Defanging IRBs: Replacing Coercion with Information

INTRODUCTION The articles in this Symposium contain many well-directed criticisms of the dominant practices of Institutional Review Boards ("IRBs") in both the biological and the social sciences. The trenchant criticisms against the IRB procedures and protocols fall into two broad groups: those which are directed to the wisdom of the various practices, and those which are directed to the alleged constitutional infirmities of the current IRB procedures. The substantive critique stresses the general dangers of IRB oversight.1 In biomedical cases, the delays are extensive, and the need for documentation is exhaustive, so that the opportunities for progress labor under an ever heavier form of government and institutional oversight - where the latter is often used in order to provide the universities a shield against powerful government sanctions. In the behavioral sciences, these concerns remain, but they are compounded by an aggressive unwillingness to allow social science research to probe such controversial topics as date rape, academic cheating, and nude dancing, for fear that a discussion of those topics might do harm to the human subjects who participate in the research project.2 Right now, it appears necessary to receive IRB clearance to conduct the interviews needed for oral history projects.3 The First Amendment may praise a culture in which debate is "uninhibited, robust, and wide-open," even if that debate "may well include vehement, caustic, and sometimes unpleasantly sharp attacks on government and public officials."4 But the IRB culture often waters down any questions asked of public figures (or ordinary persons, for that matter) for fear of upsetting people whose lives were steeped in controversy. The individuals who may be freely abused in public life are entitled to a sheltered life thereafter, at least from the prying eyes of academic researchers. The major constitutional attack on government IRBs treats them as a garden- variety form of prior restraint in violation of the First Amendment,5 a view which has been voiced most forcefully by Philip Hamburger.6 As a matter of current law, the First Amendment does not appear to place any strong restraints on the activities of IRBs in their dealings with either government-funded or private research undertaken in universities. In Hamburger's view, which he reiterates in this volume, the entire system represents an obnoxious form of prior restraint through a licensing system that requires all investigators to come hat-in-hand to review boards whose every procedure bears the heavy sign of government interference. On this issue, I wish that I could agree with his facial constitutional condemnation, but regrettably, I do not.7 I do not think that his ingenious arguments overcome the objection that the speech interests implicated in university research (especially in the biomedicai area) are often tangential (or, as constitutional lawyers are fond of saying, "incidental") to their major, or at least ostensible, purpose of protecting the health and safety of the ordinary people who are recruited into these various research endeavors. Facial challenges are therefore likely to fail, even if some applied challenges may succeed. The constitutional case against the frontal assault on IRBs, moreover, is strengthened, if not clinched, because the government ties its vast regulatory apparatus to the receipt of its own research dollars, so that it becomes research institutions to take the bitter with the sweet. If they wish to be part of the government program, then they must play by the rules that government, like any other grantor, sets. The application of these rules for government-funded research are hard to displace categorically on any of the traditional tests for unconstitutional conditions.8 These conditions are surely germane to the grant. Nor do they involve the obvious exercise of state monopoly power given that other sources of funds are available. …