NIH GUIDE, Volume 26, Number 3, January 31, 1997


P.T. 34


  Grants Administration/Policy+ 

  Clinical Medicine, General 

  Children (Patients) 


National Institutes of Health


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 Academy

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.  In the meantime, investigators

are encouraged to consider including children in clinical research





Questions or concerns regarding this notice may be directed to:


Belinda Seto, Ph.D.

Office of Extramural Research

Building 1, Room 252

Bethesda, MD  20892

Telephone:  (301) 402-9128

Email:  bs11e@nih.gov



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