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August 13, 1997

Reporting Institutional Review Board Approval and Patient Consent

Author Affiliations

University of Washington Medical Center Seattle

JAMA. 1997;278(6):477. doi:10.1001/jama.1997.03550060053031

To the Editor.  —The articles by Drs Amdur and Biddle1 and Dr Rennie and Ms Yank2 highlight the importance of documenting ethical conduct of research on humans.We compared their findings with those from our review3 of comparative interventional studies published between 1966 and 1994 involving patients in cardiopulmonary arrest. Among 47 studies meeting our inclusion criteria, 24 (51%) mentioned approval by an institutional review board (IRB) and 12 (26%) mentioned subjects' consent. The 53 prospective studies on humans recently published in 5 general medical journals described by Rennie and Yank2 did better: 42% recorded IRB approval, 53% recorded consent, and 32% recorded both (ie, 74% recorded IRB approval and 85% recorded informed consent).However, some of this difference is due to better reporting over time. In our series,3 significantly more studies documented IRB approval and consent during more recent years. For example, all studies