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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.
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 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
| 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 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, 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 |
|---|---|---|
| Infographic: Applying the Existing Dataset or Resource Definition | Infographic that walks through the elements of the existing dataset or resource definition to help users understand whether how it applies to their research. | August 2, 2024 |
| 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 Lisrt: 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 | 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: NIH's 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. | August 27, 2018 |
| Human Subjects System (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 Workshop Report | Summary report from the Inclusion Across the Lifespan workshop held June 1-2, 2017 | July, 2017 |