NIH Genomic Data Sharing Policy

Table of contents

I.       Genomic Data Sharing Policy submissions and the IRB

II.      Genomic Data Sharing Certification

III.    Use Cases

IV.    Documents Required for Submission

V.     References

 

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 Guidance on Consent for Future Research Use and Broad Sharing and NIH 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.

 

For Samples collected AFTER 1/25/2015 with consent

Include the following, along with other applicable answers.

 

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

Include the following, along with other applicable answers.

 

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

Include the following, along with other applicable answers.

 

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

Include the following, along with other applicable answers.

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 Resources for Researchers webpage provides many links to detailed guidance.

A. Institutional Certification

Download the appropriate template from the NIH GDS Institutional Certifications webpage

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, and additional guidance Points to Consider in Developing Effective Data Use Limitation Statements. 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

Consult with ORSP on GDS plan expectations, and refer to NIH Guidance for Institutions Submitting Data Under the GDS Policy (heading “Responsibilities of Investigators and Institutions …”). 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 4 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

    • Uploadin 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 NIH Genomic Data Sharing Policy (pp5-6) and 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 Detailed Genomic Data 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. See NIH Genomic Data Sharing Policy (pp5-6).

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 Certificationwith
      • 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

 

Page created 2/6/2017
Updated 7/18/2017