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Health Agencies Update
January 22/29, 2014

Less Oversight Needed for Gene Transfer Studies

Author Affiliations

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(4):350. doi:10.1001/jama.2013.286118

An additional layer of review by the National Institutes of Health (NIH) for gene transfer studies is no longer needed because the field has become established and many of the early concerns about safety have been resolved, according to an Institute of Medicine (IOM) report.

Studies in which genetic sequences are introduced into humans require several layers of oversight to prevent harm to research participants or society, including the US Food and Drug Administration and local institutional review boards and biosafety committees. Since the 1970s, the NIH Recombinant DNA Advisory Committee (RAC) also provided oversight for such studies.

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