In April 2014, NIH released its Genomic Data Sharing (GDS) Policy (NOT-OD-14-124). “The GDS Policy became effective on January 25, 2015, and applies to all NIH-funded research (e.g., 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.”
The general responsibilities of investigators submitting genomic data sharing plans are listed below. More specific details of non-human and human genomic data sharing plans are found within the policy.
“Investigators seeking NIH funding 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. NIH expects investigators and their institutions to provide basic plans for following this Policy in the “Genomic Data Sharing Plan” located in the Resource Sharing Plan section of funding applications and proposals. 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. A more detailed genomic data sharing plan should be provided to the funding IC prior to award. The Institutional Certification (for sharing human data), should also be provided to the funding IC prior to award, along with any other Just-in-Time information. NIH expects intramural investigators to address compliance with genomic data sharing plans with their IC scientific leadership prior to initiating applicable research and are encouraged to contact their IC leadership or the Office of Intramural Research for guidance. The funding NIH IC will typically review compliance with genomic data sharing plans at the time of annual progress reports or other appropriate scientific project reviews, or at other times, depending on the reporting requirements specified by the IC for specific programs or projects….
Genomic data undergo different levels of data processing, which provides the basis for NIH’s expectations for data submission and timelines for the release of the data for access by investigators. These expectations and timelines are provided in the Supplemental Information. ”
In a March 2015 notice (NOT-OD-15-083), NIH reminded the research community that:
- 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.
Applications proposing such research are expected to include a genomic data sharing plan. Guidance on developing data sharing plans may be found here: http://gds.nih.gov/pdf/NIH_guidance_developing_GDS_plans.pdf.
Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories as a secondary user, to achieve the specific aim(s) of the research proposed, in the Research Plan of 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. “
Additional information on the GDS Policy may be found at: http://gds.nih.gov/index.html.