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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 financial disclosure annually in the InfoEd Financial Interests [FCOI] system: https://uchealth.infoed.uconn.edu/WebPortal/Main.asp?Mode=COIUserSearch.  See How-to Guides and Materials for assistance with using the InfoEd FCOI system: https://research.uchc.edu/rcs/fcoi/howto/
  • Attend to your on-going responsibility to disclose, within thirty (30) days, any newly acquired or discovered SFIs.  You must update your disclosure within the InfoEd Financial Interests [FCOI] system when this occurs.
  • Investigators, coordinators, and persons obtaining consent must also disclose SFIs pursuant to UConn Health Human Subject Protection Program (HSPP) policies.

What is new in 2018?

  • The Office of the Vice President for Research, Research Compliance Services, transitioned the annual financial disclosure electronic submission process to a new vendor platform, InfoEd Financial Interests (FCOI).
  • When the 2018 Annual Financial Disclosure reporting period opened, an automated e-mail inviting some individuals to complete the financial disclosure questionnaire was distributed. The sender name on the e-mail is fcoi@uchc.edu and the email subject is: ACTION REQUIRED: Annual Financial Disclosure Due.
  • Individuals at UConn Health who have been identified as subject to the Individual, Clinical, and/or Institutional conflict of interest policies will receive the email invitation and must log in to the new InfoEd FCOI system to submit the required disclosure.
  • If you receive the invitation and believe you are not subject to the policies, you will have an opportunity to report this on the Welcome page of the financial disclosure form.

What individuals at UConn Health are required to submit a financial disclosure in the new InfoEd FCOI system?

  • Please see the information below regarding the three roles at UConn Health (i.e., research investigators, clinical practitioners, and certain Institutional Officials) who are subject to the policies and are required to submit a financial disclosure.  Please note, individuals who have more than one of these roles at UConn Health are only required to submit one disclosure in the InfoEd FCOI system.  The one disclosure will cover any of the above policies for which the individual is required to disclose.
  • Researchers and Institutional Officials/Covered Officials responsible for research oversight:  Individuals who previously disclosed in the previous electronic system as a Researcher or IO/CO will receive an e-mail invitation to InfoEd FCOI.  If you do not receive an automated e-mail invitation and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or gfernandez@uchc.edu or fcoi@uchc.edu.
  • Others (Clinical practitioners):  Individuals who have never been a Researcher or IO/CO and who receive the invitation have been identified by the Clinical Conflict of Interest Committee as required to submit a financial disclosure under the Individual Financial Conflicts of Interest in Clinical Health Care policy.  If you have questions related to this policy, you may email the Clinical Conflict of Interest Committee at CCoI@uchc.edu.