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Blog</span></a></li> </ul></div> </div> </nav> <div class="engage-cta"> <div class="pull-right"> <a class="btn secondary-btn" href="/get-involved/">Get Involved</a> </div> </div> </div> </div> </header> <main id="primary" class="site-main"> <article id="post-886" class="post-886 policies type-policies status-publish hentry policy_areas-scientific-data-sharing"> <div class="entry-content"> <div class="wp-block-group alignfull"><div class="wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow"><div id="hero-block_00ef08d67abf598e07c1dac7543c912c" class="hero " style="background-image: url('https://osp.od.nih.gov/wp-content/uploads/2022/02/Rectangle-22.jpg'); color: #ffffff"> <div class="inner-container"> <div class="container-hero"> <div class="hero-left"> <h1>Scientific Data Sharing</h1> <p><p>Sharing scientific data accelerates biomedical research discovery, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies. As a steward of the nation’s investment in biomedical research, OSP develops policies that make research available to the public to achieve these goals.</p> </p> </div> </div> </div> </div> <div class="wp-block-group alignwide"><div class="wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow"><div class="yoast-breadcrumbs"><span><span><a href="https://osp.od.nih.gov/">Home</a></span> » <span><a href="https://osp.od.nih.gov/policies/">Policies</a></span> » <span class="breadcrumb_last" aria-current="page">Scientific Data Sharing</span></span></div> <div id="custom-tabs-block_7733c7c559c50e1ed43de957fba7e62f" class="custom-tabs alignwide"> <div class="panel-group" id="accordion" role="tablist" aria-multiselectable="true"></div> <div class="container-tabs"> <div class="tab-navigation"> <ul id="tabs" class="nav nav-tabs"> <h5><span>Content</span></h5> <li><a class="active" data-toggle="tab" href="#tab0"><span>NIH Data Management and Sharing</span></a></li><li><a class="" data-toggle="tab" href="#tab1"><span>NIH Data Science Policy Council</span></a></li><li><a class="" data-toggle="tab" href="#tab2"><span>NIH Genomic Data Sharing</span></a></li><li><a class="" data-toggle="tab" href="#tab3"><span>Engaging Tribal Nations on Data Management and Sharing</span></a></li> </ul> <div class="container-ql"> <h5><span>Quick Links</span></h5> <div><ul> <li><a href="https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640.v1.p1">HeLa Cell Whole Genome Sequence Data Sharing</a></li> <li><a href="https://sharing.nih.gov/">NIH Scientific Data Sharing (sharing.nih.gov)</a></li> <li><a href="/policies/genomics-health/genomic-data-sharing-faqs/categories-statistics-and-summary-information-on-policy-violations/">Compliance Statistics for NIH Policies that Govern Data Submission, Access, and Use of Genomic Data</a></li> <li><a href="https://list.nih.gov/cgi-bin/wa.exe?SUBED1=genomic-data-sharing-gds-l&amp;A=1\">GDS LISTSERV</a></li> <li><a href="/hela-cells/">Impact of HeLa Cells on Biomedical Research</a></li> </ul> <hr /> <h4><span style="font-size: 18px;"><strong>Frequently Asked Questions:</strong></span></h4> <ul> <li><a href="https://sharing.nih.gov/faqs#/genomic-data-sharing-policy.htm">NIH Genomic Data Sharing Policy</a></li> <li><a href="https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm">NIH Policy for Data Management and Sharing</a></li> </ul> <ul> <li style="list-style-type: none;"></li> </ul> </div> </div> </div> <div class="tab-content"> <div id="tab0" class="tab-pane fade active show"><h3><span style="color: #000000;">NIH Data Management and Sharing</span></h3> <p><span style="color: #000000; font-size: 16px;">Validation and progress in biomedical research – the cornerstone of developing new prevention strategies, treatments, and cures – is dependent on access to scientific data. Sharing scientific data helps validate research results, enables researchers to combine data types to strengthen analyses, facilitates reuse of hard to generate data or data from limited sources, and accelerates ideas for future research inquiries. Central to sharing scientific data is the recognized need to make data as available as possible while ensuring that the privacy and autonomy of research participants are respected, and that confidential/proprietary data are appropriately protected.</span></p> <h4><strong>Final NIH Policy for Data Management and Sharing </strong><strong>Effective (1-25-23)</strong></h4> <ul> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html" target="_blank" rel="noopener">Final NIH Policy for Data Management and Sharing</a></li> <li><a href="https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-final-nih-policy-data-management-sharing" target="_blank" rel="noopener">NIH Director’s Statement on Final Policy</a></li> <li><a href="https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm" target="_blank" rel="noopener">Frequently Asked Questions</a></li> </ul> <p><strong> <u>Supplemental Information to the NIH Policy for Data Management and Sharing</u></strong></p> <ul> <li style="list-style-type: none;"> <ul> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html" target="_blank" rel="noopener">Elements of an NIH Data Management and Sharing Plan</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-015.html" target="_blank" rel="noopener">Allowable Costs for Data Management and Sharing</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-016.html" target="_blank" rel="noopener">Selecting a Repository for Data Resulting from NIH-Supported Research</a></li> </ul> </li> </ul> <p><strong> <u>Additional Resources</u></strong></p> <ul> <li style="list-style-type: none;"> <ul> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-213.html" target="_blank" rel="noopener">Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-214.html" target="_blank" rel="noopener">Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data</a></li> <li><a href="/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf"><em>Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing</em>.</a></li> <li><a href="https://sharing.nih.gov/about/learning/DMS-Update" target="_blank" rel="noopener">NIH Data Management and Sharing Policy Webinar Series Part I and II</a></li> <li><a href="https://www.youtube.com/watch?v=ZcD641ptWIY" target="_blank" rel="noopener">2021 NIH Virtual Seminar on Program Funding and Grants Administration: Update on Implementation of New NIH Data Management and Sharing Policy</a></li> <li><a href="https://www.nationalacademies.org/our-work/changing-the-culture-of-data-management-and-sharing-a-workshop" target="_blank" rel="noopener">Changing the Culture of Data Management and Sharing: A Workshop</a></li> </ul> </li> </ul> <p><strong><em> <u>Under the Poliscope</u></em></strong><strong><u> Blogs</u></strong></p> <ul> <li style="list-style-type: none;"> <ul> <li><em><a href="/gearing-up-for-2023-part-ii-implementing-the-nih-data-management-and-sharing-policy/">Gearing Up for 2023 Part II: Implementing the NIH Data Management and Sharing Policy</a></em></li> <li><em><a href="/gearing-up-for-2023-implementing-the-nih-data-management-and-sharing-policy/">Gearing Up for 2023: Implementing the NIH Data Management and Sharing Policy</a></em></li> <li><u><a href="/nih-releases-new-policy-data-management-and-sharing/">NIH Releases New Policy for Data Management and Sharing</a></u></li> </ul> </li> </ul> <div id="accordion-entry"> <div class="card"> <div class="card-header" id="heading0"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-0-0" aria-expanded="false" aria-controls="collapse0"> Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance (November 2019) </div> </h5> </div> <div id="collapse-acc-0-0" class="collapse" aria-labelledby="heading0" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="/wp-content/uploads/Draft_NIH_Policy_Data_Management_and_Sharing.pdf" target="_blank" rel="noopener noreferrer">Draft NIH Poicy for Data Management and Sharing</a></li> <li><a href="/wp-content/uploads/RFI_Final_Report_Feb2020.pdf" target="_blank" rel="noopener noreferrer">Public Comments</a></li> <li><a href="/wp-content/uploads/DRAFT_Supplemental_Guidance_Allowable_Costs.pdf" target="_blank" rel="noopener noreferrer">Supplemental Draft Guidance: Allowable Costs</a></li> <li><a href="/wp-content/uploads/Supplemental_DRAFT_Guidance_Elements_NIH_Data_Management_and_Sharing_Plan.pdf" target="_blank" rel="noopener noreferrer">Supplemental Draft Guidance: Elements of a Data Management and Sharing Plan</a></li> <li><span style="color: #000000"><em>Under the Poliscope:</em></span> <a href="/draft-data-management-and-sharing-policy-we-need-to-hear-from-you/">NIH’s DRAFT Data Management and Sharing Policy: We Need to Hear From You!</a></li> <li><a href="https://www.federalregister.gov/documents/2019/11/08/2019-24529/draft-nih-policy-for-data-management-and-sharing-and-supplemental-draft-guidance" target="_blank" rel="noopener noreferrer">Federal Register Notice</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-013.html" target="_new" rel="noopener noreferrer">NIH Guide Notice</a></li> <li><span style="color: #000000">December 16, 2019 Webinar</span> <ul> <li><a href="/wp-content/uploads/Draft_DMS_Policy_Webinar_Dec2019.pdf" target="_blank" rel="noopener noreferrer">Slides</a></li> <li><a href="/wp-content/uploads/Webinar_Audio_DRAFT_DMS_Policy_121619.mp3" target="_new" rel="noopener noreferrer">Audio</a></li> </ul> </li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading1"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-0-1" aria-expanded="false" aria-controls="collapse1"> NIH RFI on Proposed Provisions for a Future Draft Data Management and Sharing Policy (October 2018) </div> </h5> </div> <div id="collapse-acc-0-1" class="collapse" aria-labelledby="heading1" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="/wp-content/uploads/Data_Sharing_Policy_Proposed_Provisions.pdf" target="_new" rel="noopener noreferrer">Proposed Provisions for a Draft NIH Data Management and Sharing Policy</a></li> <li><a href="/wp-content/uploads/Comments_on_Proposed_Provisions.pdf" target="_new" rel="noopener noreferrer">Public Comments on Proposed Provisions</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-014.html" target="_new" rel="noopener noreferrer">NIH Guide Notice</a></li> <li><span style="color: #000000"><em>Under the Poliscope</em> blog:</span> <a href="/data-sharing-renaissance-music-ears/">A Data Sharing Renaissance: Music to My Ears!</a></li> <li><span style="color: #000000">November 19, 2018 Webinar</span> <ul> <li><a href="/wp-content/uploads/Draft_Webinar_for_Data_Management_and_Sharing_Policy_Provisions_RFI.pptx" target="_new" rel="noopener noreferrer">Slides</a></li> <li><a href="/wp-content/uploads/Webinar-Audio.mp3" target="_new" rel="noopener noreferrer">Audio</a></li> </ul> </li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading2"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-0-2" aria-expanded="false" aria-controls="collapse2"> NIH RFI on Strategies for Data Management, Sharing, and Citation (November 2016) </div> </h5> </div> <div id="collapse-acc-0-2" class="collapse" aria-labelledby="heading2" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="/wp-content/uploads/Public_Comments_Data_Managment_Sharing_Citation.pdf" target="_blank" rel="noopener">Public Comments</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/not-od-17-015.html" target="_blank" rel="noopener noreferrer">NIH Guide Notice</a></li> <li><span style="color: #000000"><em>Under the Poliscope</em> blog:</span> <a href="/the-what-and-how-of-data-sharing/">The What and How of Data Sharing</a></li> <li><span style="color: #000000">November 19, 2018 Webinar</span> <ul> <li><a href="/wp-content/uploads/Draft_Webinar_for_Data_Management_and_Sharing_Policy_Provisions_RFI.pptx" target="_new" rel="noopener noreferrer">Slides</a></li> <li><a href="/wp-content/uploads/Webinar-Audio.mp3" target="_new" rel="noopener noreferrer">Audio</a></li> </ul> </li> </ul> </div> </div> </div> </div> </div><div id="tab1" class="tab-pane fade "><h3><span style="color: #000000;">NIH Data Science Policy Council</span></h3> <p>The NIH Data Science Policy Council (DSPC) is an internal NIH committee consisting of senior NIH and Institute and Center (IC) leaders and data scientists. The DSPC was created in 2017 as part of a restructuring of NIH programs and governance related to data science, aiming to provide a forum for trans-NIH data science policy development and oversight. The DSPC is intended to address the growing policy challenges and opportunities associated with ‘big data’ and data science (broadly defined) in biomedical research, thereby promoting maximum public benefit from data utilization in a manner that fulfills the agency’s principles toward responsible stewardship of data. This includes bioethical responsibilities to research participants and the general public with regard to data management, access, and sharing practices.</p> <ul> <li><a href="/wp-content/uploads/2023/07/DSPC_Roster_05-31-2023.pdf">NIH Data Science Policy Council (DSPC) Roster</a></li> <li><a href="/wp-content/uploads/2022/11/Revised_DSPC_Charge_10-20-2021.pdf">NIH Data Science Policy Council (DSPC) Charge</a></li> </ul> </div><div id="tab2" class="tab-pane fade "><h3>NIH Genomic Data Sharing</h3> <p>The NIH GDS Policy is effective for competing grant applications submitted for the January 25, 2015, receipt date; contract proposals submitted to NIH on or after January 25, 2015; and for intramural projects generating genomic data on or after August 31, 2015. The NIH GDS Policy applies to all NIH-funded research (e.g., grants, contracts, and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of these data for subsequent research. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data. Non-NIH funded data generation projects are not subject to the GDS Policy.</p> <p>Questions about the Policy can be e-mailed to <a href="/cdn-cgi/l/email-protection#e1c4d3d1a6a5b2a18c80888dcf8f8889cf868e97"><span class="__cf_email__" data-cfemail="40070413002d21292c6e2e29286e272f36">[email protected]</span></a>.</p> <h4><strong>NIH Genomic Data Sharing Policy</strong></h4> <ul> <li><a href="https://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html" target="_blank" rel="noopener">NIH GDS Policy </a>(NOT-OD-14-124)</li> <li><a href="/wp-content/uploads/NIH_Guidance_Elements_Consent_under_the_GDS_Policy.pdf">NIH Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy</a></li> <li><a href="https://sharing.nih.gov/sites/default/files/flmngr/GDS_Points_to_Consider_for_Institutions_and_IRBs.pdf" target="_blank" rel="noopener">Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human Genomic Data under the National Institutes of Health Genomic Data Sharing Policy</a></li> <li><a href="/wp-content/uploads/NIH_Intramural_Investigator_Responsibilities_under_the_GDS_Policy.pdf">NIH Intramural Investigator Responsibilities under the NIH GDS Policy </a></li> <li><a href="https://sharing.nih.gov/genomic-data-sharing-policy" target="_blank" rel="noopener">NIH Scientific Data Sharing Website – NIH Genomic Data Sharing Policy</a></li> </ul> <div id="accordion-entry"> <div class="card"> <div class="card-header" id="heading0"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-0" aria-expanded="false" aria-controls="collapse0"> Harmonization of Sharing Plans </div> </h5> </div> <div id="collapse-acc-2-0" class="collapse" aria-labelledby="heading0" data-parent="#accordion"> <div class="card-body"> <p>The  <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html" target="_blank" rel="noopener">Data Management and Sharing (DMS) policy expects</a> the submission of a DMS Plan that describes how the applicant will manage and share scientific data generated from NIH funds. To reduce the burden on applicants and staff, NIH now expects a single data sharing plan at the time of funding application that satisfies both the Genomic Data Sharing (GDS) Policy and the DMS Policy (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-198.html" target="_blank" rel="noopener">NOT-OD-22-198</a>). Therefore, as of January 25, 2023, NIH will no longer be collecting separate GDS Plans.</p> <p>Genomic data sharing considerations, such as where and when genomic data will be shared, will be expected to be addressed in DMS Plans using the DMS Plan elements. For further details, see <a href="https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/writing-a-data-management-and-sharing-plan#after" target="_blank" rel="noopener">Writing a Data Management & Sharing Plan</a>.</p> <p>In addition, compliance and enforcement for awards subject to the GDS Policy will be handled in accordance with the compliance and enforcement terms in the DMS Policy as described in <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html" target="_blank" rel="noopener">NOT-OD-21-013</a> Section VIII, which is not expected to result in any significant change in how noncompliance is enforced.</p> <p>For additional information about the Data Management and Sharing Policy visit: <a href="/policies/scientific-data-management-policy/">https://osp.od.nih.gov/policies/scientific-data-management-policy/</a>.</p> </div> </div> </div> <div class="card"> <div class="card-header" id="heading1"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-1" aria-expanded="false" aria-controls="collapse1"> Information on Registering, Submitting and Accessing Data in dbGaP </div> </h5> </div> <div id="collapse-acc-2-1" class="collapse" aria-labelledby="heading1" data-parent="#accordion"> <div class="card-body"> <p>Responsible stewardship of controlled-access data subject to the NIH GDS Policy is shared among the NIH, the investigators approved to access the data, and the investigators’ institutions. Investigators who are interested in obtaining controlled-access data from NIH-designated data repositories for secondary research use must submit a Data Access Request (DAR) through the dbGaP <a href="https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?page=login" target="_blank" rel="noopener">authorized-access portal</a> using their eRA Commons user ID.</p> <p><strong>Resources for Requesting Access to dbGaP Data</strong></p> <ul> <li><a href="https://sharing.nih.gov/accessing-data/accessing-genomic-data/how-to-request-and-access-datasets-from-dbgap" target="_blank" rel="noopener">NIH Scientific Data Sharing Website – How to Request and Access Datasets from dbGaP</a></li> <li><a href="https://sharing.nih.gov/sites/default/files/flmngr/Flyer_dbGaP_Access.pdf" target="_blank" rel="noopener">NIH Extramural Investigator Data Access Request Flowchart NIH Staff Data Access Request Flowchart</a></li> <li><a href="https://osp.od.nih.gov/wp-content/uploads/2023/01/NIH_Position_Statement_on_Cloud_Computing.pdf">NIH Position Statement on Use of Cloud Computing for Storage and Analysis of Controlled-Access Data under the NIH GDS Policy</a></li> </ul> <p><strong>Resources for Registering and Submitting a Study in dbGaP</strong></p> <ul> <li><a href="https://sharing.nih.gov/genomic-data-sharing-policy/submitting-genomic-data/how-to-register-and-submit-a-study-in-dbgap" target="_blank" rel="noopener">NIH Scientific Data Sharing Website – How to Register and Submit a Study in dbGaP</a></li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading2"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-2" aria-expanded="false" aria-controls="collapse2"> Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy (November 2021) </div> </h5> </div> <div id="collapse-acc-2-2" class="collapse" aria-labelledby="heading2" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-029.html" target="_blank" rel="noopener">Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy</a></li> <li><a href="/wp-content/uploads/CompiledPublicComments_RFI_LongTermConsiderationsNIHGDS.pdf">Public Comments on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy.</a></li> <li><a href="https://www.hhs.gov/ohrp/sachrp-committee/recommendations/tab-c-nih-genomic-data-sharing-policy-nih-request-for-public-comments.html" target="_blank" rel="noopener">Read the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommendations on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy</a></li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading3"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-3" aria-expanded="false" aria-controls="collapse3"> NIH Management of Genomic Summary Results Access (November 2018) </div> </h5> </div> <div id="collapse-acc-2-3" class="collapse" aria-labelledby="heading3" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="/provide-access-gsr/">Protecting Participants, Empowering Researchers: Providing Access to Genomic Summary Results</a> (<em>Under the Poliscope</em> Blog)</li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html" target="_blank" rel="noopener">NIH Guide Notice</a></li> <li><a href="/wp-content/uploads/What_are_Genomic_Summary_Results.pdf">What are Genomic Summary Results?</a></li> <li><a href="/wp-content/uploads/Responsible_Use_of_Human_Genomic_Data_Informational_Resource.pdf">Responsible Use of Human Genomic Data Informational Resource</a></li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading4"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-4" aria-expanded="false" aria-controls="collapse4"> Previously Compiled Public Comments </div> </h5> </div> <div id="collapse-acc-2-4" class="collapse" aria-labelledby="heading4" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="/wp-content/uploads/2022/09/RFC_Compiled_Report_Final.pdf" target="_blank" rel="noopener noreferrer">Public Comments on NIH Request for Comments: Proposal to Update Data Management of Genomic Summary Results Under the NIH Genomic Data Sharing Policy</a></li> <li><a href="/wp-content/uploads/dbGaP_Public_Comments_Data_Submission_Access_Management.pdf" target="_blank" rel="noopener noreferrer">Public Comments on the NIH Request for Information on Processes for database of Genotypes and Phenotypes (dbGaP) Data Submission, Access, and Management</a></li> <li><a href="/wp-content/uploads/Public_Comments_Data_Managment_Sharing_Citation.pdf" target="_blank" rel="noopener noreferrer">Public Comments on the NIH Request for Information on Strategies for Data Management, Sharing, and Citation</a></li> </ul> </div> </div> </div> <div class="card"> <div class="card-header" id="heading5"> <h5 class="mb-0"> <div class="btn-link collapsed" data-toggle="collapse" data-target="#collapse-acc-2-5" aria-expanded="false" aria-controls="collapse5"> Related Resources </div> </h5> </div> <div id="collapse-acc-2-5" class="collapse" aria-labelledby="heading5" data-parent="#accordion"> <div class="card-body"> <ul> <li><a href="https://grants.nih.gov/policy/nihgps/index.htm" target="_blank" rel="noreferrer noopener">NIH Grants Policy Statement</a></li> <li><a href="http://grants2.nih.gov/grants/intell-property.htm">NIH Intellectual Property Policy Page</a></li> <li><a href="http://grants.nih.gov/grants/sharing.htm">NIH Sharing Policies</a></li> <li><a href="http://www.hhs.gov/ohrp/">Office for Human Research Protections</a></li> <li><a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">HHS Human Subject Protection Regulations at 45 CFR part 46</a></li> <li><a href="http://grants.nih.gov/grants/policy/coc/index.htm">NIH Guidance on Certificates of Confidentiality</a></li> <li><a href="http://www.genome.gov/informedconsent/">NHGRI Informed Consent for Genomics Research Resource</a></li> <li><a href="http://genomicsandhealth.org/">Global Alliance for Genomics and Health</a></li> </ul> </div> </div> </div> </div> </div><div id="tab3" class="tab-pane fade "><h3>Engaging Tribal Nations on Data Management and Sharing</h3> <p>NIH strives to facilitate inclusion of American Indian and Alaska Native (AI/AN) populations in biomedical research studies, as this representation is critical for ensuring that scientific discoveries can be translated into improved prevention and treatment strategies useful for the diverse needs of these communities. As part of NIH’s commitment and aligned with the goals outlined in the <a href="https://dpcpsi.nih.gov/sites/default/files/2019_THRO_StrategicPlan_508.pdf" target="_blank" rel="noreferrer noopener">NIH Strategic Plan for Tribal Health Research</a>, NIH seeks to engage communities in conversations around how to achieve its commitment to responsible data sharing, including through the development of culturally sensitive data management and sharing resources for NIH researchers where appropriate.</p> <p>NIH respects that Tribal Nations are sovereign nations and established the <a href="https://dpcpsi.nih.gov/thro" target="_blank" rel="noreferrer noopener">NIH Tribal Health Research Office (THRO)</a> to facilitate collaboration with Tribal Nations and ensure meaningful input is incorporated into NIH programs and policies. NIH initiated Tribal Consultation, per the <a href="https://www.hhs.gov/sites/default/files/iea/tribal/tribalconsultation/hhs-consultation-policy.pdf" target="_blank" rel="noreferrer noopener">HHS Tribal Consultation Policy</a> and the <a href="https://dpcpsi.nih.gov/thro/policy" target="_blank" rel="noreferrer noopener">NIH Guidance on the Implementation of the HHS Tribal Consultation Policy</a>, to inform the Agency’s policy proposal on data management and sharing.</p> <p>NIH considered all of the points heard from the Tribal Consultation when writing its DRAFT Policy on Data Management and Sharing (DMS Policy), published in the <a href="https://www.federalregister.gov/documents/2019/11/08/2019-24529/draft-nih-policy-for-data-management-and-sharing-and-supplemental-draft-guidance" target="_blank" rel="noreferrer noopener">Federal Register</a> on November 6, 2019, with a closing date of January 10, 2020. NIH incorporated feedback from Tribes on the Draft Policy in the development of the <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html" target="_blank" rel="noreferrer noopener">final DMS Policy</a> and supplemental information. The <a href="https://osp.od.nih.gov/wp-content/uploads/Tribal_Report_Final_508.pdf" target="_blank" rel="noreferrer noopener">NIH Tribal Consultation Report – NIH Draft Policy for Data Management and Sharing</a> describes the process and includes a summary and analyses of findings. Importantly, the final DMS Policy includes a statement that NIH respects Tribal sovereignty in the absence of written Tribal laws or policies.</p> <p>While the DMS Policy itself does not go into significant depth on specific research areas because it is designed to be applicable to the entire portfolio of NIH-funded research, the preamble to the DMS Policy (the text that precedes the Policy), discusses in-depth NIH’s thinking on particular issues.</p> <p>NIH looks forward to working with Tribal communities to develop resources for researchers that encourages them to, among other things:</p> <ul> <li>Thoughtfully consider the unique data sharing concerns of Tribal communities;</li> <li>Respectfully negotiate agreements for data use with Tribal nations; and</li> <li>Enhance their awareness of processes Tribal nations use to review prospective research.</li> </ul> <p><strong>RESOURCES</strong></p> <ul> <li><strong><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-214.html" target="_blank" rel="noopener">(New) Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data</a></strong></li> </ul> <p> </p> <ul> <li><strong><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-064.html">Request for Public Comments on DRAFT Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data</a></strong></li> <li><a href="https://osp.od.nih.gov/wp-content/uploads/Tribal_Report_Final_508.pdf" target="_blank" rel="noreferrer noopener"><strong>NIH Tribal Consultation Report – NIH Draft Policy for Data Management and Sharing</strong></a> <ul> <li><a href="https://osp.od.nih.gov/wp-content/uploads/dear_tribal_leader_letter.pdf" target="_blank" rel="noreferrer noopener">Dear Tribal Leader Letter for Final Tribal Consultation Report</a></li> </ul> </li> <li><a href="https://dpcpsi.nih.gov/sites/default/files/NIH_Dear_Tribal_Leader_Letter-Data_Sharing_Management_508.pdf" target="_blank" rel="noreferrer noopener"><strong>Dear Tribal Leader letter</strong></a></li> <li><strong>National Congress of American Indians </strong><a href="https://youtu.be/ZmbVKQw7IrM" target="_blank" rel="noreferrer noopener"><strong>Charting a Path Forward for Responsible Data Sharing Webinar</strong></a> <ul> <li>Date & Time: May 2, 2019, 3:00-4:00 pm ET</li> <li>Event Details: <a href="https://www.youtube.com/watch?v=ZmbVKQw7IrM&feature=youtu.be" target="_blank" rel="noreferrer noopener">NCAI Webinar Archive</a></li> </ul> </li> <li><strong>HHS Regional Consultation (Region 9)</strong> <ul> <li>Location: Sacramento, CA</li> <li>Date & Time: June 20, 2019, 1:30-3:30 pm PT</li> </ul> </li> <li><strong>HHS Regional Consultation (Region 10)</strong> <ul> <li>Location: Spokane, WA</li> <li>Date & Time: July 11, 2019, 1:30-3:30 pm PT</li> </ul> </li> <li><strong>HHS Regional Consultation (Regions 1, 2, 3, & 4)</strong> <ul> <li>Event cancelled by organizers</li> </ul> </li> <li><strong>HHS Regional Consultation (Regions 6, 7, & 8)</strong> <ul> <li>Location; Denver, CO</li> <li>Date & Time: August 21, 2019, 8:45-10:45 pm PT</li> </ul> </li> </ul> </div> </div> </div> </div></div></div> </div></div> </div> <footer class="entry-footer"> </footer> </article> </main> <footer id="colophon" class="site-footer"> <div class="footer-page-date"> <p>Last updated: July 2023</p> </div> <div class="footer-container"> <div class="footer-menu inner-container"> <div class="footer-menu-1"> <h5>ABOUT US</h5> <div class="menu-footer-1-menu-container"><ul id="footermenu-1" class="menu" itemscope itemtype="http://www.schema.org/SiteNavigationElement"><li id="menu-item-16966" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-16966"><a href="/about-us/leadership">Meet the Senior 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