Inclusion Across the Lifespan in Human Subjects Research Policy SOP

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

Some links will work for NIAID staff only.

Purpose

To increase participation of individuals across the lifespan in human subjects research so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. 

Procedure

You must include individuals of all ages including children and older adults in all proposed human subjects research conducted or supported by NIH unless you have scientific or ethical reasons for excluding them.

NIH developed its inclusion of individuals across the lifespan policy to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study. The intent of this policy is to provide the opportunity for individuals, including children and older adults, to participate in research studies when there is a sound scientific rationale for including them, and their participation is appropriate.

NIH policy defines a child as a person under the age of 18, which aligns NIH’s definition with the typical age of consent and an older adult is defined as an individual 65 years of age or older. 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—HHS policy for Protection of Human Subjects.

NIH-funded research using newborn dried blood spots is considered human subjects research as defined in section 46.102 and must follow the HHS policy for Protection of Human Subjects 45 CFR 46.

Studies may use a specific age range of children or adults if that age range is properly justified and the application includes a rationale for including or excluding an age group. For more details, check Inclusion Across the Lifespan in Human Subjects Research and Office for Human Research Protections Children: Information on Special Protections for Children as Research Subjects.

Investigators

  • Describe plans for including individuals across the lifespan in grant applications and contract proposals involving human subjects.
    • Follow human subjects instructions as well as any special instructions in the notice of funding opportunity or solicitation.
  • If you are including or excluding a specific age group of children, adults, or older adults, provide a justification.
  • If excluding children altogether, provide the scientific or ethical reasons for doing so.
  • Provide data on participant age at enrollment in progress reports.
  • If you propose using newborn dried blood spots in research, include a complete human subjects section according to NIH instructions. Note: You must obtain parental permission to use newborn dried blood spots in NIH-funded research. No waiver of parental permission is permitted.

To learn more, refer to Human Subjects—Warning, Research Using Human Subjects, 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 individuals across the lifespan in your written request.

Center for Scientific Review and Scientific Review Program Staff

  • Before initial peer review, determine if applications meet requirements for including individuals across the lifespan 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 or older adults.
  • 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 lifespan inclusion codes in IMPAC II.

With the implementation of the Simplified Review Criteria for most Research Project Grant applications submitted on or after January 25, 2025, inclusions will be evaluated as part of the Approach (Factor 2) to emphasize their importance in evaluating scientific merit and will no longer be part of the Additional Review Criteria. For details, check Simplifying Review of Research Project Grant Applications.

Program Officers

  • Resolve inclusion of individuals across the lifespan including children and older adults compliance issues for applications coded unacceptable before funding.

Grants Management Staff and Program Officers

Contacts

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

If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

Links

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