November 14, 2007

The Dysregulation of Human Subjects Research

Author Affiliations

Author Affiliations: University of Wisconsin School of Medicine and Public Health, Madison (Dr Fost); and Yale University School of Medicine, New Haven, Connecticut (Dr Levine).

JAMA. 2007;298(18):2196-2198. doi:10.1001/jama.298.18.2196

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.36 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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