NIH Genomic Data Sharing Policy
Genomic research advances our understanding of factors that influence health and disease, and sharing genomic data provides opportunities to accelerate that research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human data from a wide range of genomic research and to provide appropriate protections for research involving human data, the National Institutes of Health (NIH) issued the NIH Genomic Data Sharing Policy (GDS Policy) on August 27, 2014 in the NIH Guide Grants and Contracts (available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html), and in the Federal Register (available at https://federalregister.gov/a/2014-20385) on August 28, 2014. The GDS Policy and related documents are available at:
The GDS Policy applies to all NIH-funded research (e.g., grants, contracts, 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. Supplemental Information to the GDS Policy provides examples of genomic research projects that are subject to the Policy.
The GDS Policy takes effect 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 January 25, 2015. It describes the responsibilities of investigators and institutions for the submission of human and non-human genomic data to data repositories and the secondary research use of such data as well as expectations regarding intellectual property. The GDS Policy also reflects NIH’s commitment to responsible data stewardship and includes a number of provisions to assure the protection of human data.
Research that was initiated prior to the effective date of the GDS Policy will continue to operate under the terms of the policies that were in effect when the research began, such as the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy), the 2004 NIH Policy on Sharing of Model Organisms for Biomedical Research, or the 2003 NIH Data Sharing Policy, however, NIH strongly encourages investigators to comply with the expectations outlined in the Policy. For studies initiated before the Policy’s effective date that involved human specimens and did not use consents that meet the expectations of the GDS Policy, investigators should plan to transition to a consent for future research uses and broad sharing, if possible.
The draft GDS Policy was published in the Federal Register on September 20, 2013, for a 60-day public comment period, which ended November 20, 2013. The draft Policy remains available at http://www.federalregister.gov/a/2013-22941, and the public comments are available at http://gds.nih.gov/pdf/GDS_Policy_Public_Comments.pdf. A webinar explaining the draft NIH GDS Policy Public Consultation was held on November 6, 2013 and is available at http://pdf/Draft_GDS_Policy_Webinar_November_6_2013.pdf.
Other NIH Data Sharing Policies
- Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (2008)
- NIH Data Sharing Policy (2003)
The following NIH websites provide additional information on genomic research and the GWAS Policy: