The Council on Governmental Relations (COGR), representing over 170 research universities and affiliated institutions, provided comprehensive feedback to the National Institutes of Health (NIH) regarding its proposed policy for sharing data from Genome-Wide Association Studies (GWAS). While COGR supports the NIH’s objective to enhance research through broad data availability, it raises substantive concerns about the policy’s applicability, data submission requirements, and implications for human subject protections and intellectual property rights. The organization argues that the policy should be limited to awarded projects rather than all applicants, and it questions the necessity of submitting extensive supporting documentation beyond the genotype and phenotype data. COGR expresses apprehension that such requirements could compromise participant de-identification and privacy, particularly for studies of rare conditions, and notes potential inconsistencies with existing regulatory guidance from the Office for Human Research Protections (OHRP), especially regarding informed consent and local Institutional Review Board (IRB) authority.
Furthermore, COGR highlights operational challenges the policy may create for institutions, such as complex data management, IRB responsibilities, and differing standards for de-identification. The group stresses that the policy may inadvertently discourage institutional participation and research funding. Regarding intellectual property, COGR supports open data sharing but finds the NIH’s proposed restrictions on patenting research conclusions derived from shared datasets overreaching and potentially at odds with the Bayh-Dole Act, which governs patent rights from federally funded research. The organization calls for greater clarity and consistency in NIH policies, arguing that excessively broad limitations on patenting could impede technological innovation, the commercialization of research tools, and ultimately, public benefit. COGR concludes by urging the NIH to carefully reconsider these issues as it finalizes the GWAS data-sharing policy.
