The Council on Governmental Relations (COGR), representing over 170 major research universities, presented a detailed critique to the National Institutes of Health (NIH) regarding its proposed policy on data sharing from Genome-Wide Association Studies (GWAS). While COGR supports NIH’s overarching goal to maximize research resources and address health challenges via genetic data sharing, it raises several critical concerns about policy implementation. COGR argues that the policy should apply strictly to active grant awards rather than all applicants and questions the necessity of submitting extensive supporting documentation, highlighting risks of compromising participant identity and increasing administrative burden without clear benefit.
Furthermore, COGR expresses substantial reservations about human subjects protections, particularly regarding informed consent for future, unspecified research uses, and the potential conflicts between NIH policy and existing Office of Human Research Protections (OHRP) guidance. The letter points out ambiguities around data de-identification standards and the management of consent exclusions, warning that increased complexity may deter institutional participation. COGR also scrutinizes intellectual property provisions, arguing that overly broad restrictions on patent claims could stifle innovation and conflict with the Bayh-Dole Act, potentially impeding technology transfer to the public. COGR urges NIH to clarify these aspects, emphasizing the need for alignment with existing legal frameworks, respect for local Institutional Review Boards (IRBs), and practical considerations for data management and sharing.
