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A Review of Current Events in Human Subjects Protection

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Abstract

Bioethics is a subject that has been gaining increased attention through the last few years. Factors such as globalization of research, genetic medicine, and tragic events in clinical trials have drawn attention to the importance of protecting human participants in medical research. The October 2000 revision of the Declaration of Helsinki and the release of two reports by the National Bioethics Advisory Commission are just a few examples of the recent efforts by policymaking bodies to modernize bioethical standards. This review provides an introduction to several of the groups that are participating in the reshaping of bioethical policy in the United States and around the globe. Although there are multiple bioethical issues currently being debated, three specific topics are discussed: the use of placebo controls in clinical trials, posttrial access to medicines, and financial conflicts of interest.

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References

  1. National Bioethics Advisory Commission. Ethical and policy issues in research involving human participants. Commissioned report released May 2001. Available at: http://bioethics.gov/pubs.htmUffinal.

    Google Scholar 

  2. Key events drive evolution of federal human subject protection policy. Washington Drug Letter. Nov 27, 2000.

    Google Scholar 

  3. Code of Federal Regulations: 21 CFR 312.120.

  4. National Bioethics Advisory Commission. Available at: http://www.bioethics.gov.

  5. Siang S. Greg Koski and the US Office of Human Research Protections: doing it right... together. Available at: http://www.clinical-researcher.com/dispart.asp?id=20.

  6. National Human Research Protections Advisory Committee. Charter. Available at: http://ohrp.osophs.dhhs.gov/nhrpac/charter.htm.

  7. National Human Research Protections Advisory Committee. NHRPAC Meeting Transcripts. April 9–10, 2001. Available at: http://ohrp.osophs.dhhs.gov/nhrpac/mtg04-01/mtg04-01.htm.

    Google Scholar 

  8. Institute of Medicine. Preserving the public trust: accreditation and human research participant program. April 2001. Available at: http://www.nap.edu/books/0309073286/html/.

    Google Scholar 

  9. Subpart D, harmonization top off OHRT priority list. FDA Week. March 23, 2001.

    Google Scholar 

  10. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Revised, 52nd WMA General Assembly, Edinburgh, Scotland, October 2000.

    Google Scholar 

  11. International Conference on Harmonization. Guidance for Industry: E10 Choice of Control Groups and Related Issues in Clinical Trials. Updated May 2001. Available at: http://www.fda.gov/cder/guidance/4155fnl.htm.

    Google Scholar 

  12. World Medical Association. Declaration of Helsinki: Note of Clarification on Placebo Controlled Trials. Available at: http://www.wma.net/e/home.html (accessed Oct 19, 2001).

    Google Scholar 

  13. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries. Commissioned report released April 2001. Available at: http://bioethics.gov/pubs.htm#clinical.

    Google Scholar 

  14. Stephens J. The body hunters. The Washington Post. Series of six articles. December 17–22, 2000.

    Google Scholar 

  15. Wilson D, Heath D. Uninformed Consent. Seattle Times. Series of five articles. March 11–15, 2001.

    Google Scholar 

  16. Department of Health and Human Services. Draft Interim Guidance: Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider when Dealing with Issues of Financial Interests and Human Subject Protection. January 10, 2001. Available at: http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finmain.htm.

    Google Scholar 

  17. Drazen J, Koski G. To protect those who serve. N Engl J Med. Nov 30, 2000;64:22.

    Google Scholar 

  18. FDA suggests new panel, not IRBs, monitor financial conflict of interest. FDA Week. March 30,2001.

    Google Scholar 

  19. Kahn JP, Mastroianni AC. Moving from compliance to conscience. Arch IntMed. April 9,2001:925–928.

    Google Scholar 

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Authors and Affiliations

  1. U.S. Regulatory Affairs, Eli Lilly and Company, Rockville, Maryland, USA

    Laura Coleman PharmD (Visiting Scientist)

  2. U.S. Regulatory Affairs, Eli Lilly and Company, Lilly Corporate Center, Drop Code 4008, Indianapolis, IN, 46285, USA

    Stacy Holdsworth PharmD, RAC (Manager)

Authors
  1. Laura Coleman PharmD
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  2. Stacy Holdsworth PharmD, RAC
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Coleman, L., Holdsworth, S. A Review of Current Events in Human Subjects Protection. Ther Innov Regul Sci 36, 261–267 (2002). https://doi.org/10.1177/009286150203600204

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