This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
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 18, which aligns NIH’s definition with the typical age of consent. 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. Investigators must provide a rationale for including or excluding an age group. For more details, see Inclusion Across the Lifespan and Office for Human Research Protections Special Protections for Children as Research Subjects.
- 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 notice of funding opportunity 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.
- 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, see 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 children in your written request.
Center for Scientific Review 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 II.
- 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 Grant Awards SOP.
See the GMP Assignments by Geographic Region and Program Code for the appropriate specialist.
Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at email@example.com.
- 45 CFR 46, Protection of Human Subjects, HHS
- Apply for a Grant
- Human Subjects Research Requirements in Grants SOP and other Human Subjects Resources
- eRA System SOP
- Human Subjects Research
- Inclusion Across the Lifespan
- Office for Human Research Protections, HHS
- Vulnerable and Other Populations Requiring Additional Protections
- Rules and Policies for Clinical Research