FCOI Training

The Department of Health and Human Services (HHS) revised Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F), generally referred to as the Financial Conflict of Interest (FCOI) regulations, effective August 24, 2012.

A new component of the regulations impacts PHS-funded Investigators at TSRI.  An Investigator means anyone who is responsible for the design, conduct or reporting of PHS-funded research.  To facilitate compliance with PHS training requirements, TSRI has developed an on-line tutorial that must be completed prior to engaging in PHS-funded research.  Integrity of the on-line training is met by requiring certification at the end of the tutorial.  The certification is then recorded by TSRI.

All TSRI Investigators MUST complete FCOI training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances:

• institutional FCOI policies change in a manner that affects Investigator requirements;
• an Investigator is new to an Institution; or
• an Institution finds an Investigator noncompliant with Institution's FCOI policy or management plan.

TSRI has developed an on-line FCOI tutorial for PHS-funded Investigators available at http://coitraining.scripps.edu regarding the revised regulations.  All PHS-funded Investigators must complete online FCOI training prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards.  Training must be completed at least every four years.  Although PHS Notice of Awards that were received prior to August 24, 2012, are not subject to these new requirements until the noncompeting continuation award, and because research staff cycle on and off awards at varying times, TSRI is requiring that ALL research staff take the on-line FCOI tutorial to ensure compliance and consistency.