PM&R
Volume 2, Issue 1 , Pages 57-63 , January 2010

The Controversy Surrounding Central Institutional Review Boards

  • Kristi L. Kirschner, MD (Feature Editor)

      Affiliations

    • PM&R, and Medical Humanities and Bioethics, Northwestern University Feinberg School of Medicine, Chicago, IL⁎
    • Corresponding Author InformationAddress correspondence to: K.L.K.
    • ,
  • John Whyte, MD, PhD (Guest Discussant)

      Affiliations

    • Moss Rehabilitation Research Institute, Albert Einstein Healthcare Network, Elkins Park, PA†
    • ,
  • R. Norman Harden, MD (Guest Discussant)

      Affiliations

    • Rehabilitation Institute of Chicago and Department of Physical Medicine and Rehabilitation, Northwestern University, Evanston, IL‡
    • ,
  • Teresa A. Savage, PhD, RN (Contributor)

      Affiliations

    • Rehabilitation Institute of Chicago and Donnelley Family Disability Ethics Program, Chicago, IL
    • ,
  • Debjani Mukherjee, PhD (Contributor)

      Affiliations

    • Rehabilitation Institute of Chicago, Donnelley Family Disability Ethics Program and Northwestern University Feinberg School of Medicine, Chicago, IL∥

References 

    Feature Editor Introduction
  1. Emanuel EJ, Lemmens T, Elliott C. Commercial IRBs have a fundamental conflict of interest. PLoS Med. 2006;3:942–943
  2. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. April 18, 1979;http://www.dhhs.gov/ohrp/humansubjects/guidance/belmont.htmAccessed December 22, 2009
  3. Jones J. Bad Blood: The History of the Tuskegee Syphilis Experiment. New York, NY: Free Press; 1993;
  4. Brody BA. The Ethics of Biomedical Research: An International Perspective. New York, NY: Oxford University Press; 1998;
  5. Advisory Committee on Human Radiation Experiments. http://www.gwu.edu/∼nsarchiv/radiationAccessed December 22, 2009
  6. Kent DM, Mwamburi DM, Bennish ML, Kupelnick B, Ioannidis JPA. Clinical trials in sub-Saharan Africa and established standards of care. JAMA. 2004;292:237–242
  7. Gelsinger P, Shamoo AE. Eight years after Jesse's death, are human research subjects any safer?. Hast Cent Rep. 2008;38:25–27
  8. Press briefing: Hopkins issues internal review committee report on research volunteer's death, 2001. www.hopkinsmedicine.org/press/2001/JULY/010716.htmAccessed December 22, 2009
  9. Gilbert S. Trials and tribulations. Hast Cent Rep. 2008;38:14–18
  10. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008;358:1354–1361
  11. Angell M. The Truth About Drug Companies: How They Deceive Us and What To Do About It. New York, NY: Random House; 2004;
  12. Bass A. Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial. Chapel Hill, NC: Algonquin Books; 2008;
  13. Brody H. Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Lanham, MD: Rowman & Littlefield Publishers, Inc; 2007;
  14. Elliott C. The soul of a new machine: Bioethicists in the bureaucracy. Camb Q Healthc Ethics. 2005;14:379–384
  15. Evans D, Smith M, Willen L. Big Pharma's Shameful Secret (Bloomberg Markets). November 2, 2005;http://www.ahrp.org/infomail/05/11/03.phpAccessed July 30, 2009
  16. Bowen A. Research ethics boards: Error and misconception. PLoS Med. 2006;3:e457–e458
  17. WIRB website Info for research subject. http://www.wirb.com/content/research_subjects.aspxAccessed August 18, 2009
  18. U.S. Department of Health and Human Services. Final Guidance Document: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection; 2004. http://www.dhhs.gov/ohrp/humansubjects/finreltn/fguid.pdfAccessed November 12, 2009
  19. National Institute of Health, Office for Human Research Protections, Association of American Medical College, & American Society of Clinical Oncology. Alternative models of IRB review: Workshop Summary Report, 2005. http://www.hhs.gov/ohrp/sachrp/documents/AltModIRB.pdfAccessed July 30, 2009
  20. National conference on alternative IRB models: Optimizing human subject protection. November 19-21, 2006. http://www.aamc.org/research/irbreview/irbconf06rpt.pdfAccessed November 11, 2009
  21. Speers M. Shared authority and responsibilities. 2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protection, November 19-21, 2006, Marriott Wardman Park Hotel, Washington, DC.
    Commentary from John Whyte, MD, PhD
  1. Kjaergard LL, Als-Nielsen B. Association between competing interests and authors' conclusions: Epidemiological study of randomised clinical trials published in the BMJ [see comment]. BMJ. 2002;325:249
  2. U. S. Food and Drug Administration. Medical Device Exemptions 510(k) and GMP Requirements. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfmAccessed November 25, 2009

 Disclosure Key can be found on the Table of Contents and at www.pmrjournal.org

PII: S1934-1482(09)01676-1

doi: 10.1016/j.pmrj.2009.12.013

PM&R
Volume 2, Issue 1 , Pages 57-63 , January 2010

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