Financial Conflict of Interest (FCOI): A situation associated with an investigator's participation in a sponsored project in which it reasonably appears, on an actual or potential basis, that the investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the sponsored project.
Designated Official: The university official designated to review the investigator's Significant Financial Interest Disclosure Form (Exhibit A attached hereto) and to determine if any reported interests reasonably appear to represent a conflict of interest. The Designated Official at UNF is the Associate Provost or such other person as the Provost appoints from time to time as the individual within the University responsible to oversee the University's compliance with conflict of interest regulations and policies.
Investigator: The principal investigator, the co-principal investigator, or any other person (including faculty, staff, students, and non-UNF individuals) who have significant influence over the design, conduct, or reporting of a project sponsored by UNF, even if the individual does not have sole or primary responsibility for the project. It does not include project participants involved in project tasks who do not otherwise have significant influence on the design, conduct, or reporting of that project.
Non-UNF Investigator: Any person who is responsible for the design, conduct, or reporting of sponsored activities managed by UNF; and who is employed by an entity other than UNF, working pursuant to a subrecipient agreement with another entity, working as an independent contractor or collaborator, or otherwise not employed by UNF.
Significant Financial Interest (SFI): Anything of monetary value belonging to the investigator and his or her spouse or domestic partner and dependent children that could reasonably appear to be related to an investigator's responsibilities for a sponsored project, including but not limited to:
- Salary, royalties, or other payments for services, such as consulting fees or honoraria, unless they are expected to total $5,000 or less over the next 12 months when aggregated for the investigator and his or her spouse and dependent children.
- Equity interests, such as stocks, stock options, or other ownership interests, unless they amount to $5,000 or less in value and represent a 5% or less ownership interest in a single entity when aggregated for the investigator and his or her spouse and dependent children.
- Travel payments (i.e., travel reimbursements or travel paid on the investigator's behalf):
- For investigators who request or receive any funding from PHS, or other federal agency with similar conflict of interest requirements, all travel that is reimbursed or sponsored by a third-party sponsor/organizer;
- For all other investigators, travel that is reimbursed or sponsored by an entity that, when aggregated, exceeds $5,000.
- Intellectual property rights, such as patents and copyrights, and royalties from these rights.
Significant financial interest does not include the following:
- Salary, royalties, or other remuneration from UNF (including payments or other technology commercialization proceeds).
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
- Income from service on advisory committees or review panels for public or nonprofit entities.
- Interests in blind trusts if the investigator has no knowledge of the trust assets.
- Interests in widely held investment funds if:
- The investigator does not exercise control over or have the ability to exercise control over the fund's financial interests; and
- The fund is publicly traded or available; or
- Its assets are widely diversified, such as if the fund holds no more than 5% of its portfolio value in the securities of any one issuer, other than the federal government, and no more than 20% of its portfolio value in any particular economic or geographic sector.
Sponsored Activity/Project: Includes research as well as other related activities, including curriculum development, public service projects, instrumentation and infrastructure awards, training grants, conference grants, and any other activity funded, either directly or indirectly, by a governmental agency, non-profit organization, for-profit corporation, or any other party external to UNF.
Subrecipient: A subcontractor, contractor, or collaborator with whom UNF has a written agreement regarding sponsored activity.
Failure to file a complete SFI for a sponsored project, or to adhere to this policy and associated procedures, will be grounds for disciplinary action under applicable University regulations and collective bargaining agreements. In addition, sponsors may terminate current awards and/or contracts and may determine an investigator ineligible to receive future awards if University policy is violated.
If UNF identifies a SFI that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by UNF during a PHS-funded project (e.g., was not timely reviewed or reported by a subrecipient), the Designated Official shall, within 60 days of learning of the failure of the disclosure or review of the SFI, review the SFI, determine whether it is related to the project, determine whether a FCOI exists, and, if so, implement a management plan (as described in Section 4(b) above) that shall specify the actions that have been and will be taken to manage such FCOI going forward.
In addition, whenever a FCOI on a PHS-funded project is not identified or managed in a timely manner, including failure by the investigator to disclose a SFI that is determined by the Designated Official to constitute a FCOI, failure by UNF to review or manage such a FCOI, or failure by the investigator to comply with a management plan, the Designated Official shall, within 120 days of UNF's determination of non-compliance, complete a retrospective review of the investigator's activities and the sponsored project to determine whether any activities, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct, or reporting of such activities.
Based on the results of the retrospective review, if appropriate, UNF shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, UNF will notify PHS promptly and submit a mitigation report. The report must include, at a minimum, the key elements documented in the retrospective review and a description of the impact of the bias on the project and UNF's plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, UNF will submit FCOI reports to PHS annually. Depending on the nature of the FCOI, UNF may determine that additional interim measures are necessary with regard to the investigator's participation in the PHS-funded project between the date that the FCOI or the investigator's non-compliance is determined and the completion of UNF's retrospective review.