Full Text NOT-97-003
 
POLICY ON THE INCLUSION OF CHILDREN AS SUBJECTS IN CLINICAL RESEARCH
 
NIH GUIDE, Volume 26, Number 3, January 31, 1997
 
P.T. 34

Keywords: 
  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
projects.
 
INQUIRIES
 
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:  [email protected]
 
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