The Council on Governmental Relations (COGR), representing 183 research universities and affiliated institutions, provides a detailed response to the Public Health Service (PHS) proposed amendments concerning the responsibility of applicants to promote objectivity in research, as outlined in federal regulations. COGR underscores the importance of ensuring research objectivity, favoring regulatory amendments that directly serve this aim while cautioning against measures that impose undue administrative burden, increase compliance costs, and potentially deter valuable collaborations between academia and industry, especially early-career investigators. Of particular concern to COGR is the requirement for publicly posting financial conflicts of interest (FCOI) online. COGR argues that such public disclosures may be misinterpreted by those lacking sufficient context, leading to unwarranted reputational harm for researchers and inhibiting productive, translational research partnerships. They advocate instead for a more measured, consultative approach to transparency and accountability, including possible centralized reporting by PHS/NIH, and recommend a delayed implementation of any public posting requirement to allow adequate community input and system adaptation.
COGR also critiques the PHS's underestimation of the costs and administrative efforts entailed by the proposed regulations, particularly in system upgrades, training, subrecipient monitoring, and annual disclosure requirements. The Council rejects the assumption that existing administrative cost recovery mechanisms (F&A rates) can absorb these new expenses, pressing for supplemental support such as targeted grants akin to past NIH programs. Specific substantive feedback is provided on definitions, management plans, training frequency, and implementation timelines, emphasizing the need for consistency, clarity, and institutional flexibility. The Council appreciates the restraint PHS has shown on institutional FCOI regulations and stresses that enforcement and inter-institutional notification policies must balance institutional autonomy with compliance responsibilities. Ultimately, COGR urges that the effective date for any new requirements, especially public FCOI postings, be no sooner than October 2013, and calls for active partnership between the research community and PHS in refining and implementing regulatory changes that genuinely promote research integrity without unduly hampering scientific progress.
