Institutional Review Board Mission

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,