The NIH announced the final Genomic Data Sharing (GDS) Policy, effective January 25, 2015. This policy sets forth new expectations to ensure "broad and responsible sharing of genomic research data."

The GDS policy applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent research. This policy apples to: 

• Competing grant applications that are submitted to NIH for the January 25, 2015, receipt date or subsequent receipt dates
• Proposals for contracts that are submitted to NIH on or after January 25, 2015
• NIH intramural research projects generating genomic data on or after January 25, 2015

Examples of such research include, but are not limited to, projects involving:

• Sequence data from more than one gene or region of comparable size in the genomes of more than 1,000 human research participants
• Sequence data from more than 100 genes or region of comparable size in the genomes of more than 100 human research participants
• Data from 300,000 or more variant sites in more than 1,000 human research participants
• Sequence data from more than 100 isolates from infectious organisms
• Sequence data from more than 100 metagenomes of human or model organism microbiomes
• Whole genome or exome sequence data of more than one model organism species or strain
• Comprehensive catalog of transcripts and non-coding RNA from one or more model organism species of strains
• Catalog of more than 100,000 single nucleotide polymorphisms (SNPs) from one or more model organism species or strains
• Comparisons of genome-wide methylated sites across more than 10 cell types
• Comparisons of differentially methylated sites genome-wide at single-base resolution within a given sample (e.g., within the same subject over time or across cell types within the same subject) 

Investigators should contact NIH program officials as early as possible to discuss expectations and timelines for data sharing in a particular proposed study. In addition, funding proposals must include a section for GDS within the Resource Sharing Plan, and the project budget should include any resources needed to support the GDS plan (e.g., preparation of data for submission). The NIH will then expect a more detailed GDS plan during the just-in-time process. 

The institutional certification required for sharing data should be provided to the funding IC prior to award, along with other just-in-time documents. Subsequently, the GDS plan will be referenced as a condition of award. Compliance with the GDS plan typically will be reviewed by the funding NIH IC at the time of annual progress reports or other appropriate scientific project reviews. The GDS plan may be requested at other times, depending on the reporting requirements specified by the IC for specific programs or projects. 

Frequently Asked Questions:

Why did NIH issue this policy?

The National Institutes of Health issued the Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products, and procedures that improve health while protecting the privacy of research participants. The GDS policy is an extension of and replaces the Genome-Wide Association Studies (GWAS) data sharing policy. 

What is the new policy?

Briefly, this policy sets forth new expectations to ensure "broad and responsible sharing of genomic research data."

The GDS policy applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the use of these data for subsequent data. With regard to the effective date, this policy applies to:

• Competing grant applications that are submitted to NIH for the January 25, 2015, receipt date or subsequent receipt dates
• Proposals for contracts that are submitted to NIH on or after January 25, 2015
• NIH intramural research projects generating genomic data on or after January 25, 2015

Does the new GDS policy apply to research funded before the effective date of the policy?

Although the GDS policy does not apply to research submitted prior to the policy's effective date, NIH still encourages investigators to comply with the expectations outlined in the policy. Investigators should provide an updated genomic data sharing plan to the funding IC within the submission of the Research Performance Progress Report. For studies involving human participants that were initiated before the policy's effective date and that used consents that do not meet the expectations of the GDS policy, investigators are expected to plan a transition to a compliant consent for future research uses and broad sharing (particularly for new or additional collections of specimens). There will be reasonable accommodation, determined on a case-by-case basis by the funding IC, for long-term projects ongoing at the time of the policy's effective date to align with NIH's expectations for consent and data sharing. 

Does the GDS policy apply to genomic data derived from non-human sources, such as vertebrate animals, non-human primates, invertebrates, microbes, and viruses? 

Yes. The GDS policy applies to all NIH-funded research that generates large-scale human and/or non-human genomic data, as well as the use of these data for subsequent research. Examples of the types of data subject to this policy can be found on the GDS supplementary information website. 

Does the GDS policy apply to all NIH-funded research projects?

Yes. The GDS policy has no direct-cost-threshold associated with it and applies to grant activities that request support for research: 

• Research project grants (R's)
• Program projects (P's) and SCORs (S's)
• Cooperative agreements for research (U's)
• Individual career development awards (K's) that include a research component
• S activities that include a research component, and
• All other activities that include a research component

Large-scale data includes genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transciptomic, metagenomic, epigenomic, and gene expression data, irrespective of funding level or funding mechanism (e.g. grant, contract, cooperative agreement, or intramural support). Note that the scope is intentionally general enough to accommodate the evolving nature of genomic technologies; therefore, it is not limited to the types of data listed above. 

The GDS does not apply to:

• Institutional training grants (T32s, T34s, T35s, and TL2s)
• K12 career development awards (KL2s)
• Individual fellowships (F's)
• Resource grants and contracts (S's)
• Linked awards derived from previously reviewed applications (KL1, KL2, RL1, RL2, RL5, RL9, TL1, UL1)
• Facilities or coordinating centers funding through related initiatives to provide genotyping, sequencing, or other core services in support of GDS 

What are the investigator's responsibilities in relation to the GDS policy?

Investigators should review the policy in full, particularly the supplemental information that outlines data types and expectations for submission and the release of data. 

Investigators preparing 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. 

Investigators proposing such research are expected to include a genomic data sharing plan that meets the expectations of the GDS policy with the extramural funding application or prior to the start of the intramural research projects. NIH advises investigators seeking funding to contact relevant extramural program directors or an NIH institute or center's Genomic Program Administrator (GPA) as early as possible to discuss data sharing expectations and timelines that would apply to their propsoed studies. For a list of GPAs, visit the NIH website. 

What is VUMC's responsibility in relation to the GDS policy?

NIH expects any insitution submitting data to certify that the data were collected in a legal and ethically appropriate manner and that personal identifiers, such as names or addresses, have been removed. The NIH GDS policy also expects investigators and their institutions to provide basic plans for following the GDS policy as part of funding proposals and applications. 

With the implementation of the GDS policy, submission of the Institutional Certification for human genomic data will become part of the NIH grant application process. The authorized institutional official of the insitution submitting the application should provide the institutional certification to assure that the proposal for data submission and sharing is consistent with the appropriate laws and regulations and to delineate the appropriate research uses of data. Following initial peer review and prior to award, potential grantee institutions will be asked to submit an Institutional Certification through the standard just-in-time process. 

Are there any exceptions to the requirement to share human data?

In situations where the sharing of human data is not possible (i.e. the Institutional Certification criteria cannot be met), applicants should provide a justification explaining why they cannot share these data and provide an alternate data sharing plan. Exceptions to NIH expectations for data submission to an NIH-designated data repository will be considered on a case-by case basis by the NIH funding institute or center (IC). 

Does NIH specify which data repositories must be used?

Non-human data may be made available through any widely used data repository, whether NIH-funded or not, such as the Gene Expression Omnibus (GEO), Sequence Read Archive (SRA), Trace Archive, ArrayExpress, Mouse Genome Informatics (MGI), WormBase, the Zebrafish Model Organism Database (ZFIN), GenBank, European Nucleotide Archive (ENA), or DNA Data Bank of Japan (DDBJ). NIH expects investigators to continue submitting data types to the same repositories that they submitted the data to before the effective date of the GDS policy (e.g. DNA sequence data to GenBank/ENA/DDBJ, expression data to GEO or Array Express). Data types not previously submitted to repositories may be submitted to these or other widely used repositories as agreed to by the funding IC. 

Investigators should register all studies with human genomic data that fall within the scope of the GDS policy in dbGaP by the time that data cleaning and quality control measures begin, regardless of which NIH-designated data repository will receive the data. After registration in dbGaP, investigators should submit the data to the relevant NIH-designated data repository (e.g. dbGap, GEO, SRA). NIH-designated repositories need not be the exclusive source for facilitating the sharing of genomic data; that is, investigators may also elect to submit data to a non-NIH-designated data repository in addition to an NIH-designated data repository. However, investigators should ensure that appropriate data security measures are in place and that confidentiality, privacy, and data use measures are consistent with GDS policy. 

Will the genomic data sharing plan submitted with an application be subject to peer review? 

During peer review, reviewers will be asked to comment on the genomic data sharing plan, but reviewers will not factor the plan into the overall impact score, unless specified in the Funding Opportunity Announcement. After initial peer review, NIH program officers may do one of three things: accept the plan as provided, recommend changes to the application, or request additional information. 

Will the GDS policy impact grant award terms and conditions?

Yes. If the grant is funded, the resource sharing plan, including the genomic data sharing plan, will be referenced as a special term and condition on the notice-of-award (NGA or NOA). Failure to comply with the special award terms and conditions may result in an enforcement action as outlined in the NIH Grants Policy Statement Section 8.5: Special Award Conditions and Enforcement Actions. 

How will NIH oversee the new GDS policy?

The NIH GDS governance structure will be responsible for oversight of the GDS policy, including policy needs and issues related to data submission and access. The committees will also monitor scientific and ethical or legal developments that might warrant further policy development. Compliance with the policy will become a special condition in the grant or contract award. Failure to comply could lead to enforcement actions. 

Where can I get more information and guidance?

Investigators proposing such research are expected to include a genomic data sharing plan that meets the expectations of the GDS policy with the extramural funding application or prior to the start of intramural research projects. NIH advises investigators seeking funding to contact relevant extramural program directors or an NIH institute or center Genomic Program Administrator (GPA) as early as possible to discuss data sharing expectations and timelines that would apply to their proposed study.

GWAS Data Sharing Plan

GDS Policy Supplemental Information

GWAS Points-to-Consider