1. Service Units
  2. Research Integrity & Compliance
  3. Financial Conflict of Interest
  4. Key Definitions
  • uconn
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Key Definitions

Who is an investigator?

Per the U.S. Public Health Service (PHS) definition, an “investigator” is the principal investigator (PI) and any other person (regardless of title or position) identified by the PI as someone responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

How has the UConn FCOI policy changed?

UConn’s revised FCOI 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.

Significant Financial Interest (SFI) – PHS funding:

  • 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
  • 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 Immediate Family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.

*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

Significant Financial Interest (SFI) – Non-PHS funding:

  • An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
  • Salary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $5,000 or are expected to exceed $5,000 over the next 12 months.

 

Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:

  • Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
  • A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
  • Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.

 

The term Significant Financial Interest does not include the following types of financial interests:

  • Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights;
  • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
  • Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
  • Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
  • Travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.