Conflict of Interest in Research Process
The following steps are provided to assist employees with an overview of the Conflict of Interest in Research Process.
Step 1: File a Disclosure
All disclosures of outside activities, financial interests or other conflicts of interest shall be done via the Division of Human Resources’ Outside Activity Report (OAR) / Conflict of Interest Electronic Reporting System. If you would like information on what disclosure obligations are consistent with the State of Florida and Federal Law requirements or assistance with the online portal, please click here. Furthermore, additional guidance on the disclosure process, please click here.
Complete the Outside Activity Report (OAR) on the HR electronic portal and explain the employee’s (or his/her spouse’s or dependent children’s) interest in the business entity (e.g., start-up company). All questions, including university and non-university research as well as foreign activities questions of the OAR must be completed. Once completed, the OAR will proceed to the various approvers for the University, including to ORED for review as relates to research/intellectual property.
Overview of the OAR Review Process (for Conflicts Involving Research)
Step 2: Complete the CITI Online COI Training Course
FIU utilizes the CITI (Collaborative Institutional Training Initiative) program for providing access to an online COI (Conflict of Interest) training course. The online training course covers the following four modules:
Step 3: Determine if you need a Monitoring Plan
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 sponsored 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 awarded to the employee’s start-up company. A monitoring plan must be in place before such sponsored research agreement may be executed. Similarly, a monitoring plan is a pre-requisite for FIU to enter into a license agreement with the employee’s start-up for the commercialization of FIU IP.
As set forth in the Conflict of Interest in Research policy # 2370.005, to comply with Florida Statute Section 1012.977, FIU employees engaged in sponsored research on behalf of FIU must report their financial interests and outside activities that are related to the employee’s expertise and/or are not part of the employee’s assigned duties. The Florida statute requires that FIU must make a determination that the outside activity or financial interest reported does not affect the integrity of FIU before engaging in said outside activity or financial interest. Therefore, if ORED determines that an outside activity or financial interest of an employee engaged in research may affect the integrity of the University, ORED will refer the matter to the Conflict of Interest in Research Committee to make that determination and to implement a monitoring plan, if appropriate, to provide for any conditions necessary so that the integrity of the University is not affected. Note that, as stated in Policy #2370.005, an employee who fails to disclose any outside activity or financial interest as required by the Florida law and the policy, shall be suspended without pay pending the outcome of an investigation which shall not exceed sixty (60) days. Upon conclusion of the investigation, the University may terminate the employee.
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-sponsored research) should ORED determine that a conflict of interest exists that must be managed.
Step 4: File a Monitoring Plan & Exemption Disclosure Form
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.
Step 5: Monitoring Plan Process
If the employee was required to complete a Request for Exemption Form and a Monitoring Plan was approved by the monitors, the following will also be required: