³ÉÈËAVÊÓƵ

Regulations & Policies

Academic Affairs - Research and Sponsored Programs

I. PURPOSE

The primary purpose of this policy is to protect the integrity, trust, and respect of the ³ÉÈËAVÊÓƵ, its academic community, and its sponsored activities. Members of the University community are engaged in many contractual, consulting, and advisory relationships with other universities, government agencies, and private sector entities. ³ÉÈËAVÊÓƵ encourages these relationships for their contributions to research, education, technological advancement, and professional development. ³ÉÈËAVÊÓƵ members must be cautious, however, to prevent unresolved conflicts of interest in these relationships that might undermine the credibility of their work or damage their reputation.

The purpose of this policy is also to satisfy requirements of Public Health Service (PHS) regulation 42 CFR Part 50 Subpart F and 45 CFR Part 94, which applies to all PHS-supported contracts and agreements, including those issued by the National Institutes of Health. The policy further complies with the provisions of the National Science Foundation (NSF) Proposal & Award Policies & Procedures Guide, Part II, Award & Administration Guide (AAG) Chapter IV.A, and the requirements and guidances of several other federal agencies. The policy is also consistent with Florida state statutes that require University employees to disclose their outside activities and financial interests pursuant to the State of Florida Code of Ethics for Public Officers and Employees, Part III, Chapter 112, Florida Statutes.

Financial conflicts of interest may occur when an investigator's sponsored project responsibilities compete with his or her private financial interests, raising questions of objectivity and improper gain. Conflicts of interest are inevitable in modern universities and do not imply any impropriety on the part of the investigator. A financial conflict of interest may exist despite the highest standards of conduct and candor, and most can be successfully resolved without impeding sponsored activities.

The policy accordingly is designed to inform investigators involved in sponsored projects of their disclosure responsibilities, provide an efficient yet compliant procedure for making disclosures, and facilitate effective identification and management of financial conflicts of interest. It does not cover other possible conflicts of interest, which are regulated by the collective bargaining agreement and ³ÉÈËAVÊÓƵ Policy 4.0170R Conflicts of Interest and Outside Employment/Activity.

II. STATEMENT OF POLICY

1. Applicability

    

   This policy applies to all investigators, including non-³ÉÈËAVÊÓƵ investigators as defined in Section II(2), who are participating in sponsored projects managed by and/or awarded to ³ÉÈËAVÊÓƵ.

    

2. Definitions

    

   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 ³ÉÈËAVÊÓƵ 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-³ÉÈËAVÊÓƵ individuals) who have significant influence over the design, conduct, or reporting of a project sponsored by ³ÉÈËAVÊÓƵ, 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-³ÉÈËAVÊÓƵ Investigator: Any person who is responsible for the design, conduct, or reporting of sponsored activities managed by ³ÉÈËAVÊÓƵ; and who is employed by an entity other than ³ÉÈËAVÊÓƵ, working pursuant to a subrecipient agreement with another entity, working as an independent contractor or collaborator, or otherwise not employed by ³ÉÈËAVÊÓƵ.

    

   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:

   1. 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.
   2. 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.
   3. Travel payments (i.e., travel reimbursements or travel paid on the investigator's behalf):
      1. 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;
      2. For all other investigators, travel that is reimbursed or sponsored by an entity that, when aggregated, exceeds $5,000.
   4. Intellectual property rights, such as patents and copyrights, and royalties from these rights.

      Significant financial interest does not include the following:

      1. Salary, royalties, or other remuneration from ³ÉÈËAVÊÓƵ (including payments or other technology commercialization proceeds).
      2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
      3. Income from service on advisory committees or review panels for public or nonprofit entities.
      4. Interests in blind trusts if the investigator has no knowledge of the trust assets.
      5. Interests in widely held investment funds if:
         1. The investigator does not exercise control over or have the ability to exercise control over the fund's financial interests; and
         2. Either
            1. The fund is publicly traded or available; or
            2. 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 ³ÉÈËAVÊÓƵ.

    

   Subrecipient: A subcontractor, contractor, or collaborator with whom ³ÉÈËAVÊÓƵ has a written agreement regarding sponsored activity.

    

3. (3) Investigator Responsibilities
   1. Disclosure

       

      Investigators covered under this policy are expected to govern their professional activities in accordance with the University mission and all regulations. Covered persons are expected to identify and, when possible, avoid financial conflicts of interest (FCOI). If an FCOI cannot be avoided, a Significant Financial Interest Disclosure Form must be completed to allow for elimination or management of the financial conflicts.

       

      Additionally, investigators on sponsored projects are required to disclose any significant financial interest (SFI) that involves themselves, spouse, and dependent children in non-³ÉÈËAVÊÓƵ organizations or companies whose financial interests could reasonably appear to affect or be affected by their sponsored activities. A SFI must be disclosed through a Significant Financial Interest Disclosure Form prior to submission of a grant application or contract to the Office of Research and Sponsored Programs. The principal investigator on a project must further ensure that all investigators in the proposal disclose SFIs, in addition to any real or apparent FCOIs.

       

      Covered persons must update their disclosure forms at least annually during the period of a sponsored project award, and within 30 days of any of the following changes to a project: a new SFI has developed (e.g., through purchase, marriage, or inheritance), an existing SFI ends or is materially altered, or a new investigator with a SFI is hired to work on the sponsored project.

       

      Investigators must also disclose the occurrence of any reimbursed or sponsored travel from any non-³ÉÈËAVÊÓƵ organization or business that is related to their project responsibilities. However, this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with ³ÉÈËAVÊÓƵ.

       

      Sponsored projects may require the University to enter into subrecipient agreements with outside entities or persons. In those situations, the investigator must inform the Office of Research and Sponsored Programs of the intent to include subrecipient(s) on the project prior to submission of a grant application or contract. It is the responsibility of the investigator to ensure that the subrecipient provides any necessary FCOI documentation.

       

      All disclosures should be made to the Office of Research and Sponsored Programs. Sponsored activities may not begin until the University has reviewed all SFI and FCOI disclosures, and all parties have agreed to any management strategies, if needed.

       

   2. Training

       

      Each investigator must complete training regarding this policy, disclosure responsibilities, and relevant federal regulations prior to engaging in activities related to any grant or contract and at least every four years while engaged in sponsored projects, as well as immediately under the following designated circumstances:

      1. ³ÉÈËAVÊÓƵ FCOI policies change in a manner that affects investigator requirements;
      2. An investigator is new to ³ÉÈËAVÊÓƵ; and
      3. ³ÉÈËAVÊÓƵ finds an investigator non-compliant with ³ÉÈËAVÊÓƵ's FCOI policy or management plan.
4. University Responsibilities
   1. Disclosure Review

       

      Prior to commencement of any new sponsored activity or the expenditure of any funds on a new sponsored project, the Designated Official, in consultation with other administrative units as needed and appropriate, shall review the investigator disclosures of SFIs to determine whether any is related to the sponsored activity and, if so, whether the SFI is a FCOI. An investigator's SFI is related to the sponsored activity when the Designated Official reasonably determines that the SFI could be affected by the sponsored project, or is in an entity whose financial interest could be affected by the sponsored project. The Designated Official may contact the investigator for additional information, as needed, and may involve the investigator in the Designated Official's determination of whether a SFI is related to the sponsored project. A FCOI exists when the Designated Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the sponsored project

       

      If an SFI is disclosed on an existing project that is sponsored by any sponsor other than the PHS, the University shall review such SFI and impose actions (e.g., updating an existing management plan) using the same processes as set forth above.

       

      If, in the course of an existing project sponsored by PHS (or any sponsor the adopts the PHS FCOI requirements), an investigator who is new to the project discloses a SFI, or an existing investigator discloses a new SFI, the Designated Official shall review the disclosure to determine whether it is related to ongoing sponsored activity, whether a FCOI exists and, if so, implement a management plan (as described in Section 4(B) below). This review shall occur within 60 days of receipt of the disclosure. Depending on the nature of the SFI, the Designated Official may determine that interim measures are necessary with regard to the investigator's participation in the ongoing project between the date of the disclosure and the completion of ³ÉÈËAVÊÓƵ's review.

       

   2. FCOI Management

       

      If a FCOI exists, the Designated Official may determine that the FCOI is such that the sponsored project may not proceed, or the Designated Official may determine that the sponsored project may proceed upon conditions imposed to manage the FCOI, including any financial conflicts of an investigator or a subrecipient (e.g., subcontractor or consortium member). Such conditions shall be set forth in a management plan. The management plan shall specify the actions that have been, and shall be, taken to manage the FCOI.

       

      Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are not limited to:

      1. Public disclosure of FCOIs (e.g., when presenting or publishing the research);
      2. For projects involving human subjects research, disclosure of FCOIs directly to participants;
      3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the sponsored project against bias resulting from the FCOI;
      4. Modification of the sponsored project plan;
      5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the sponsored project;
      6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
      7. Severance of relationships that create financial conflicts.

      ³ÉÈËAVÊÓƵ shall monitor investigator compliance with the management plan on an ongoing basis until the completion of the sponsored project.

       

   3. Subrecipient Monitoring

       

      ³ÉÈËAVÊÓƵ is responsible for ensuring that all recipients of subawards comply with all regulations regarding FCOI. Prior to proposal submission, the investigator will notify the Office of Research and Sponsored Programs if a subrecipient is affiliated with the project. ³ÉÈËAVÊÓƵ will incorporate, as part of the written agreement with the subrecipient, terms that establish whether ³ÉÈËAVÊÓƵ's FCOI policy or that of the subrecipient will apply to subrecipient's personnel who will be involved in the sponsored program. If the subrecipient organization does not have an FCOI policy that complies with federal regulations, the subrecipient's personnel involved in the sponsored program will be required to adhere to ³ÉÈËAVÊÓƵ's policy and procedures.

       

      The subrecipient agreement will specify timing for reporting FCOIs by subrecipient investigators to ³ÉÈËAVÊÓƵ to enable timely review and reporting of such FCOIs in compliance with funding agency requirements. ³ÉÈËAVÊÓƵ will report any identified FCOI on the part of a subrecipient to the relevant sponsor within 60 days of disclosure, or as otherwise required through ³ÉÈËAVÊÓƵ's agreement with the sponsor.

       

   4. Reporting to Project Sponsor

       

      The University shall report any FCOI to the sponsors on projects as required by applicable sponsor regulations and the sponsor award document.

       

      For NSF-funded projects, or other federal agency with similar FCOI requirements, the University must inform the NSF's Office of the General Counsel if the University finds that it is unable to satisfactorily manage an actual or potential FCOI.

       

      Prior to expenditure of any funds under a new PHS-funded project, or other sponsor with similar FCOI requirements, ³ÉÈËAVÊÓƵ shall provide a FCOI report to the sponsor regarding any investigator's SFI found by ³ÉÈËAVÊÓƵ to be conflicting and ensure to the sponsor that ³ÉÈËAVÊÓƵ has implemented a management plan. This report will be made within 60 days of its discovery. If ³ÉÈËAVÊÓƵ identifies a FCOI and eliminates it prior to the expenditure of PHS-awarded funds, ³ÉÈËAVÊÓƵ need not submit a FCOI report to the sponsor.

       

      A FCOI report shall include sufficient information to enable the sponsor to understand the nature and extent of the financial conflict, and to assess the appropriateness of ³ÉÈËAVÊÓƵ's management plan. For any FCOI previously reported by ³ÉÈËAVÊÓƵ with regard to an ongoing PHS-funded project, ³ÉÈËAVÊÓƵ shall provide an annual FCOI report, concurrently with the annual progress report, that addresses the status of the FCOI and any changes to the management plan for the duration of the sponsored project, including extensions with or without funds. The annual FCOI report shall specify whether the FCOI is still being managed or explain why it no longer exists.

       

      For existing projects funded by PHS, or sponsor with similar FCOI requirements, ³ÉÈËAVÊÓƵ shall provide an updated FCOI report to the PHS within 60 days of the identification of a FCOI for an investigator who is newly participating or the identification of a new FCOI for an existing investigator on a PHS-funded project.

       

      It will be the responsibility of the University to file with the requisite sponsor any inability of the University to satisfactorily manage a FCOI. Additional details on reporting responsibilities for non-compliance are found in Section II(5) below.

       

   5. Public Accessibility to FCOI Information

       

      Prior to ³ÉÈËAVÊÓƵ's expenditure of any funds under a PHS-funded project, or any sponsor that adopts the PHS FCOI requirements, if requested, the University shall make available within five business days of the University Designated Official's receipt of the written request, information regarding any FCOI of senior/key personnel on the sponsored project. This information shall remain available, for responses to written requests, for at least three years from the date that the information was most recently updated.

5. Non-Compliance

    

   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 ³ÉÈËAVÊÓƵ identifies a SFI that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by ³ÉÈËAVÊÓƵ 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 ³ÉÈËAVÊÓƵ 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 ³ÉÈËAVÊÓƵ'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, ³ÉÈËAVÊÓƵ shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, ³ÉÈËAVÊÓƵ 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 ³ÉÈËAVÊÓƵ's plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, ³ÉÈËAVÊÓƵ will submit FCOI reports to PHS annually. Depending on the nature of the FCOI, ³ÉÈËAVÊÓƵ 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 ³ÉÈËAVÊÓƵ's retrospective review.

    

6. Maintenance of Records

    

   The University shall keep and maintain records of all disclosures and all actions taken to manage any actual or potential FCOI for at least 3 years beyond the termination or completion of the award or until resolution of any action by any sponsor involving the records, whichever is longer.

   SFI Disclosure Form

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