The NIH Genomic Data Sharing (GDS) Policy
last updated 2022
The NIH Genomic Data Sharing (GDS) Policy set forth expectations that ensure the broad and responsible sharing of genomic research data. The GDS policy became 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 NIH-funded research (e.g., certain 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. Examples of genomic research projects that are subject to the Policy and the timeline for submission and sharing of data from such projects may be found in the Supplemental Information to the NIH GDS Policy available at the NIH GDS Policies links here.
According to the GDS Policy, investigators who intend to use research or clinical specimens collected or cell lines created after January 25, 2015, to generate genomic data may only do so when informed consent processes explicitly discuss future research use and broad data sharing, even if the data are generated from specimens that are de-identified. NIH-designated data repositories will not accept genomic data derived from specimens or cell lines collected or created after January 25, 2015, without this type of consent. NIH strongly encourages the broadest appropriate future use and sharing of genomic and phenotypic data.
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.
Researchers may start with the following resources:
2) National Institutes of Health Genomic Data Sharing Policy
3) For help with developing a Genomic Data Sharing Plans, please see National Institutes of Health Guidance for Investigators in Developing Genomic Data Sharing Plans
Additional Resources:
2) Supplemental Information to the National Institutes of Health Genomic Data Sharing Policy provides examples of research within the scope of the GDS policy, and expectations for data submissions and release.
3) A slide presentation on the GDS policy.
4) Genomic Data Sharing Policies Webinar held on Nov 21, 2020
Informed Consent:
The requirement for informed consent was discussed in the 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.
For studies initiated after the effective date (January 25, 2015) of the GDS Policy, 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. The consent should include an explanation about whether participants' individual-level data will be shared through unrestricted- or controlled-access repositories.
For studies proposing to use genomic data from cell lines or clinical specimens that were collected or created after the effective date of the Policy, NIH expects that consent for future research use and broad sharing will have been obtained, even if the cell lines or clinical specimens are de-identified. If there are compelling scientific reasons that necessitate the use of genomic data from cell lines or clinical specimens that were created or collected after the effective date of this Policy and that lack consent for research use and data sharing, investigators should provide a justification in the funding request for their use. The funding IC (NIH Institute or Centers) will review the justification and decide whether to make an exception to the consent expectation
Institutional Certification:
Institutional Certification must accompany the submission of all large-scale human data to the NIH Database of Genotypes and Phenotypes (dbGaP). The Institutional Certification (for sharing human data), should also be provided to the funding NIH Institute or Center prior to award, along with any other Just in Time information (for extramural researchers) or at the time of scientific review (for intramural researchers).