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.

• 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 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 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 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/fiduciary /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 Remain PI, receives ≤ $25,000 per 12-month period Remain a team member, receives ≤ $100,000 per 12-month period Recuse from project if received > $100,000 in prior 12-month period 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)