“Turn off the oxygen …”

Abstract

Malcolm Feeley's Presidential Address ranges widely over the current condition of law and society studies. However, as he himself acknowledges, its core is the critique of institutional review boards (IRBs). Aldiough there have been growing rumbles of discontent, he is one of the few senior scholars to step out of line and fundamentally challenge the system. He indicts the entire IRB structure for regulation without legality, unconstrained by any acknowledgment of public accountability, the rights of investigators, or due process. This is an important critique and has implications well beyond the borders of the United States. However, I am not wholly convinced by Professor Feeley's resistance strategy. I want to preface my response with an explicit statement of support for the principle of ethical regulation in some areas, a position with which Professor Feeley would not, I think, disagree. However, this is not clearly articulated in his speech, and I believe that it is essential to stress that neither of us are ethical nihilists. Certain kinds of experimental research in biomedical science and psychology have an indisputable potential for harm that cannot necessarily be identified when subjects are recruited and that cannot easily be reversed once the study has begun. In March 2006, for example, six British men experienced multiple organ failure as a result of the administration of TGN1412, an experimental drug, in a clinical trial unit attached to Northwick Park, a leading research hospital in London. All survived but have suffered long-term health consequences. Although subsequent investigation revealed a number of procedural lapses, none were relevant to the outcome: in the areas that mattered, regulatory clearance, including the equivalent of IRB approval, had been obtained and observed. Participation in biomedical research carries very serious risks. When the stakes are so high, it is entirely proper that investigators should not be judge and jury in their own cause. Independent review provides a means of ensuring that an adequate risk analysis has taken place, that reasonably foreseeable risks are clearly communicated to participants, and that there is no improper pressure to take part. If there is still an adverse outcome, the public can be assured that this was caused by an unforeseeable risk that was voluntarily accepted by participants. These arguments do not apply to most empirical research in the social sciences and humanities. This work is not comparable with injecting potentially toxic green stuff that cannot be neutralized or rapidly eliminated from the body if something goes wrong. There may be some potential to cause minor and reversible distress, but these disciplines' strong traditions of protecting the identity of informants and research sites limit the risks of serious harm, which would, in any case, be mostly reputational. While it is possible that some criminologists might place their informants at risk of reprisals, there is no documented case of this happening. Moreover, at least some of that risk is shared by fieldworkers: 'James Patrick (1973) chose to publish his observational study of a Glasgow gang under a pseudonym because of his own fear of attack by discontented members. Consent is an ongoing process and may be suspended or withdrawn at any time. Any experienced social scientist has had informants terminate interviews or fieldwork access because they do not feel comfortable with the direction of inquiry. When that happens, we cannot compel compliance: we are not agents of homeland security. The International Significance of IRBs Professor Feeley's critique should attract wide attention because of the international impact of U.S. developments. This takes two forms: the extraterritorial claims of U.S. legal institutions and the isomorphic pressures that arise from U.S. cultural hegemony. Those of us who live and work outside the United States have long been familiar with the American claim to universal jurisdiction. …