What is a monitoring plan?
A monitoring plan (sometimes referred to as a “management plan”) is a document that sets forth the conditions to manage conflicts of interest so that the research or contract may proceed.
When is a monitoring plan needed?
A. Florida Law Requirements
Florida Law requirements pertaining to contracts with an employee’s entity Pursuant to Florida law, FIU is generally prohibited from entering into an agreement with an entity in which a 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 IP or for the performance of research and an approved monitoring plan has been instituted to manage conflicts of interest.
Office of Research and Economic Development (ORED) Procedure # 2370.005(a), Ethics in Purchasing for Research and Intellectual Property Contracts under Florida Law.
For example, 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.
B. Federal Law Requirements
Federal Law requirements pertaining to conflicts in research a monitoring plan is also required by Federal regulations if a FIU employee has a manageable conflict of interest that could affect research funded by the PHS or NSF.
ORED Conflict of Interest in Research Policy #2370.005.
C. ORED Requirements
A monitoring plan is also required in any other research should ORED determine that a conflict of interest exists that must be managed.