Children in Research Policy

Purpose

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

Procedure

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 HHS Questions and Answers page for Human Research, Research with Children.

Investigators

• Describe plans for including children in grant applications involving human subjects.
• Follow human subjects instructions in either the Grant Application Guide (for an electronic application) or PHS 398 (for a paper application). If responding to a request for applications or program announcements, follow any special instructions.
• If excluding children, provide a justification. Peer reviewers will evaluate plans for including or excluding children. Inadequate plans may negatively affect your score and you will be asked to resolve them before award. This could mean a bar to award.
• If you are including or excluding a specific age group of children, provide a justification. Reviewers will assess whether your justification is appropriate. 

To learn more, see Human Subjects -- Warning, What Happens if Reviewers Have Concerns?, and the Bars to Grant Awards SOP.

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

• Take appropriate action to lift a bar to award. See the Bars to Grants Awards SOP.

Contacts

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

Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

45 CFR 46, Protection of Human Subjects, HHS

• 45 CFR 46 Subpart A, Basic HHS Policy for Protection of Human Research Subjects.
• 45 CFR 46 Subpart D, Additional Protections for Children Involved as Subjects in Research.

Electronic Application Resources

Human Subjects SOPs

Human Subjects, Clinical Research

IMPAC and CRISP SOP

OER Inclusion of Children Policy Implementation

OER Inclusion of Children Policy Implementation Page

Office for Human Research Protections, HHS

Trans NIAID Clinical Research Toolkit