Annals of Emergency Medicine
Volume 53, Issue 3 , Pages 341-350.e2 , March 2009

The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent

  • Eileen M. Bulger, MD

      Affiliations

    • University of Washington, Seattle, WA
    • Corresponding Author InformationAddress for correspondence: Eileen M. Bulger, MD, Box 359796 Harborview Medical Center, 325 9th Ave, Seattle, WA 98104; 206-731-6448, fax 206-731-3656
    • ,
  • Terri A. Schmidt, MD, MS

      Affiliations

    • Oregon Health & Science University, Portland, OR
    • ,
  • Andrea J. Cook, PhD

      Affiliations

    • University of Washington, Seattle, WA
    • ,
  • Karen J. Brasel, MD, MPH

      Affiliations

    • Medical College of Wisconsin, Milwaukee, WI
    • ,
  • Denise E. Griffiths, BS

      Affiliations

    • Oregon Health & Science University, Portland, OR
    • ,
  • Peter J. Kudenchuk, MD

      Affiliations

    • University of Washington, Seattle, WA
    • ,
  • Daniel Davis, MD

      Affiliations

    • University of California, San Diego, CA
    • ,
  • Berit Bardarson, RN

      Affiliations

    • University of Washington, Seattle, WA
    • ,
  • Ahamed H. Idris, MD

      Affiliations

    • University of Texas, Southwestern Medical Center, Dallas, TX
    • ,
  • Tom P. Aufderheide, MD

      Affiliations

    • Medical College of Wisconsin, Milwaukee, WI
    • ,
  • The ROC Investigators

Received 12 March 2008 ,Revised 16 June 2008 ,Accepted 14 July 2008.

References 

  1. US Department of Health and Human Services Code of Federal Regulation, Protection of Human Subjects: informed consent and waiver of informed consent requirements in certain emergency research: final rules 21 CFRPart 50.24 and 45 CFR Part 46.101. Fed Reg. 1996;61:5147–51528
  2. Food and Drug Administration. Code of federal regulations, title 21, part 50: protection of human subjects, exception from informed consent requirements for emergency research: 21 CFR section 50.24. Fed Reg. 1996;61:51528–51531
  3. US Department of Health and Human Services, Food and Drug Administration draft guidance: exception from informed consent-emergency research. http://www.fda.gov/ora/compliance_ref/bimo/defaulthtm#emerAccessed August 6, 2008
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  9. McGee G, McErlean M, Triner W, et al. Keynote address: toward a pragmatic model for community consultation in emergency research. Acad Emerg Med. 2005;12:1019–1021
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 Supervising editor: Theodore R. Delbridge, MD, MPH

 Author contributions: All authors were involved in conception and design of the study and data acquisition. EMB was responsible for data analysis and primary drafting of the article. AJC provided statistical support for data analysis. TAS, AJC, KJB, DEG, PJK, DD, BB, AHI, and TPA contributed to critical revision of the article. EMB takes responsibility for the paper as a whole.

 Funding 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 might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This study was supported by a cooperative agreement (5U01 HL077863) with the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, The Canadian Institutes of Health Research (CIHR)–Institute of Circulatory and Respiratory Health, Defense Research and Development Canada, and the Heart and Stroke Foundation of Canada.

 Publication dates: Available online September 27, 2008.

 Reprints not available from the authors.

PII: S0196-0644(08)01512-6

doi: 10.1016/j.annemergmed.2008.07.021

Annals of Emergency Medicine
Volume 53, Issue 3 , Pages 341-350.e2 , March 2009

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