On This Page:

1. Implementation of the NIH Policy for the Inclusion of Children in Research
2. PHS 398 Instructions with Respect to the Inclusion of Children in Research

a. Implementation of the NIH Policy for the Inclusion of Children * in Research

Applicants must address the inclusion of children* in applications/proposals submitted for NIH funding.

*Note that the NIH uses 2 definitions for “children”:
• Children for the purposes of the requirement to address inclusion are defined as individuals under the age of 21. (NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects)
• Children with regard to protections from risks in research are defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” (46.402)

Additional information about requirements for justifications for the appropriate exclusion of children can be found at the NIH Inclusion of Children Policy Implementation Page.

This page contains helpful information including questions and answers about the policy and a number of case studies.

b. PHS 398 Instructions with Respect to the Inclusion of Children in Research

The PHS 398 Instructions provide the instructions and requirements for the descriptions that must be found in the Research Plan of the application. Children, using the NIH Inclusion Policy definition of individuals aged under 21, must be included in research unless the applicant provides an acceptable justification for their exclusion. Some potential justifications for the exclusion of children are found below:

• The research topic to be studied is irrelevant to children
• 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.
• 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.
• A separate, age-specific study in children is warranted and preferable. Examples include:
  1. The relative rarity of the condition in children, as compared to adults such that an extraordinary effort would be needed to include children
  NOTE: 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
  2. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; requiring inclusion of children in the proposed adult study would be both difficult and duplicative and, therefore, unnecessary
  3. The research design and/or hypotheses would differ for adult and child populations
     • Due to different cognitive, developmental or disease stages; or
     • Due to different age-related metabolic processes
  4. While these situations may represent justifications for excluding children, consideration should be given to taking these differences into account in the study design and/or 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 risks in children. In this case, one of the research objectives could be to obtain sufficient adult data to make this judgment.
  6. 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.
  7. Studies designed to collect additional data on pre-enrolled adult study participants (e.g., longitudinal follow-up studies that did not originally include data on children).