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).
This study was supported by Contract No.
N01-OD-4-2139, TO #115 between the National Academy of Sciences and the National
Institute of Child Health and Development and also the U.S. Food and Drug
Administration. Any opinions, findings, conclusions, or recommendations expressed in
this publication are those of the author(s) and do not necessarily reflect the view
of the organizations or agencies that provided support for this project.
NOTICE: The project that is the subject of this report was approved by the Governing
Board of the National Research Council, whose members are drawn from the councils of
the National Academy of Sciences, the National Academy of Engineering, and the
Institute of Medicine. The members of the committee responsible for the report were
chosen for their special competences and with regard for appropriate balance.
© 2004, National Academy of Sciences.