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Development of a Policy and an Implementation Plan for Enhancement of the Inclusion of Children in Sponsored Research:

Request for Comments

As was announced in the NIH GUIDE, Volume 26, Number 3,January 31, 1997, the National Institutes of Health (NIH) has embarked on a thoughtful deliberation to develop a policy and an implementation plan for requiring applicants proposing clinical research that addresses conditions or disorders that affect adults and may also affect children, to describe their plans for including or justifications for excluding children in the research. The NIH and the American Aca of Pediatrics held a joint workshop in June 1996 concerning the participation of children in clinical research. There is valid concern that treatment modalities developed based on research conducted on adults, without adequate data from children, are being used to treat children for many diseases/disorders. One of the outcomes of the workshop was the recommendation that the NIH develop a policy for including children in clinical research.

The NIH concluded that when there is a sound scientific rationale for including children in research, investigators should be expected to do so unless there is a strong overriding reason that justifies their exclusion from the studies. Although this is the same scientific rationale that is the basis for the policy requiring the inclusion of women and minorities in clinical research, this policy does not mandate the inclusion of children in all clinical research. Because the issues and sensitivities surrounding children~s participation in research are significantly different from those regarding women and minorities, such a mandate would be inappropriate. Nonetheless, even though the inclusion of children is not an absolute requirement, applicants for NIH funding will be expected to address this issue in their proposals.

The NIH recognizes that the development and implementation of this policy will require the education and preparation of the scientific community, parents, Institutional Review Boards, Initial Review Groups, Advisory Councils, and NIH program staff. The purpose of this notice is to provide information about ongoing efforts towards the new policy--ample advance notice will be provided prior to the formal implementation of the policy--and to REQUEST COMMENTS FROM ALL INTERESTED PARTIES. In the meantime, investigators are encouraged to consider including children in clinical research projects.


Peter S. Jensen, M.D.
Chair, Outreach Subcommittee
Committee on Inclusion on Children in Research
Email Address: pjensen@nih.gov

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