ATTENTION: NIH Issues Update on Genomic Data Sharing

The National Institutes of Health (NIH) is updating its Genomic Data Sharing (GDS) Policy to align with evolving practices in data management, particularly concerning controlled-access human genomic data. The updates, which are effective Jan. 25 and apply to the 20 repositories listed here, focus on two main areas: modernizing security standards for data protection for Approved Users and setting minimum access requirements for Developers. Researchers accessing human genomic data from NIH controlled access repositories must attest the institutional systems they use to store or access the data meet the requirements of NIST SP 800-171 regardless of whether the research project involving the genomic data is sponsored or funded by NIH. The policy will apply to new user agreements beginning Jan. 25, 2025. Existing user agreements will need to address the new security standards when their data use certifications/agreements require renewal.

Q: I am a PI. What should I do prior to providing attestation for a new or renewing project?

A: You must consult your IT or central IT representative (ITS/HITS) to discuss your project-specific data access and storage needs and to confirm project and institutional compliance.

Q: My data is already stored in a university enclave. Do I need to move it?

A: It is possible that you may need to shift the data to a different system/enclave to be compliant with the policy update.

Q: What if IT systems compliance needs require funding or resources?

A: Meeting compliance requirements often involves additional costs. PIs should work with their unit IT or central IT representative (ITS/HITS) as part of proposal development to assess compliance requirements and determine if additional funding is required.

Q: I have not yet submitted a data access request. Where can I seek support for submitting a request?

A: Your unit IT or central IT representative (ITS/HITS) can discuss how the project can be supported and provide any additional information.

For additional questions regarding this policy, please contact the NIH Office of Science Policy.