On August 25, 2011, the U.S. Department of Health and Human Services (HHS) published the final rule on financial conflicts of interest (FCOI) related to the conduct of research funded by the Public Health Service (PHS), entitled, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.”
In 2012, the AAMC initiated the COI Metrics Project to evaluate the cost and impact of the regulations covering one year prior to implementation of the regulations and two years following. The 74 participating institutions provided data about their COI programs and review processes, including the cost to implement and carry out the requirements and the number of FCOIs identified and reported to the National Institutes of Health (NIH) and other PHS funding entities.
In 2020, the AAMC conducted a limited follow up survey to understand the current impact of the regulations. In this component of the project, the AAMC engaged 65 institutions, 24 of which had participated in the initial data collection. Institutions provided data on the number of FCOIs identified and reported to a PHS funding entity in 2019 only. Results demonstrate that institutions committed substantial resources to come into compliance with the requirements. The number of financial interests reviewed by institutions also dramatically increased after implementation of the rule without a proportional increase in the number of FCOIs identified and reported to a funding agency. Access the COI Metrics Project Final Report here.
AAMC COI Metrics Project Results
- AAMC Conflicts of Interest Metrics Project Final Report: Measuring the Impact of the Public Health Service Regulations on Conflicts of Interest (December 2020)
- Analysis in Brief (April 2015) - Results from the first two years of the Metrics Project.
- AAMC Resources on Conflicts of Interest and Transparency
- AAMC Comments to White House Office of Science and Technology Policy (January 2020)
- AAMC COI Metrics Project Frequently Asked Questions
- Metrics Project Participating Institutions – Location Map
- AAMC Report on Institutional Approaches to Implementing the Final NIH Rule on Financial Conflicts of Interest (March 2012)
- HHS Final Rule, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought (August 25, 2011)
- AAMC-AAU-ACE-APLU Comment Letter in Response to NPRM (August 17, 2010)
For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel (firstname.lastname@example.org) or Daria Grayer, JD, MA, Senior Lead Specialist, Science Policy and Regulations (email@example.com).