NIH Genomic Data Sharing (GDS) Policy

NIH applicants seeking funding for research that generates large-scale human or non-human genomic data are expected to provide a plan for sharing of these data or an appropriate explanation why data sharing is not possible. Large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.

Investigator and institution responsibilities for data submission and access are governed by the NIH Genomic Data Sharing (GDS) Policy, NIH Guide NOT-OD-14-124 and is effective with NIH grant applications submitted for the January 25, 2015 due date and thereafter. Supplemental Information to the Genomic Data Sharing Policy provides examples of genomic research projects that are subject to the policy. Investigators proposing to generate human genomic data from clinical specimens or cell lines collected after the effective date of the GDS policy are expected to obtain explicit consent for the use and sharing of genomic and phenotypic data for future research purposes to be shared broadly, even if those specimens or cell lines are de-identified. If there are compelling scientific reasons to conduct the research with such unconsented specimens the reasons must be stated in the application.

NIH expects all funded investigators to adhere to the GDS Policy, and compliance with this Policy will become a special term and condition in the Notice of Award or the Contract Award. Failure to comply with the terms and conditions of the funding agreement could lead to enforcement actions, including the withholding of funding.

The GDS Policy has no direct cost threshold associated with it and applies only to grant activities requesting support for research, such as:
    - Research project grants (Rs);
    - Program projects (Ps) and SCORs (Ss);
    - Cooperative agreements for research (Us);
    - Individual career development awards (Ks) that include a research component;
    - S activities that include a research component; and
    - All other activities that include a research component.

The GDS Policy does not apply to:
    - Institutional training grants (T32s, T34s, T35s, and TL2s);
    - K12 career development awards (KL2s);
    - Individual fellowships (Fs);
    - Resource grants and contracts (Ss);
    - Linked awards derived from previously reviewed applications (KL1, KL2, RL1, RL2, RL5, RL9, TL1, UL1);
    - Facilities or coordinating centers funded through related initiatives to provide genotyping, sequencing, or other core services in support of GDS.

At Submission Time
Investigators preparing grant applications should contact appropriate IC Program Official or Project Officer as early as possible to discuss data sharing expectations and timelines that would apply to their proposed studies. Per NIH notice NOT-OD-15-027, applicants preparing such grant applications are expected to:
- state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data, and
- include a genomic data sharing plan in the application. If sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan.
- Any resources that may be needed to support a proposed genomic data sharing plan (e.g., preparation of data for submission) should be included in the project's budget.
- Applicants who plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in the application should:
- briefly address their plans for requesting access to the data, and
- state their intention to abide by the NIH Genomic Data User Code of Conduct, in the Research Plan of the application.

At Just-In-Time (JIT)
- A more detailed genomic data sharing plan should be provided to the funding IC prior to award, if requested.
- The Institutional Certification (for sharing human data) should also be provided to the funding IC prior to award. OSPA will get the required certification verification information from the IRB in order to provide this certification.

The Institutional Certification for Human Genomic Data
The Institutional Certification should state whether the data will be submitted to an unrestricted- or controlled-access database.  For submissions to controlled access and, as appropriate for unrestricted access, the Institutional Certification should assure that:

  • The data submission is consistent, as appropriate, with applicable national, tribal, and state laws and regulations as well as relevant institutional policies;
  • Any limitations on the research use of the data, as expressed in the informed consent documents, are delineated;
  • The identities of research participants will not be disclosed to NIH-designated data repositories; and
  • An IRB, privacy board, and/or equivalent body, as applicable,  has reviewed the investigator’s proposal for data submission and assures that:
    • The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR Part 46;
    • Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained;
    • Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing;
    • To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing; and
    • The investigator’s plan for de-identifying datasets is consistent with the standards outlined in this Policy (see section IV.C.1.)

Large-Scale Non-Human Genomic Data Sharing
Large-scale non-human genomic data, including data from microbes, microbiomes, and model organisms, as well as relevant associated data (e.g., phenotype and exposure data), are to be shared in a timely manner. Genomic data undergo different levels of data processing, which provides the basis for NIH's expectations for data submission. These expectations are provided in the Supplemental Information.  In general, investigators should make non-human genomic data publicly available no later than the date of initial publication.  However, earlier availability (i.e., before publication) may be expected for certain data or IC-funded projects.

Useful Links
NIH Genomic Data Sharing (GDS)
Supplemental Information to the NIH Genomic Data Sharing Policy (including examples of Research within the Scope of the GDS Policy)
NIH Genomic Data Sharing Policy (NOT-OD-14-124)
Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications (NOT-OD-14-111)
Data Sharing Plan Boilerplate


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