Inclusion Across the Lifespan - Policy Implementation

NIH Inclusion Across the Lifespan in Research Involving Human Subjects

This page describes the NIH policies and procedures on Inclusion Across the Lifespan in research involving human subjects.

The new NIH policy requires that applicants and grantees include individuals of all ages when conducting clinical research, unless there is a strong justification for their exclusion.  Inclusion Across the Lifespan must be addressed in all grant applications submitted on/after January 25, 2019, and all responses to solicitations issued on/after this date.

Research that is ongoing and grant applications/proposals submitted prior to January 25, 2019 continue to be subject to the Inclusion of Children in Clinical Research Policy.


Policy References


Title Description Link Original Posting Date
NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects Guide Notice NOT-OD-18-116: This policy revises previous policy and guidelines regarding the inclusion of children in research.
Changes to the policy include (1) the applicability of the policy to individuals of all ages, (2) clarification of potentially acceptable reasons for excluding participants on the basis of age, and (3) a requirement to provide data on participant age at enrollment in progress reports.
Website 12/19/2017
Inclusion of Children in Clinical Research: Change in NIH Definition
Guide Notice NOT-OD-16-010For the purposes of inclusion policy, the age of a child is defined as individuals under 18 years old.
Applicants/offerors for NIH funding are still expected to justify the age range of the proposed participants in their clinical research.
Website 10/13/2015
NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects NIH Guide Notice. The goal of this policy is to increase the participation of children in research so that adequate data will be developed to support the treatment modalities for disorders and conditions that affect adults and may also affect children. Website 03/06/1998
Decision Tree for Participation of Children in Research This is a tool for deciding if the inclusion of children is appropriate for a specific study. It is an attachment to the 03/06/98 NIH Guide shown above. Website Lock 03/06/1998

FAQs and Other Resources


Title Description Link Original Posting Date
Inclusion Across the Lifespan Policy Infographic A snapshot of key basic information regarding the Inclusion Across the Lifespan Policy PDF January 10, 2018
Inclusion of Children Case Studies (SCIENTIFIC)
Case Studies have been developed to assist Investigators in evaluating when children should be included in research studies supported by the NIH. Website