Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent

Author:

Biros Michelle H.1,Dickert Neal W.23,Wright David W.4,Scicluna Victoria M.5,Harney Deneil6,Silbergleit Robert6,Denninghoff Kurt7,Pentz Rebecca D.8

Affiliation:

1. The Department of Emergency Medicine Hennepin County Medical Center and University of Minnesota; Minneapolis MN

2. The Division of Cardiology; Atlanta GA

3. The Department of Epidemiology; Emory University Rollins School of Public Health; Atlanta GA

4. The Department of Emergency Medicine; Atlanta GA

5. Emory University School of Medicine; Atlanta GA

6. The Department of Emergency Medicine; University of Michigan; Ann Arbor MI

7. The Department of Emergency Medicine; The University of Arizona, and The Arizona Emergency Medicine Research Center; Tucson AZ

8. Department of Hematology and Oncology; Atlanta GA

Publisher

Wiley

Subject

Emergency Medicine,General Medicine

Reference9 articles.

1. 21 CFR 50.24: protection of human subjects; informed consent-FDA; final rule;U. S. Code of Federal Regulations;Fed Regist,1996

2. The birth of the NETT: NIH-funded network will launch emergency neurological trials;Cearnal;Ann Emerg Med,2006

3. Enrolling subjects by exception from consent versus proxy consent in trauma care research;Wright;Ann Emerg Med,2008

4. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience;Silbergleit;Acad Emerg Med,2012

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