Comment Letter

COGR Submits Comment Letter in Response to Notice to Announce NIH Updated Policy Guidance for Subaward/Consortium Written Agreements (88 FR 36603)

The Council on Governmental Relations (COGR), representing over 200 research universities and affiliated institutions in the United States, submitted formal comments to the NIH concerning the recently updated policy guidance on subaward/consortium written agreements, specifically the provision requiring foreign subrecipients to provide prime recipients with all lab notebooks, data, and documentation supporting research outcomes semiannually. COGR expressed significant concern that this Foreign Subrecipient (FS) Provision is overly broad and imposes substantial administrative and financial burdens that could undermine important international research collaborations. While COGR supports the general goal of transparency and accountability in federal research funding, it argues the FS Provision duplicates and exceeds requirements already addressed by the 2023 NIH Data Management and Sharing (DMS) Policy.

COGR contends that the 2023 DMS Policy provides a more effective framework for data sharing by requiring data management plans and annual monitoring, adequately supporting the integrity and reproducibility of research. In contrast, the FS Provision mandates collection and transfer of extensive raw data, including lab notebooks—materials excluded from the DMS Policy’s definition of scientific data—making compliance impractical and potentially conflicting with international intellectual property, privacy, and data protection laws, such as the GDPR. COGR warns that enforcing this provision solely on the basis of foreign status, without a risk-based justification, risks fostering perceptions of xenophobia and will likely chill or sever vital global collaborations. The organization recommends eliminating the FS Provision and, instead, modifying the DMS Policy to allow for enhanced reporting requirements only in cases of elevated risk, as determined by research type or collaboration with countries of concern. Ultimately, COGR urges the NIH to balance research integrity with the need to foster and preserve international scientific partnerships, which are critical to addressing global health challenges.

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