Office of Research, UC Riverside
Office of Research Integrity

Institutional Review Board - Socio-Behavioral (IRB-SB)

NIH Policy on Children in Research

3/19/98

The NIH has announced a new policy requiring the inclusion of children in research involving human subjects, unless certain conditions are met. This policy was developed in response to directives from the House and Senate appropriations committees as well as from suggestions by the American Academy of Pediatrics.

The new policy is effective October 1, 1998, meaning it applies to all applications/proposals submitted for receipt dates after Oct. 1. Under the new policy, investigators must create a section in their research plan titled "Participation of Children". This section should provide a description of the plan to include children or or an explanation of the reasons for excluding children as participants. The policy provides possible reasons for exclusion:

 

  1. The research topic is irrelevant to children.
  2. There are laws barring their inclusion.
  3. The knowledge being sought is already available for children.
  4. A separate age-specific study in children is warranted.
  5. Insufficient data are available to judge the risk of participation to children.
  6. The study involves follow-up on a previous adult study.
  7. Other justifications are found acceptable by review groups and the Institute Director.

For purposes of the policy "child" is defined as an individual under the age of 21. HRRB's are expected to examine the appropriateness of pediatric participation in research studies, while at the same time continuing to meet the special review requirements (45CFR 46, Subpart D) to protect the well-being of children who participate in research. Also scientific review groups will be required to evaluate the proposed research plan for inclusion or exclusion of children as acceptable or unacceptable.

The complete policy announcement may be found on the NIH web site at: http://www.nih.gov/grants/guide/notice-files/not98-024.html