In August 2011, the US Department of Health and Human Services issued its final rule on governing Financial Conflict of Interest (FCOI) in research funded by the Public Health Service (PHS). In an effort to support institutional compliance with federal regulations, Saint Louis University published a revised Financial Conflict of Interest in Research Policy effective August 24, 2012. This policy includes significant changes for all individuals involved in the design, conduct, or reporting of research regardless of the funding source. The key changes to institutional policy includes the following:
- Mandatory FCOI Training (Online FCOI training through CITI)
- Lower Threshold Disclosure
- Any combined income, compensation or stock in excess of $5,000 from a publicly-traded or non-publicly traded entity to the Investigator, including the Investigator's spouse and dependent children must be disclosed.
- Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity (such as a start-up company) to the Investigator, including the Investigator's spouse and dependent children must be disclosed, regardless of value.
- Mandatory Travel Disclosure
- Any reimbursed or sponsored travel to the Investigator (including Investigator's spouse and/or dependent children) paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution of higher education or a research institute affiliated with such, a medical center, or an academic teaching hospital must be disclosed within 30 days of each occurrence.
- Mandatory Disclosures Annually and Within 30 days of Discovery
- All persons involved in the design, conduct, or reporting of research are required to disclose all Significant Financial Interests (including travel) whether or not an actual Financial Conflict of Interest exists. Each investigator must submit an updated disclosure of Significant Financial Interests within 30 days of discovering or acquiring a new Significant Financial Interest.
Financial Conflict of Interest in Research Policy
FCOI - Overview
Click Here for eFCOI Disclosure Instructions