NIH Genomic Data Sharing Policy
This article outlines U-M guidance for principal investigators seeking NIH funding for projects subject to the NIH Genomic Data Sharing Policy, including proposal, just-in-time and institutional certification requirements.
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Principal investigators (PIs) applying for NIH funding should review the NIH Genomic Data Sharing Policy (GDS) early in the proposal process to determine whether it applies to their research. If applicable, PIs must address genomic data sharing expectations in the proposal, coordinate with the appropriate NIH institute or center, and work with U-M offices to meet just-in-time (JIT) and institutional certification requirements for human or non-human genomic data.
Guidelines for compliance
Prior to proposal preparation
- Review the NIH Genomic Data Sharing Policy (GDS) and visit NIH’s Genomic Data Sharing Website for further clarification and understanding.
- Review NIH’s Supplemental Information to the NIH Genomic Data Sharing Policy to ascertain whether the GDS policy applies to their research.
PI responsibilities if GDS policy applies
- Contact the appropriate NIH institute or center (IC) program official or project officer as early as possible to discuss data sharing expectations and timelines that would apply.
- Include a statement in the cover letter if the proposed studies will generate large-scale human or non-genomic data as detailed in the NIH Genomic Data Sharing Policy.
- For applications subject to both NIH Data Management and Sharing Policy and the NIH Genomic Data Sharing Policy, investigators should address genomic data sharing expectations within the NIH Data Management and Sharing Policy. Include resources needed to support a proposed genomic data sharing plan in the project’s budget.
- NIH may request additional or revised information before award through the JIT process. For projects subject to the GDS Policy, NIH may require an updated Data Management and Sharing Plan and for human genomic data, an Institutional Certification before award.
Non-Human Genomic Data
For NIH proposals generating non-human genomic data, response to the JIT request includes a more detailed genomic data sharing plan consistent with the GDS Policy and NIH’s expectations for data sharing and timing of data release. Data is 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, Array Express, Mouse Genome Informatics (MGI), WormBase, the Zebrafish Model Organism Database (ZFIN), GenBank, European Nucleotide Archive (ENA), and DNA Data Bank of Japan (DDBJ).
Human Genomic Data
For NIH proposals generating human genomic data, response to the JIT request will include:
- A more detailed genomic data sharing plan that follows the GDS language provided by U-M’s IRB-MED and is compliant with both NIH’s GDS Policy and NIH’s Supplemental Information to the GDS Policy.
- An Institutional Certification signed by a signing official from the Office of Research and Sponsored Projects (ORSP) once U-M IRB review and assurance has been completed. The Institutional Certification shall use one of the templates provided by NIH, following the guidance provided by U-M’s IRB-MED for obtaining an Institutional Certification. Note that all U-M IRBs follow this same process for obtaining an Institutional Certification.