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Comment & Response |

Declaration of Helsinki and Protection for Vulnerable Research Participants

Samia A. Hurst, MD1
[+] Author Affiliations
1Institute for Ethics, History and Humanities, Geneva University Medical School, Geneva, Switzerland
JAMA. 2014;311(12):1252. doi:10.1001/jama.2014.1272.
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To the Editor In their Viewpoint on the 50th anniversary of the Declaration of Helsinki, Dr Millum and colleagues1 understand vulnerable groups or individuals to include not just research participants who are poor but also “participants who are at higher risk of harm, cannot consent, or, because of their position, eg, being a student, are at increased risk of coercion.”

The revised declaration’s2 shift to an approach to vulnerable groups based on wrongs or harms rather than labeling is to be welcomed. One advantage of this approach is that it allows tailored protections for different forms of vulnerability, rather than blanket protections that may be ineffective or even counterproductive: “All vulnerable groups and individuals should receive specifically considered protection” (paragraph 19).2 Understanding vulnerability in this way is a structural change. Rather than outlining protections for categories of vulnerable participants, the focus shifts to recognizing situations in which fulfilling existing, internationally valid requirements demands additional care.3,4


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March 26, 2014
Joseph Millum, PhD; David Wendler, PhD; Ezekiel J. Emanuel, MD, PhD
1National Institutes of Health, Bethesda, Maryland
2Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia
JAMA. 2014;311(12):1252-1253. doi:10.1001/jama.2014.1281.
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