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 /Conflict of Interest (OA/COI) 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/Conflict of Interest (OA/COI) Form on the HR electronic portal and explain the researcher’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 OA/COI must be completed.  Once completed, the OA/COI will proceed to the various approvers for the University, including to ORED for review as relates to research/intellectual property.

Overview of the OA/COI 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:

• Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules
• Institutional Responsibilities as They Affect Investigators
• Institution-Specific Policies
• Conflicts of Commitment, Conscience, and Institutional Conflicts of Interest

Instructions to access CITI Online COI Training

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 requires 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

Florida law requires that all University employees engaged in the design, conduct or reporting of sponsored research on behalf of FIU must report his/her financial interests (i.e., anything of value other than that provided directly by the University) and his/her outside activities (i.e., anything the University employee does for an organization or an individual other than the University that is related to the employee’s expertise and/or is not part of the employee’s assigned duties).

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 the transaction is approved, which for FIU is reflected in an approved monitoring plan that is instituted to manage the conflicts of interest.

• 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 that 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 if it is found that the employee did not disclose information as required by Florida law.

2. Federal Law Requirements

The Conflict of Interest in Research policy # 2370.005 sets forth the federal law requirements pertaining to conflicts of interest.  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 example of when the Federal law requirements would come into play, if you are a researcher in the field of virology, you have shares in connection with a viral vaccine and it’s deemed to be related to or overlap with your institutional activities.

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.

Please see Implementing a Monitoring Plan, for the documentation required from a researcher for a Monitoring Plan.

Step 5: Monitoring Plan Process

• Admin Review: The completed Monitoring Plan and the Exemption Request, if applicable, will be reviewed by the Office of Research Integrity to ensure that all required information is provided.
• COI-RC Review: The Committee will review the Monitoring Plan and the Exemption Request, if applicable, prior to the meeting.
• COI-RC Meeting: The Members will meet to determine if the conflict may be managed and if so, shall recommend to the Designated Official the conditions to be included in the Monitoring Plan to manage the conflict.

If the researcher was required to complete a Request for Exemption Form and a Monitoring Plan was approved by the monitors, the following will also be required:

• First Level Approval: The approved Monitoring Plan and the Exemption Request will be sent to the Senior Vice President for Research for his review and final approval or disapproval.
• Office of General Counsel (OGC) Review: If the Exemption Request has been signed, the ORED attorney will forward it along with the Monitoring Plan for OGC review.
• Second Level Approval: If found acceptable, the OGC shall forward the documents to the FIU President for review and if approved, signature.
• Third Level Approval: If the Exemption Request is approved by the FIU President, the OGC shall forward the Exemption Request and the Monitoring Plan to the Chair of the FIU Board of Trustees for review and if approved, signature.