The NIH Genomic Data Sharing Policy ensures the broad and responsible sharing of genomic research data and applies to all NIH-funded research that generates or uses large-scale human or non-human genomic data as well as 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.
Effective for new and renewal applications due or after January 25, 2023
In an effort to reduce the burden of duplicative reporting expectations, NIH is establishing a single Plan submission requirement for research subject to both the NIH Genomic Data Sharing Policy (GDS Policy) and the NIH Policy for Data Management and Sharing (DMS Policy).
Generation/Use of Large-Scale Genomic Data
Secondary Use Controlled-Access Human Genomic Data from NIH-Designated Respositories
Obtaining Institutional Certification
Submit Data to dbGaP
- Confirm with the PI or their delegate if there have been changes to the consent form since the JIT Stage.
- If there are no changes to the consent form:
- Maintain the confirmation as back-up for the submission
- Use the Institutional Certification Letter submitted at JIT
- If there have been changes to the consent form:
- The PI should work with IRB to obtain the GDS Data Submission Certification Letter
- OSR will provide an Institutional Certification letter with the following information to the PI for signature.
- Complete sponsor and institution contact information, project title, salutation and signature blocks.
- A Certified Officer can then forward the Institutional Certification letter to Grants Management Specialist of the funding NIH Institute with the PI’s request to submit large-scale human data to dbGaP.