Research Conflict of Interest

The Research Conflict of Interest Program (RCOI) reviews and manages Significant Financial Interests that have the potential to bias research. The program ensures UF’s compliance with sponsor COI regulations. UF Research Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Research sets forth the processes to identify and manage research Financial Conflicts of Interest.

Disclosing Outside Activities and Financial Interests

On a rolling basis, groups of UF employees become eligible to disclose through UFOLIO. More information, including what to disclose, how to navigate the system and who is currently eligible to disclose in UFOLIO is available on the UF COI Program website: https://coi.ufl.edu.

COI and Human Subjects Research

When submitting IRB applications, investigators must disclose personal and financial interests as required by the reviewing IRB. RCOI uses the guidelines found here when reviewing potential conflicts of interest related to Interventional Human Subject Research.

Significant Financial Interests

Investigators must disclose when required by the UF Research Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Research. UF Investigators, regardless of research funding sources, must disclose new SFIs related to their Institutional Responsibilities within 30 days of acquisition or discovery and complete UF’s annual disclosure process. Certain sponsors (PHS and NSF) require disclosure of SFIs prior to proposal submission.

An SFI includes 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:

*Disclosure of sponsored or reimbursed travel applies to PHS-funded researchers only

SFI Does Not Include:

• Salary, royalties or other remuneration paid by UF to the Investigator if the Investigator is currently employed or otherwise appointed by UF;
• Intellectual property rights assigned to UF 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, qualifying U.S. 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, qualifying U.S. 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.
• Sponsored or reimbursed travel sponsored or paid by a federal, state or local government agency, qualifying U.S. 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.

RCOI, Conflict of Interest Program and UFOLIO

When an Outside Activity or Financial Interest disclosed in UFOLIO relates to research, the COI Program reviewer marks the disclosure for ancillary review, and it routes to the RCOI Administrator. If additional information is required to determine whether your disclosure is a Significant Financial Interest and, if so, whether it relates to your UF research, our office will contact you directly.

Prior to engaging in research related to your Significant Financial Interests, contact the RCOI Administrator if you have not yet received a final management plan. Amber Moore, Assistant Director, is available at 352-273-3104 or coi@research.ufl.edu.

Policies

• U.S. PHS Regulation for Objectivity in Research
• NSF Proposal & Award Policies & Procedures Guide
• Florida Code of Ethics for Public Officers and Employees
• Florida COI Bill – Section 1012.977 (passed in 2020; official publication pending)
• UF Policy on Conflicts of Commitment and Conflicts of Interest
• UF Research Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Research

Related Programs and UF Guidance

• UF COI Program
• Disclosing International Relationships and Activities

COI Training

1. The Public Health Service (PHS) Conflict of Interest (COI) regulation requires Principal Investigators and all Key Personnel in PHS-funded projects to complete the Financial Conflict of Interest (FCOI) training before engaging in the research.
   1. UF has established a specific FCOI training course DSR 810, which satisfies this PHS requirement.
   2. This course can be accessed through myUFL > My Self Service > Training and Development > MyTraining.
2. Education is required of each individual initially and then every four years
3. Education is required immediately when:
   1. Financial conflict of interest policies are revised in a manner that changes researcher requirements
   2. A researcher is new to the organization
   3. A researcher is non-compliant with financial conflict of interest policies and procedures

Public Requests for Information: PHS Funded Research

Pursuant to the PHS regulation for Promoting Objectivity in Research, UF will provide a written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:

1. The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;
2. The Institution determines that the significant financial interest is related to the PHS-funded research; and
3. The Institution determines that the significant financial interest is a financial conflict of interest.

Pursuant to the PHS regulation, COI-R will provide: the Investigator’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. COI-R will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates.

To submit a request, please email: coi@research.ufl.edu.

If email is not available, please send a written letter of request to the following office address:

Research Conflict of Interest
Research Integrity
University of Florida
Grinter Hall
PO Box 115500
Gainesville, FL 32611-5500

Key Definitions

Entity: 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): A Financial Conflict of Interest exists when UF, through its Research Conflict of Interest Administrator, reasonably determines that an Investigator’s Significant Financial Interest is related to a funded research project and could directly and significantly affect the design, conduct or reporting of the funded research, or present the appearance thereof.

Human Subjects Research: Any investigation or organized activity, regardless of funding source, involving patient oriented research, behavioral research, or epidemiological, outcomes, or health services research, which requires approval by an Institutional Review Board.

Immediate Family Member: Includes an Investigator’s spouse, domestic or civil union partner, and dependent children.

Institutional Responsibilities: Include professional activities that relate to an Investigator’s responsibilities on behalf of UF, such as research, teaching, institutional committee memberships, professional practice, and administrative activities and responsibilities for UF.

Investigator: Includes anyone responsible for the design, conduct, or reporting of research, regardless of title or position, and their Immediate Family Members.

Research Conflict of Interest (RCOI) Administrator: The designated institutional official responsible for implementing the Policy on Disclosure of Financial Interests and Management of Conflict of Interests Related to Research, reviewing Significant Financial Interests and managing FCOI.

Subrecipient: A legal entity that receives a Subcontract 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.