Annals of Emergency Medicine
Volume 51, Issue 6 , Pages 775-780.e3 , June 2008

Challenges in Enrollment of Minority, Pediatric, and Geriatric Patients in Emergency and Acute Care Clinical Research

  • Seth W. Glickman, MD

      Affiliations

    • Division of Emergency Medicine, Department of Surgery, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Kevin J. Anstrom, PhD

      Affiliations

    • Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC
    • Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC
    • ,
  • Li Lin, MS

      Affiliations

    • Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Abhinav Chandra, MD

      Affiliations

    • Division of Emergency Medicine, Department of Surgery, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Daniel T. Laskowitz, MD

      Affiliations

    • Division of Neurology, Department of Internal Medicine, Duke University Medical Center, Durham, NC
    • ,
  • Christopher W. Woods, MD

      Affiliations

    • Division of Infectious Diseases, Department of Internal Medicine, Duke University Medical Center, Durham, NC
    • ,
  • Debra H. Freeman, RN

      Affiliations

    • Division of Emergency Medicine, Department of Surgery, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Monica Kraft, MD

      Affiliations

    • Division of Pulmonary, Allergy and Critical Care, Department of Internal Medicine, Duke University Medical Center, Durham, NC
    • ,
  • Laura M. Beskow, MPH, PhD

      Affiliations

    • Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC
    • Institute for Genome Sciences and Policy, Duke University Medical Center, Durham, NC
    • ,
  • Kevin P. Weinfurt, PhD

      Affiliations

    • Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • ,
  • Kevin A. Schulman, MD

      Affiliations

    • Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • General Internal Medicine, Duke University Medical Center, Durham, NC.
    • ,
  • Charles B. Cairns, MD

      Affiliations

    • Division of Emergency Medicine, Department of Surgery, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
    • Corresponding Author InformationAddress for reprints: Charles B. Cairns, MD, Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt Street, Durham, NC 27710; 919-668-8694, fax 919-668-7124

Received 25 July 2007 ,Revised 17 October 2007 ,Accepted 1 November 2007.

References 

  1. Institute of Medicine of the National Academies. Hospital-Based Emergency Care: At the Breaking Point. Washington, DC: National Academies Press; 2006;
  2. Friedman JY, Anstrom KJ, Weinfurt KP, et al. Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples. N C Med J. 2005;66:267–275
  3. Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in clinical research?. PLoS Med. 2006;3:201–209
  4. Cairns CB. FDA public hearing on the conduct of emergency clinical research. Acad Emerg Med. 2007;14:e31–e32
  5. 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 IRB approval. Arch Surg. 2006;141:1019–1023
  6. Halperin H, Paradis N, Mosesso V, et al. Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's “Exception From Informed Consent Requirements for Emergency Research.” A special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care. Circulation. 2007;116(16):1855–1863
  7. Institute of Medicine of the National Academies. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington, DC: National Academies Press; 2003;
  8. Heiat A, Gross C, Krumholz H. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162:1682–1688
  9. Smith GC, Thomas S, George M. Distrust, race, and research. Arch Intern Med. 2002;162:2458–2463
  10. Duke University Health System Institutional Review Board Policy on research involving non-English-speaking subjects (version 10/10/04). http://irb.mc.duke.edu/doc/transpolicy.100606.docAccessed June 3, 2007.

 Supervising editor: David L. Schriger, MD, MPH

 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 publication was made possible by grant number 1 UL1 RR024128-01 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Drs. Anstrom, Schulman, and Weinfurt have made available detailed listings of disclosure information at http://www.dcri.duke.edu/research/coi.jsp. No other authors reported financial disclosures.

 Author contributions: CBC had full access to all of the data in this study and takes responsibility for the integrity of the data and the accuracy of the data analysis. SWG, KJA, LMB, KW, and CBC were responsible for study concept and design. SWG, AC, DHF, and CBC acquired data. SWG and CBC drafted the article. SWG, AC, CWW, MK, LMB, KW, KAS, and CBC were responsible for critical revision of the article for important intellectual content. SWG, KJA, LL, and CBC conducted statistical analysis. SWG, LMB, and CBC obtained funding. DTL, CWW, DHF, MK, KW, KAS, and CBC were responsible for administrative, technical, and material support. KAS and CBC supervised the study. CBC takes responsibility for the paper as a whole.

 Publication dates: Available online January 11, 2008.

PII: S0196-0644(07)01742-8

doi: 10.1016/j.annemergmed.2007.11.002

Annals of Emergency Medicine
Volume 51, Issue 6 , Pages 775-780.e3 , June 2008

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