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FCOI Resources

KEY DEFINITIONS:

  • Investigator means the project director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, which may include, for example, collaborators or consultants.
  • Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the institution which may include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
  • Financial Interest Related to Research exists when the University, through its designated official(s), reasonably determines that the significant financial interest: could be affected by the research or; is in an entity whose financial interest could be affected by the research.
  • Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of research.
  • Significant Financial Interest (SFI) is a financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:
    • With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000 or represents more than 5% ownership in any single entity.  For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    • With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
    • Intellectual property rights and interests (e.g., patents, licensing agreements, trademarks, or copyrights) upon receipt of income related to such rights and interests;
    • For PHS-funded investigators, any reimbursed or sponsored travel related to their institutional responsibilities if the value when aggregated exceeds $5,000 from any single entity.

FREQUENTLY ASKED QUESTIONS:

What is a Financial Conflict of Interest?

  • Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of research.
  • The UConn Health policy on Individual Financial Conflicts of Interest in Research promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by any conflicting financial interest of an investigator.

How has the policy changed?

  • The revised policy was effective on August 24, 2012 and corresponds with the 2011 Public Health Service revised financial conflict of interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.
  • The Policy applies to all investigators responsible for the design, conduct or reporting of research.

Who is an investigator?

  • Investigator means the project director or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (regardless of sponsor or funding source), which may include, for example, collaborators or consultants.

What are my responsibilities as an investigator?

  • Understand the UConn Health policy on financial conflicts of interest in research and know the definition of SFI and how it applies to you.
  • Promptly and fully disclose any significant financial interest (including those of a spouse or dependent child) that reasonably relates to your institutional responsibilities and, if applicable, comply with financial conflict of interest management or mitigation plans.
  • Submit a disclosure in UConn Health COI-SMART annually.
  • Attend to your on-going responsibility to disclose, within thirty (30) days, any newly acquired or discovered SFIs.  You must update your disclosure in COI-SMART when this occurs.
  • Investigators, coordinators, and persons obtaining consent must also disclose SFIs to the Institutional Review Board (IRB) pursuant to UConn Health Human Subject Protection Program (HSPP) policies.