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November 23/30, 2011

Protecting Research Participants While Reducing Regulatory Burdens

Author Affiliations

Author Affiliations: Department of Medicine, Program in Medical Ethics, University of California, San Francisco (Dr Lo); and Harvard Law School, Harvard School of Public Health, Harvard University, Cambridge, Massachusetts (Mr Barnes).

JAMA. 2011;306(20):2260-2261. doi:10.1001/jama.2011.1727

The Department of Health and Human Services (HHS) has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to “enhance protection while simultaneously eliminating unreasonable burdens.”1 Although the goal is admirable, some changes intended to remove unnecessary regulatory burdens may allow serious risks (ie, the probability of harm is significant, not merely possible or conceivable), particularly to highly vulnerable participants (ie, participants' ability to give free and informed consent is seriously compromised).