Conflict of Financial Interest Relating to Federal Grant Proposals

Background

The U.S. federal government has published regulations pertaining to conflicts of financial interest as a way of providing a reasonable expectation that federally-funded projects will be carried out free of bias resulting from investigators’ financial conflicts of interest.  The government is seeking to increase transparency and accountability from grantees and to ensure that research results are not biased or unduly influenced by any outside financial interests of investigators.  This policy implements the federal mandate to document possible conflicts of financial interest.

What Must Be Disclosed: What is a Financial Conflict of Interest?

A financial conflict of interest is defined by the federal government as a “significant financial conflict of interest” that is related to federally-funded research activity which could directly and significantly affect the design, conduct, or reporting of that activity.  Specifically, a significant financial conflict of interest is:

 

  • Publicly-Traded Entity: The value of any remuneration received from an external entity in the 12 months preceding financial disclosure and any equity interest owned or acquired as of the date of financial disclosure which exceeds $5,000 when aggregated for an investigator, spouse, registered domestic partner, and dependent children.  Included are salary, consulting fees, honoraria, and the value of equity interest (stock, stock options or other ownership interest) as determined by public prices or other reasonable measure of market value as of the date of disclosure;
  • Non Publicly-Traded Entity.  The value of any remuneration received in the 12 months prior to the date of the disclosure, which when aggregated exceeds $5,000 or any equity interest (includes stock, stock options or other ownership interest) as determined by public prices or other reasonable measure of market value as of the date of disclosure;
  • Payments.  Any payments exceeding $5,000 received within the past 12 months for any intellectual property rights and interests assigned or licensed to a party other than the University of St. Thomas;
  • Travel.  Any travel reimbursement or payment exceeding $5,000 per entity by any entity (profit or non-profit) within the past 12 months, regardless of the value made to or on behalf of the Investigator related to his or her institutional responsibilities.

 


Who Must Disclose?

Any personnel, including those of any subrecipient, who are responsible for the design, conduct, or reporting of research paid for by the U.S. government – including the Principal Investigator, project director, senior and key personnel, and any others who contribute to the scientific development or execution or reporting of a federally-sponsored project in a substantive, measureable way. 

What is Excluded from Disclosure: What is NOT a Significant Financial Interest?

  • Payments (salary, honoraria, expense reimbursement, or other remuneration) from the University of St. Thomas;
  • Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels (e.g., NSF or NIH review panels);
  • Income from investment vehicles, such as mutual or pension funds or other investment in which the investigator does not exercise investment decisions;
  • Travel reimbursed or sponsored by a governmental agency, an institution of higher education, a medical center, or research institute affiliated with a U.S. institution of higher education.

When Must Disclosure Be Made?

Investigators must disclose any significant financial conflict of interest related to a federally grant-funded project at least one day before the proposal is submitted to the federal agency and at least annually throughout the period of a funded project.  Investigators must also report any new significant financial conflict of interest within thirty days of acquiring or discovering a new conflict.

Financial Conflict of Interest Training

In cases where a UST investigator chooses to submit a grant proposal to a governmental agency designated as a “Public Health Service (PHS)” entity, the investigator is required to complete PHS-compliant training prior to engaging in PHS-funded research and at least once every four years while engaged in PHS-funded research.  PHS agencies (and those that have adopted the PHS standard) include:

Agency for Healthcare Research and Quality
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Food and Drug Administration
Health Resources and Services Administration
Indian Health Services
National Institutes of Health
Office of Global Affairs
Office of the Assistant Secretary for Health
Office of the Assistant Secretary for Preparedness and Response
Substance Abuse and Mental Health Services Administration
Alliance for Lupus Research
American Cancer Society
American Heart Association
Arthritis Foundation
CurePSP Foundation for PSP/CBD and Related Brain Diseases
Juvenile Diabetes Research Foundation
Susan G. Komen for the Cure

If an investigator submits a grant proposal to any of these sponsors, he or she must contact the Sponsored Programs Office for instructions in how to complete the required training.

How Do I Disclose?

Please fill out the FCOI Form and submit to the Sponsored Programs Office at least one day before your grant proposal is due at the sponsoring agency.  Please contact Michael Warnock at mjwarnock@stthomas.edu if you have any questions about this process.