The Council on Governmental Relations (COGR), representing 188 major research entities, provided detailed feedback on the Draft NIH Policy for Data Management and Sharing. COGR expressed broad support for the NIH’s emphasis on data sharing while highlighting the need for enhanced resources, tools, and centralized guidance to support efficient policy implementation across diverse scientific disciplines. They favor the NIH’s proposal to require Data Management and Sharing Plans (DMSP) during the Just-In-Time phase, reducing administrative burden, but caution that this timing complicates budgeting for data management costs and urge NIH to permit post-application budget adjustments. COGR requests mechanisms for appealing potentially unreasonable data sharing requirements and calls for improved institutional feedback mechanisms regarding DMSP review status.
COGR further recommends harmonization of supplemental requirements among NIH Institutes, Centers, and Offices (ICOs) to avoid community confusion, suggesting standardized formats for collecting DMSP information and metadata. They stress the importance of considering legal, ethical, technical, security, and privacy issues in plan development and call for clearer NIH support and resources on these matters. The association underscores the value of NIH-led data repositories to minimize duplicative efforts and address security concerns. Special attention is given to protections for human subject data, with COGR urging alignment with IRB roles and established policies like NIH’s Genomic Data Sharing Policy. Concerns are also raised about the assessment of compliance, ongoing post-award obligations, unforeseen costs—especially those linked to digitization and technological obsolescence—and the burden of extending such requirements to all NIH-funded projects. To mitigate these, COGR recommends clear guidance on allowable costs, sufficient lead time before implementation, reasonable embargo periods for intellectual property protection, and consideration of discipline-specific standards and best practices. They conclude by urging NIH to synchronize its policy with emerging government and open-access guidelines, ensuring the research community is adequately prepared for robust data management and sharing practices.
