Conflicts of Commitment and Conflicts of Interest

1. Purpose.

This Policy sets forth expectations and requirements for university employees engaging in outside activities and holding financial interests that may impact or create conflicts of interest or commitment with their university employment. It establishes processes for the identification, reporting, and review of such activities and interests, and, when necessary, management of conflicts of interest and commitment, including conflicts related to research, in compliance with federal and state laws and regulations and university policies.

2. Applicability.

This Policy applies to the University of Florida (UF). It excludes UF Health, Direct Support Organizations (DSOs), and any related or affiliated entities.

This Policy applies to university faculty and staff with an appointment of .26 FTE or above including Technical, Executive, Administrative and Managerial Support (TEAMS), graduate assistants, Law Enforcement Officer (LEO) and Other Personnel Services (OPS) staff, hereinafter “Employees.” It applies to all employees who engage in sponsored or human subjects research regardless of their FTE level. This Policy does not apply to adjuncts and temporary faculty, regardless of FTE.

3. Definitions.

Cash Value Prizes means awards for research, scholarly or artistic accomplishments such as the Nobel prize, the Fields Medal, Clay Millennium prize, National Book Award, or Pulitzer Prize.

Conflict of Commitment (COC) means a Disclosable Interest or Outside Activity whose time of occurrence, duration or requirements would hinder the employee from carrying out Institutional Responsibilities.

Conflict of Interest (COI) means a Disclosable Interest or Outside Activity that (a) inappropriately influences the employee’s professional actions, judgment, or decisions related to the employee’s Institutional Responsibilities; or (b) creates an unlawful conflict with the employee’s public employment.

Disclosable Interests means equity, consulting or other professional services, editorial services, intellectual property rights, divestiture and cash pay-out, board membership (private companies and nonprofit organizations), outside employment, other appointments, and Innovation Inducement Prizes.

Entity means any business, company, or other organization, whether public or private, including without limitation any partnership, corporation, limited liability corporation, unincorporated association, or other institution or organization, whether for-profit or not-for-profit.

Financial Conflict of Interest (FCOI) means when the university, through the RCOI Administrator, reasonably determines that an Investigator’s Significant Financial Interest is related to research and could directly and significantly affect the design, conduct or reporting of the research or present the appearance thereof.

FCOI Management Plan means documented strategies designed to mitigate the potential for an Investigator’s Significant Financial Interests to impact or bias research objectivity and/or the safety or welfare of human research participants.

Immediate Family Member means an employee’s spouse, domestic partner, and dependent children.

Innovation Inducement Prizes means awards of cash exceeding $5,000 that recognize work performed in the area of a faculty member’s Institutional Expertise that are distinct from grants, contracts, or gifts awarded in advance for proposed work or awarded to winners of competitions including challenge prizes by federal or non-profit agencies requiring the attainment, within a specific time frame, of specific material, technology translation, or commercialization goals.

Institutional Expertise means an employee’s expertise in their university discipline or area of Institutional Responsibility.

Institutional Responsibility means any activity an employee does as part of their assigned responsibilities on behalf of UF, such as research, teaching, institutional committee memberships, professional practice, and administrative activities, including any university activities that form the basis for supervisory assessment of their university job performance.

Interventional Human Subjects Research means a research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.

Investigator means the principal Investigator, co-principal Investigator, or any other employee responsible for the design, conduct, or reporting of proposed or funded research, regardless of title or appointment type.

Malign Foreign Talent Recruitment Program (MFTRP) means any program, position, or activity that includes compensation or consideration provided by a foreign country or their designee in exchange for the individual performing actions including but not limited to: transfer of intellectual property or other nonpublic information, recruiting trainees or researchers to enroll in such a program, establishing a laboratory/appointment in a foreign country, obtaining research funding from the foreign government’s entities, omitting acknowledgement of US home institution or funding agency, or not disclosing program participation. It also means any program, position or activity designated by the state or federal government as a MFTRP or similar label.

Outside Activity means any activity not directly associated with the fulfillment of an employee’s Institutional Responsibilities.

PHS Investigator means an Investigator who is participating or planning to participate in university research funded by Public Health Service (PHS) or any other agency or sponsor that has adopted the PHS Objectivity in Research Rule.

Related Research means research that (a) may affect a Significant Financial Interest or (b) may affect an entity’s financial interests.

Research Conflict of Interest (RCOI) Administrator means the institutional official responsible for reviewing Significant Financial Interests and managing FCOI. The RCOI Administrator may appoint a designee to assist with any related procedures.

Researcher means a university employee or student listed on a UFIRST proposal workspace and/or a proposal to conduct human subjects research.

Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of an Investigator (and those of the Investigator’s Immediate Family Members) related to their Institutional Responsibilities, when combined for the 12 months preceding the disclosure date, from a single Entity. SFI are reviewed for Related Research and whether they create FCOI.

*Disclosure of sponsored or reimbursed travel applies to Researchers only and disclosure will include the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

SFI Does Not Include:

• Salary, royalties or other remuneration paid by the university to the Investigator if the Investigator is currently employed or otherwise appointed by the university;
• Intellectual property rights assigned to the university and agreements to share in royalties related to such rights;
• Equity interests through 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, US institutions of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education;
• Income from service on advisory committees or review panels for a federal, state or local government agency, US institutions of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education; and
• Except for PHS Investigators, sponsored or reimbursed travel sponsored or paid by a federal, state or local government agency, US institutions of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education.

Subrecipient means a legal entity that receives a subaward from a pass-through entity to carry out a portion of a sponsored program. A Subrecipient has responsibility for programmatic decision making; has its performance measured in relation to whether objectives of a programmatic scope of work were met; and is responsible for adherence to applicable sponsored program requirements specified in the sponsored award, as opposed to providing routine goods or services for the benefit of the pass-through entity.

Subrecipient Investigator means an Investigator who is not a university employee or student and who participates in research overseen by the university through a subcontract, subaward, or other agreement.

4. Policy Statement.

Participation in Outside Activities must not conflict or appear to conflict with an employees’ performance of Institutional Responsibilities.

4.1. Academic Freedom.

As set forth in UF Regulation 7.018, academic freedom and responsibility are essential to the full development of a true university and apply to teaching, research, and creativity. In the development of knowledge, research endeavors, and creative activities, the faculty must be free to cultivate a spirit of inquiry and scholarly criticism and to examine ideas in an atmosphere of freedom and confidence. Faculty are free to engage in scholarly and creative activity and publish the results in a manner consistent with professional obligations. A similar atmosphere is required for university teaching. Consistent with the exercise of academic responsibility, a teacher has the freedom in the classroom to discuss academic subjects, select instructional materials and determine grades. The university student must likewise have the opportunity to study a full spectrum of ideas, opinions, and beliefs, so that the student may acquire maturity for analysis and judgment. Objective and skillful exposition of such matters is the duty of every instructor.

4.2. Employee Personal Speech.

The university affirms the free speech rights of its employees to comment on matters of public concern in accordance with the First Amendment to the U.S. Constitution and Article I, Section 4 of the Florida Constitution. Statements made by employees in their capacities as individual citizens and not on behalf of the university, another person or entity, including those to the media, are not reportable Outside Activities. This includes when employees are speaking in their personal capacity about areas of their expertise and when they use their university credentials for identification purposes only. However, comments on matters of public concern become Disclosable Interests, subject to university review for potential Conflicts of Interest or Conflicts of Commitment, when employees seek to speak on behalf of or represent another as part of an activity that constitutes a Disclosable Interest.

4.3. Outside Activity Advisory Committee.

With the assistance of UF Research Integrity, Security and Compliance, the Provost shall convene and oversee an Outside Activity Advisory Committee made up of university faculty who may be called upon to provide advice to the university regarding Outside Activities and will act as an advisory committee to the Provost in the event a faculty member appeals the denial of a Disclosable Interest or PAR on the basis of a Conflict of Interest.

4.4. Annual Disclosure and Amendments.

On an at least annual basis, employees shall report Disclosable Interests (including certification of nothing to disclose) through the university system of record. Newly acquired or discovered Disclosable Interests must be disclosed within 30 calendar days of acquisition or discovery, even if the employee has already made their annual disclosure. Employees new to the university must disclose within 30 calendar days of hire. Researchers must attest that their disclosure is accurate at the time of award and when applying for Institutional Review Board (IRB) approval.

4.5. Prior Approval Requests (PAR).

Approval is required prior to engaging in any Outside Activities (a) where the outside Entity does business with the university or (b) that involve any use of university employees, students, facilities, equipment or other resources. The following also require submission and approval of a PAR:

• Textbooks and Classroom Works: Works for which the employee will receive anything of monetary value and for which the employee will require students to purchase the works.
• Public Office: Candidacy for or holding public office.
• Expert Witness: Serving as a witness or reviewing documents for a legal matter where the university, its employees or board members (in the course and scope of their university positions), UF Direct Support Organization (DSO), UF Health or UF affiliate is a party.
• Contracts with intellectual property terms that do not include the university provided rider.
• Innovation Inducement Prizes in which the employee is participating as an Outside Activity.

Employees obtain prior approval by submitting a PAR in accordance with Section 4.8 of this Policy. A PAR must be submitted at least 30 calendar days prior to the anticipated start date of the activity or interest. The university may make exceptions to this deadline in extraordinary circumstances. An employee shall not execute any contracts or agreements or engage in any Outside Activities or acquire Disclosable Interests related to a PAR prior to approval of the PAR by the university.

4.6. The following are not Disclosable Interests and do not require a PAR:

• Required jury duty.
• Serving in the United States Armed Forces or other branches of the military.
• Signing an amicus brief when a university entity is not a party. When signing an amicus brief, an employee is permitted to state their position with the university but must make clear that they are signing the amicus brief solely in their personal capacity.
• Receiving honors, academic awards, or an honorary degree from a non-profit institution that are Cash Value Prizes and not Innovation Inducement Prizes.
• Taking Sabbatical or Professional Development Leave.
• Serving as a program manager for a United States federal agency or working on an assignment through the Intergovernmental Personnel Act or a similar federal program.
• Participating in the Fulbright (Scholar) Fellowship program.
• Performing activities that are part of employee’s Institutional Responsibilities, even when external compensation is provided. This includes, but is not limited to:
  • Participating in scientific or educational conferences, invited colloquia or other events while representing the university.
  • Performing peer review, proposal review for a United States federal or state government sponsor or non-profit organization, conference committee or journal editorial duties while representing the university.
  • Research activities approved and coordinated through the university including research by Investigators conducted at Entities as part of a university-sponsored project or research funding received by the university.
  • Membership in an academic or professional society (except that serving on the Board and carrying a fiduciary role requires disclosure).
  • Serving as an external member of a thesis, dissertation, or promotion committee.

4.7. Prohibited Activities.

Malign Foreign Talent Recruitment Programs. The university prohibits participation in MFTRPs.

Outside Research. The university prohibits conducting research outside of the university. Without an approved exception by the Vice President for Research, employees may not be the PI of or be funded by research grants to a non-university entity. If an approved exception is obtained, the activity should be disclosed as consulting or other professional services. Uncompensated consulting roles on research projects at other institutions are generally considered to be part of an employee’s Institutional Responsibilities.

Engaging in MFTRPs or participating in outside research not approved by the Vice President for Research, regardless of whether they have been disclosed to the university, will result in discipline up to termination.

4.8. Review.

4.8.1. Prior Approval Requests.

Supervisors and Colleges/Units will review all PARs for Conflicts of Interest. In addition to reviewing for Conflicts of Interest, supervisors are responsible for ensuring: 1) the Outside Activity/Disclosable Interest is not listed on the faculty annual report or staff annual evaluation or otherwise part of Institutional Responsibilities, and 2) the Outside Activity/Disclosable Interest does not create an unresolvable Conflict of Commitment.

UF Research Integrity, Security and Compliance will also review the PAR if approved by a supervisor and College/Unit.

If the university determines an employee’s Outside Activity/Disclosable Interest will result in a Conflict of Interest, the university may prohibit the employee from engaging in the Outside Activity/Disclosable Interest; require the employee take personal time off or a leave of absence to participate in the Outside Activity/Disclosable Interest; or implement other measures the university deems reasonably necessary. The viewpoint and content of the employee’s speech or other activity shall not be considered when assessing whether a Conflict of Interest exists.

A supervisor’s denial of a PAR based on an unresolvable Conflict of Commitment is not appealable.

If a faculty member’s PAR is denied due to a Conflict of Interest, the employee may appeal the denial to the Outside Activity Advisory Committee within 30 calendar days of the determination. The Outside Activity Advisory Committee will provide a recommendation to the Provost who will make a final determination.

If a non-faculty member’s PAR is denied due to a Conflict of Interest, the employee may appeal the denial to the Vice President for Research within 30 calendar days who will make a final determination.

Employees do not need to seek reapproval of an approved PAR unless there is a material change to the Outside Activity. The university may rescind its previous approval of a PAR at any time based on relevant changes to the employee’s Institutional Responsibilities, Institutional Expertise, performance or conduct.

4.8.2. Expert Witness Activities

Expert witness activities do not have to be disclosed and do not require a PAR, with two exceptions as follows:

Exception 1: Expert witness activities related to legal proceedings involving clinical and/or medical matters must be submitted as a PAR and approved by the Self Insurance Program regardless of whether such activities are related to the employee’s Institutional Expertise.

Exception 2: Expert witness activities in legal proceedings where the university, its employees or board members (in the course and scope of their university positions), its Direct Support Organizations (DSOs) or its affiliates are a party to the legal proceeding must be submitted as a PAR and approved by the university regardless of whether such activities are related to the employee’s Institutional Expertise.

4.8.3. Disclosable Interests.

Supervisors and Colleges/Units will review disclosures for Conflicts of Interest. In addition to reviewing for Conflicts of Interest, supervisors are also responsible for ensuring: 1) the Disclosable Interest is not listed on the faculty annual report or staff annual evaluation or otherwise part of Institutional Responsibilities, and 2) the Disclosable Interest does not create an unresolvable Conflict of Commitment.

A supervisor’s denial of a Disclosable Interest based on an unresolvable Conflict of Commitment is not appealable.

If the university determines an employee’s Disclosable Interests create a Conflict of Interest, the university may, in accordance with this Policy, prohibit the employee from engaging in the Outside Activity; take actions to limit the employee’s activity; or implement other measures the university deems reasonably necessary to eliminate the potential conflict. The viewpoint and content of the employee’s speech or other activity shall not be considered when assessing whether a Conflict of Interest exists.

The appeals process for Disclosable Interests is the same as described for PARs in Section 4.8.1

The university may disapprove an ongoing Disclosable Interest at any time based on relevant changes to the employee’s Institutional Responsibilities, Institutional Expertise, performance or conduct.

4.8.4. Research Conflicts of Interest (RCOI).

The RCOI Administrator will conduct reviews to assess whether an Investigator’s disclosed Significant Financial Interest (SFI) is Related Research, and if so, whether the SFI could directly and significantly affect the design, conduct, or reporting of research, thus presenting a Financial Conflict of Interest (FCOI). Related Research determinations consider whether the SFI could be affected by the research or is in an Entity whose financial interest could be affected by the research.

• FCOI determinations take into account:
  • The nature and extent of an Investigator’s role on a project;
  • The nature and extent of an Investigator’s SFI, and;
  • The nature of the research activity under review.

• Timing of Reviews. Reviews and determinations should occur prior to expenditure of funds for new awards and within 60 calendar days of a newly-disclosed or discovered SFI. Reviews and determinations should occur prior to the addition of new Investigators during the life of an award.
• Related Research Review. The RCOI Administrator may determine there is not Related Research. The RCOI Administrator may refer reviews to an appropriate subject matter expert or a Research COI Committee for further evaluation and disposition. If the RCOI Administrator determines there is Related Research, the RCOI Administrator will initiate an FCOI Review.
• FCOI Review. The RCOI Administrator determines whether the SFI represents an FCOI. If an SFI is determined to be an FCOI, the RCOI Administrator will proceed to manage the conflict, as outlined in the below Management section.
• Management. If an FCOI is determined to exist, the RCOI Administrator will develop a management plan to manage, reduce, or eliminate the FCOI. Investigators must agree to management plans in order to engage in research where an FCOI exists. Depending on the nature of the FCOI and nature of the research activity, management plan controls may include:
  • Disclosure of the FCOI (to study teams, collaborators, the IRB, human research participants, and in presentations and publications);
  • Reduced role in the research, and/or independent review of research data and results;
  • Additional conflict of interest management strategies, as appropriate; and
  • In certain cases, prohibition from participating in research or divestment of financial interests may be required.
• Reporting. Pursuant to law or sponsor requirements, the RCOI Administrator will provide to the sponsor initial and ongoing reports describing an FCOI and related management.
  • For PHS-funded research, FCOI reports must be submitted to the PHS awarding component prior to the expenditure of funds for new projects, within 60 calendar days of newly determined FCOI (whether the result of a new Investigator, newly disclosed SFI, or identification of an SFI that was not disclosed timely or an SFI that was not previously reviewed), and on an annual basis during the life of the project.
  • In addition, PHS requires the university to make available to the public, upon request, specific information regarding FCOI relative to senior/key personnel and PHS-funded research. The university is required to provide specific information relative to such public requests within 5 business days of the request.
• Human Subjects Research. In general, there is a rebuttable presumption that Investigators with Financial Conflicts of Interest will not participate in Interventional Human Subject Research unless there are compelling circumstances.
  • Compelling Circumstances. The RCOI Administrator and/or Research COI Committee may consider compelling circumstances when making a determination about a conflicted Investigator’s permitted involvement in Interventional Human Subject Research. The RCOI Administrator or Research COI Committee will make the final determination as to whether compelling circumstances exist. The following factors will be considered when determining whether compelling circumstances exist:
    • the nature of the research;
    • the magnitude of the SFI and the degree to which it is related to the research;
    • the extent to which the SFI could be directly and substantially affected by the research;
    • the degree of risk to the human subjects involved that is inherent in the research protocol;
    • the extent to which the conflicted Investigator is uniquely qualified to perform a research study with important public benefit; and
    • the extent to which the FCOI is amenable to effective oversight and management.
  • IRB Notification and Review. The IRB will be notified of FCOI determinations, and conflict of interest management strategies implemented, relative to research involving human research participants. It is in the purview of the IRB to review the conflict of interest management strategies associated with IRB protocols and determine whether the conflict of interest management is sufficient with respect to the rights and welfare of human research participants or requires additional mitigation. In the case of the UF IRB, if the IRB determines that additional conflict of interest management is necessary to protect the rights and welfare of human research participants, the IRB will notify the RCOI Administrator in writing.
• Monitoring. The conditions of, and compliance with, Investigator management plans are reviewed on at least an annual basis by the Research COI Committee or designee. On an ad hoc basis, the RCOI Administrator may also conduct independent monitoring and verification to ensure that the conditions of the management plans are being met.
• Subrecipients. The university must apply relevant originating sponsor conflict of interest requirements to Subrecipients. Therefore, if required by the originating sponsor, the university must identify whether or not a Subrecipient has a conflict of interest policy compliant with applicable originating sponsor conflict of interest requirements. If a Subrecipient does not have a conflict of interest policy compliant with applicable originating sponsor conflict of interest requirements, in order to proceed with the university collaboration, the Subrecipient must agree to abide by this Policy relative to the Subrecipient Investigators and the specific Subrecipient research activity for the duration of that activity. The subaward must incorporate terms that establish whether this Policy or that of the Subrecipient will apply to Subrecipient Investigators, and obligations of the Subrecipient relative to conflict of interest in either case.
• Training. Investigators may be required to complete research conflict of interest training. When required by sponsor terms, the university will require the completion of training before engaging in the relevant funded research, and repeated as required by such terms. For PHS funding, the university will require training immediately when:
  • a. The University revises its FCOI policies or procedures in any manner that affects the requirements of PHS Investigators; or
  • b. A PHS Investigator is new to the university; or
  • c. The university finds that a PHS Investigator is not in compliance with this Policy or applicable management plan.
• Record Retention. The university will maintain all review files and associated reports and management plans for three (3) years after any applicable research project’s final financial report is submitted to a sponsor, or until three (3) years after the final action has been taken on any audit, litigation, or claim. Records will be retained longer if required by law of UF regulation.
• Appeals. Investigators may appeal decisions of the RCOI Administrator or the Research COI Committee initially to the Research COI Committee within 30 days of a determination. If the Committee’s response is unsatisfactory to the Investigator, the Investigator may appeal to the Vice President for Research. The Vice President’s determination is final. If the Vice President for Research has a conflict of interest, the Chief Compliance Officer will make the determination. In the case of human subjects research, any decision regarding conflict management made by the reviewing IRB is determinative and cannot be appealed via the Research COI appeals process.

5. University Affiliation.

Employees engaging in Outside Activities do so as private citizens and shall not represent themselves to the outside employer or other recipient of services as engaging in such activity on behalf of the university except when specifically authorized in writing by the COI Program to do so.

6. Noncompliance.

The university may take administrative or disciplinary action concerning violations of this Policy up to and including termination of employment in accordance with the employee’s classification.

Failure to report a Disclosable Interest by a respective deadline shall result in a written delinquency notification from the university, with copies to the employee’s supervisor, department chair and dean, directing the employee to complete their disclosure within 10 business days. Upon receipt of the delinquency notification, the employee must cease the activity. The employee may choose to discontinue the activity with no further disclosure or may seek approval to continue the activity.

Failure to disclose an ongoing activity more than 10 business days following the receipt of a delinquency notification shall result in a written reprimand from the university, with copies to the employee’s supervisor, department chair and dean. Continued failure to timely disclose will result in further disciplinary action.

The following are examples of noncompliance with this Policy:

• Failure to submit a timely disclosure (e.g. more than 30 calendar days after discovery or acquisition of a new Disclosable Interest);
• Commencing an activity requiring a PAR before receiving formal approval;
• Submission of an incomplete, erroneous or misleading initial, updated or annual disclosure;
• Failure to disclose information as required by this Policy;
• Failure to comply with prescribed management plans; or
• Other instances of non-compliance as determined by the RCOI Administrator.

6.1. Non-Compliance Involving PHS-funded Research.

When an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose an SFI, or failure of an Investigator to comply with the conditions of an FCOI Management Plan, the university must conduct a retrospective review of the Investigator’s research activities on the project to determine if there is bias in the design, conduct, or reporting of the research resulting from the FCOI.

• Retrospective Review. The retrospective review must be completed within 120 calendar days of the determination of noncompliance. The retrospective review will be documented by the RCOI Administrator or designee. If bias is found in the course of the retrospective review, the university must promptly notify PHS and submit a mitigation report that addresses the impact of the bias on the research and the university’s plan of action to eliminate or mitigate the effect of the bias.
• PHS-funded Clinical Research. In instances of non-compliance in PHS Clinical Research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, the Investigator is thereafter required to disclose the FCOI in each public presentation of the results of the relevant research and also request an addendum to previously published presentations of the relevant research.

7. Procurement.

See UF Regulation 3.020 for university Procurement procedures, including conflicts of interest in selection of university vendors and contractors.

8. References and Related Information.

• Florida Code of Ethics for Public Officers and Employees
• Florida Statutes § 1012.977
• NSF Proposal & Award Policies & Procedures Guide
• UF Regulation 7.049 Textbook and Instructional Materials Affordability and Transparency
• US PHS Regulation for Objectivity in Research
• UF Regulation 3.020 Procurement
• UF Regulation 5.0764 College of Medicine Policy on Pharmaceutical, Medical Device, and Biotechnology Industry Conflicts of Interest
• UF Regulation 1.011 Disclosure and Regulation of Outside Activities and Financial Interests

History