Ethical Conduct of Clinical Research Involving Children

Excerpt

Concerns about the adequacy of the system for protecting child participants in research, combined with the public commitment to expanding clinical research involving children, provided the impetus for this Institute of Medicine (IOM) report, which was requested in the Best Pharmaceuticals for Children Act of 2002 (P.L. 107-109). The legislation charged the IOM with preparing a report that reviewed federal regulations, reports, and research and that made recommendations about desirable practices in clinical research involving children. Specifically designated topics were (1) the appropriateness of the regulations for children of various ages, (2) the interpretation of regulatory criteria for approving research, (3) the processes for securing parents' and children's agreement to a child's participation in research, (4) the expectations and comprehension of children and parents about participating in research, (5) the appropriateness of payments related to the child's participation in research, (6) compliance with and enforcement of federal regulations, and (7) the unique roles and responsibilities of institutional review boards (IRBs).