Office of Research Compliance
USF Health · Office of Research

Conflict of Interest Review Processes

 

USF Health faculty and staff are primarily responsible for determining and disclosing their own conflicts. Failure to monitor, disclose and manage one's conflicts may result in noncompliance with state law and University regulations and/or policy.

The following are some the common situations in which a conflict of interest may arise, and a summary of the process for disclosing and managing these conflicts in the best interests of the employee and the University:

 

If You Are an Investigator on an Individual Research Project

NOTE: There are two COI committees on campus. The USF Health Conflict of Interest Committee reviews all human subjects research (regardless of the origin) and research conducted by employees of USF Health. The USF Committee for Conflicts of Interest in Research, within the USF Office of Research, Division of Research Integrity and Compliance, reviews financial disclosures for the rest of the University System. The following process addresses USF Health and human subjects research only. For information regarding the conflict of interest review process for the rest of the University System, click here.
  1. Any investigator, including a USF student, who has a financial or other business interest in an individual research project or whose spouse or dependents have a financial or business interest in the project, must complete the Financial Interest Disclosure Form.
  2. The investigator submits the form for review and signature to the responsible administrative official with immediate supervisory authority over the investigator (i.e., Department Chair or program leader).
  3. The responsible administrative official will direct the signed and completed form to one of the following offices as appropriate:
    1. For all COM research: to the College of Medicine Research Office (for all COM Research) for further submission to the Division of Sponsored Research (DSR) (for sponsored research) or the USF Health, Director of Research Compliance (for non-sponsored research); or
    2. For sponsored research other than COM research: directly to DSR (Liz O'Connell—ADM 200); or
    3. For all non-sponsored research other than COM research: directly to the USF Health, Director of Research Compliance (Camille McWhirter—MDC 002).
  4. The office receiving the form will perform its administrative responsibilities relative to the form as necessary and will subsequently direct the form to the USF Health, Director of Research Compliance (Camille McWhirter—MDC 002).
  5. The USF Health, Director of Research Compliance will review the form and may discuss with the investigator any potential conflicts before making a final determination regarding the management, reduction or elimination of the conflict or apparent conflict.
  6. If any of the following are true:
    1. The investigator disagrees with the determination regarding the management, reduction or elimination of the conflict or apparent conflict; OR
    2. if the research involves an institutional conflict of interest; OR
    3. if the research involves human subjects; OR
    4. the disclosure does not meet the criteria for expedited review;
then:

The USF Health, Director of Research Compliance will forward the form (with a recommendation and proposed management plan, if any) to the USF Health COI Committee for review and a final determination of whether the financial or management interests disclosed could directly and significantly affect the design, conduct, or reporting of the proposed project. For research involving human subjects, the COI Committee's review will include the issue of whether compelling circumstances exist to rebut the presumption that the investigator may not conduct the research. See USF Health Conflict of Interest Committee Operating Procedures for additional insight into the review process and the basis for COI Committee decisions.

  1. If the research involves human subjects: The Committee's determination will be communicated by the USF Health, Director of Research Compliance to the USF IRB Administrator, or other IRB responsible for the review of the research, for review and approval of the research by the IRB. In the event that there is any discrepancy between the determination of the COI Committee and the determination of the IRB relative to the conduct of the research or any management controls designed to address the conflict of interest, the more stringent determination will be dispositive.
  2. For all disclosures: the Investigator and any other relevant parties (e.g., Department Head, project leader, etc.) will be advised of the determination following each level of review. The investigator may not proceed with the research until a final determination allowing the research to proceed has been reached by all review bodies required to review the disclosure. An appropriate management plan must be in place before the University will accept any sponsored award in which a financial or management conflict has been determined to exist.
  3. The USF COI Review Committee will monitor any management plans established and, as part of that management, will require updates of disclosures from individuals involved in those management plans at least annually.
  4. Regarding the appeal of USF Health COI Committee or IRB determinations on conflicts of interest: The USF Health COI Committee's determination shall be final if the research does not involve human subjects. If the research involves human subjects, the IRB's determination shall be final.

For additional information on conflicts of interest in research see the complete USF Health Policy on Conflicts of Interest and Conflicts of Commitment. If you still have questions, contact Camille McWhirter, Director of Research Compliance, USF Health (cmcwhirt@health.usf.edu or 974-6676).

 

If You Are A USF Health Employee Who Wishes To Engage In An Outside Activity

  1. All USF Health employees who propose to engage in any outside activity which the employee should reasonably conclude may create a conflict of interest are to complete a USF Health Report of Outside Activity and submit it to the responsible administrative official with immediate supervisory authority over the investigator (i.e., Department Chair or program leader):
    • Upon initial employment with the University
    • Prior to engaging in any new outside activity
    • Annually thereafter for continuing outside activity (with the reporting period being July through June 30)
    • Any time there is a significant change (e.g., nature, extent, funding) to previously reported and approved outside activities.
    • Any outside activity in which the employee is currently engaged but has not previously reported, shall be reported immediately.
  2. The employee shall submit the completed form within sufficient time to secure the appropriate approvals before engaging in any outside activity.
  3. The recipient of the form will review the form and discuss the matter with the employee within fourteen (14) days of the employee's submission of the form.
  4. If the matter is unresolved following this discussion, the employee may refer the matter to the Dean of the College. The Dean shall review the matter within fourteen (14) days of the referral.
  5. If the matter remains unresolved, the employee may refer the matter to the Vice President for USF Health who shall determine whether the outside activity creates an unmanageable conflict of interest or otherwise interferes with the employee's University duties.
  6. The employee shall be notified in writing of the Vice President's determination within thirty (30) days of the date that the matter was referred to the Vice President.
  7. The employee may engage in the outside activity pending the decision of the Vice President. If the Vice President determines that there is a conflict of interest or other interference with the employee's duties, the employee shall cease such activity immediately and turn over to the University any compensation earned there from.

For additional information on conflicts of interest or conflicts of commitment with University employment or reporting outside activities see the complete USF Health Policy on Conflicts of Interest and Conflicts of Commitment. If you still have questions, contact Olga Joanow, Director of Faculty Affairs (ojoanow@health.usf.edu or 974-1676).

 

If You Are An Inventor Who Has An Ownership Or Other Financial Or Management Interest In A Start-Up Company Doing Business With The University

  1. Faculty members or other employees who propose to participate as an owner or to hold a management interest in an emerging or start-up company doing business with the University must follow the steps outlined in the process set forth above for disclosure of outside activities.
  2. In addition to reporting this special outside activity as required by the USF Health Policy on Conflicts of Interest and Conflicts of Commitment, the faculty member should complete the USF Health document entitled Disclosure of Information Form for Commercial Enterprise and submit both documents to the employee's Department Head/Chair and the Vice President for USF Health for approval prior to engaging in the activity.
  3. Finally, if the faculty member or employee has an employment or contractual relationship with the company, the activity will fall within one of the state law prohibitions on doing business with one's agency. Therefore, this relationship must be specifically authorized by the University President and Chair of the University Board of Trustees prior to engaging in the activity.

For additional information on addressing conflicts that may arise from a faculty member's interest in a company doing business with the University, see Types of Conflicts of Interest, "Ownership in Company Doing Business with the University". If you still have questions, contact Olga Joanow, Director of Faculty Affairs (ojoanow@health.usf.edu or 974-1676).

 

Other Situations

If you are uncertain whether you have a conflict of interest situation, or if you believe you have a conflict of interest that is not addressed by one of the review processes described here, please contact Olga Joanow, Director of Faculty Relations, USF Health Office of Faculty Affairs (ojoanow@health.usf.edu or 974-1676) to discuss your situation and obtain additional guidance.