NIH Guide, Volume 26, Number 15, May 9, 1997
Notice: P.T. 34; K.W. 1014006
Agency for Health Care Policy and Research
Purpose
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.
Inquiries
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
Internet Citation:
AHCPR Policy on the Inclusion of Children in Health Services Research. May 1997. Agency for Health Care Policy and Research, Rockville, MD. http://www.ahrq.gov/fund/nih5997.htm