Confronting the Ethical Conduct of Resuscitation Research: a consensus opinion.
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.
Mann
N Clay
NC
Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. clay.mann@hsc.utah.edu
Schmidt
Terri A
TA
Richardson
Lynne D
LD
D003245:Consensus Statements as Topic; D004635:Emergency Medicine / Q000941:ethics; D032984:Ethics, Research; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards*; D012108:Research Personnel / Q000706:statistics & numerical data; D012151:Resuscitation / Q000941:ethics*; D014481:United States; D014486:United States Food and Drug Administration