Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations

Author:

Govindarajan Prasanthi1,Dickert Neal W.2,Meeker Michele3,De Souza Natalie1,Harney Deneil4,Hemphill Claude J.3,Pentz Rebecca5

Affiliation:

1. Department of Emergency Medicine; University of California; San Francisco CA

2. Division of Cardiology; Department of Medicine; Emory University; Atlanta GA

3. Department of Neurology; San Francisco General Hospital; San Francisco CA

4. Department of Emergency Medicine; University of Michigan; Ann Arbor MI

5. Hematology and Oncology in Ethics; Winship Cancer Institute; Atlanta GA

Publisher

Wiley

Subject

Emergency Medicine,General Medicine

Reference11 articles.

1. Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules. 21 CFR part 50.24;Department of Health and Human Services/U.S. Food and Drug Administration;Federal Registrar,1996

2. Department of Health and Human Resources/U.S. Food and Drug Administration Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. Exception from Informed Consent Requirements for Emergency Research. Draft Guidance 2006 http://www.fda.gov/ohrms/dockets/98fr/06d-0331-gdl0001.pdf

3. Communicating with communities about emergency research;Richardson;Acad Emerg Med.,2005

4. RAMPART (Rapid anticonvulsant Medication Prior to Arrival Trial): a double-blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics;Silbergleit;Epilepsia,2011

5. Measuring trust in medical researchers;Hall;Med Care.,2006

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