Victims in Our Own Minds? IRBs in Myth and Practice

During Malcolm Feeley's 2006 Presidential Address, audience members were not just whispering to colleagues sitting next to them, they were being loud. When Feeley cracked, "Institutional Review Boards [are] known to graduate students on my campus as the Committees for the Prevention of Research on Human Subjects!" it was the closest thing I have seen to someone bringing down the house at an academic conference. Before it became a publication, Feeley's Presidential Address was an uproarious event. What audience members were cheering was Feeley's argument that institutional review boards (IRBs) at American universities represent a failure of law: IRBs infringe on investigators' rights to carry out research because boards can force changes to studies before the research even takes place, often passing judgment on the perceived merit of the research, constraining low-risk qualitative research and high-risk clinical trials alike, and producing decisions against which investigators have little recourse. As a result, Feeley argued, IRBs blunt the potential for researchers to use their scholarship as a medium for political critique and, more ominously, IRBs change the very shape and integrity of academic research with the restrictions they impose. That is to say, regulations aimed at protecting human subjects actually violate researchers' rights. Admirably, Feeley did not let us (or himself) off the hook with his pointing finger. In his experience, Feeley said, "Even our liberal, productive, research-oriented colleagues are not immune to this tendency [to censor research as IRB members]," and, more to the point, all of us who passively go along with research review are complicit in what he described as an unjust human subjects system. Following this impassioned rallying cry against IRBs, I was pleasandy surprised to learn that, to Feeley's mind, LSA members' local involvement offers the only real solution to these problems. (A common reaction to IRBs from professional organizations is to demand that members mobilize to change federal regulations-a dubious prospect to which I return in my final section.) To my mind, frustrations with IRBs are justifiable. I have occasionally butted heads-or worse, had protracted and unnecessary memo wars-with several boards. In the comments that follow, however, I draw on archival and ethnographic evidence from my research on IRBs at American universities (Stark 2006), rather than recounting my personal anecdotes about getting IRB approval.1 After these empirical observations, I take a more prescriptive stance and suggest how the ethics review system could usefully be improved by spelling out the conditions under which IRBs work more or less well with investigators. The suggestions with which I close are based on my view as a sociologist that ethics review in some form is here to stay because of institutional inertia, and on my belief as a potential research subject that ethics review is not an entirely bad idea, even for social scientists. Rights, Harms, and Responsibilities in Historical Context When reading critiques of IRBs, it is often difficult to imagine why oversight of social and behavioral researchers ever seemed sensible. Is it possible that we social scientists are victims of a terrible mistake-that sometime around 1966, our disciplinary forefathers unwittingly got trapped inside a human subjects bureaucracy only meant to regulate researchers who injected people with dangerous substances? From the outset, human subjects protections were intended to regulate social and behavioral researchers. Recent insinuations to the contrary fail to appreciate, first, the changing meaning of "real harm" since the 1960s and, second, the extent to which human subjects regulations were never exclusively about preventing harm, but about protecting people's rights not to be researched, even when everyone involved regarded the practices as harmless by any definition.2 One of the great ironies of recent critiques of IRBs is that the federal rules aimed at protecting human subjects, which emerged during the late 1960s and early 1970s, were a product of the same liberal spirit that safeguarded academic freedom during this period as well (Altbach 1980). …