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September 20, 2016

Ensuring Respect for Human Research ParticipantsInstitutional Review Boards and Sharing Results From Research

Author Affiliations
  • 1Clinical Center, Department of Bioethics, National Institutes of Health, Bethesda, Maryland

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;316(11):1149-1150. doi:10.1001/jama.2016.7970

The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that investigators report summary results of eligible clinical trials to within 1 year of trial completion. This requirement is in part intended to promote medical innovation by enabling meta-analyses and further research based on the results of clinical trials.1 Sharing trial results helps to counteract a publication bias favoring positive trials that can “distort the evidence base” of clinical guidelines and patient care.2 In addition, sharing the results of clinical trials is important for ethical reasons: it helps to justify exposing participants to the risks of clinical trials and shows respect for those who assume these risks.

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