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July 20, 2011

Research Enrollment and Informed Consent—Reply

Author Affiliations

Author Affiliation: Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland (

JAMA. 2011;306(3):266. doi:10.1001/jama.2011.986

In Reply: Validating participants' consent for clinical research is important. It is also difficult. Dr Labrique and colleagues highlight the need to evaluate different methods for obtaining consent, with the goal of identifying methods that enable potential participants to understand the essential elements of consent and make their own decisions whether to participate. It is commonly assumed that these goals are more difficult to achieve in lower-income settings. Although this seems plausible, the empirical data are unclear.13 Nonetheless, as their letter points out, the methods used to solicit consent need to be sensitive to the culture, context, and circumstances of potential participants.

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