Surgery
Volume 145, Issue 6 , Pages 630-635 , June 2009

Exception from informed consent requirements for emergency research

  • Peter K. Moore, BA

      Affiliations

    • University of Colorado Denver School of Medicine, Denver, CO
    • ,
  • Ernest E. Moore, MD

      Affiliations

    • Department of Surgery, Denver Health Medical Center and University of Colorado Denver, Denver, CO
    • Corresponding Author InformationReprint requests: Ernest E. Moore, MD, Chief of Surgery, Denver Health Medical Center, Denver, CO 80204.
    • ,
  • Frederick A. Moore, MD

      Affiliations

    • Department of Surgery, Methodist Hospital and Weill Cornell Medical School, Houston, TX

,Accepted 9 March 2009.

References 

  1. McRae A, Weijer CUS. Federal Regulations for emergency research: a practical guide and commentary. Acad Emerg Med. 2008;15:88–97
  2. Vaslef SN, Cairns CB, Falletta JM. Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval. Arch Surg. 2006;141:1019–1024
  3. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA. 1997;277:925–926
  4. Department of Health and Human Resources/U.S. Food and Drug Administration. Guidelines for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research. Draft guidance http://www.fda.gov/ora/compliance.
  5. Department 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 Parts 50, 56, 312, 314, 601, 612 and 814. Federal Registrar. 1996;61:51497–51531
  6. Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38:185–193
  7. Holcomb JB, McMullin NR, Pease L, et al. Causes of death in U.S. Special Operations Forces in the global war on terrorism: 2001–2004. Ann Surg. 2007;245:986–991
  8. Ciesla DJ, Moore EE, Johnson JL, et al. A 12-year prospective study of postinjury multiple organ failure. Arch Surg. 2005;140:432–438
  9. Holcomb JB, Jenkins D, Rhee P, et al. Damage control resuscitation: directly addressing the early coagulopathy of trauma. J Trauma. 2007;62:307–310
  10. Moore FA, McKinley BA, Moore EE. The next generation in shock resuscitation. Lancet. 2004;363:1988–1996
  11. Mattox KL, Maningas PA, Moore EE, et al. Prehospital hypertonic saline/dextran infusion for post-traumatic hypotension. The U.S.A. Multicenter Trial. Ann Surg. 1991;213:482–491
  12. Moore EE, Moore FA, Fabian TC, et al. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: The USA Multicenter Trial. J Am Coll Surg. 2009;208:1–13
  13. Silverman T, Aebersold P, Landow L, et al. Regulatory perspective on clinical trials for trauma, transfusion, and hemostasis. Transfusion. 2005;45:15S–21S
  14. Cohn SM, Nathens AB, Moore FA, et al. Tissue oxygen saturation predicts the development of organ dysfunction during traumatic shock resuscitation. J Trauma. 2007;62:44–54
  15. Moore FA, Nelson T, McKinley BA, et al. Massive transfusion in trauma patients: tissue hemoglobin oxygen saturation predicts poor outcome. J Trauma. 2008;64:1010–1023
  16. Contant C, McCullough LB, Mangus L, et al. Community consultation in emergency research. Crit Care Med. 2006;34:2049–2052
  17. Dichert N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005;95:1123–1127
  18. Longfield JN, Morris MJ, Moran KA, et al. Community meetings for emergency research community consultation. Crit Care Med. 2008;36:731–736
  19. Richardson LD, Rhodes R, Ragin DF, et al. The role of community consultation in the ethical conduct of research without consent. Am J Bioeth. 2006;6:33–34
  20. McClure KB, Delorio NM, Schmidt TA, Chiodo G, Gorman P. A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent. J Med Ethics. 2007;33:289–293

PII: S0039-6060(09)00129-9

doi: 10.1016/j.surg.2009.03.003

Surgery
Volume 145, Issue 6 , Pages 630-635 , June 2009

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