Annals of Emergency Medicine
Volume 50, Issue 4 , Pages 448-455.e4 , October 2007

Implementing Emergency Research Requiring Exception From Informed Consent, Community Consultation, and Public Disclosure

  • Joshua G. Salzman, MA

      Affiliations

    • Emergency Medical Services Program, Regions Hospital, St. Paul, MN
    • Corresponding Author InformationAddress for reprints: Joshua Salzman, MA, 640 Jackson St, MS: 13801B, St. Paul, MN 55101; 651-793-4002, fax 651-778-3778
    • ,
  • Ralph J. Frascone, MD

      Affiliations

    • Emergency Medical Services Program, Regions Hospital, St. Paul, MN
    • ,
  • Bobette K. Godding, BA

      Affiliations

    • Institutional Review Board, HealthPartners Research Foundation, St. Paul, MN
    • ,
  • Terry A. Provo, BS

      Affiliations

    • Clinical Trials, Advanced Circulatory Systems, Inc., Eden Prairie, MN
    • ,
  • Elie Gertner, MD

      Affiliations

    • Department of Rheumatology, Regions Hospital, St. Paul, MN
    • Institutional Review Board, HealthPartners Research Foundation, St. Paul, MN
    • University of Minnesota Medical School, Minneapolis, MN.

Received 13 April 2006 ,Revised 2 October 2006 ,Accepted 13 October 2006.

References 

  1. Trials of War Criminals before the Nuremberg Military Tribunals under Central Council Law No. 10. Washington, DC: US Government Printing Office; 1949-1953:181-182.
  2. World Health Organization. Declaration of Helsinki. British Medical Journal. 1996;313:1448–1449
  3. US Department of Health and Human Services. Protection of human subjects. Code Fed Regul Public Welfare. 1981;Title 50 (Section 23).
  4. US Department of Health and Human Services. Protection of human subjects. Code Fed Regul Public Welfare. 1983;Title 45 (Section 46-116).
  5. Abramson NS, Meisel A, Safar P. Deferred consent: a new approach for resuscitation research on comatose patients. JAMA. 1986;255:2466–2471
  6. Ellis G. Informed consent: legally effective and prospectively obtained [Department of Health and Human Services Office for Protection for Research Risks]. Available at: http://hhs.gov/ohrp/humansubjects/guidance/hsdc93-03.htm. Accessed August 14, 2006.
  7. US Department of Health and Human Services. Protection of human subjects: informed consent: FDA: final rule. Fed Reg. 1996;61:51498–51533
  8. Hiller KM, Haukoos JS, Heard K, et al. Impact of the Final Rule on the rate of clinical cardiac arrest research in the United States. Acad Emerg Med. 2005;12:1091–1098
  9. Nichol G, Huszti E, Rokosh J, et al. Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research?. Resuscitation. 2004;62:3–23
  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. Ornato JP, McBurnie MA, Nichol G, et al. The Public Access Defibrillation (PAD) Trial: study design and rationale. Resuscitation. 2003;56:135–147
  12. Hallstrom AP, Ornato JP, Weisfeldt M, et al. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med. 2004;351:637–646
  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
  14. 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
  15. Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. N Engl J Med. 2001;345:631–637
  16. Lowenstein DH, Alldredge BK, Allen F, et al. The Prehospital Treatment of Status Epilepticus (PHTSE) Study: design and methodology. Control Clin Trials. 2001;22:290–309
  17. Ong ME, Ornato JP, Edwards DP, et al. Use of an automated, load-distributing band chest compression device for out-of-hospital cardiac arrest resuscitation. JAMA. 2006;295:2629–2637
  18. Santora TA, Cowell V, Trooskin SZ. Working through the public disclosure process mandated by use of 21 CFR 50.24 (exception to informed consent): guidelines for success. J Trauma. 1998;45:907–913
  19. Shah AN, Sugarman J. Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Ann Emerg Med. 2003;41:72–78
  20. ClinicalTrials.gov. ResQ Trial: Impact of an ITD and active compression decompression CPR on survival from out-of-hospital cardiac arrest [ClinicalTrials.gov Web site]. Available at: http://www.clinicaltrials.gov/ct/show/NCT00189423?order=5. Accessed August 14, 2006.
  21. McClure KB, DeIorio NM, Gunnels MD, et al. Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med. 2003;10:352–359

 Supervising editor: Keith T. Ghezzi, MDFunding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that may create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. Supported by grant 2-R44-HL65851-03, National Institutes of Health, Heart, Lung and Blood Institute, HealthPartners Research Foundation Internal grant 04-032, Metropolitan 911 Board grant, Guidant Foundation grant, and Local 21 grant.Publication dates: Available online January 12, 2007.

PII: S0196-0644(06)02413-9

doi: 10.1016/j.annemergmed.2006.10.013

Annals of Emergency Medicine
Volume 50, Issue 4 , Pages 448-455.e4 , October 2007

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