{"id":781,"date":"2018-05-09T07:49:11","date_gmt":"2018-05-09T07:49:11","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/nih-genomic-data-sharing-policy\/"},"modified":"2026-03-13T11:12:48","modified_gmt":"2026-03-13T15:12:48","slug":"nih-genomic-data-sharing-policy","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/nih-genomic-data-sharing-policy\/","title":{"rendered":"NIH Genomic Data Sharing Policy"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[66,75],"update-type":[97],"class_list":["post-781","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local","update-type-information-only"],"acf":{"use_legacy_editor":true,"updated_date":"2018-01-03 09:30:00","update_notice":false,"author":"IRBMED","summary":"All U-M <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRBs<\/a> (<a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-medical-school-irbmed\">IRBMED<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/irb-hsbs\">IRB-HSBS<\/a>, IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing.\u00a0 Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance below.","button_links":null,"related_content":"","legacy_path":"nih-genomic-data-sharing-policy","legacy_node_id":324,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"I. Genomic Data Sharing Policy submissions and the IRB","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">Investigators<\/a> receiving <a class=\"gtip\" href=\"\/medschool\/glossary\/nih\">NIH<\/a> funding for a study that generates \u201clarge-scale human genomic data\u201d are generally required by the\u00a0<a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not-od-14-124.html\">2014 NIH Genomic Data Sharing (GDS) Policy<\/a>\u00a0to submit the genomic data to an\u00a0<a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/submitting-genomic-data\/where-to-submit-genomic-data\">NIH data repository<\/a>\u00a0in order to \u201censure the broad and responsible sharing of genomic research data.\u201d\u00a0<strong>U-M investigators should<\/strong>\u00a0<a href=\"http:\/\/orsp.umich.edu\/nih-genomic-data-sharing-policy\">work with ORSP<\/a>\u00a0<strong>to include appropriate plans for genomic data submission in a proposal covered by the GDS Policy.<\/strong>\r\n\r\nThe\u00a0<a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not-od-14-124.html\">2014 NIH Genomic Data Sharing (GDS) Policy<\/a>\u00a0is the latest of several NIH policies regarding sharing of genomic data; its immediate predecessor was the 2008 <a href=\"\/medschool\/glossary\/genome-wide-association-studies-gwas\">Genome-Wide Association Studies (GWAS)<\/a> Policy. The terms of the policies that were in effect when the research began govern the requirements for data submission from each study, although NIH encourages investigators to comply with the expectations outlined in the 2014 Policy also for existing studies.\r\n\r\nContact\u00a0<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">your IRB staff<\/a> to determine the best way to apply for Institutional Certification for your study if the study is funded by an existing grant, or if your genomic data submission is not subject to an NIH grants mandate.\r\n\r\nResearchers request IRB \u201creview and assurance\u201d of GDS plans through\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/informational\/eresearch-regulatory-management-errm\">eResearch Regulatory Management<\/a>\u00a0(i.e., through HUM application or <a class=\"gtip\" href=\"\/medschool\/glossary\/amendment-ame\">Amendment<\/a> to an existing HUM). IRB provides to ORSP the results of the \u201creview and assurance\u201d determination through\u00a0<a href=\"http:\/\/orsp.umich.edu\/processing-proposals\">eResearch Proposal Management<\/a>\u00a0(i.e., Posted Comment on the PAF);\u00a0<a href=\"http:\/\/orsp.umich.edu\/nih-genomic-data-sharing-policy\">ORSP finalizes U-M\u2019s \u201cInstitutional Certification\u201d<\/a> and provides it to NIH.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"II. Genomic Data Sharing Certification","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<strong>IRBs are expected to review the <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> materials and other study documentation to determine whether it is appropriate for data to be shared for this secondary research use (i.e., shared with a data <a class=\"gtip\" href=\"\/medschool\/glossary\/repository\">repository<\/a>).\u00a0 Therefore, documentation associated with original study approval and informed consent(s) must be provided for IRB review if the documents exist.\u00a0\u00a0The IRB must review every consent version upon which the GDS data submission is relying.<\/strong> \u00a0\u00a0In the event \u00a0some specimens were not associated with a research consent document, the IRB will consider alternative information, as it is available, for <a class=\"gtip\" href=\"\/medschool\/glossary\/compliance\">compliance<\/a> with the NIH standards.\r\n\r\nIRB <a class=\"gtip\" href=\"\/medschool\/glossary\/assurance\">Assurance<\/a> and Institutional Certification\u00a0may\u00a0restrict or disallow submission to the data repository, consistent with the relevant informed consent(s). The IRB may require an investigator to seek explicit consent for GDS data submission, even if a \u201cwaiver of consent\u201d applied to the study under which specimens were collected. For details, see <a class=\"gtip\" href=\"\/medschool\/glossary\/nih\">NIH<\/a> guidance such as\u00a0<a href=\"https:\/\/osp.od.nih.gov\/wp-content\/uploads\/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf\">Informed Consent for Secondary Research with Data and Biospecimens<\/a>\u00a0and\u00a0<a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/sharing-policies\/gds\/institutional-certifications#what-is-the-role-of-an-institutional-review-board-(irb)-in-reviewing-an-institutional-certification?\">Points to Consider for IRBs and Institutions.<\/a>\r\n\r\nDepending on the IRB <a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approval<\/a> status of the study and the grant proposal, the submission to the IRB may require a new application or an <a class=\"gtip\" href=\"\/medschool\/glossary\/amendment-ame\">Amendment<\/a>. Including all appropriate references and supporting documents is critical to smooth processing. Please use the\u00a0<strong>IRB Submission\u00a0-\u00a0Use Cases<\/strong>\u00a0below, and\u00a0<strong>Documents Required for Submission\u00a0<\/strong>guidelines later on this page. Contact\u00a0your <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">IRB staff<\/a>\u00a0with any questions. Study coordinators and PIs working on the IRB applications will usually need to work with research administrator(s) on the PAF applications to find all the necessary information.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"III. Use Cases","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"A. STEP ONE: For All Circumstances","legacy_section_text":"<strong>Every<\/strong>\u00a0new initial application (HUM) or <a class=\"gtip\" href=\"\/medschool\/glossary\/amendment-ame\">Amendment<\/a> submission (Ame) requesting IRB \u201creview and <a class=\"gtip\" href=\"\/medschool\/glossary\/assurance\">assurance<\/a>\u201d for GDS should include the following\r\n<ul>\r\n \t<li>If a sponsored projects application (<a href=\"http:\/\/orsp.umich.edu\/route-submit-proposal\/proposal-approval-form-paf\"><em>PAF<\/em><\/a>) exists, Section\u00a0<strong>02<\/strong>: link to it (even if pending)<\/li>\r\n \t<li>(<em>For IRBMED only<\/em>)\u00a0Question\u00a0<strong>44.2<\/strong>: Include\r\n<ul>\r\n \t<li>Text: \u201cGenomic Data Submission Request\u201d<\/li>\r\n \t<li>NIH Grant\/contract title<\/li>\r\n \t<li>NIH Grant\/contract number<\/li>\r\n \t<li>PAF ID (format\u00a0<em>yy-PAF0xxxxx<\/em>)<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"B. STEP TWO:","legacy_section_text":"<strong>Initial application (HUM)<\/strong>\r\n\r\nOpen a new\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/informational\/eresearch-regulatory-management-errm\">eResearch Regulatory Management<\/a> study (HUM).\r\n<ul>\r\n \t<li>Question\u00a0<strong>1.1\u00a0<\/strong>(Study Title) includes text \u201cGenomic Data Sharing\u201d\r\n<ul>\r\n \t<li><em>If applicable<\/em>,\u00a0Study Title ALSO includes text \u201cNIH JIT submission\u201d<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Section\u00a0<strong>01-1<\/strong>\u00a0(Application Type): Choose \u201c<strong>Projects lacking immediate plans\u2026<\/strong>\u201d (also known as \u201cUmbrella application\u201d)\r\n<ul>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload the research <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">protocol<\/a>.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<strong>OR<\/strong>\r\n\r\n<a class=\"gtip\" href=\"\/medschool\/glossary\/amendment-ame\"><strong>Amendment (AME)<\/strong><\/a>\r\n<ul>\r\n \t<li>Title of Amendment (Ame question\u00a0<strong>00.1<\/strong>\u00a0or\u00a0<strong>1.1<\/strong>) includes text \u201cGenomic Data Sharing\u201d\r\n<ul>\r\n \t<li>If applicable,\u00a0Title of Amendment ALSO includes text \u201cNIH JIT submission\u201d<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>If there is a new consent version\u00a0(e.g., subjects will be re-consented), upload in question\u00a0<strong>10-1.1<\/strong>\u00a0a copy of the document\u00a0<strong>without highlighting changes to the text, and without highlighting sections relevant to genomic data sharing.<\/strong><\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"C. STEP THREE:","legacy_section_text":"In a small number of cases it may necessary to include a\u00a0Provisional <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">Institutional Certification<\/a>\u00a0with the JIT submission, to be followed by a full formal\u00a0Institutional Certification\u00a0at a later date.\u00a0<strong>Contact\u00a0your <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">IRB staff<\/a> with any questions.<\/strong>\r\n\r\nThe instructions that follow are for full formal Institutional Certification.\r\n<h4><strong>For Samples not yet collected<\/strong><\/h4>\r\nInclude the following, along with other applicable answers.\r\n<ul>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload\r\n<ul>\r\n \t<li>Institutional Certification\u00a0based on\u00a0\u201cCollected ON OR AFTER \u2026\u201d <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">template<\/a><\/li>\r\n \t<li>Highlighted version(s)\u00a0of\u00a0Consent Document(s)\u00a0for IRB review<\/li>\r\n \t<li>Data Management\u00a0and Sharing Plan\u00a0from Proposal<\/li>\r\n \t<li>Research protocol for new study<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<h4><strong>For Samples collected AFTER 1\/25\/2015 with consent<\/strong><\/h4>\r\nInclude the following, along with other applicable answers.\r\n<ul>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload\u00a0Institutional Certification filled out from\u00a0NIH \u201cCollected ON OR AFTER \u2026\u201d <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">template<\/a>\r\n<ul>\r\n \t<li>Highlighted version(s)\u00a0for IRB review of new and\/or existing\u00a0Consent Document(s)\u00a0on which the data submission will be relying<\/li>\r\n \t<li>Data Management and Sharing Plan\u00a0from Proposal<\/li>\r\n \t<li><em>If analyzing materials from non U-M sources, External site approval documentation<\/em><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<h4><strong>For Existing samples collected BEFORE 1\/25\/2015 with consent<\/strong><\/h4>\r\nInclude the following, along with other applicable answers.\r\n<ul>\r\n \t<li>If data\/specimens were collected under a prior (now <a class=\"gtip\" href=\"\/medschool\/glossary\/terminated\">terminated<\/a>) U-M study,\u00a0question\u00a0<strong>1.1.2<\/strong>\u00a0(related projects) must include the earlier HUM# or IRBMED Legacy#<\/li>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload\r\n<ul>\r\n \t<li>Institutional Certification\u00a0based on \u201cCollected BEFORE \u2026 With Consent\u201d <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">template<\/a><\/li>\r\n \t<li>Highlighted version(s)\u00a0for IRB review of new and\/or existing\u00a0Consent Document(s)\u00a0on which the data submission will be relying<\/li>\r\n \t<li>Data Management and Sharing Plan\u00a0from Proposal<\/li>\r\n \t<li><em>If analyzing materials from non U-M sources,\u00a0<\/em>External site approval documentation as described below (heading \"IV. Documents required\"; subheading \"D.\").<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<h4><strong>For Existing samples collected BEFORE 1\/25\/2015 that lack consent<\/strong><\/h4>\r\nInclude the following, along with other applicable answers.\r\n<ul>\r\n \t<li>If data\/specimens were collected under a prior (now terminated) U-M study,\u00a0question\u00a0<strong>1.1.2<\/strong>\u00a0(related projects) must include the earlier HUM# or IRBMED Legacy#<\/li>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload\u200b\r\n<ul>\r\n \t<li>Institutional Certification\u00a0filled out from\u00a0NIH \u201cCollected BEFORE \u2026 Without Consent\u201d <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">template<\/a><\/li>\r\n \t<li><em>If\u00a0new consent will be obtained,<\/em> \u00a0Highlighted version(s) for IRB review<\/li>\r\n \t<li>Data Management and Sharing Plan\u00a0from Proposal<\/li>\r\n \t<li><em>If re-consent is not feasible<\/em>,\u00a0this plan should include justification (e.g., identity of sample donors cannot be ascertained)<\/li>\r\n \t<li><em>If analyzing materials from non U-M sources, <\/em>External site approval documentation as described below (heading \"IV. Documents required\"; subheading \"D.\").<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<h4><strong>For Samples collected BEFORE AND AFTER 1\/25\/2015 with consent<\/strong><\/h4>\r\nInclude the following, along with other applicable answers.\r\n<ul>\r\n \t<li>If data\/specimens were collected under a prior (now terminated) U-M study,\u00a0question\u00a01.1.2\u00a0(related projects) must include the earlier HUM# or IRBMED Legacy#<\/li>\r\n \t<li>Question\u00a0<strong>44.1<\/strong>: Upload\u200b\r\n<ul>\r\n \t<li>2 separate Institutional Certifications,\u00a0based on \u201cCollected AFTER \u2026\u201d and on \u201cCollected BEFORE \u2026 With Consent\u201d templates<\/li>\r\n \t<li>Highlighted version(s)\u00a0for IRB review of new and\/or existing\u00a0Consent Document(s)\u00a0on which the data submission will be relying<\/li>\r\n \t<li>Data Management and Sharing Plan\u00a0from Proposal<\/li>\r\n \t<li><em>If analyzing materials from non U-M sources,<\/em><em>\u00a0<\/em>External site approval documentation as described below (heading \"IV. Documents required\"; subheading \"D.\").<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"IV. Documents Required for Submission","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<strong>Study coordinators and PIs working on the IRB applications will usually need to work with research administrator(s) on the PAF applications to find all the necessary information. Guidance from NIH staff directly may also be necessary. The NIH\u00a0<a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\">GDS website<\/a>\u00a0provides many links to detailed guidance.<\/strong>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"A. Institutional Certification","legacy_section_text":"Download the appropriate <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">template <\/a>from the\u00a0GDS Institutional Certifications\u00a0webpage\r\n<ul>\r\n \t<li>Sample Collected AFTER January 25, 2015<\/li>\r\n \t<li>Sample Collected BEFORE January 25, 2015\r\n<ul>\r\n \t<li>With Consent<\/li>\r\n \t<li>Without Consent<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nInformation you\u2019ll need to fill out the Institutional Certification form:\r\n<ul>\r\n \t<li>Name of the\u00a0<a href=\"https:\/\/sharing.nih.gov\/contacts-and-help#gds_support\">Genomic Program Administrator<\/a> for the NIH Institute or Center sponsoring your data submission.<\/li>\r\n \t<li>Name of the study, as IRB-<a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approved<\/a>, under which participants provide consent for the samples<\/li>\r\n \t<li>Names of all collaborating sites on behalf of which U-M is providing Institutional Certification<\/li>\r\n \t<li>Whether participants\u2019 individual-level data should be shared through unrestricted access (data made publicly available to anyone, e.g. through\u00a0<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/geo\/\">GEO<\/a>\u00a0or\u00a0<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/sra\">SRA<\/a>) or controlled access (data made available for secondary research only after investigators have obtained approval from NIH to use the requested data for a particular project, e.g.\u00a0<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/gap\">dbGaP<\/a>).<strong>\u00a0Controlled access is more often appropriate.<\/strong><\/li>\r\n \t<li>Whether display, in public variation archives, of variant alleles and\/or frequencies from this study should be permitted. Public variations archives include<a href=\"http:\/\/Single Nucleotide Polymorphism Database (dbSNP)\">\u00a0Single Nucleotide Polymorphism Database (dbSNP)<\/a>\u00a0for genetic variation within and across species, and\u00a0<a href=\"http:\/\/Database of Genomic Structural Variants (dbVar).\">Database of Genomic Structural Variants (dbVar).<\/a><\/li>\r\n \t<li>Appropriate data use limitations based on original informed consent of participants. NIH provides\u00a0<a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/sharing-policies\/gds\/completing-institutional-certification-form#step-5:-restrictions:-data-use-limitations-(duls)\">standard categories and DULs<\/a>\u00a0for appropriate secondary research use. Factors to consider in developing DULs may include whether the informed consent stated that the data would be shared with other investigators, was silent on the matter of data sharing or future uses of data, or stated that the data could only be used for a specific purpose.<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"B. Detailed Genomic Data Sharing Plan from Proposal","legacy_section_text":"Follow ORSP Guidance on GDS plan expectations, and refer to\u00a0NIH\u00a0<a href=\"https:\/\/sharing.nih.gov\/data-management-and-sharing-policy\/planning-and-budgeting-for-data-management-and-sharing\/writing-a-data-management-and-sharing-plan#after\">Writing a Data Management and Sharing Plan<\/a> (which includes GDS guidance). Preferably, the Data Sharing Plan will include an explanation of consent plan(s), such as whether prior consent is adequate to current NIH standards, re-consent of some or all subjects, and\/or justification why re-consent is not feasible.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"C. Consent Document(s)","legacy_section_text":"<h4><strong>Highlighted version(s) for IRB review<\/strong><\/h4>\r\n<strong>The IRB will review every consent version on which the data submission is relying\u00a0<\/strong>(every version that was or will be signed by a subject whose data will be submitted). If some or all of the data submitted relies on previously obtained consent, study teams may have to prepare multiple prior versions for IRB review.\r\n\r\nUpload in question\u00a0<strong>44.1<\/strong>\u00a0upload a copy of each relevant consent version, highlighting\u00a0sections that are relevant to genomic data sharing:\r\n<ul>\r\n \t<li>Genetic research or analysis<\/li>\r\n \t<li>Specific permissions or restrictions<\/li>\r\n \t<li>Subsequent use and sharing of the data<\/li>\r\n \t<li>Risks to <a class=\"gtip\" href=\"\/medschool\/glossary\/individual\">individuals<\/a>, families and groups or populations associated with submission of data to the repository<\/li>\r\n \t<li>Whether participants\u2019 individual-level data will be shared through unrestricted or controlled-access repositories<\/li>\r\n<\/ul>\r\n<h4><strong>Initial application (HUM) submitted as a \u201cprojects lacking immediate plans\u201d (Umbrella)\u200b<\/strong><\/h4>\r\nFor an Initial application (HUM) submitted as a \u201cprojects lacking immediate plans\u201d (Umbrella) application type, the consent draft may be limited to Section 12\u00a0of the\u00a0<a href=\"\/medschool\/templates\/standard-informed-consent-template\">IRBMED Standard Consent Template<\/a>, delineating the required information about genomic data sharing.\u00a0(Full consent draft not required at this time.)\u00a0Upload in question\u00a044.1.\r\n<h4><strong>New consent or re-consent<\/strong><\/h4>\r\n<ul>\r\n \t<li>Upload in question\u00a0<strong>10-1.1<\/strong>\u00a0consent(s) to be signed in the future\u00a0<strong>without highlighting.<\/strong><\/li>\r\n \t<li>Upload in question<strong>\u00a044.1<\/strong>\u00a0Highlighted version(s) for IRB review<\/li>\r\n<\/ul>\r\nFor studies proposing to use genomic data from cell lines or clinical specimens that were created or collected after January 25, 2015, NIH expects investigators to obtain participants\u2019 consent for their genomic and phenotypic data to be used for future research purposes and to be shared broadly, even if the cell lines or specimens are <a class=\"gtip\" href=\"\/medschool\/glossary\/de-identified\">de-identified.<\/a> For detailed guidance, see\u00a0<a href=\"http:\/\/www.genome.gov\/27026588\">NHGRI Informed Consent for Genomics Research<\/a>\u00a0website (including sample language).\r\n<h4><strong>Existing consent, or specimens previously created or collected without consent<\/strong><\/h4>\r\nUpload in question<strong>\u00a044.1<\/strong>\u00a0Highlighted version(s)\u00a0for IRB review\r\n\r\nThe eResearch application should include (preferably as part of the\u00a0Data Management and Sharing Plan\u00a0from Proposal) an explanation whether prior consent is adequate to current NIH standards.\u00a0I<em>f it is not adequate<\/em>,\u00a0also include a plan for re-consent of some or all subjects, and\/or justification why re-consent is not feasible.\r\n\r\nIn the event \u00a0some specimens were not associated with a research consent document, the IRB will consider alternative information, as it is available, for <a class=\"gtip\" href=\"\/medschool\/glossary\/compliance\">compliance<\/a> with the NIH standards.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"D. External site approval documentation","legacy_section_text":"If U-M will be providing\u00a0Institutional Certification\u00a0for samples collected elsewhere (external sites in a <a class=\"gtip\" href=\"\/medschool\/glossary\/multi-site-trial\">multi-site study<\/a>, or U-M obtained samples\/data from an external repository), upload in question\u00a0<strong>44.1<\/strong>:\r\n<ul>\r\n \t<li>Documentation of research ethics\/IRB approval for original specimen collection<\/li>\r\n \t<li>Highlighted existing\u00a0Consent Document(s)\u00a0from each <a class=\"gtip\" href=\"\/medschool\/glossary\/site\">site<\/a> where specimens were collected<\/li>\r\n \t<li>Institutional Certification\u00a0with\r\n<ul>\r\n \t<li>Page 1 indicating all collaborating sites<\/li>\r\n \t<li>Page 2 indicating a Data Use Limitation selection for each collaborating site based on that site\u2019s own consent document(s)<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><em>For international specimens<\/em>, a reference to the research ethics policies\/regulations that governed the specimen collection. (Ideally, the specimen provider could provide a comparison of the international standard that applies with the U.S. IRB regulations\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR Part 46<\/a>, since the IRB Review and Assurance responsibilities include assurance that \u201cThe protocol for the collection of genomic and phenotypic data is consistent with\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR Part 46<\/a>.\u201d)<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"V. References","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li>U-M ORSP\u00a0<a href=\"http:\/\/orsp.umich.edu\/nih-genomic-data-sharing-policy\">NIH Genomic Data Sharing Policy<\/a>\u00a0guidance webpage<\/li>\r\n \t<li>NIH\u00a0<a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/not-od-14-124.html\">2014 Genomic Data Sharing Policy<\/a><\/li>\r\n \t<li>NIH <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\">Genomic Data Sharing<\/a> webpage\r\n<ul>\r\n \t<li><a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/developing-genomic-data-sharing-plans\">Developing Genomic Data Sharing Plans<\/a><\/li>\r\n \t<li>Institutional Certifications\u00a0<a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/completing-an-institutional-certification-form\">templates<\/a><\/li>\r\n \t<li><a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/institutional-certifications\/about-institutional-certifications\">About Institutional Certifications<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[97],"update_notice_start":"2023-03-03 10:30:00","update_notice_end":"2023-05-05 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>Per NIH GDS <a href=\"https:\/\/sharing.nih.gov\/genomic-data-sharing-policy\/developing-genomic-data-sharing-plans\">Developing Genomic Data Sharing Plans<\/a> webpage,<\/p>\n\n<p><em>The&nbsp;2023 NIH&nbsp;Data Management and Sharing (DMS) policy&nbsp;expects 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 time of funding application satisfies both the Genomic Data Sharing (GDS) Policy and the DMS Policy. Therefore, on or after January 25, 2023, NIH will no longer be collecting separate GDS Plans.<\/em><\/p>\n\n<p>Other aspects of submitting Institutional Certification for compliance with GDS policy are unchanged.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By:\u00a0<a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 13, 2026 11:15AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/781","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/781\/revisions"}],"predecessor-version":[{"id":1925,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/781\/revisions\/1925"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/97"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=781"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=781"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=781"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=781"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=781"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}