Conflict of Interest Guidelines

The University of Miami values the relationships of our investigators with outside entities, and encourages appropriate collaborations that foster new scientific insights while assuring transparency and objectivity in research and the integrity of the scientific record.

Disclosures & Relationship Management and the Conflict of Interest Committee

The role of Disclosures & Relationship Management (DRM) and the Conflict of Interest (COI) Committee is to determine whether an investigator’s relationship with an external entity creates a situation that could introduce bias into a research project conducted at UM or by UM investigators, and, where this occurs, to manage it.

The UM COI Committee acts to determine, through a risk-based, case-by-case review, whether a COI is created between a research project and an external relationship. If a COI is found, the COI Committee works with the investigator to develop a management plan.

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  • Determination of Relationship

    A financial or obligatory interest can be called “related” to a research project if it involves the same or similar focus (disease or injury, molecular target, drug or device) as some aspect of the project. Examples include but are not limited to:

    • An investigator having a financial interest in or obligation to:
      • the sponsor of the project
      • an entity investigating the same/similar area as that to be studied/used in the new project
      • an entity that can reasonably be expected to benefit directly from the project
      • an entity that can reasonably be expected to compete with the product or procedure that will predictably result from the project
      • an entity that has a material transfer or confidentiality agreement for material used in the project
      • the intellectual property (IP) to be used in the project
    • The investigator is/was/will be
      • the IDE/IND holder (sponsor)
      • an inventor on the IP to be used or investigated in the project
      • directly involved in the design of the project with the sponsor
      • directly involved in bringing the product to market
      • directly involved in research involving the same or similar focus as an entity in which the investigator has an interest

  • Relationship components considered by the COIC

    • What is the nature of the relationship?
      • consulting
      • lecturing
      • board member (e.g. Scientific Advisory Board (SAB), Data Safety Monitoring Board (DSMB))
      • equity interest (stock, stock options or other ownership interest)
      • IP interest
    • How does the entity relate to the project?
      • financial or scientific sponsor
      • business activities of the entity same or similar focus as the project
    • What is the investigator’s role on the project?
      • could the Investigator affect the conduct or analysis of this research project (e.g. data capture, data analysis, patient selection)?
      • does the investigator supervise any trainees on the project (students, fellows,etc.)?
    • If the project involves human subjects:
      • will the Investigator be able to affect the outcome of the study?
      • what is the study design (clinical trial phase, randomization/blinding, single site or
      • will there be independent monitoring / a DSMB?

  • COI Management Plans

    External Activities:
    advisory board/
    consulting/lecturing
    /leadership role at entity
    Possible management plan components:
    • Role limitation
    • Requirement of study oversight
    • Modification of study design
    • Cessation of the external activities
    • Disclosures in ICF (human subject only)
    • Disclosures in professional communications
    • Limit compensation to ≤ $25,000 per 12 month period
    • Review travel compensation upon receipt of $15,000
    • Forbid involvement in contract negotiations
    • Disclosure to the university in new proposal submissions
    • Requirement to update the university upon changes to disclosures
    • UM will report COI to Funding Agency (if required)
    Any Equity Interest
    (Private Company)

    Equity Interest > $5000
    (Public Company)
    Possible management plan components:
    • Role limitation
    • Requirement of study oversight
    • Modification of study design
    • Restriction in exercising/trading stock options or stock
    • Divestiture of interest
    • Disclosures in ICF (human subject only)
    • Disclosures in professional communications
    • Disclosure to the university in new proposal submissions
    • Requirement to update the university upon changes to disclosures
    • UM will report COI to funding agency (if required)
    Intellectual Property Possible management plan components:
    • Role limitation
    • Modification of study design
    • Disclosures in ICF (human subject only)
    • Disclosures in professional communications
    • Disclosure to the university in new proposal submissions
    • Requirement to update the university upon changes to disclosures
    • UM will report COI to Funding Agency (if required)

COI Contacts

If you have specific questions or would like to arrange a presentation for your group on UM’s COI in Research policy and disclosure review process, please contact Dr. Lory Hayes, Director of DRM, or call the UDisclose System helpline (305-243-0877).