Success Rates for Notification of Enrollment in Exception From Informed Consent Clinical Trials

Author:

Brienza Ashley M.1,Sylvester Raeanne1,Ryan Christopher M.2,Repine Melissa1,DiFiore Sara1,Barone Jean3,Callaway Clifton W.1

Affiliation:

1. Department of Emergency Medicine; University of Pittsburgh School of Medicine; Pittsburgh PA

2. Human Research Protection Program; University of California at San Francisco; San Francisco CA

3. Human Research Protection Office; University of Pittsburgh; Pittsburgh PA

Funder

National Heart, Lung, and Blood Institute

Publisher

Wiley

Subject

Emergency Medicine,General Medicine

Reference6 articles.

1. Finding family for prospective consent in emergency research;Robertson;Clin Trials,2007

2. Surrogate consent by family members for out-of-hospital cardiac arrest research;Hsieh;Acad Emerg Med,2001

3. 21CFR50.24 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf

4. Research without consent: current status, 2003;Biros;Ann Emerg Med,2003

5. Ethics committee experience with emergency exception from informed consent protocols;DeIorio;J Empir Res Hum Res Ethics,2007

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