American Journal of Bioethics.

Making Sense of the Undue Burden Interpretation of Minimal Risk

The concept of minimal risk in research with children has been fraught with controversy since the pediatric regulations (45 CFR 46, Subpart D) were first adopted in 1991. The pediatric regulations allow an institutional review board (IRB) to approve Department of Health and Human Services-funded nonbeneficial research judged to have no more than minimal risk (45 CFR 46.404) or a minor increase over minimal risk (45 CFR 46.406). Minimal risk is defined as either risks “ordinarily encountered in daily life” or risks encountered “during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102i). […]

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Volume 14, Issue 9
September 2014