AHCPR Policy on the Inclusion of Children in Health Services Research
NIH Guide, Volume 26, Number 15, May 9, 1997
Notice: P.T. 34; K.W. 1014006
Agency for Health Care Policy and Research
The Agency for Health Care Policy and Research (AHCPR) announces that it is developing a policy and an implementation plan to encourage greater inclusion of children in health services research. The National Institutes of Health (NIH) and the American Academy of Pediatrics sponsored a joint workshop in June 1996, in which AHCPR participated, concerning the participation of children in clinical research. Valid concerns were raised that treatment modalities developed based on research conducted on adults are being used to treat children for many diseases/disorders without adequate data on children. One of the outcomes of the workshop was the recommendation that NIH develop a policy for including children in clinical research. An announcement by NIH was published in the NIH Guide for Grants and Contracts, Volume 26, Number 3, January 31, 1997.
AHCPR believes that when there is a sound scientific rationale for including children in health services 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 minority populations in research, this policy does not mandate the inclusion of children in all research because the issues and sensitivities surrounding children's participation in research are significantly different from those regarding women and minorities. Nonetheless, applicants for AHCPR funding will be expected to address this issue in their applications. If an applicant proposes research that addresses conditions or disorders that affect adults and may also affect children, or that deals with issues in the health care system that are relevant to children, the applicant will be expected to describe the plans for including or justification for excluding children in the research.
AHCPR recognizes, as does NIH, that the development and implementation of a policy on inclusion of children will require adjustments in administrative mechanisms and, most importantly, the education and preparation of the scientific community, parents, institutional review boards, initial review groups, advisory bodies, and program staff. NIH has formed several working groups on these topics and will share and coordinate efforts with other PHS components. AHCPR will use the results of these efforts and the perspectives of the health services research community in further developing and implementing this policy. Ample advance notice will be provided before formal implementation. In the meantime, investigators are encouraged to consider the inclusion of children in their health services research projects.
Questions or concerns regarding this notice may be directed to:
Patricia Thompson, Ph.D.
Office of Extramural Research , Education, and Priority Population
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 2000
Rockville, MD 20850