The regulatory system for protecting human subjects in research in the United States is increasingly dysfunctional. While many critics assert that research participants are inadequately protected,1,2 there are increasing concerns that the system is overregulated, with more time and expense devoted to activities of marginal utility in protecting human research participants.3- 6 In some cases these activities actually appear to be reducing protections for participants in research, by diverting energy that could be spent on more fruitful tasks and by creating disincentives to institutional review board (IRB) membership.
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