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The Research on Community Consultation: An Annotated Bibliography

  1. Jill M. Baren MD, MBE1,*,
  2. Michelle H. Biros MD, MS2

Article first published online: 28 JUN 2008

DOI: 10.1197/j.aem.2007.01.002

Issue

Academic Emergency Medicine

Academic Emergency Medicine

Volume 14, Issue 4, pages 346–352, April 2007

Additional Information

How to Cite

Baren, J. M. and Biros, M. H. (2007), The Research on Community Consultation: An Annotated Bibliography. Academic Emergency Medicine, 14: 346–352. doi: 10.1197/j.aem.2007.01.002

Author Information

  1. 1

    Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA

  2. 2

    Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN

**(Email: barenj@uphs.upenn.edu).

Publication History

  1. Issue published online: 28 JUN 2008
  2. Article first published online: 28 JUN 2008
  3. Received January 2, 2007; accepted January 3, 2007

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References

  • 21 CFR 50.24 and 45 CFR 46.101(i) Protection of Human Subjects: Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules Fed Regist 1996;61 51498–332.
  • Mosesso VN, Cone DC. Using the exception from informed consent regulations in research Acad Emerg Med 2005;12:1031–1039.
  • Biros MH. Struggling with the rule: the exception from informed consent in resuscitation research Acad Emerg Med 2007;14:344–345.
  • 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 Draft Guidance, 2006.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 Jan 3, 2007.
  • 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.
  • Kremers MS, Whisnant DR, Lowder LS Gredd L. Initial experience using the food and drug administration guidelines for emergency research without consent Ann Emerg Med 1999;33:224–229.
  • Lowenstein DH, Alldredge BK, Allen F, et al. The prehospital treatment of status epilepticus (PHTSE) study: design and methodology Controlled Clin Trials 2001;22:290–309.
  • Mosesso VN, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the public access defibrillation (PAD) trial experience Resuscitation 2004;61:29–36.
  • Dix ES, Esposito D, Spinosa F, Olson N, Chapman S. Implementation of community consultation for waiver of informed consent in emergency research: one institutional review board's experience J Investig Med 2004;52:113–115.
  • Contant C, McCollugh LB, Mangus L, Robertson C, Valadka A, Brody B. Community consultation in emergency research Crit Care Med 2006;34:2049–2052.
  • Baren JM, Anicetti JP, Ledesma S, Biros MH, Mahabee-Gittens M, Lewis RJ. An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent Acad Emerg Med 1999;6:1210–1215.
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  • Morris MC, Nadkarni VN, Ward FR Nelson RM. Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest Pediatrics 2004;114:776–781.
  • McClure KB, DeIorio NM, Gunneis, MD, Baum, A, Ochsner, MJ, Baum, A, Biros, MH, Baum, A, Schmidt, TA. 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.
    Direct Link:
  • Richardson LD, Wilets I, Ragin DF, et al. Research without consent: community perspectives from the community VOICES study Acad Emerg Med 2005;12:1082–1090.
  • 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.
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  • Allen S. Measuring care in state's hospital. Boston Globe. Sept 21, 2004.
  • Kipnis K, King N, Nelson R. An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial Am J Bioethics 2006;6(3):18–21.
  • Magnus DC. Blood, sweat and tears Am J Bioethics 2006;6(3):1–2.
  • Holloway KFC. Accidental communities; race, emergency medicine and the problem of PolyHeme Am J Bioethics 2006;6(3):7–17.
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