Any University employee who is responsible for the design, conduct, or reporting of a research project which is conducted under the auspices of the University must report financial or other interests that are, or may be perceived to be, related to the project.

Investigators must fully report all interests for each research proposal at the time the proposal is submitted to the Investigator's department committee or hospital committee.

Investigators must provide updates of such interests on an annual basis and/or whenever they acquire new interests.

It is the responsibility of each Health-Affiliated Individual to report conflicts of interest, regardless of the magnitude, appropriateness, time or location of the activity. All financial interests must be reported, whether or not the financial interest reaches the "significant financial interest" threshold defined in this policy, or any other threshold established by state or federal law.

The following financial interests MUST BE REPORTED PRIOR TO ENGAGING IN THE RESEARCH:

• Anything of monetary value, including, but not limited to, salary or other payments for services (e.g. consulting fees or honoraria);
• Equity interest (e.g. stocks, stock options, or other ownership interests);
• Intellectual property rights (e.g. patents, copyrights, and royalties from such rights);

Any other related interests or activities of the Investigator that possibly could affect, or be perceived to affect, the results of the research or educational activities funded or proposed for funding. The Investigator's interests are related to a research project if the work to be performed under the project, or the results of such work, can be expected to have an impact on the Investigator's interests. Such relationships include project subcontracts, leases, and purchases.

The following interests and activities are considered "significant financial interests" and will be reviewed by the COI Committee prior to approval of the research project:

1. Income including salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, or any other payments or considerations from a single business entity or their nonprofit affiliate entity exceeding $10,000 per annum or $50,000 over the course of the study and one year thereafter when aggregated for the Investigator. [The amounts stated are based on current FDA rules and may be amended from time to time.]
2. Equity in the form of stock, stock options, real estate, or any other investment of ownership representing more than 5% interest for any one entity when aggregated for the Investigator. [The percentages stated are based on current FDA rules and may be amended from time to time.]
3. A Position as director, officer, partner, trustee, or member of board of directors of any business entity.
4. An interest in Intellectual property in which the property is held by a party other than the University.

The required report should be made on the Financial Interest Disclosure form (Appendix B) and submitted by the Investigator to the Designated University Official.

Financial Interest Disclosure forms for all Investigators shall be submitted to the Responsible Institutional Official for review upon submission of the research proposal to the Designated University Official or the Principal Investigator's department committee or hospital. The Responsible Institutional Official 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. If the research involves human subjects, the matter will be forwarded to the COI Committee for review and determination of whether compelling circumstances exist to rebut the presumption that the Investigator may not conduct the research. The Investigator will be advised of the determination.

If the Investigator disagrees with the determination of the Responsible Institutional Official, or if the research involves human subjects, the Responsible Institutional Official shall submit the Financial Interest Disclosure form and any relevant documentation to the COI Committee for consideration and resolution through management, reduction or elimination of the conflict or apparent conflict. The COI Committee's determination shall be final if the research does not involve human subjects. If the research involves human subjects, the IRB must also approve the research and the more stringent determination will be dispositive. The Investigator will be advised of the determination.

As a general rule, a financially interested individual may not conduct the human subjects research in question. This rule is not intended to be absolute: a financially interested individual may rebut the presumption by demonstrating facts that, in the opinion of the COI committee, constitute compelling circumstances. The individual would then be allowed to conduct the research under conditions specified by the COI committee and approved by the responsible IRB.

Compelling circumstances are those facts that convince the institution's COI committee that a financially interested individual should be permitted to conduct human subjects research. When considering a request by a financially-interested individual to conduct human subjects research, the circumstances that the COI committee should evaluate include the nature of the research, the magnitude of the interest and the degree to which it is related to the research, the extent to which the interest could be directly and substantially affected by the research, and the degree of risk to the human subjects involved that is inherent in the research protocol. The committee should also consider the extent to which the interest is amenable to effective oversight and management.

When the financial interest is directly related to the research and may be substantially affected by it, (e.g., an equity interest in a start-up company that manufactures the investigational product) the risk is greatest and the bar must be high; however, even direct and potentially lucrative financial interests may be justified in some circumstances. For example, when the individual holding such interests is uniquely qualified by virtue of expertise and experience and the research could not other-wise be conducted as safely or effectively without that individual, he or she should be permitted the opportunity to rebut the presumption against financial interests by demonstrating these facts to the satisfaction of the COI committee. The COI committee might approve the involvement of such an individual in the research, subject to conditions that ensure effective management of the conflict and credible oversight of the research.

At a minimum, the COI Committee shall require that the existence of any significant financial interest held by the Investigator and the institution be disclosed

1. in the research consent forms. The precise wording of the disclosure in the consent form should be determined by the IRB, but should include an explanation of the fact that the financial interest in question has been reviewed by COI committee, approved subject to oversight, and determined by both COI Committee and the IRB not to pose any additional significant risk to the welfare of research subjects or the integrity of the research. The disclosure statement should also indicate that all approving authorities have disclosed any conflict and that additional information will be provided to research subjects upon request.
2. to state and federal officials if required by statute or regulation.
3. to research sponsors or granting agencies.
4. to the editors of any publication to which the Investigator submits a manuscript concerning the research.
5. to trainees and prospective collaborators; and
6. in any substantive public communication of the research results, whether internal or external, oral or written.

In addition, the COI Committee shall prohibit payments to the Investigator from the sponsor or University which payments are conditioned upon a particular research result or are tied to a successful research outcome. Payments for subject enrollment or referral of patients to research studies should be permitted only to the extent that such payments 1) are reasonably related to the costs incurred, as specified in the research agreement between the sponsor and the Investigator/institution; 2) reflect the fair market value of the services performed and 3) are commensurate with the efforts of the individual performing the research.

Additional considerations of the COI Committee for review of human subjects research shall be as set forth more specifically in the COI Committee manual.

Financial relationships between the institution, its officials, and the agency sponsoring a research project warrant the highest degree of scrutiny by the COI Committee:

• when the institution is entitled to receive royalties from the sale of the investigational product,
• when the institution has obtained an equity interest in a non-publicly traded sponsor,
• when, through technology licensing activities or investments, the institution has obtained an ownership interest or an entitlement to equity of greater than $100,000 in value, in a publicly-traded sponsor,
• when institutional officials hold a significant financial interest in the commercial research sponsor or the investigational product,
• when other special circumstances arise, including times when the institution has received substantial gifts from a potential commercial sponsor of human subjects research.

• An employee shall not engage in any outside activity that interferes with the full and competent performance of the employee's duties on behalf of the University.
• An employee engaging in any outside activity shall not use the facilities, equipment, or services of the University in more than an incidental manner in connection with such outside activity without prior written approval of the Vice President for USF Health. Such approval may be conditioned upon reimbursement for the direct costs resulting from the use thereof.

All 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 via eDisclose and submit it to the Designated University Official:

• 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 within (45) days of the effective date of this policy. Failure to report outside activity as required pursuant to this policy will shall constitute grounds for disciplinary action.
• The University recognizes that certain matters that are the subject of outside activities may be confidential, for example, matters which are exempt from disclosure pursuant to sections 240.299 and 240.241 of the Florida Statutes relating to trade secrets, potentially patentable material and other proprietary information. Confidential aspects of outside activities need not be disclosed in the Outside Activity form, but the financial and commitment aspects of the activity should be reported.
• Institutions and Health-Affiliated Individuals bear a shared responsibility for the oversight of conflicts of commitment.

The following outside activities MUST BE REPORTED AND APPROVED PRIOR TO ENGAGING IN THE ACTIVITY:

• outside activities in which there is more than an incidental use of University facilities, equipment, and/or services.
• outside activities in which a University student or other University employee is directly or indirectly supervised by the employee if the employee in any way supervises or evaluates the student or other employee at the University.
• management, employment, consulting, and contractual activities with, or ownership interests in, a business entity (or state agency) that does business with the University. In the case of material financial and managerial interests, the information required extends to the spouse and children of the employee, and for managerial interests, to relatives.
• management, employment, consulting, and other contractual activities with, or ownership interest in, a business entity which competes with the University.
• candidacy for public office.
• required use of books, supplies, equipment, or other instructional resources at the University of South Florida when they are created or published by the employee or by an entity in which the employee has a financial interest.
• professional compensated activities, including, but not limited to consulting activity related to the employee's field of discipline, teaching at another institution, participating in an activity in which an honorarium in excess of travel expenses is to be received, and employment as an expert witness.
• business activities, including membership on an advisory council, scientific advisory board, service on the board of directors or other management interests or positions, with regard to a business entity with activities in the same discipline or field in which the faculty or staff member is employed.
• any employment, contractual relationship, or financial interests of the employee which may create a continuing or recurring conflict between the employee's interests and the performance of the employee's public responsibilities and obligations, including time commitments. This includes any outside activity in which the employee is required to waive rights to intellectual property and any outside activity or financial interest with a business entity that supports the employee's research or training program at the University.
• outside activities and financial interests required to be reported under federal contract and grant regulations.
• other activities that the employee should reasonably conclude may create an actual or apparent conflict of interest, including a conflict of time commitments.

The required disclosure should be made on the USF Health Report of Outside Activity annually and updated to report changes or additional activities.

• name of employing or contracting entity or person, or name of entity in which the financial interest is held, and nature of its business.
• involvement of students and other employees in the activity, employing entity, or entity in which the financial interest is held, if that involvement is known to the employee making the disclosure.
• nature of activity or financial interest (description of equity interest or intellectual property), including time spent if an activity is involved (estimated hours per week including travel time). The source and type of compensation must be noted, location and anticipated dates of activity.
• any conditions of the activity which involve waiving or impairing the employee's or University's rights to intellectual property.
• use of University's equipment, facilities, or services in more than an incidental way in connection with the activity.
• number of other outside activities and financial interests previously filed for the contractual year.
• prior approval of the activity or financial interest in the previous contractual year, if applicable.

Other information may also be requested in order to assume a complete review of the activity if there are potential conflicts involved. All individuals have responsibility for the reporting powers and of assuring its proper management.

Employees shall submit the completed USF Health Report of Outside Activity via eDisclose to the Designated University Official within sufficient time to secure the appropriate approvals before engaging in any outside activity. The Designated University Official shall review the form and discuss the matter with the employee within fourteen (14) days of the employee's written notification. 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. 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. 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.

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 therefrom.

Junior Faculty. Senior faculty may offer junior faculty opportunities for professional development through involvement in outside professional activities. However, senior faculty must not compromise their objectivity in evaluating their junior faculty in issues of promotion and tenure by virtue of outside professional activities in collaboration with junior faculty members, nor should senior faculty allow internal relationships with junior faculty to influence external relationships, expectations, or assignments. The Designated University Official should approve any new involvement or change in outside professional relations of senior and junior faculty after joint discussion with both senior and junior faculty concerned.

Students or Trainees. Part-time involvement of students or trainees in the outside professional activities of faculty may, under certain conditions, offer the potential for substantial benefits to the education of the student. In each case of such involvement, the faculty member should obtain prior approval from the Designated University Official after discussion with the Designated University Official and the student. In this context, involvement means any substantive activity, whether paid or unpaid.

In considering such arrangements, faculty should be guided by the need to avoid conflicts of interest and to avoid infringement upon the student's academic duties and rights. Generally, if the faculty member has a role in supervising the student's thesis or in supervising the work of the student as a graduate teaching assistant or instructor, such outside involvement should not be undertaken--thus avoiding potential conflicts of interest in the evaluation of the student's performance. If the faculty member does not have a role in supervising the student's thesis and/or the student's work as a teaching assistant or instructor, such involvement may be undertaken. If the outside work is related to the student's thesis, special care should be taken to avoid conflict.

If faculty members are already associated with students in outside professional activities, they should disqualify themselves from becoming research supervisors, academic program advisors, or examiners for an advanced degree of those students. Within a USF research laboratory or academic unit, faculty members should take care not to give the impression of favoritism to those students with whom they are associated in outside activities. Generally, full-time research assistants should not be involved in outside professional activities of faculty - both to avoid conflicts of interest and in light of the obligations of full-time research assistants. A part-time research assistant may engage in such activity if the outside work is not thesis-related and if the faculty member is not his or her supervisor.

Support Staff. Support staff play an important role in assisting the faculty with their USF teaching, research, and administrative activities. It may also be appropriate for support staff to assist faculty members in their outside professional activities, depending upon the nature and extent of the support staff involvement. Such involvement, however, is a potential source of conflict between faculty and their support staff. It is especially important, therefore, that faculty discuss with their support staff the appropriateness of any such support activities requested. Any special arrangements for providing support for faculty outside professional activities, including compensation from non-USF sources, must be acceptable to all the parties involved. If support staff will be compensated for work on outside professional activities, such work must be performed on the staff member's own time and not during hours compensated by the University.

Guidelines defining appropriate support are given below; faculty members should discuss any circumstances that do not obviously meet these guidelines with the Designated University Official.

• It is normally appropriate for support staff to assist faculty in their professional public service activities, i.e., those professional activities in which faculty provide a service to institutions other than the University for public benefit, and in which compensation is incidental. If the effort required to provide such support is likely to be substantial and long term, however, a faculty member should review the circumstances with his or her Designated University Official.
• It may also be acceptable for support staff to provide limited assistance to faculty in other types of outside professional activities. Any assistance provided for such outside activities must not be in conflict with the faculty and support staff's responsibilities to the University.
• Faculty may not require support staff to perform duties related to the faculty member's personal and nonprofessional activities.

Employees may not use University resources, including facilities, personnel, equipment, or confidential information, except in a purely incidental way, as part of their outside activities or for any other purposes that are unrelated to the education, research, scholarship, and public service missions of the University. When applicable, complete the Use of University Equipment, Facilities and Services Form via eDisclose.

Under special circumstances (e.g., start-up phase of University-based company) use of University resources may be permitted with appropriate reporting to and discussion with the Designated University Official and may be conditional upon reimbursement for direct and indirect costs resulting from such use.