Notice Number: NOT-OD-18-116
Release Date: December 19, 2017
National Institutes of Health (NIH)
This revised Notice replaces NOT-98-024. The purpose of this Notice is to inform the research community that NIH is revising its NIH Policy and Guidelines on the Inclusion of Children. Changes to the policy include (1) the applicability of the policy to individuals of all ages, including children and older adults; (2) clarification of potentially acceptable reasons for excluding participants based on age; and (3) a requirement to provide data on participant age at enrollment in progress reports.
NIH’s long-standing policy has been that children must be included in all human subjects’ research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. This policy was developed due to concerns that children were not appropriately included in clinical research studies, resulting in insufficient data to establish the effectiveness of treatments in children.
Section 2038 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions requiring NIH to address the consideration of age as an inclusion variable in research involving human subjects, to identify criteria for justification for any age-related exclusions in NIH research, and to provide data on the age of participants in clinical research studies. As required by the Act, on June 1-2, 2017 NIH held a workshop on Inclusion Across the Lifespan to discuss barriers and opportunities for participation of children and older adults in clinical research studies. This event is available on videocast at https://videocast.nih.gov/launch.asp?23334. In addition, NIH issued a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan (NOT-OD-17-059) to solicit input from the wider scientific community and general public regarding appropriate inclusion of pediatric and older populations in research studies involving human subjects. NIH considered stakeholder input and reviewed current policies to identify opportunities to align NIH policies with the goal of ensuring that the distribution of study participants reflects the population needed to accomplish the scientific goals of the study.
This policy applies to all NIH conducted or supported research involving human subjects, including research that is otherwise "exempt" in accordance with Sections 101(b) and 401(b) of 45 CFR 46 - Federal Policy for the Protection of Human Subjects.
The policy will apply to all competing grant applications for due dates on or after January 25, 2019. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date. For the intramural program, the policy applies to intramural studies submitted initiated on or after January 25, 2019.
It is the policy of NIH that individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. The inclusion of individuals across the lifespan as subjects in research must be in compliance with all applicable subparts of 45 CFR 46 as well as with other pertinent federal laws and regulations.
Applications or proposals for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in the proposed research project. Applications/proposals must include a description of plans for including individuals across the lifespan, including a rationale for selecting the specific age range justified in the context of the scientific question proposed. If individuals will be excluded from the research based on age, the recipient/offeror must provide an acceptable justification for the exclusion. Acceptable reasons for excluding individuals based on age may include:
Scientific review groups at the NIH will assess each application/proposal as being "acceptable" or "unacceptable" with regard to the age-appropriate inclusion or exclusion of individuals in the research project, in addition to evaluating the plans for conducting the research in accord with these provisions. NIH staff will monitor implementation of this policy during the development, review, award and conduct of research; and manage the NIH research portfolio to comply with the policy.
NIH recipients/offerors must submit data on participant age at enrollment in progress reports. Investigators planning to conduct research involving human subjects should design their studies in such a way that de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment may be provided to NIH in progress reports. Age at enrollment may be reported to NIH in units ranging from hours to years. Recipients/offerors are responsible for ensuring informed consent documents allow submission of de-identified individual-level data on participant sex/gender, race, ethnicity, and age at enrollment to NIH.
Further information regarding NIH expectations for the inclusion of individuals across the lifespan is available at the following website: https://grants.nih.gov/grants/funding/children/children.htm.
Please direct all inquiries to:
NIH Inclusion Policy Officer
Office of Extramural Research (OER)