Author Affiliations: Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Drs Labrique and Bartlett) (email@example.com); and Berman Institute of Bioethics, Johns Hopkins University, Baltimore (Dr Merritt).
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
Labrique AB, Bartlett LA, Merritt MW. Research Enrollment and Informed Consent. JAMA. 2011;306(3):266. doi:10.1001/jama.2011.985