COIC & COI Guidelines
The University of Miami (UM) 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. The role of the Office of Disclosures & Conflict of Interest (COI) Management and the 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.
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?
- 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 PlansThe COIC reviews each case on an individual basis; however, management plans typically include common elements, the inclusion of which depends on the type of relationship involved. These elements are based on recommendations from the AAU/AAMC (February 2008) and Institute of Medicine (January 2009) reports. Please note these are potential components, specific COI management plans will vary.
/leadership role at entity
|Any Equity Interest
Equity Interest > $5000