Annals of Emergency Medicine
Volume 41, Issue 1 , Pages 72-78 , January 2003

Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community

Received 18 April 2001 ,Revised 1 August 2002 ,Accepted 12 August 2002.

References 

  1. Department of Health and Human Services/Food and Drug Administration/Office of the Secretary . Protection of human subjects: Informed consent and waiver of informed consent requirements in certain emergency research. Fed Reg. 1996;61(192):51497–51533
  2. Department of Health and Human Services/Food and Drug Administration . Guidance for institutional review boards, clinical investigators, and sponsors: Exception from informed consent requirements for emergency research. Draft Guidance. Available at http://www.fda.gov/ora/compliance_ref/bimo/err_guide.htmApril 2000; Accessed
  3. Sharp RR, Foster MW. Involving study populations in the review of genetic research. J Law Med Ethics. 2000;28:41–51
  4. Melton GB, Levine RJ, Koocher GP, et al.  Community consultation in socially sensitive research: Lessons from clinical trials of treatments for AIDS. Am Psychol. 1988;43:573–581
  5. 45 CFR 46.101.b.4.
  6. Sutherland HJ, Till JE. Opinion polling and decision making: A critical appraisal of quality of life assessment. Qual Life Res. 1994;3:155–162
  7. Dula A. Bearing the brunt of the new regulations: Minority populations. Hasting Center Rep. 1997;27:11–12
  8. 21 CFR 312.54(a).
  9. 21 CFR 812.47(a).
  10. Sloan EP, Koenigsberg M, Gens D, et al.  Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: A randomized controlled efficacy trial. JAMA. 1999;282:1857–1864
  11. ICOS Corporation Web site . ICOS announces clinical results of hemorrhagic shock trial. Available at http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ICOS&script=460&layout=0&item_id=178159October 19, 2002; Accessed
  12. Longstreth WT, Fahrenbruch CE, Olsufka M, et al.  Randomized clinical trial of magnesium, diazepam, or both after out-of-hospital cardiac arrest. Neurology. 2002;59:506–514
  13. Kremers MS, Whisnant DR, Lowder LS, et al.  Initial experience using the Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med. 1999;33:224–229

☆ Dr. Shah is currently with the Department of Orthopedic Surgery, Boston Medical Center, Boston, MA.

☆☆ Address for reprints: Jeremy Sugarman, MD, MPH, Center for the Study of Medical Ethics and Humanities, 108 Seeley G. Mudd Building (DUMC 3040), Duke University Medical Center, Durham, NC 27710; 919-668-9000, fax 919-668-1789; E-mail sugar001@mc.duke.edu .

PII: S0196-0644(02)84937-X

doi: 10.1067/mem.2003.14

Annals of Emergency Medicine
Volume 41, Issue 1 , Pages 72-78 , January 2003

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