Academic journal article Independent Review

Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State

Academic journal article Independent Review

Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State

Article excerpt

In this article, I scrutinize the process by which scientific research on human subjects is regulated by Institutional Review Boards (IRBs). At the outset, let us agree that at least some biomedical scientific research on human subjects must be externally monitored and that whether government should sometimes be involved in that process is at least an open question. We simply cannot forget the lessons learned from Nuremburg and Tuskegee. My argument, however, is that although the IRB process may have been at least marginally well suited to serve its original mission (to protect federally funded biomedical research subjects from physical harm), that process has become buried in an avalanche of new and unrelated socially constructed mandates. Today, the IRB process consumes an inordinate amount of time, energy, and resources in attempting to prevent a growing list of imagined harms, minor harms, or highly unlikely harms. Consequently, IRBs no longer serve their original mandate well. Worse, they have surreptitiously undermined legitimate and useful social science, science education, and freedom of inquiry. Despite a growing body of scholarly criticism, seasoned with IRB horror stories, the beat goes on ("Communications Scholars' Narratives" 2005).

Mission drift denotes a devolutionary process familiar to most scholars who study the history of public institutions: the process of co-opting a successful and well-conceived process (or in this case a marginally successful process), then gradually and mindlessly expanding it until it is no longer capable of performing its original function--the familiar Peter Principle, as applied to institutions (Peter and Hull 1969) The gradual expansion of public schools from relatively simple, locally administered educational institutions to complex socioeconomic institutions remotely controlled by a web of local, state, and federal agencies is a prime example of mission drift. Mission creep, the term I prefer here, signifies a more deliberate, sneaky, and nefarious form of devolutionary change than the more unintentional, randomized "drift" evident in other government institutions.

During the past thirty years, the IRB has devolved to become an ineffective means of regulating the diverse activities that the government ambiguously calls "scientific research on humans." Moreover, the government's continued reliance on monopolistic, one-size-fits-all institutionalized solutions, such as the IRB process, clearly threatens the future of behavioral science, if not of biomedical science, by overloading the system with paperwork and by wasting the time, effort, and resources of everyone involved, including researchers, board members, students, teachers, and government officials. Even more troubling, the process undermines science education and the last vestiges of "academic freedom."

We may well recognize that some IRBs at some institutions are less overworked, more efficient, and less intrusive than others, and therefore are less likely to elicit controversy (Ferraro et al. 1999). Some colleges and universities focus more on teaching than on research, and many of those institutions do not rely on the IRB process to regulate students' behavioral research. In addition, significant puzzles surround the social dynamics that emerge between local IRBs and researchers (Keith-Spiegel 2005). Finally, across the board, many researchers imperceptibly employ IRB avoidance and deliberately design their own research and their students' research to minimize IRB scrutiny. In light of the foregoing considerations, it is difficult to assess scientifically either researchers' satisfaction with the IRB process or the costs and benefits associated with the process as a whole. Prevention of imaginary harms can be especially tough to quantify!

Nevertheless, I argue from a utilitarian standpoint that the protection afforded research subjects across the social-science disciplines by the IRB program is now far outweighed by the costs of implementing it. …

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