Presented at the National Association of EMS Physicians annual meeting, Phoenix, AZ; January 2010.
Biros Section on Research Ethics
Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations
Version of Record online: 13 JAN 2013
© 2013 by the Society for Academic Emergency Medicine
Academic Emergency Medicine
Volume 20, Issue 1, pages 98–103, January 2013
How to Cite
Govindarajan, P., Dickert, N. W., Meeker, M., De Souza, N., Harney, D., Hemphill, C. J., Pentz, R. (2013), Emergency Research: Using Exception from Informed Consent, Evaluation of Community Consultations. Academic Emergency Medicine, 20: 98–103. doi: 10.1111/acem.12039
The primary author was funded by a career development award (1K08HS017965-01) from the Agency of Healthcare Research and Quality and the American Heart Association/American Stroke Association Western States Clinical Research Program.
The authors have no potential conflicts of interest to disclose.
A related commentary appears on page 104.
- Issue online: 13 JAN 2013
- Version of Record online: 13 JAN 2013
- Manuscript Accepted: 29 APR 2012
- Manuscript Revised: 20 APR 2012
- Manuscript Received: 14 FEB 2012
- 1Department of Health and Human Services/U.S. Food and Drug Administration. Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules. 21 CFR part 50.24. Federal Registrar. 1996;61:51497–531.
- 2Department 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 Draft Guidance, 2006. Available at: http://www.fda.gov/ohrms/dockets/98fr/06d-0331-gdl0001.pdf. Accessed Jul 13, 2012.
- 4Neurological Emergency Treatment Trials (NETT) Investigators. 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. Epilepsia. 2011;52(Suppl 8):45–7., , , ;
- 6Majority Opinion Research. Research Tools and Techniques. Available at: http://majorityopinionresearch.com/about/tools/tools.htm. Accessed Jul 13, 2012.
- 11Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med. 2003; 10:352–9., , , , , .