Why do I need a monitoring plan?
The purpose is unbiased research. Federal and Florida law require that certain standards be met to ensure that research is conducted in an objective and unbiased manner, free from personal interests of the researchers. The ORED policies and procedures set forth the requirements to ensure compliance with those laws. In addition, below is a summary of those requirements.
When is a monitoring plan needed?
1. Florida Law Requirements
Pursuant to Florida Law, FIU is generally prohibited from entering into an agreement with an entity in which an FIU employee or his/her spouse and/or dependent children has an interest. However, Florida law provides a limited exemption which allows for such contracts when they are for the purpose of commercializing FIU intellectual property or for the performance of research and an approved monitoring plan has been instituted to manage the conflicts of interest. The ORED Ethics Procedures set forth the processes at FIU to comply with the Florida requirements.
An example of when the Florida law requirements would come into play is if an FIU employee wishes FIU to enter into a research agreement with the employee’s start-up company so that research may be done at FIU for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) project funded to the employee’s start-up company. A monitoring plan must be in place before such research agreement may be executed. Similarly, a monitoring plan is a pre-requisite to FIU entering into a license agreement with the employee’s start-up for the commercialization of FIU IP.
2. Federal Law Requirements
Federal Law requires that financial conflicts of interest in federally funded research must be identified and managed by the University if they are capable of being managed. As required by Federal law, the COI in Research Policy requires that all Investigators (all capitalized terms are defined in the COI in Research Policy) report their Significant Financial Interests (SFIs) to the University. The University Designated Official or designee is required to review those SFIs and determine if a Financial Conflict of Interest (FCOI) exists that is related to sponsored research. The matter may be referred to a conflict of interest committee for review and recommendation to the Designated Official.
An FCOI exists when the Designated Official or designee reasonably determines that the Investigator’s SFIs is/are: (1) “related to” the subject research project (i.e., could be affected by the research or is in an entity whose financial interest could be affected by the research); and (2) could directly and significantly affect the design, conduct or reporting of the subject research. If it is determined that the SFIs is/are related to a sponsored project and that they constitute a FCOI and the Designated Official determines that the FCOI is not capable of being managed, then the project may not proceed. However, if the FCOI can be managed, then the research project may proceed only in accordance with the conditions set forth in a monitoring plan that is implemented to manage the FCOI.
If ORED determines that there may be a FCOI in relation to an awarded sponsored project in light of the SFIs reported by the Investigator(s) of the project, the matter will be referred to the Conflict of Interest Research Committee (COI-RC) for review. The Office of Research Integrity (ORI) will notify the applicable Investigator (and the project Principal Investigator if the Investigator is not the PI) that the matter is being referred to the COI-RC. Upon notification from ORI, the subject Investigator must complete the COI Monitoring Plan Process.
3. ORED Requirements
A monitoring plan is also required in any other research (i.e., non-federally sponsored research) should ORED determine that a conflict of interest exists that must be managed.