Those who care about and for children are sometimes faced with a dilemma. We want children to benefit from the dramatic and accelerating rate of progress in medical care that is fueled by scientific research. At the same time, we do not want to place children at risk of harm by participating in such research, even though their involvement may be essential to future improvements in children's health and health care. And because children usually do not have the legal capacity and the maturity to provide informed consent, which is a cornerstone of ethical human research, we have to provide them with special protections.

To address concerns about the adequacy of the current system for protecting child participants in research given a public commitment to expanding pediatric clinical research, the Institute of Medicine convened the Committee on Clinical Research Involving Children. In the resulting report, The Ethical Conduct of Research Involving Children, the committee addressed three broad themes: creating a robust system for protecting child research participants; providing appropriate pediatric expertise at all stages in the design, review and conduct of studies that include children; and encouraging the inclusion of children in research when that is ethically and scientifically appropriate.