The document, a presentation by Heather Pierce, addresses the evolution, implementation, and impact of federal regulations on financial conflicts of interest (FCOI) in research, specifically those funded by the Public Health Service (PHS). It outlines the timeline of regulatory revisions, beginning with the original rules from 1995, the advance notice in 2009, proposed changes in 2010, and culminating with the final rule in 2011, which became enforceable in 2012. The presentation details the criteria for significant financial interests (SFIs) disclosure and the reporting responsibilities of both investigators and institutions, emphasizing thresholds such as $5,000 and $10,000 and the inclusion of travel disclosures.
An extensive analysis conducted by the Association of American Medical Colleges (AAMC) measured institutional investments required for compliance, revealing that 71 institutions collectively spent $23 million in one-time implementation costs, with subsequent annual administrative costs averaging over $300,000 per institution. The data show that the introduction of stricter FCOI regulations led to a notable decrease in the proportion of disclosed SFIs that were determined to be actual FCOIs (from 4.8% to 1.4%). This suggests clearer definitions and stricter oversight following the regulatory overhaul. The document also notes increased administrative demands, including staffing needs, and references ongoing efforts to streamline the disclosure process, such as the development of secure, user-friendly, and interoperable digital platforms. In summary, the presentation comprehensively evaluates regulatory changes' cost, operational implications, and early effectiveness, providing a foundation for continued monitoring and future improvements in managing conflicts of interest in research.
