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Complying With the HEAL Data Sharing Policy | NIH HEAL Initiative
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class="gtm-breadcrumb">Data</a></li> <li class="breadcrumb-item active is-active gtm-breadcrumb" aria-current="page">Complying With the HEAL Data Sharing Policy</li> </ol> </nav> </div> </div> <div class="col-sm-12 col-md-5"> </div> </div> </div> <div class="layout-content"> <div> <div id="block-particle-content"> <h1> Complying With the HEAL Data Sharing Policy </h1> <div> <div class="paragraph paragraph--type--basic-content paragraph--view-mode--default"> <div class="container"> <div class='basic-content content-align-left padding-bottom--1'> <div class='basic-content-grid-container ' style=''> <div class="basic-content-grid-no-media"> <div> <p>Research teams funded by the Helping to End Addiction Long-term<sup>®</sup> Initiative, or NIH HEAL Initiative<sup>®</sup>, must make their HEAL data Findable, Accessible, Interoperable, and Reusable (FAIR) in line with the <a href="/data/public-access-data">HEAL Data Sharing Policy</a> and the broader efforts across NIH, as outlined in the <a href="https://datascience.nih.gov/nih-strategic-plan-data-science">NIH Strategic Plan for Data Science</a>.</p> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--basic-content paragraph--view-mode--default"> <div class="container"> <div class='basic-content content-align-left padding-bottom--1'> <div class='basic-content-grid-container ' style=''> <div class="basic-content-grid-no-media"> <div> <div class="card gradient"> <h2>HEAL-specific Requirements</h2> <p>These HEAL-specific requirements should be integrated into data management and sharing plans developed for HEAL applications, and implemented during data generation for HEAL-funded projects.</p> <ul> <li>Select a <a href="https://www.healdatafair.org/resources/guidance/selection" target="_blank">HEAL compliant repository</a> for long-term data storage.</li> <li><a href="https://heal.github.io/platform-documentation/study-registration/" target="_blank">Register your HEAL study</a> in the HEAL Data Platform.</li> <li><a href="https://github.com/HEAL/heal-metadata-schemas/blob/main/study-level-metadata-schema/schema-clean/md/study-metadata-schema-for-humans.md" target="_blank">Submit metadata</a> to the HEAL Data Platform.</li> <li>Pain clinical studies must use <a href="https://heal.nih.gov/data/common-data-elements">HEAL core Common Data Elements (CDEs)</a>. All studies collecting data from human participants should prioritize using HEAL-specified CDEs if possible.</li> <li>To the extent possible, HEAL awardees should use broad consent language.</li> </ul> <p>Program officers evaluating HEAL DMSPs should ensure these components are included. Specific requirements under each element are integrated in the details below. Implementation details are included under “Preview the Checklist for HEAL-compliant data”.</p> </div> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--basic-content paragraph--view-mode--default"> <div class="container"> <div class='basic-content content-align-left padding-bottom--1'> <div class='basic-content-grid-container ' style=''> <h2 class='basic-content-grid-h2-no-media'> Writing An Application? </h2> <div class="basic-content-grid-no-media"> <div> <p>Under the <a href="https://heal.nih.gov/data/public-access-data">NIH HEAL Initiative Public Access and Data Sharing Policy</a>, and the <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html">NIH Policy for Data Management and Sharing</a>, all HEAL applicants—regardless of direct cost amounts requested for any budget or project period—are required to include a Data Management and Sharing Plan (DMSP) outlining how they will manage and share scientific data, accompanying metadata, other relevant data, and associated documentation. This guide is an applicant resource for including HEAL-compliant components in a plan. Applicants should also include details and information relevant to all other NIH policies applicable to their work (e.g., Genomic Data Sharing Policy, <a href="https://grants.nih.gov/policy/clinical-trials/reporting/index.htm">clinical trial dissemination requirements</a>, and <a href="https://sharing.nih.gov/other-sharing-policies">other policies</a>).</p> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--accordion paragraph--view-mode--default"> <div class="container"> <div class="pattern"> <div id="accordion-1843569719" class="col-12 accordion"> <div class="card-header col-12" id="heading-1843569719-0"> <h2 class="mb-0"> <button class="btn btn-link h2 expand-link" data-toggle="collapse" data-target="#collapse-1843569719-0" aria-expanded="false" aria-controls="collapse-1843569719-0"> Elements of the Public Access and Data Sharing Plan </button> </h2> </div> <div id="collapse-1843569719-0" class="collapse " aria-labelledby="heading-1843569719-0" data-parent="#accordion-1843569719"> <div class="card-body"> <p>NIH developed <a href="https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/writing-a-data-management-and-sharing-plan#elements-to-include-in-a-data-management-and-sharing-plan">overarching guidance for each element</a>, and under each one, HEAL indicates special HEAL applicant and awardee requirements and considerations.</p> <h3 id="h3-data-type-">Data Type</h3> <ul> <li>Ensure your DMSP summarizes the types and estimated amounts of your anticipated scientific research data. Providing a clear description of project data types, sizes, and expected formats will help you select appropriate <a href="https://www.healdatafair.org/resources/guidance/selection">repositories</a> and estimate curation-support needs.</li> <li>Related Tools, Software, and/or Code <ul> <li>HEAL highly encourages that all protocols, software, analysis materials, and documentation necessary for study method and result empirical reproducibility be made broadly accessible and reusable within a relevant repository.</li> </ul> </li> <li>Genomic data have special Data Management and Sharing Plan requirements for both non-human and human genomic data. These requirements are detailed in Section IV of the <a href="https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html">NIH Genomic Data Sharing Policy</a></li> </ul> <h3 id="h3-standards-">Standards</h3> <ul> <li><a href="https://heal.nih.gov/data/common-data-elements">HEAL core CDEs, supplemental CDEs</a> <ul> <li>New HEAL clinical pain studies <strong>are required</strong> to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program creates CDE files containing standardized variable names, responses, coding, and other information. HEAL Initiative clinical studies using copyrighted questionnaires must obtain use licenses, and share them with the HEAL CDE team and program officer prior to using copyrighted material or collecting data.</li> <li>All HEAL studies collecting data from human participants and planning to use CDEs are strongly encouraged to search for applicable CDEs within the HEAL database, and use questionnaires from this database if possible. HEAL CDEs can be accessed in the HEAL CDE repository (core set) and contacting <a href="/cdn-cgi/l/email-protection#b4dcd1d5d8ebd7d0d1f4dcc7d79ac1c0d5dc9ad1d0c1"><span class="__cf_email__" data-cfemail="8ce4e9ede0d3efe8e9cce4ffefa2f9f8ede4a2e9e8f9">[email protected]</span></a> (supplemental set).</li> <li>Studies using CDEs, regardless of whether they are part of the HEAL repository, will be required to report which questionnaires are being used.</li> </ul> </li> <li>Registration and metadata requirements <ul> <li>Within a year of award, HEAL awardees must complete <a href="https://heal.github.io/platform-documentation/study-registration/">Study Registration within the HEAL Platform</a>.</li> <li>Awardees must submit all relevant <a href="https://github.com/HEAL/heal-metadata-schemas/blob/main/study-level-metadata-schema/schema-clean/md/study-metadata-schema-for-humans.md">HEAL Study-Level Metadata</a> via CEDAR within 1 year of the award issue date, completing timely updates in accordance with any study data release. Additional HEAL metadata resources: <ul> <li><a href="https://github.com/HEAL/heal-metadata-schemas/blob/main/study-level-metadata-schema/schema-clean/md/study-metadata-schema-for-humans.md">Human Readable Study-Level Metadata Elements</a></li> <li><a href="https://heal.github.io/cedar-form-docs/">Process and Guidance for Completing HEAL Study-Level Metadata</a></li> <li><a href="https://github.com/HEAL/heal-metadata-schemas/tree/main/study-level-metadata-schema">Additional Documentation of HEAL Study-Level Metadata Model</a></li> </ul> </li> </ul> <ul> <li>Tools and Resources for Creating Machine-Readable Variable-Level Metadata (<em>forthcoming</em>)</li> <li>Platform Submission Documentation and Portal (<em>forthcoming</em>)</li> </ul> </li> <li>Data Preservation, Access, and Associated Timelines <ul> <li>HEAL investigators must deposit their data within a <a href="https://www.healdatafair.org/resources/guidance/selection">HEAL Data Ecosystem-Compliant Repository</a>. To assist, the HEAL Stewards produced a <a href="https://www.healdatafair.org/resources/guidance/selection">Repository Selection Guide</a>.</li> <li>Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance/award/support period, whichever comes first.</li> </ul> </li> </ul> <h3 id="h3-access-distribution-or-reuse-considerations-">Access, Distribution, or Reuse Considerations</h3> <ul> <li>To the extent possible, in alignment with human subjects data protections, HEAL awardees should integrate <a href="https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf">broad data sharing consent language</a> (PDF) into their informed consent forms, making as much data shareable as possible.</li> <li>Even when data are broadly consented and de-identified, HEAL investigators should address appropriate privacy protections in their plan and repository selections.</li> <li>Additional <a href="https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-data/data-sharing-approaches#sharing-data-from-human-participants-">guidance on sharing data from human participants</a>.</li> <li>Genomics data have special consent and controlled access requirements. For more information, please refer to sections 4.C.3 and 4.C.4 of the <a href="https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html">NIH Genomic Data Sharing Policy</a></li> </ul> <h3 id="h3-oversight-of-data-management-and-sharing-">Oversight of Data Management and Sharing</h3> <ul> <li>Provide an oversight plan! For additional guidance, as you implement your plan, check out the <a href="https://www.healdatafair.org/resources/road-map">Step-by-Step Guide to HEAL-Compliant Data</a>.</li> <li>Institutional certification should be provided prior to award, consistent with the genomic data sharing plan submitted with the request for funding. For more details about institutional certification, please refer to section 4.C.5 of the <a href="https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html">NIH Genomic Data Sharing Policy</a>.</li> </ul> <h2>Additional Guidance and Resources</h2> <ul> <li><a href="https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/budgeting-for-data-management-sharing">Allowable Costs for Data Management and Budgeting</a></li> <li><a href="https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/writing-a-data-management-and-sharing-plan">NIH-Wide Guidance on Writing a Data Management & Sharing Plan</a></li> <li><a href="https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm">Frequently Asked Questions About NIH Data Sharing</a></li> <li><a href="https://www.healdatafair.org/resources/faqs">Frequently Asked Questions About HEAL Data Sharing</a></li> </ul> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--basic-content paragraph--view-mode--default"> <div class="container"> <div class='basic-content content-align-left padding-bottom--1'> <div class='basic-content-grid-container ' style=''> <h2 class='basic-content-grid-h2-no-media'> Already Funded? </h2> <div class="basic-content-grid-no-media"> <div> <p>The HEAL Data Stewardship Group (HEAL Stewards) has been funded to guide researchers with a funded HEAL award through the process of making their data FAIR. On their website, you can find a complete Checklist for HEAL-Compliant Data that deep dives into each of the items below. Completing each of these items will ensure that your work is compliant with the <a href="https://heal.nih.gov/data/public-access-data">HEAL Data Sharing Policy</a> and the broader efforts across NIH as outlined in the <a href="https://datascience.nih.gov/nih-strategic-plan-data-science">NIH Strategic Plan for Data Science</a>. Preview the list below and <a href="https://docs.google.com/forms/d/e/1FAIpQLSc1gGjOQ7UsmBlMuqUzczPnbjKnbH2hjWgGLrY2xVsRH3n1vg/viewform">contact the HEAL Stewards</a> for help planning or implementing.</p> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--accordion paragraph--view-mode--default"> <div class="container"> <div class="pattern"> <div id="accordion-1664632214" class="col-12 accordion"> <div class="card-header col-12" id="heading-1664632214-0"> <h2 class="mb-0"> <button class="btn btn-link h2 expand-link" data-toggle="collapse" data-target="#collapse-1664632214-0" aria-expanded="false" aria-controls="collapse-1664632214-0"> Preview the Checklist for HEAL-Compliant Data </button> </h2> </div> <div id="collapse-1664632214-0" class="collapse " aria-labelledby="heading-1664632214-0" data-parent="#accordion-1664632214"> <div class="card-body"> <ul> <li>Award Received</li> <li>Provide Your Data Management and Sharing Plan to the HEAL Stewards</li> <li>Register Your Study on ClinicalTrials.gov</li> <li>Register Your Study With the HEAL Data Platform</li> <li>Complete Your Study-Level Metadata Form</li> <li>Select a Repository</li> <li>Use HEAL Common Data Elements to Collect Your Data </li> <li>Submit Data and Metadata to a Repository</li> <li>Ensure HEAL-supported Manuscripts are Immediately Publicly Open and Accessible</li> <li>Report Your Research Publication</li> </ul> <p><a class="btn btn-secondary gtm-content-button ext" href="https://www.healdatafair.org/resources/road-map" target="_blank">View Complete Checklist on HEALdataFAIR.org</a></p> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--basic-content paragraph--view-mode--default"> <div class="container"> <div class='basic-content content-align-left padding-bottom--1'> <div class='basic-content-grid-container ' style=''> <h2 class='basic-content-grid-h2-no-media'> You May Also Be Interested In: </h2> <div class="basic-content-grid-no-media"> <div> </div> </div> </div> </div> </div> </div> <div class="paragraph paragraph--type--cards paragraph--view-mode--default"> <div class="container"> <div class="row card-grid pattern"> <div class='col-lg-4 col-md-6 col-sm-12'> <div class='border-none card'> <div class='card-body'> <h3 class='card-title'> About the HEAL Data Ecosystem </h3> <div class='card-text'> <p>The HEAL Data Ecosystem aims to transform research data, findings, and publications into a virtual, annotated, searchable catalog in which datasets and findings from different studies can be analyzed, compared, and combined.</p> </div> <a class="btn btn-primary gtm-card-button bottom-button mt-2" target="" href=/data/heal-data-ecosystem> View the webpage </a> </div> </div> </div> <div class='col-lg-4 col-md-6 col-sm-12'> <div class='border-none card'> <div class='card-body'> <h3 class='card-title'> Common Data Elements (CDEs) Repository </h3> <div class='card-text'> <p>To facilitate cross-study comparisons and improve the interpretability of findings, clinical pain research grantees collaborate and agree to use common data elements for patient-reported outcomes (PROs).</p> </div> <a class="btn btn-primary gtm-card-button bottom-button mt-2" target="" href=/data/common-data-elements-repository> Access the CDEs Repository </a> </div> </div> </div> <div class='col-lg-4 col-md-6 col-sm-12'> <div class='border-none card'> <div class='card-body'> <h3 class='card-title'> Public Access and Data Sharing Plan </h3> <div class='card-text'> <p>Through the NIH HEAL Initiative Public Access and Data Sharing Policy (the Policy), NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate.</p> </div> <a class="btn btn-primary gtm-card-button bottom-button mt-2" target="" href=/data/public-access-data> View the webpage </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </main> <div 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