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Comment & Response
March 26, 2014

Declaration of Helsinki and Protection for Vulnerable Research Participants—Reply

Author Affiliations
  • 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

In Reply We agree with Dr Hurst that investigators and sponsors could choose to satisfy paragraph 19 of the Declaration of Helsinki,1 which calls for “specifically considered” protections for vulnerable groups, by offering them a fair level of benefits. Thus, the revised declaration is consistent with the fair benefits framework.2 If this is all that Hurst means, we are in agreement.