The Council on Governmental Relations (COGR), representing 200 U.S. research universities and affiliated institutions, submitted comments to the National Institutes of Health (NIH) on proposed updates and long-term considerations for the NIH Genomic Data Sharing (GDS) Policy. COGR commends NIH’s efforts to solicit public input on balancing the imperative of data sharing—essential for scientific progress and research integrity—with the complex privacy, consent, and security concerns inherent in sharing human genomic data. Their response highlights the need for consistency between the GDS Policy and the HIPAA Privacy Rule, particularly regarding definitions and standards for identified and de-identified data. COGR advocates for harmonizing de-identification options, supports clear definitions for potentially identifiable data elements, and encourages careful consideration around the use and sharing of such data elements. They also recommend permitting data linkage under clearly defined protections and insist on the importance of addressing data linkage comprehensively in the participant consent process, including providing stakeholders with guidance and example consent language.
COGR further supports harmonizing the GDS and NIH Data Management and Sharing (DMS) Policies, especially in areas such as data management plan requirements, timelines for data sharing, and sensitive data identification, though they emphasize the current heterogeneity of data types. They recommend aligning data sharing timelines with those outlined in the DMS Policy while allowing flexibility for earlier sharing. Regarding policy scope, COGR suggests extending GDS Policy considerations to other omics research with similar privacy standards but advises against including small-scale studies unless explicit participant consent is obtained. Additionally, they recommend that training and career awards not automatically come under GDS Policy unless substantial research is directly funded. Lastly, COGR supports including NIH-funded research that generates large-scale genomic data, even if NIH does not fund the sequencing itself, within the scope of the GDS Policy, underlining the consistent nature of privacy and consent concerns across all research involving human genomic data.
