Effective Jan. 25, NIH grant application submissions involving the generation or use of large-scale genomic data have new requirements. The new policy promotes sharing, for research purposes, of large-scale human and non-human genomic1 data generated from NIH-funded research.
Applicants preparing such 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, and
- include a genomic data sharing plan in the application. If sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan.
- Applicants who plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in 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, in the Research Plan of the application.
- Applicants preparing applications that involve research funded prior to the Policy’s effective date should:
- make every effort to include a genomic data sharing plan in the application that outlines plans to comply with the expectations outlined in the Policy, and
- plan to transition to a consent for future research uses and broad sharing, if possible, if the studies involve human participants and were initiated before the Policy’s effective date and used consents that do not meet the expectations of the GDS Policy.
With implementation of the Genomic Data sharing Policy, submission of the Institutional Certification for human genomic data will become part of the standard Just-in-Time process. Additional guidance for, researchers and institutions submitting grant applications and contract proposals involving large-scale genomic data is available on the Genomic Data Sharing website: (https://gds.nih.gov/).
