Inclusion Across the Lifespan - Policy Implementation

NIH Inclusion Across the Lifespan in Research Involving Human Subjects

NIH has two main policies concerning inclusion in funded research. This page describes the NIH policies and procedures on Inclusion Across the Lifespan in research involving human subjects. For more information about the inclusion of women and minorities in funded research, visit the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects policy implementation website.

The purpose of the Inclusion Across the Lifespan Policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also:

  • Clarifies potential justifications for age-based exclusion criteria
  • Requires participant age at enrollment to be provided in progress reports

The Inclusion Across the Lifespan policy is now in effect, and applies to all grant applications submitted for due dates on or after January 25, 2019. The policy also applies to solicitations for R & D contracts issued January 25, 2019 or later, and intramural studies submitted on/after this date. Ongoing, non-competing awards will be expected to comply with the policy at the submission of a competing renewal application. Until then, ongoing research continues to be subject to the Inclusion of Children in Clinical Research Policy.

See our Policy Information website for links to the policies and additional information.

Other age-related requirements for investigators:

  • Inclusion of individuals of all ages must still be addressed in competing and non-competing grant applications.
  • On the new SF424 (R&R) Version E (used for applications with due dates on/after January 25, 2018), investigators specify the age range of study participants and attach inclusion information in Section 2- Study Population Characteristics of the PHS Human Subjects and Clinical Trials Information Form. See the Application Guide for instructions.

Important News:

Starting June 9, 2018, the Human Subjects System (HSS) replaced the Inclusion Management System (IMS). The new system will be used by NIH staff, grant applicants, and recipients to manage human subjects information, including inclusion data. Please see guide notice NOT-OD-18-179 for details. For information about HSS, click here. Link to Non-U.S. Government Site - Click for Disclaimer

Additional Resources


Title

Description

Link
Original Posting Date
Inclusion Across the Lifespan FAQs Frequently asked questions about the Inclusion Across the Lifespan Policy. Website November 2018
Podcast: The Inclusion Across the Lifespan Policy The "All About Grants" podcast featuring an interview with the NIH Inclusion Policy Officer about the Inclusion Across the Lifespan policy. MP3

Transcript
August 27, 2018
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

Word
March 26, 1999
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, and only applies to applications submitted for due dates BEFORE January 25, 2019. Website

(Staff only)
March 6, 1998

Have additional questions? Contact the Inclusion policy team: Inclusion@od.nih.gov