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November 27, 2013

The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges

Author Affiliations
  • 1Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland
  • 2Fogarty International Center, National Institutes of Health, Bethesda, Maryland
  • 3Office of the Provost, University of Pennsylvania, Philadelphia
  • 4Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia
JAMA. 2013;310(20):2143-2144. doi:10.1001/jama.2013.281632

Since 1964, through 7 revisions, the World Medical Association’s (WMA’s) Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. The declaration is consulted by ethics review committees, funders, researchers, and research participants; has been incorporated into national legislation; and is routinely invoked to ascertain the ethical appropriateness of clinical trials.

There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. The Working Group extensively consulted stakeholders and justified the proposed revisions. The result is a declaration that is better organized into clear sections, more precise, and likely to be more effective at protecting research participants.