Too Many Rationales, Not Enough Reason: A Call to Examine the Goals of Including Lay Members on Institutional Review Boards

ABSTRACT

Every major U.S. commission appointed to review Institutional Review Boards (IRBs) as well as numerous reports and scholarly articles have recommended increasing the number of lay (nonscientist and unaffiliated) members on IRBs. Meanwhile, qualitative studies have shown that lay IRB members experience confusion about their roles, including ambiguity whether their roles are different from other members of the board. Without articulating the unique reasons why unaffiliated and nonscientist members are needed, IRBs have little guidance on how to recruit and train these members, and how many should be at the table. By looking back through the history of IRB regulations, policies, and commentaries we can articulate unique contributions these members can make. Only with these contributions in mind can we make arguments for how to best achieve them and make the case that increasing their numbers is necessary.

KEYWORDS:

• Ethics and public policy
• history of research ethics
• human subjects ethics
• human subjects regulation and oversight
• legal and regulatory issues in research
• public trust
• research ethics
• research ethics in university contexts

Notes

1. In this manuscript, I use the term “lay” to refer to both nonscientist and unaffiliated members on IRBs, unless one or the other is specifically noted. Most scholarship and policy documents tend to refer to these members interchangeably, and they are often empirically studied together as well (as noted in Klitzman, 2012)

2. This is not to say that lay IRB members cannot or some do not make unique contributions, but rather that if they do, it is not a result of any intentional decisions on the IRB’s part, either in terms of recruitment or training.

3. I am using the awkward combination “public/community” here because it accurately reflects an ambiguity in the policies and recommendations (and sometimes in scholarly literature as well). The different implications of applying these contributions to “the public” in general or to “communities” in particular will be discussed in the next section.

4. Unlike the first three contributions that could apply either to particular subpopulations or to the public at large, this contribution makes little sense if the referent is the public in general. Representatives of the public are unlikely and rare, unless they are people who hold some sort of public office. I use the term “population” here to refer to either a community or a group, presupposing the conceptual distinction between an unstructured group of people (“group”) and a structured group with established leadership (“community”) and referring to both (Hausman, 2007; Ross et al., 2010).