March 27, 2015 - COGR Letter to NIH on Proposed Extension of Reporting Requirements for FCOI

The document is a formal response from the Council on Governmental Relations (COGR), representing over 190 research universities, to the National Institutes of Health (NIH) regarding a proposed three-year extension of the reporting requirements associated with revised financial conflict of interest (FCOI) regulations for Public Health Service-funded research. COGR expresses general support for the goals of promoting research objectivity and increasing transparency but emphasizes the significant administrative and financial burdens imposed by the revised rules. COGR provides survey data illustrating sharp increases in workload, disclosures, and costs for research institutions following the implementation of the new FCOI requirements, including detailed accounts of the extensive effort required for disclosure and management of financial interests, particularly for unfunded proposals and subrecipients.

Despite a measurable rise in the number of disclosures, COGR notes that there has not been a corresponding increase in cases requiring conflict management, suggesting that the lower reporting thresholds and expanded scope of required disclosures contribute more to administrative burden than to enhanced oversight. The letter argues that some current requirements, such as disclosing significant financial interests at the proposal stage rather than upon award activation, and mandatory reporting of minor travel reimbursements or nonprofit income, have led to unnecessary inefficiencies without a significant benefit to research integrity. COGR urges NIH to reassess and potentially modify the FCOI reporting obligations to better balance transparency and oversight with the need to reduce administrative burden and costs, aligning future regulations with Congressional calls to optimize federal research investment by streamlining compliance requirements.