Ensuring Respect for Human Research Participants: Institutional Review Boards and Sharing Results From Research

JAMA. 2016;316(11):1149-1150
Authors: Samuel N. Doernberg, David Wendler
“The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that investigators report summary results of eligible clinical trials to ClinicalTrials.gov 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. Sharing trial results helps to counteract a publication bias favoring positive trials that can “distort the evidence base” of clinical guidelines and patient care. 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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