General Clinical Research Center

Inclusion of Children in Research
It is the policy of the NIH that 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, including research that is otherwise "exempt" from the Federal Policy for the Protection of Human Research Subjects. Certain categories of research are "exempt" because they pose minimal risk to participants. Examples of "exempt" research include surveys, evaluation of educational interventions, and studies of existing data or specimens. Exempt studies should also include children as participants.

GCRC Protocol Guidelines

  • The Human Subjects section of your research plan must include a section called, "Participation of Children".
    This section should include:
    • a description of the plans to include children and a rationale for selecting or excluding a specific age range OR

    • an explanation of the reason(s) for excluding children as participants. Some potential justifications for exclusions are listed below; for more information, refer to the NIH policy.
      1. The research topic is irrelevant to children.
      2. There are laws or regulations barring the inclusion of children in the research.
      3. The knowledge being sought is already available for chilren or will be obtained from another ongoing study.
      4. A separate, age-specific study in children is warranted and preferable.
      5. Insufficient data are available in adults to judge potential risks in children.
      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).

  • When children are studied, the plan must include:
    • a description of the expertise of the investigative team for dealing with children at the ages included.
    • the appropriateness of the available facilities to accommodate the children.
    • the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study.


    • The NIH has developed a "decision tree" to assist you in determining when to include children as subjects in your research studies. If you have any questions about implementation of this policy, please call the GCRC office at 384-8305.

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