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Inclusion Across the Lifespan in Human Subjects Research | Grants & Funding
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Funding Opportunities Specific to COVID-19" data-drupal-link-system-path="policy-and-compliance/policy-topics/natural-disasters/corona-virus/funding-opportunities">Funding Opportunities Specific to COVID-19</a> <div class="d-none"> </div> </li> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/nih-omb-memo" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020" data-drupal-link-system-path="node/747">NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020</a> <div 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Access</a> <div class="d-none"> </div> </li> <li class="level-2 py-0 px-0 border-0 dropdown list-inline"> <a href="/policy-and-compliance/policy-topics/research-integrity" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Research Integrity" data-drupal-link-system-path="node/590"> Research Integrity <i class="bi bi-caret-right me-24"></i> </a> <div class="d-none"> <ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3"> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/research-integrity/confidentiality-peer-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Integrity and Confidentiality in NIH Peer Review" data-drupal-link-system-path="node/664">Integrity and Confidentiality in NIH Peer Review</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 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href="https://www.nih.gov/anti-sexual-harassment/nih-staff" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Anti-Sexual Harassment Policies and Resources for NIH Staff">Anti-Sexual Harassment Policies and Resources for NIH Staff</a> <div class="d-none"> </div> </li> </ul> </div> </li> </ul> </div> </li> </ul> </div> </li> </ul> </nav> </div> </div> <div class="order-1 order-lg-2 syndicate col-12 col-lg-9 ps-0 ps-lg-5"> <div class="region region-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-nihod5-subtheme-page-title" class="block block-core block-page-title-block"> <h1><strong><span class="field field--name-title field--type-string field--label-hidden">Inclusion Across the Lifespan in Human Subjects Research</span> </strong></h1> </div> <div id="block-nihod5-subtheme-content" class="block block-system block-system-main-block"> <article class="node node--type-page node--view-mode-full"> <div class="node__content"> <div class="layout layout--onecol"> <div class="layout__region layout__region--content"> <div class="block block-layout-builder block-field-block-node-page-field-scope-note"> <div class="clearfix text-formatted field field--name-field-scope-note field--type-text-long field--label-visually_hidden"> <div class="field__label visually-hidden">Scope Note</div> <div class="field__item"><p>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.</p></div> </div> </div> <div class="block block-layout-builder block-field-block-node-page-body"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><style type="text/css"> .image { margin: auto; width: 50%; } </style><h2 id="Purpose">Purpose</h2><p>The purpose of the <a href="/grants/guide/notice-files/NOT-OD-18-116.html" target="_blank">Inclusion Across the Lifespan Policy</a> 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 <a href="/grants/guide/notice-files/not98-024.html" target="_blank">Inclusion of Children in Clinical Research Policy</a> to include individuals of all ages, including <a href="/grants/glossary.htm#Child">children </a>and <a href="/grants/glossary.htm#OlderAdult">older adults</a>. The policy also requires that the age at enrollment of each participant be collected in progress reports.</p><h2 id="Implementation">Implementation</h2><p>The Inclusion Across the Lifespan policy applies to all grant applications submitted for <strong>due dates on or after January 25,</strong> <strong>2019</strong>. 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 <em>before</em> January 25, 2019 continues to be subject to the <a href="/grants/guide/notice-files/not98-024.html" target="_blank">Inclusion of Children in Clinical Research Policy</a>.</p><h3>Applications & Proposals</h3><p>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 <a href="/grants-process/write-application/how-to-apply-application-guide" target="_blank">PHS Human Subjects and Clinical Trial Information Form Instructions </a>for complete guidance on what to address.</p><h3>Peer Review</h3><p>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 <a href="/grants/peer/guidelines_general/Review_Human_Subjects_Inclusion.pdf">Guidelines for the Review of Inclusion in Clinical Research</a>. For information regarding the coding used to rate inclusion during peer review, see the list of <a href="/sites/default/files/NIH_Peer_Review_Inclusion_Codes.pdf">NIH Peer Review Inclusion Codes</a>.</p><h3>Progress Reports</h3><p>NIH recipients/offerors must submit individual-level data on participant age at enrollment in <a href="/grants-process/post-award-monitoring-and-reporting/reporting-requirements#progress-reports">Progress Reports</a>. 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.</p></div> </div> <div class="block block-layout-builder block-field-block-node-page-field-body-2"> <div class="clearfix text-formatted field field--name-field-body-2 field--type-text-long field--label-hidden field__item"><h2 id="Policy Notices"> Policy Notices </h2> <div class="table-responsive"> <table data-ds-id="ebyfa1be" class="table table-striped border" cellpadding="5" cellspacing="0"> <thead class="table-secondary"> <tr> <th style="width:200px;"> <strong>Title</strong> </th> <th style="width:505px;"> <strong>Description</strong> </th> <th style="width:137px;"> <strong>Posted Date</strong> </th> </tr> </thead> <tbody> <tr> <td> <a href="/grants/guide/notice-files/NOT-OD-18-116.html" >NOT-OD-18-116: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects</a> </td> <td> This policy revises previous policy and guidelines regarding the inclusion of children in research.<br> Changes to the policy include 1) the applicability of the policy to individuals of all ages, 2)<br> clarification of potentially acceptable reasons for excluding participants on age, and<br> 3) a requirement to provide data on participant age at enrollment in progress reports. </td> <td> December 19, 2017 </td> </tr> <tr> <td> <a href="/grants/guide/notice-files/NOT-OD-16-010.html" >NOT-OD-16-010: Inclusion of Children in Clinical Research: Change in NIH Definition</a> </td> <td> 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<br> in their clinical research. </td> <td> October 13, 2015 </td> </tr> <tr> <td> <a href="/grants/guide/notice-files/not98-024.html">NOT-OD-98-024: NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects</a> </td> <td> The goal of this policy is to increase the participation of children in research so that adequate data<br> will be developed to support the treatment modalities for disorders and conditions that affect adults<br> and may also affect children. </td> <td> March 6, 1998 </td> </tr> </tbody> </table> </div> <br> <h2 id="Resources"> Resources </h2> <div class="table-responsive"> <table data-ds-id="ebyfa1be" class="table table-striped border" cellpadding="5" cellspacing="0"> <thead class="table-secondary"> <tr> <th> <strong>Title</strong> </th> <th style="width:505px;"> <strong>Description</strong> </th> <th style="width:137px;"> <strong>Posted Date</strong> </th> </tr> </thead> <tbody> <tr> <td><a href="https://grants.nih.gov/news-events/podcasts?episode=1141" rel="noreferrer" target="_blank" heap-ignore="true">Allowable Costs for Clinical Research Participation</a></div> </td> <td>This podcast discusses costs that may be allowable for clinical research related to planning and executing recruitment and retention of participants across the lifespan, women, and members of racial and ethnic minorities as appropriate to reach the scientific goals of the study. Developing budgets, unintended costs, and other topics are also discussed.</div> </td> <td>October 24, 2024</div> </td> </tr> <tr> <td><a href="https://grants.nih.gov/news-events/podcasts?episode=1104" rel="noreferrer" target="_blank" heap-ignore="true">Considering Language Access for Participants in NIH-Supported Clinical Research</a></div> </td> <td >In this podcast, NIH staff explain how to consider language access when proposing research in a grant application. Language access policies, budgets and allowable costs, the importance of communication with research participants, and more are covered.</div> </td> <td >August 13, 2024</td> </tr> <tr> <td> <a href="/sites/default/files/ExistingDatasetDefinitionInfographicFinal.pdf" >Infographic: Applying the Existing Dataset or Resource Definition</a> </td> <td style="width:504px;"> Infographic that walks through the elements of the existing dataset or resource definition to help users understand whether how it applies to their research. </td> <td style="width:137px;"> August 2, 2024 </td> </tr> <tr> <td> <a href="https://report.nih.gov/RISR/#/" >Report: Inclusion statistics by NIH RCDC category</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> October 31, 2023 </td> </tr> <tr> <td> <a href="/sites/default/files/IAL-Case-studies-for-Extramural-community.pdf">Inclusion Across the Lifespan Case Studies</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> September 09, 2023 </td> </tr> <tr> <td> <a href="/sites/default/files/Allowable-costs-related-to-participant-inclusion-activities.pdf">Allowable Costs Related to Participant Inclusion Activities in NIH Grants</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> August 10, 2023 </td> </tr> <tr> <td> <a href="/news-events/podcasts?episode=996" >Podcast: Inclusion Plans (Part 1): The Application</a> </td> <td style="width:504px;"> <div style="box-sizing:border-box;"> 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. </div> </td> <td style="width:137px;"> April 20, 2022 </td> </tr> <tr> <td> <a href="/news-events/podcasts?episode=969" >Podcast: Inclusion Plans (Part 2): Peer Review and Post-Award</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> April 20, 2022 </td> </tr> <tr> <td> <a href="/sites/default/files/Participant-level%20data%20template%20tip%20sheet.pdf">Tip Sheet: Using the Participant-level Data Template</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> January 20, 2022 </td> </tr> <tr> <td> <a href="/sites/default/files/Resources_Recruitment_and_Retention_WM%2CIAL_final508c.pdf">Resource Lisrt: Recruitment and Retention</a> </td> <td style="width:504px;"> Document listing resources on recruitment and retention of women, racial and ethnic minorities, and individuals across the lifespan. Resources include toolkits, articles, and more. </td> <td style="width:137px;"> May 9, 2022 </td> </tr> <tr> <td> <a href="https://www.youtube.com/watch?v=tmdOgmEKxdw">Video: Including Diverse Populations in NIH-Funded Clinical Research</a> <ul> <li> <a href="/sites/default/files/Including-Diverse-Populations-in-NIH-Funded-Clinical-Research.transcript.pdf">Transcript</a> </li> </ul> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> January 27, 2023 </td> </tr> <tr> <td> <a href="/sites/default/files/IAL-II-Workshop-Report.pdf">Inclusion Across The Lifespan-II Workshop Report</a> (PDF, 1.1 MB) </td> <td style="width:504px;"> Report summarizing the presentations and discussions that took place during the Inclusion Across the Lifespan II Workshop on September 2, 2020. </td> <td style="width:137px;"> December 10, 2020 </td> </tr> <tr> <td> <a href="https://nexus.od.nih.gov/all/2020/12/10/some-thoughts-following-the-nih-inclusion-across-the-lifespan-2-workshop/" >Open Mike Blog: Some Thoughts Following the NIH Inclusion Across the Lifespan II Workshop</a> </td> <td style="width:504px;"> Blog post by NIH's Deputy Director of Extramural Research, Dr. Mike Lauer, highlighting the Inclusion Across the Lifespan II Workshop. </td> <td style="width:137px;"> December 10, 2020 </td> </tr> <tr> <td> <a href="http://era.nih.gov/era-training/era-videos.htm#HSCT-Template">Video Tutorial: Entering Inclusion Data Using the Participant Level Data Template</a> </td> <td style="width:504px;"> This video tutorial demonstrates how to enter inclusion data using the Participant Level Data Template in the Human Subjects System (HSS). </td> <td style="width:137px;"> February 26, 2020 </td> </tr> <tr> <td> <a href="/sites/default/files/IAL%20policy%20infographic%20rev%204-23-19%20508c.pdf">Infographic: Guidance for Applying the Inclusion Across the Lifespan Policy</a> </td> <td style="width:504px;"> At-a-glance guidance for complying with the policy in applications and progress reports. </td> <td style="width:137px;"> May 3, 2019 </td> </tr> <tr> <td> <a href="https://grants.nih.gov/news-events/podcasts?episode=909">Podcast: NIH's Inclusion Across the Lifespan Policy</a> </td> <td style="width:504px;"> The "All About Grants" podcast featuring an interview with the NIH Inclusion Policy Officer about the Inclusion Across the Lifespan policy. </td> <td style="width:137px;"> August 27, 2018 </td> </tr> <tr> <td> <a href="https://era.nih.gov/help-tutorials/hss">Human Subjects System (HSS) Overview and Training Information</a> </td> <td style="width:504px;"> 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. </td> <td style="width:137px;"> May 25, 2018 </td> </tr> <tr> <td> <a href="https://nexus.od.nih.gov/all/2018/11/13/understanding-age-in-the-nih-portfolio-implementation-of-the-nih-inclusion-across-the-lifespan-policy/">Open Mike Blog: The Inclusion Across the Lifespan Policy</a> </td> <td style="width:504px;"> 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 </td> <td style="width:137px;"> November 13, 2018 </td> </tr> <tr> <td> <a href="https://report.nih.gov/sites/report/files/docs/NIH%20Inclusion%20Across%20the%20Lifespan%20Workshop%20Summary%20Report.pdf">Workshop Summary: Inclusion Across the Lifespan Workshop Report</a> </td> <td style="width:504px;"> Summary report from the Inclusion Across the Lifespan workshop held June 1-2, 2017 </td> <td style="width:137px;"> July, 2017 </td> </tr> </tbody> </table> </div></div> </div> <div class="block block-layout-builder block-extra-field-block-node-page-workbench-moderation-control"> </div> </div> </div> </div> </article> </div> <div id="block-grants-learningcenterresources" class="block block-oer-resources-module block-learning-center-resources-block"> <div class="border-2 border-secondary border-top container mb-5 mt-5" id="faq-wrapper"> <div class="row"> <h3 class="border-5 border-secondary border-top col-12 col-md-3 pt-3 text-secondary">FAQs</h3> <div class="border-5 border-top border-white col-12 col-md-9 pt-3"> <div id="featured-faq-wrapper"></div> </div> </div> </div> <script> let faq_block = document.getElementById("faq-wrapper"); let faq_header = document.getElementById("faq-name"); let faq_raw_data = {"tags":[{"value":"664bc53088485d79a20a3218","_attributes":[]}],"project_id":"https:\/\/search.grants.nih.gov\/lc\/api\/resources\/tags","project":"64888cbd5b0ce2db990fc8d3","fqs":[{"value":"faq630","_attributes":[]}],"query":"OR","see_also":"<ul><li><a href=\"\/policy-and-compliance\/policy-topics\/human-subjects\">Human Subjects Research<\/a><\/li><li><a href=\"https:\/\/www.nia.nih.gov\/\" target=\"_blank\">National Institute on Aging<\/a><\/li><li><a href=\"https:\/\/www.nichd.nih.gov\/\" target=\"_blank\">National Institute of Child Health and Human Development<\/a><\/li><li><a href=\"https:\/\/extramural-intranet.nih.gov\/policy-and-guidance\/policy-topics\/human-subjects-clinical-trials-specimens\/inclusion-across-the-lifespan\" target=\"_blank\">For NIH Staff<\/a> <i class=\"bi bi-lock-fill\"><\/i><\/li><\/ul>","page_contact":"<p>Have additional questions? 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