Abstract

The author discusses the social influences that gave rise to the presumption in favor of children's participation in research and emphasizes the need for an ethical framework to guide decision-making in this context. Specifically, the author proposes a framework of child-centered bioethics that integrates the core bioethics principles of beneficence and autonomy with an assessment of children's needs and interests. Finally, the author articulates recommendations regarding mature minors and institutional review boards consistent with this framework in order to resolve the difficult ethical issues posed by including children of all ages in clinical drug trials.