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Table 1 Regulatory definition of minimal risk

From: Overcoming burdens in the regulation of clinical research in children. Proceedings of a consensus conference, in historical context

45 CFR 46.102i: "The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests."
Secretary's Advisory Committee on Human Research Protections recommendation (July 28, 2005): For children below the age of legal consent, the standard "should be interpreted as those risks encountered during daily life by normal, average, healthy children living in safe environments...(and)...should be indexed to risks... experienced by children the same age and developmental status as the subject population."