Significant Financial Interest

A significant financial interest (SFI) is defined as a financial interest consisting of one or more of the following interests of the Investigator (or those of his/her spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.  An SFI exists as defined in the following scenarios:

  • Publicly traded entity: If the value of any remuneration received from the entity in the 12 months preceding the disclosure   the value of any equity interest2 in the entity as of the date of disclosure, when aggregated, exceeds $5,000.  This includes:
    • Salary
    • Any payment for services not otherwise identified as salary
    • Consulting fees
    • Honoraria
    • Paid authorship
    • Equity interest (e.g., stock, stock option, or other ownership interest)

 

  • Non-publicly traded entity: If the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated exceeds $5,000, or when the Investigator holds any equity interest

 

  • Intellectual property rights and interests upon receipt of income related to such rights and interests
    • Patents
    • Copyrights

 

  • Reimbursed or Sponsored Travel: 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; provided, however, that this disclosure requirement does not apply to 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. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

Exemptions

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 Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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.

Equity interest includes any stock, stock option, or other ownership interest, as determined through public prices or other reasonable measures of fair market value.

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.