Declaration of Helsinki

The 50th Anniversary of the Declaration of HelsinkiProgress but Many Remaining Challenges FREE ONLINE FIRST

Joseph Millum, PhD1,2; David Wendler, PhD1; Ezekiel J. Emanuel, MD, PhD3,4

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JAMA. Published online October 19, 2013. doi:10.1001/jama.2013.281632

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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.

For the first time, the declaration requires compensation and treatment for research-related injuries (paragraph 15), an explicit recognition that research participants should not bear the costs of research gone wrong.1 The revised declaration’s emphasis on the dissemination of research results, including studies with negative results, should increase the value of medical research (paragraphs 23, 35, and 36)./.../

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October 19, 2013

Special Communication World Medical Association Declaration of Helsinki:  Ethical Principles for Medical Research Involving Human Subjects     World Medical Association. JAMA. Published online October 19, 2013. doi:10.1001/jama.2013.281053 Viewpoint The Declaration of Helsinki, 50 Years Later     Paul Ndebele, PhD. JAMA. Published online October 19, 2013. doi:10.1001/jama.2013.281316 The 50th Anniversary of the Declaration of Helsinki:  Progress but Many Remaining Challenges     Joseph Millum, PhD, David Wendler, PhD, Ezekiel J. Emanuel, MD, PhD. JAMA. Published online October 19, 2013. doi:10.1001/jama.2013.281632

JAMA is publishing the revised Declaration of Helsinki, 2 related Viewpoints, and an audio interview to coincide with the release of the 7th revision of the declaration by the World Medical Association #WMAGA13.