Policy Perspective

RIN 0925-AA53, Docket No NIH-2010-0001

The Council on Governmental Relations (COGR), representing 183 major research universities and affiliated centers, submitted comprehensive comments regarding proposed amendments to Public Health Service (PHS) regulations on promoting objectivity in research funded by the federal government. COGR expresses support for the overarching goal of ensuring research objectivity and transparency around financial conflicts of interest (FCOI), but raises significant concerns about the practical implications, costs, and potential unintended consequences of the proposed amendments. The organization cautions that requirements such as public posting of FCOI information may risk misinterpretation, damage reputations without improving oversight, and discourage valuable collaborations—especially among junior investigators or in translational research areas. COGR strongly recommends delaying any public posting requirement until after October 2013, allowing for meaningful consultation with the research community and alignment with related federal transparency initiatives.

COGR further argues that the proposed regulations underestimate the compliance costs for institutions, which have already been facing capped administrative cost recovery and numerous unfunded federal mandates. To address these challenges, the organization suggests that NIH provide dedicated grant support to assist institutions with systems development, training, and other compliance activities. In its detailed feedback, COGR proposes specific revisions to definitions, reporting thresholds, institutional responsibilities, and management plans, emphasizing the need for clear, feasible, and uniform regulations that respect both institutional diversity and legal constraints, especially for state-assisted and international collaborators. The organization concludes by affirming its commitment to research objectivity and requests a measured, consultative approach to regulatory changes that balances public trust with operational realities.