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July 20, 2011

Research Enrollment and Informed Consent

Author Affiliations

Author Affiliations: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Drs Labrique and Bartlett) (alabriqu@jhsph.edu); and Berman Institute of Bioethics, Johns Hopkins University, Baltimore (Dr Merritt).

JAMA. 2011;306(3):266. doi:10.1001/jama.2011.985

To the Editor: Dr Wendler's Commentary proposed a pragmatic framework for validating informed consent.1 As researchers who design, conduct, and perform ethical reviews of large, international community-based studies and randomized trials in extremely resource-constrained settings, we find that the challenges to obtaining valid consent are amplified by low literacy, linguistic barriers, unfamiliarity with scientific concepts, and cultural factors.2,3

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