NIH GUIDE, Volume 26, Number 15, May 9, 1997


P.T. 34


  Grants Administration/Policy+ 


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,

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 Scientific Affairs

Executive Office Center, Suite 400

2101 E. Jefferson Street

Rockville, MD 20852

Telephone: (301) 594-1437 x1607

Email: pthompso@ahcpr.gov



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