Saturday, September 17, 2011

Research ethics committees and the power of complaint

Research ethics committees have had a bit of a rough summer. The Advanced Notice of Proposed Rulemaking (ANPRM) mentioned below implies that US research ethics committees working with the current version of the Common Rule are somewhat wrongheaded. When you are told that you need 'streamlining' in order to 'increase efficiency', it is hard not to conclude that you are bloated, misguided and ineffectual. It is noteworthy that the ANPRM is the first major revision of an influential research ethic regulation that is driven more by (researcher) criticism than by scandals (involving participants). The recent report by the Presidential Commission for the Study of Bioethical Issues -- centered on abusive US-funded research in Guatemala from 1946-48 -- does not seem to have motivated or made much of a mark on the proposed changes to the Common Rule.

That the ANPRM is complaint-driven, rather than scandal-driven, shows: there seems to be more emphasis overall about making ethical review of research more user-friendly for researchers than enhancing research participant protections. It remains to be seen where this 'deregulation' of ethical review is headed, and whether deregulation in this domain will have more positive effects than deregulation in financial circles.

The complaints and doubts about research ethics committees also seem to be going global. The current issue of the Indian Journal of Medical Ethics is largely devoted to the ethics of research ethics committees. How democratic are they? What gives them legitimacy? How should their roles be defined and their power monitored? These are all valid and fundamental questions. Such committees are hardly beyond criticism. But there should also be skepticism about the skepticism towards research ethics committees, or at least we should not only evaluate the reasons for the criticisms, but also where the criticisms are coming from and where they might be leading us.

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