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Analysis in Brief

Analysis in Brief presents recent findings from the AAMC's data collection and research activities in a concise, easy-to-read report. Published several times a year, it addresses a wide range of topics and trends that affect medical schools and teaching hospitals.

Implementing the Regulations on Financial Conflicts of Interest: Results from the AAMC Conflict of Interest Metrics Project

This Analysis in Brief presents key results from the first two years of the AAMC Conflict of Interest Metrics Project, an initiative to understand the effect of changes to the U.S. Department of Health and Human Services regulations on conflicts of interest in federally funded research. The 2011 revised rule maintained the framework of the previous regulations but made specific changes to the values and types of significant financial interests (SFIs) that investigators must disclose.  As demonstrated by the results presented here, 71 institutions participating in the AAMC COI Metrics Project spent almost $23 million to come into compliance with the requirements of the regulations, including $11.6 million in one-time personnel costs, $9.7 million in capital expenditures, primarily financial interest-tracking software, and $1.2 million in other costs, such as training.  During the same period, the number of SFIs reviewed by institutions dramatically increased after implementation of the rule, without a proportional increase in the number of reported financial conflicts of interest identified and reported to a funding agency.  The methods and results for this initiative not only provide a mechanism to assess the effect and effectiveness of this regulatory change, but also suggest a model for the evaluation of burdens and benefits of other current or proposed regulations

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AAMC COI Metrics Project