Institutional Review Board
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Policy and Guidelines on the Inclusion of Children as Participants

NIH policy requires that children (i.e., individuals under the age of 21) must be included in all human subjects research conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all NIH conducted or supported research involving human subjects. Proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion. It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:

1. The research topic to be studied is irrelevant to children.

2. There are laws or regulations barring the inclusion of children in the research. For example, the regulations for protection of human subjects allow consenting adults to accept a higher level of risk than are permitted for children.

3. The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. Documentation of other studies justifying the exclusions should be provided. NIH program staff can be contacted for guidance on this issue if the information is not readily available.

4. A separate, age-specific study in children is warranted and preferable. Examples include:

a. The relative rarity of the condition in children, as compared to adults (in that extraordinary effort would be needed to include children, although in rare diseases or disorders where the applicant has made a particular effort to assemble an adult population, the same effort would be expected to assemble a similar child population with the rare condition);

b. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network, so that requiring inclusion of children in the proposed adult study would be both difficult and unnecessary (in that the topic was already being addressed in children by the network) as well as potentially counterproductive (in that fewer children could be available for the network study if other studies were required to recruit and include them);

c. Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages or different age-related metabolic processes). While this situation may represent a justification for excluding children in some instances, consideration should be given to taking these differences into ac count in the study design and expanding the hypotheses tested or the interventions to allow children to be included rather than excluding them.

5. Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis.

6. Study designs aimed at collecting additional data on pre-enrolled adult study participants (e.g., longitudinal follow-up studies that did not include data on children).

7. Other special cases justified by the investigator and found acceptable to the review group and the Institute Director.

This policy applies to all initial applications (Type 1) proposals beginning with the October 1, 1998 receipt date.