Financial Conflict of Interest

Policy 404: Conflict of Interest for Externally Funded Projects

Key Definitions:

Investigator. Any individual who is responsible for the design, conduct, or reporting of PHS and other sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as Principal Investigator or co-Investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants, as appropriate.

Institutional Responsibilities. The investigator’s responsibilities associated with their institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal, and external professional committee service.

Financial Interest. Anything of current or potential monetary value received or held by an Investigator or an Investigator’s family member, whether or not the value is readily ascertainable.

Significant Financial Interest (SFI). Significant Financial Interest (SFI). A financial interest, foreign or domestic, for the Investigator, or a family member, that reasonably appears to be related to the Investigator’s institutional responsibilities:

1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the twelve (12)-month period preceding the disclosure, and the value of any equity interest during the twelve (12)-month period preceding or as of the date of disclosure, exceeds five thousand dollars ($5,000.00); or
2. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the twelve (12)-month period preceding the disclosure exceeds five thousand dollars ($5,000.00); or
3. if with a non-publicly traded entity, an equity interest of any value held during the twelve (12)-month period preceding or as of the date of disclosure; or
4. the receipt of income greater than five thousand dollars ($5,000.00) related to intellectual property rights and interests not reimbursed through the institution, including royalties from such rights and agreements to share in such royalties related to licensed intellectual property rights, during the twelve (12)-month period preceding or as of the date of the disclosure.

Any reimbursed or sponsored travel valued more than five thousand dollars ($5,000.00) undertaken in the preceding twelve (12)months by the investigator and related to their institutional responsibilities is considered a Significant Financial Interest. This includes travel that is paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.

A Significant Financial Interest does not include:

1. salary, royalties, or other remuneration from the University, if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
2. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education; or
3. equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

Financial Conflict of Interest. A significant financial interest that the University reasonably determines could directly and significantly affect the design, conduct, or reporting of institutional research.

Investigator Disclosure Requirements:

Disclosures at the time of application. Prior to entering into sponsored projects or applications for sponsored projects where the Investigator has a significant financial interest, the Investigator must submit to the Institutional Official an ad hoc updated disclosure of their significant financial interests with the outside entity. Please use the Cayuse Outside Interests module to make the required disclosure.

Annual Disclosures during the award. All Investigators must disclose their significant financial interests to the University, through the Institutional Official, on an annual basis.

Ad hoc Disclosures during the award. Certain situations require ad hoc disclosure. All Investigators must submit to the Institutional Official an ad hoc disclosure of any significant financial interest they acquire during the course of the year within thirty (30) days of discovering or acquiring the significant financial interest.

Travel Disclosure. Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of significant financial interest, prior to travel or within 30 days of the travel occurrence.

Investigator Training Requirements:

Public Health Services (PHS) requires that all Investigators submitting proposals to PHS complete FCOI training before engaging in research, at least every four (4) years thereafter, and immediately under these prescribed circumstances:

• Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
• An Investigator is new to an Institution
• An Institution finds that an Investigator is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.

Investigators submitting to other federal agencies will take the FCOI training as required by the agency. If the Institutional Official determines that an Investigator has a significant financial interest that has not been disclosed, the Investigator will be required to complete the FCOI training.

COI training is provided by MTSU through CITI Program. When completing the Add a Course questionnaire, please answer yes to Question #4 “Would you like to take the Conflict of Interest mini-course?”.

Public Accessibility:

The University will make available within 5 business days of a written request information concerning any significant financial interest that meets the following criteria:

1. The significant financial interest was disclosed and is still held by the senior/key personnel;
2. A determination has been made that the significant financial interest is related to the externally funded research; and
3. A determination has been made that the significant financial interest is a financial conflict of interest.

The information to be made available shall include:

1. Investigator’s name;
2. Investigator’s title and role with respect to the research project; 
3. Name of the entity in which the Significant Financial Interest is held;  
4. Nature of the Significant Financial Interest; and   
5. Approximate dollar value of the Significant Financial Interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

Requests for access to or copies of research records must also comply with Policy 120 Public Records – Inspecting and Copying.

To request information regarding a significant financial interest, please email compliance@mtsu.edu.