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Research ArticleSymposium Papers

How to Do Human-Subjects Research If You Do Not Have an Institutional Review Board

Todd W Rice
Respiratory Care October 2008, 53 (10) 1362-1367;
Todd W Rice
Division of Allergy, Pulmonary, and Critical Care Medicine and the Vanderbilt Institutional Review Board, Vanderbilt University School of Medicine, Nashville, Tennessee.
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Abstract

Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abides by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

  • ethics
  • institutional review board
  • IRB
  • human-subjects research
  • non-academic health care facilities

Footnotes

  • Correspondence: Todd W Rice MD MSc, Division of Allergy, Pulmonary, and Critical Care Medicine, T-1218 MCN and the Vanderbilt Institutional Review Board, Vanderbilt University School of Medicine, Nashville TN 37232-2650. Email: todd.rice{at}vanderbilt.edu.
  • Dr Rice presented a version of this paper at the RESPIRATORY CARE Journal Symposium at the 53rd International Respiratory Congress of the American Association for Respiratory Care, held December 1-4, 2007, in Orlando, Florida.

  • The author reports no conflict of interest related to the content of this paper.

  • Copyright © 2008 by Daedalus Enterprises Inc.
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Respiratory Care: 53 (10)
Respiratory Care
Vol. 53, Issue 10
1 Oct 2008
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How to Do Human-Subjects Research If You Do Not Have an Institutional Review Board
Todd W Rice
Respiratory Care Oct 2008, 53 (10) 1362-1367;

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How to Do Human-Subjects Research If You Do Not Have an Institutional Review Board
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Respiratory Care Oct 2008, 53 (10) 1362-1367;
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Keywords

  • ethics
  • institutional review board
  • IRB
  • human-subjects research
  • non-academic health care facilities

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