh O'Neil Lane, "Decision-Making in the Human Subjects Review System" (PhD diss. Georgia Tech, 2005) for support.]
Klitzman finds some confirmation:
One interviewee, a longtime IRB administrator, said, “I’m not a scientist or physician, so sometimes I think my questions are stupid." She did not feel looked down on but, rather, saw herself apart in a room of white men in white coats—not purposefully disrespected but at times intimidated. Several interviewees recognized that community members may feel similarly.
But his main finding is that many IRB chairs and members are perplexed by the regulatory requirement itself:
In viewing, choosing, and engaging nonscientific and nonaffiliated members, academic medical center IRBs often struggle, and their practices vary widely. IRBs range from having these members review entire protocols to having them perform only limited roles (particularly reading consent forms) to being more pro forma. Nonetheless, a few interviewees described situations in which these members’ input was very important.
Quandaries emerge as to whether these individuals do, or should, represent anyone specifically and, if so, whom they should represent, how well they do so, and how IRBs assess that role. Revealingly, confusion exists concerning even their name—whether they are nonaffiliated, lay, or community members—underscoring the ambiguities of who these members are. IRBs seem to vary even in the degrees to which they are disturbed by the apparent lack of representativeness of these members to their communities and in how they interpret the intent of the regulations.
In fact, the 1974 Federal Register announcement promulgating 45 CFR 46 was pretty explicit about the regulations' intent:
the requirement for nonemployee members on organizational committees is an essential protection against the development of insular or parochial committee attitudes . . . it assists in maintaining community contacts, and would augment the credibility of the committee’s independent role in protection of the subject.
We know from Laura Stark's work that IRBs remain insular and parochial, relying on their own "local precedents," rather than outside evidence, to shape their decisions. And Klitzman himself has found that "particular aspects of institutional histories (e.g., past federal audits and “shutdowns” of research) and IRB chairs’ and/or vocal members’ personalities, idiosyncrasies, and abilities to anticipate all future logistical problems," rather than community attitudes, best explain IRB variability.
As for maintaining community contacts and augmenting credibility, Klitzman finds that the record is spotty. As one interviewee put it,
There might be some better criteria about who our community members are. We have not had people like leaders of local churches, [nongovernmental organizations], or other social service agencies—something with a strong minority membership . . . . One long-term community member is a medical malpractice attorney. He’s been a great member and contributed important things. But I don’t think that’s the idea of what a community member really is or brings. Another community member is a retired director of research at a few local institutions. During retirement, he’s been on our IRBs and another institution’s IRBs. He contributes a lot and brings a nice cross-fertilization from the other institution. But he’s not what you think of as a community member. On the other hand, we’ve also had attorneys from the juvenile public defenders’ office. They are very good and genuine advocates for people in their community.
"The fact that these members are often found in unsystematic ways, through happenstance, may be acceptable and perhaps inevitable," Klitzman argues. "But the lack of guidance concerning these issues is disturbing."