Confronting the Ethical Conduct of Resuscitation Research: A Consensus Opinion |
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Authors: | N. Clay Mann PhD MS Terri A. Schmidt MD MS Lynne D. Richardson MD |
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Affiliation: | Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT;Department of Emergency Medicine and Center for Ethics in Health Care, Oregon Health &Sciences University, Portland, OR;Department of Emergency Medicine, Mount Sinai School of Medicine, New York, NY. |
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Abstract: | An objective of the 2005 Academic Emergency Medicine Consensus Conference, “Ethical Conduct of Resuscitation Research,” was to identify if consensus exists regarding application of the Food and Drug Administration (FDA) Final Rule allowing an exception from informed consent in resuscitation research. At the start of the consensus conference, 49 attendees participated in a survey containing three sections: 1) demographic questions characterizing respondents, 2) questions regarding application of the FDA Final Rule, and 3) complexities associated with seeking informed consent in an emergency setting. Consensus analysis was used to determine if a formal consensus was reached, relying on a Bayesian posterior probability of 0.99 to consider survey responses a “consensus.” Respondents demonstrated consensus regarding the need to further refine and standardize application of the FDA Final Rule in resuscitation research. However, participants agreed that current regulations provide adequate and appropriate protection to safeguard patients. Complexities associated with seeking informed consent in emergency departments were prevalent among most institutions represented at the conference. There was general agreement that current efforts to safeguard human subjects are effective, but participants agreed that refinements to and standardization of the FDA Final Rule would facilitate resuscitation research and enhance patient safety. |
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Keywords: | medical ethics emergency medicine research consensus expert opinion |
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