Inclusion Across the Lifespan

Learn about the Inclusion Across the Lifespan policy and how to comply with this policy in applications and progress reports. All human subjects research supported by NIH must include participants of all ages, including children and older adults, unless there are scientific or ethical reasons not to include them.

On This Page:

• Purpose
• Implementation
• Policy Notices
• Resources

Purpose

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 in Clinical Research Policy to include individuals of all ages, including children and older adults. The policy also requires that the age at enrollment of each participant be collected in progress reports. 

Implementation

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 Research & Development 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. Research that was submitted before January 25, 2019 continues to be subject to the Inclusion of Children in Clinical Research Policy.

Applications & Proposals

Applications and proposals involving human subjects research must address plans for including individuals across the lifespan in the PHS Human Subjects and Clinical Trial Information Form. Any age-related exclusions must include a rationale and justification based on a scientific or ethical basis. Refer to the PHS Human Subjects and Clinical Trial Information Form Instructions for complete guidance on what to address. 

Peer Review

Scientific Review Groups 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. For additional information on review considerations, refer to the Guidelines for the Review of Inclusion in Clinical Research. For information regarding the coding used to rate inclusion during peer review, see the list of NIH Peer Review Inclusion Codes.

Progress Reports

NIH recipients/offerors must submit individual-level data on participant age at enrollment in progress reports. Age at enrollment must be provided along with information on sex or gender, race, and ethnicity in the Inclusion Enrollment Report. Units for reporting age at enrollment range from minutes to years.

Policy Notices

Resources

Title	Description	Posted Date
Report: Inclusion statistics by NIH RCDC category	Report on the representation of participants in human subjects studies from fiscal years 2018-2021 for FY2018 projects associated with the listed Research, Condition, and Disease Categorization (RCDC) categories.	October 31, 2023
Inclusion Across the Lifespan Case Studies	This document describes several mock studies as examples of how to consider the Inclusion Across the Lifespan policy in study design and eligibility criteria. Examples include commentary on scientific and ethical reasons that may be acceptable or unacceptable for age-based exclusion.	September 09, 2023
Allowable Costs Related to Participant Inclusion Activities in NIH Grants	This one-page resource highlights allowable costs for NIH grants that can be utilized to enhance inclusion through recruitment and retention activities. Allowable costs listed in the NIH Grants Policy Statement are provided with examples of inclusion-related activities.	August 10, 2023
Podcast: Inclusion Plans (Part 1): The Application	In Part 1 of this NIH All About Grants podcast miniseries, NIH’s Inclusion Policy Officer Dawn Corbett tells us how to consider inclusion plans when putting together an application.	April 20, 2022
Podcast: Inclusion Plans (Part 2): Peer Review and Post-Award	NIH’s Inclusion Policy Officer Dawn Corbett covers inclusion plans during peer review and post-award in Part 2 of this NIH All About Grants podcast miniseries.	April 20, 2022
Tip Sheet: Using the Participant-level Data Template	For research that falls under the Inclusion Across the Lifespan policy, submission of individual-level data is required in progress reports. This tip sheet serves as a quick guide for using the participant-level data template in the Human Subjects System to populate data in the cumulative (actual) enrollment table.	January 20, 2022
Resource List: Recruitment and Retention	Document listing resources on recruitment and retention of women, racial and ethnic minorities, and individuals across the lifespan. Resources include toolkits, articles, and more.	May 9, 2022
Video : Including Diverse Populations in NIH-funded Clinical Research Transcript	Video presentation by the NIH Inclusion Policy Officer for the NIH Grants Conference PreCon event, Human Subjects Research: Policies, Clinical Trials, & Inclusion, in December 2022. The presentation explains NIH inclusion policies and requirements for applicants and recipients.	January 27, 2023
Inclusion Across The Lifespan-II Workshop Report - (PDF - 1.1 MB)	Report summarizing the presentations and discussions that took place during the Inclusion Across the Lifespan II Workshop on September 2, 2020.	December 10, 2020
Open Mike Blog:  Some Thoughts Following the  NIH Inclusion Across the Lifespan II Workshop	Blog post by NIH's Deputy Director of Extramural Research, Dr. Mike Lauer, highlighting the Inclusion Across the Lifespan II Workshop.	December 10, 2020
Video Tutorial: Entering Inclusion Data Using the Participant Level Data Template	This video tutorial demonstrates how to enter inclusion data using the Participant Level Data Template in the Human Subjects System (HSS).	February 26, 2020
Infographic: Guidance for Applying the Inclusion Across the Lifespan Policy	At-a-glance guidance for complying with the policy in applications and progress reports.	May 3, 2019
Podcast: The Inclusion Across the Lifespan Policy Transcript	The "All About Grants" podcast featuring an interview with the NIH Inclusion Policy Officer about the Inclusion Across the Lifespan policy.	August 27, 2018
Human Subjects System (HSS): HSS overview and training information	As of June 9, 2018, the Human Subjects System (HSS) replaced the Inclusion Management System (IMS). Similar to IMS, HSS is used by NIH staff, grant applicants, and recipients to manage human subjects information, including inclusion information.	May 25, 2018
Open Mike Blog: The Inclusion Across the Lifespan Policy	Blog post by Dr. Mike Lauer, Deputy Director of Extramural Research, and Dawn Corbett, NIH Inclusion Policy Officer, titled Understanding Age in the NIH Portfolio: Implementation of the NIH Inclusion Across the Lifespan Policy	November 13, 2018
Workshop Summary: Inclusion Across the Lifespan	Summary report from the Inclusion Across the Lifespan workshop held June 1-2, 2017	July, 2017
Case Studies: Inclusion of Children Case Studies	Case Studies help investigators evaluate when children should be included in research studies supported by the NIH.	March 26, 1999

 
 Have additional questions? Contact your program officer or the Inclusion policy team: Inclusion@od.nih.gov