The new NIH policy for Genomic Data Sharing (GDS) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html requires investigators to incorporate a genomic data sharing plan in the ‘resource sharing’ section of their application. This policy applies to:
- Competing grant applications that are submitted to NIH for the January 25, 2015, due date or subsequent due dates;
- Proposals for contracts that are submitted to NIH on or after January 25, 2015; and
- NIH intramural research projects generating genomic data on or after January 25, 2015.
The following are key points from the policy:
- The policy sets forth expectations that ensure the 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. Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data, irrespective of funding level and funding mechanism (e.g., grant, contract, cooperative agreement, or intramural support). The Supplemental Information to the NIH Genomic Data Sharing Policy provides examples of research projects involving large-scale genomic data that are subject to the Policy. NIH Institute or Centers (IC) may expect submission of data from smaller scale research projects based on the state of the science, the programmatic priorities of the IC funding the research, and the utility of the data for the research community.
- 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.
- 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.
- 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. This certification will be obtained from the Pitt Office of Research.
- Data Submission Expectations and Timeline
Investigators should submit large-scale human genomic data as well as relevant associated data (e.g., phenotype and exposure data) to an NIH-designated data repository in a timely manner. Investigators should also submit any information necessary to interpret the submitted genomic data, such as study protocols, data instruments, and survey tools. This timeline should be summarized in the data sharing plan.
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 general, NIH will release data submitted to NIH-designated data repositories no later than six months after the initial data submission begins, or at the time of acceptance of the first publication, whichever occurs first, without restrictions on publication or other dissemination.
Investigators should de-identify human genomic data that they submit to NIH-designated data repositories according to the standards set forth in the HHS Regulations for the Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained with the data. Investigators should also strip the data of identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The de-identified data should be assigned random, unique codes by the investigator, and the key to other study identifiers held by the submitting institution.
- It is imperative that investigators develop a realistic budget for the data sharing solution that is being proposed
A committee is being convened by the Office of Research to develop guidance and examples of data sharing plans and informed consent form language. In addition, the CTSI will develop educational programs and make CTSI Research Facilitators available to assist with data sharing plans. More information about these resources will be sent at a later date.