Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure.
Conducting emergency research in the out-of-hospital and emergency department setting is a challenge because of the inability of patients to provide informed consent in many situations. Federal guidelines allowing research under an exception from informed consent for emergency research have been established (21 CRF 50.24). Community consultation and public disclosure, 2 required components of obtaining this exception, are seen by many as a barrier to resuscitation research. This article will provide a brief overview of the history of the exception from informed consent for emergency research and summarize our methods recently used to successfully complete community consultation and public disclosure for a trial evaluating 2 devices used during cardiopulmonary resuscitation in a large metropolitan area.
Salzman
Joshua G
JG
Emergency Medical Services Program, Regions Hospital, St. Paul, MN, USA. joshua.g.salzman@healthpartners.com
Frascone
Ralph J
RJ
Godding
Bobette K
BK
Provo
Terry A
TA
Gertner
Elie
E
D001294:Attitude to Health; D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation* / Q000379:methods; D003256:Community Participation; D030881:Disclosure; D004632:Emergency Medical Services / Q000941:ethics*; D005260:Female; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent; D008297:Male; D008910:Minnesota; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000379:methods