Guidance

NIH Genomic Data Sharing Policy

IRBMED
Jan 3, 2018 9:30 am
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All U-M IRBs (IRBMED, IRB-HSBS, IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing.  Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance below.

  • I. Genomic Data Sharing Policy submissions and the IRB

    Investigators receiving NIH funding for a study that generates “large-scale human genomic data” are generally required by the 2014 NIH Genomic Data Sharing (GDS) Policy to submit the genomic data to an NIH data repository in order to “ensure the broad and responsible sharing of genomic research data.” U-M investigators should work with ORSP to include appropriate plans for genomic data submission in a proposal covered by the GDS Policy.

    The 2014 NIH Genomic Data Sharing (GDS) Policy is the latest of several NIH policies regarding sharing of genomic data; its immediate predecessor was the 2008 Genome-Wide Association Studies (GWAS) 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.

    Contact your IRB staff 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.

    Researchers request IRB “review and assurance” of GDS plans through eResearch Regulatory Management (i.e., through HUM application or Amendment to an existing HUM). IRB provides to ORSP the results of the “review and assurance” determination through eResearch Proposal Management (i.e., Posted Comment on the PAF); ORSP finalizes U-M’s “Institutional Certification” and provides it to NIH.

  • II. Genomic Data Sharing Certification

    IRBs are expected to review the informed consent 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 repository).  Therefore, documentation associated with original study approval and informed consent(s) must be provided for IRB review if the documents exist.  The IRB must review every consent version upon which the GDS data submission is relying.   In the event  some specimens were not associated with a research consent document, the IRB will consider alternative information, as it is available, for compliance with the NIH standards.

    IRB Assurance and Institutional Certification may restrict 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 “waiver of consent” applied to the study under which specimens were collected. For details, see NIH guidance such as Informed Consent for Secondary Research with Data and Biospecimens and Points to Consider for IRBs and Institutions.

    Depending on the IRB approved status of the study and the grant proposal, the submission to the IRB may require a new application or an Amendment. Including all appropriate references and supporting documents is critical to smooth processing. Please use the IRB Submission - Use Cases below, and Documents Required for Submission guidelines later on this page. Contact your IRB staff with 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.

  • III. Use Cases

    A. STEP ONE: For All Circumstances

    Every new initial application (HUM) or Amendment submission (Ame) requesting IRB “review and assurance” for GDS should include the following

    • If a sponsored projects application (PAF) exists, Section 02: link to it (even if pending)
    • (For IRBMED only) Question 44.2: Include
      • Text: “Genomic Data Submission Request”
      • NIH Grant/contract title
      • NIH Grant/contract number
      • PAF ID (format yy-PAF0xxxxx)

    B. STEP TWO:

    Initial application (HUM)

    Open a new eResearch Regulatory Management study (HUM).

    • Question 1.1 (Study Title) includes text “Genomic Data Sharing”
      • If applicable, Study Title ALSO includes text “NIH JIT submission”
    • Section 01-1 (Application Type): Choose “Projects lacking immediate plans…” (also known as “Umbrella application”)
      • Question 44.1: Upload the research protocol.

    OR

    Amendment (AME)

    • Title of Amendment (Ame question 00.1 or 1.1) includes text “Genomic Data Sharing”
      • If applicable, Title of Amendment ALSO includes text “NIH JIT submission”
    • If there is a new consent version (e.g., subjects will be re-consented), upload in question 10-1.1 a copy of the document without highlighting changes to the text, and without highlighting sections relevant to genomic data sharing.

    C. STEP THREE:

    In a small number of cases it may necessary to include a Provisional Institutional Certification with the JIT submission, to be followed by a full formal Institutional Certification at a later date. Contact your IRB staff with any questions.

    The instructions that follow are for full formal Institutional Certification.

     

    For Samples not yet collected

    Include the following, along with other applicable answers.

    • Question 44.1: Upload 
      • Institutional Certification based on “Collected ON OR AFTER …” template
      • Highlighted version(s) of Consent Document(s) for IRB review
      • Data Management and Sharing Plan from Proposal
      • Research protocol for new study

     

    For Samples collected AFTER 1/25/2015 with consent

    Include the following, along with other applicable answers.

    • Question 44.1: Upload Institutional Certification filled out from NIH “Collected ON OR AFTER …” template
      • Highlighted version(s) for IRB review of new and/or existing Consent Document(s) on which the data submission will be relying
      • Data Management and Sharing Plan from Proposal
      • If analyzing materials from non U-M sources, External site approval documentation

     

    For Existing samples collected BEFORE 1/25/2015 with consent

    Include the following, along with other applicable answers.

    • If data/specimens were collected under a prior (now terminated) U-M study, question 1.1.2 (related projects) must include the earlier HUM# or IRBMED Legacy#
    • Question 44.1: Upload
      • Institutional Certification based on “Collected BEFORE … With Consent” template
      • Highlighted version(s) for IRB review of new and/or existing Consent Document(s) on which the data submission will be relying
      • Data Management and Sharing Plan from Proposal
      • If analyzing materials from non U-M sources, External site approval documentation

     

    For Existing samples collected BEFORE 1/25/2015 that lack consent

    Include the following, along with other applicable answers.

    • If data/specimens were collected under a prior (now terminated) U-M study, question 1.1.2 (related projects) must include the earlier HUM# or IRBMED Legacy#
    • Question 44.1: Upload​
      • Institutional Certification filled out from NIH “Collected BEFORE … Without Consent” template
      • If new consent will be obtained,  Highlighted version(s) for IRB review
      • Data Management and Sharing Plan from Proposal
      • If re-consent is not feasible, this plan should include justification (e.g., identity of sample donors cannot be ascertained)
      • If analyzing materials from non U-M sources, External site approval documentation

     

    For Samples collected BEFORE AND AFTER 1/25/2015 with consent

    Include the following, along with other applicable answers.

    • If data/specimens were collected under a prior (now terminated) U-M study, question 1.1.2 (related projects) must include the earlier HUM# or IRBMED Legacy#
    • Question 44.1: Upload​
      • 2 separate Institutional Certifications, based on “Collected AFTER …” and on “Collected BEFORE … With Consent” templates
      • Highlighted version(s) for IRB review of new and/or existing Consent Document(s) on which the data submission will be relying
      • Data Management and Sharing Plan from Proposal
      • If analyzing materials from non U-M sources, External site approval documentation

  • IV. Documents Required for Submission

    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 GDS website provides many links to detailed guidance.

    A. Institutional Certification

    Download the appropriate template from the GDS Institutional Certifications webpage

    • Sample Collected AFTER January 25, 2015
    • Sample Collected BEFORE January 25, 2015
      • With Consent
      • Without Consent

    Information you’ll need to fill out the Institutional Certification form:

    • Name of the Genomic Program Administrator for the NIH Institute or Center sponsoring your data submission.
    • Name of the study, as IRB-approved, under which participants provide consent for the samples
    • Names of all collaborating sites on behalf of which U-M is providing Institutional Certification
    • Whether participants’ individual-level data should be shared through unrestricted access (data made publicly available to anyone, e.g. through GEO or SRA) 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. dbGaP). Controlled access is more often appropriate.
    • Whether display, in public variation archives, of variant alleles and/or frequencies from this study should be permitted. Public variations archives include Single Nucleotide Polymorphism Database (dbSNP) for genetic variation within and across species, and Database of Genomic Structural Variants (dbVar).
    • Appropriate data use limitations based on original informed consent of participants. NIH provides standard categories and DULs for 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.

    B. Detailed Genomic Data Sharing Plan from Proposal

    NOTE: NIH now expects a single data sharing plan at time of funding application satisfies both the Genomic Data Sharing (GDS) Policy and the 2023 Data Management and Sharing (DMS) Policy (NOT-OD-22-198). Therefore, on or after January 25, 2023, NIH will no longer be collecting separate GDS Plans.

    Follow ORSP Guidance on GDS plan expectations, and refer to NIH Writing a Data Management and Sharing Plan (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.

    C. Consent Document(s)

    Highlighted version(s) for IRB review

    The IRB will review every consent version on which the data submission is relying (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.

    Upload in question 44.1 upload a copy of each relevant consent version, highlighting sections that are relevant to genomic data sharing:

    • Genetic research or analysis
    • Specific permissions or restrictions
    • Subsequent use and sharing of the data
    • Risks to individuals, families and groups or populations associated with submission of data to the repository
    • Whether participants’ individual-level data will be shared through unrestricted or controlled-access repositories

    Initial application (HUM) submitted as a “projects lacking immediate plans” (Umbrella)​

    For an Initial application (HUM) submitted as a “projects lacking immediate plans” (Umbrella) application type, the consent draft may be limited to Section 12 of the IRBMED Standard Consent Template, delineating the required information about genomic data sharing. (Full consent draft not required at this time.) Upload in question 44.1.

    New consent or re-consent

    • Upload in question 10-1.1 consent(s) to be signed in the future without highlighting.
    • Upload in question 44.1 Highlighted version(s) for IRB review

    For 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’ 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 de-identified. For detailed guidance, see NHGRI Informed Consent for Genomics Research website (including sample language).

    Existing consent, or specimens previously created or collected without consent

    Upload in question 44.1 Highlighted version(s) for IRB review

    The eResearch application should include (preferably as part of the Data Management and Sharing Plan from Proposal) an explanation whether prior consent is adequate to current NIH standards. If it is not adequate, also include a plan for re-consent of some or all subjects, and/or justification why re-consent is not feasible.

    In the event  some specimens were not associated with a research consent document, the IRB will consider alternative information, as it is available, for compliance with the NIH standards.

    D. External site approval documentation

    If U-M will be providing Institutional Certification for samples collected elsewhere (external sites in a multi-site study, or U-M obtained samples/data from an external repository), upload in question 44.1:

    • Documentation of research ethics/IRB approval for original specimen collection
    • Highlighted existing Consent Document(s) from each site where specimens were collected
    • Institutional Certification with
      • Page 1 indicating all collaborating sites
      • Page 2 indicating a Data Use Limitation selection for each collaborating site based on that site’s own consent document(s)
    • For international specimens, 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 45 CFR Part 46, since the IRB Review and Assurance responsibilities include assurance that “The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46.”)

  • V. References
Units: Institutional Review Boards (IRBMED)
Topic: Investigator & Study Team Responsibilities Regulations & Policies (Federal, State & Local)
Questions?

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Edited By: [email protected]
Last Updated: May 1, 2024 10:30 AM