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Improving Balance in Regulatory Oversight of Research in Children and Adolescents

A Clinical Investigator's Perspective


Address for correspondence: Robert L. Rosenfield, M.D., University of Chicago Comer Children's Hospital, Section of Pediatric Endocrinology, 5841 S. Maryland Avenue (M/C 5053), Chicago, IL 60637. Voice: +1-773-702-6432, fax: +1-773-702-0443.


The current regulatory environment, designed to protect children, imposes barriers to research in children that are a deterrent to high-quality clinical research in minors. This article summarizes the special procedures necessary to obtain approval for research in healthy children that poses more than minimal risk according to the code of federal regulations (45 CFR 46.407 and 21 CFR 50.54). The operational realities of the process are illustrated by the case of the most recent research protocol to be reviewed under these rules. The current process poses obstacles to future studies of complex research questions in children and adolescents that require unaffected controls, such as the relationship of adolescent anovulatory disorders to adult illness. It is concluded that current regulatory procedures, while protecting children, increase the potential for the neglect of important research needs of children and are a disincentive to pursuit of a career in clinical research for young clinicians. Suggestions are made for improving the balance between the need for research in children and adolescents and its regulation.