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Research examining the safe and effective treatment of diseases and disorders affecting children offers one of the best prospects for improving the medical treatment of children. But the inclusion of children in research raises difficult ethical questions, among them: To how much risk is it permissible to expose children in research? Various thresholds have been proposed to constrain research risks that do not offer children the prospect of direct medical benefit. These proposals include limiting research risks to (1) the risks of routine medical examinations, (2) the risks of participation in charitable activities, (3) the risks of family life, and (4) the risks-of-daily-life. I examine which, if any, of these proposals is defensible. I argue that only the risks-of-daily-life threshold is defensible and I offer a new justification for this risk threshold. I argue that the risks of daily life are justifiable because they are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives.

Original publication




Journal article


Kennedy Inst Ethics J

Publication Date





413 - 442


Biomedical Research, Child, Humans, Research Subjects, Risk Assessment