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

Medicine

Family Medicine & Medical Science Research

Author(s): Joseph Millum, David Wendler, Ezekiel J Emanuel

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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). Nevertheless, the proposed declaration contains persistent flaws. While the document purports to be a statement of enduring ethical principles, the nearly continuous process of revision undermines its authority.2 Moreover, the declaration continues to assert that “consistent with the mandate of the WMA,” its primary audience is physicians (paragraph 2). This is a mistake. Indeed, the document then offers recommendations for other health professionals (paragraph 9), research ethics committees (paragraph 23), sponsors and governments (paragraph 34), and editors and publishers (paragraph 36). It is time for the WMA to recognize that the Declaration of Helsinki should address physicians as well other health professionals and personnel involved in research. A statement of ethical principles does not require a mandate from the people who ought to follow those principles.2 The revised declaration’s treatment of informed consent remains inadequate. It fails to recognize the possibility of waiving consent for some research involving competent adults, even though such research is common and widely endorsed. Similarly, the declaration avoids providing guidance on when it can be appropriate to ask participants to give broad consent for their biological samples to be used in a wide range of future studies, rather than seeking consent for each specific study. This is a pressing issue on which researchers need clear guidance. In addition, the declaration prohibits individuals who cannot consent from participating in research that does not address the condition that caused their incapacity (paragraph 30), even when the research offers participants the potential for important medical benefit and there are no—or few—potential participants who can consent. This approach transforms a protection into a barrier.

This article was published in JAMA and referenced in Family Medicine & Medical Science Research

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