Inclusion Across the Lifespan

Learn about the Inclusion Across the Lifespan policy and how to comply with this policy in applications and progress reports.

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.

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/gender, race, and ethnicity in the Inclusion Enrollment Report. Units for reporting age at enrollment range from minutes to years.

Policy Notices

Title	Description	Posted Date
NOT-OD-18-116: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects	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.	December 19, 2017
NOT-OD-16-010: Inclusion of Children in Clinical Research: Change in NIH Definition	For 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.	October 13, 2015
NOT-OD-98-024: NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects	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.	March 6, 1998

Resources

Title	Description	Posted Date
Inclusion Across The Lifespan-II Workshop Report - (PDF - 1.1 MB)		December 10, 2020
Video Tutorial: Entering Inclusion Data Using the Participant Level Data Template	This video tutorial will demonstrate how to enter inclusion data using the Participant Level Data Template in the Human Subjects System (HSS).	February 26, 2020
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.	July 10, 2019
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 will be 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	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 to assist Investigators in evaluating 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

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