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. (shrink)

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the (...) AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults. (shrink)

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment (...) of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver. (shrink)