Policy Revision Notification

In August 2011, the U.S. Department of Health and Human Services (HHS) issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations regarding Financial Conflicts of Interest (FCOI). (42 C.F.R. Part 50, Subpart F - Responsibility of Applicants for Promoting Objectivity in Research and 45 C.F.R. Part 94 - Responsible Prospective Contractors).  An Institution applying for or receiving PHS funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than August 24, 2012.  Major changes to the previous regulations from 1995 include:

  • Lower significant financial disclosure thresholds ($5,000 minimum threshold)
  • New FCOI training (every 4 years for investigators receiving PHS funds)
  • New FCOI public accessibility requirements
  • Increased transparency for reimbursed or sponsored travel
Hartford HealthCare and Hartford Hospital Research Institute’s FCOI in Research policy has been revised to meet PHS requirements and can be found on Hartford Hospital’s website.  In addition, Institutional FCOI procedural changes applicable to all researchers are underway, including revised FCOI Disclosure forms, frequency of reporting, and reporting requirements.  Additional information and training sessions will be provided in the near future.

For questions please contact:
Cherie Bilbie, Director, Human Research Protection Program ext. (860)972-0088 or
Angelo Quaresima, Senior Auditor/Research ext. (860)972-7065

HHC/HH Research Institute FCOI Policy

Frequently Asked Questions (FAQs)


ADDITIONAL RESOURCES

NIH Grants Policy Statement – effective 10/1/11
NIH Summary of Major COI Changes
NIH – FCOI Web Page
NIH FAQs to 2011 Revised FCOI Regulations
NIH FCOI Training Tutorial