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Children in Research Policy SOP

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This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.


To increase participation of children in human subjects research so investigators can gather data to support treatments that may affect children.


You must include children in all human subjects research conducted or supported by NIH unless you have scientific or ethical reasons for excluding them.

NIH developed its inclusion of children policy because medical treatments used in children are frequently based on tests performed only on adults, and children have less access to scientifically evaluated treatments because of barriers that exclude them from research studies.

NIH policy defines a child as a person under the age of 21. It applies to all human subjects research, including research that is exempt from other human subjects requirements according to Sections 101 (b) and 401 (b) of 45 CFR 46—Federal Policy for the Protection of Human Subjects.

Studies may use a specific age range of children. Investigators must provide a rationale for including or excluding an age group. For more details, see NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects and Office for Human Research Protections, Research Involving Children Frequently Asked Questions.


  • Describe plans for including children in grant applications and contract proposals involving human subjects.
    • Follow human subjects instructions as well as any special instructions in the funding opportunity announcement or solicitation.
  • If you are including or excluding a specific age group of children, provide a justification.
  • If excluding children altogether, provide the scientific or ethical reasons for doing so.

To learn more, see Human Subjects—Warning, If Reviewers Have Concerns, and the Bars to Grant Awards SOP.

After award, you must request prior approval to change human subjects involvement. If applicable, include documentation of new or revised inclusion plans for children in your written request.

CSR and Scientific Review Program Staff

  • Before initial peer review, determine if applications meet requirements for including children in the research.
  • Ask reviewers to assess the appropriateness of the justification provided for including or excluding children and, if applicable, for including or excluding a specific age group.
  • Include appropriate expertise on the review panel for the review of applications involving children.
  • Following the review of grant applications, assess the review panel's recommendations, document the final opinion in the summary statement, and record the human subjects and child inclusion codes in IMPAC.

Program Officers

  • Resolve inclusion of children compliance issues for applications coded unacceptable before funding.

Grants Management Staff and Program Officers


See the GMP Assignments by Geographic Region and Program Code for the appropriate specialist.

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45 CFR 46, Protection of Human Subjects, HHS

NIAID's Application portal

Human Subjects Research Requirements SOP and other Human Subjects SOPs

Lock icon: This link will not work for public visitors.IMPAC SOP

NIAID Human Subjects Resources portal

OER Inclusion of Children Policy Implementation

Lock icon: This link will not work for public visitors.OER Inclusion of Children Policy Implementation Page

Office for Human Research Protections, HHS

Trans NIAID Clinical Research Toolkit

Last Updated November 12, 2015

Last Reviewed March 16, 2015