Implementing a Monitoring Plan

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.

How to Implement a Monitoring Plan?

Step 1: Monitoring Plan Form Completion

Complete Sections 1 and 2 of the Monitoring Plan Form, as well as, “Exhibit A. Notice and Agreement by Company”, “Exhibit B. Employee Disclosure Statement” and “Exhibit C. Ownership Interest in the Company”, which are located on the final pages of this form.  Furthermore, a copy of the Outside Activities and Financial Interest Report(s) must be provided.

If applicable, complete the Exemption/Disclosure Request Form. This form is only required if the employee seeks to have FIU enter into a contract.

Step 2: Submission to ORI

The employee must email the completed Monitoring Plan, Exhibits, Outside Activities and Financial Interest Report and the Exemption Request (if applicable) to the Office of Research Integrity at ori@fiu.edu for review to ensure that all required information is provided. If the information is not complete, it shall be returned to the employee for completion.

Step 3: Representatives Review and Meeting

Once the required form(s) is/are complete, ORI shall: (1) forward the required documents to the following persons; and (2) schedule a meeting for them to discuss the matter:

  • The employee’s Chair or supervisor (or other Department representative if deemed appropriate by ORI);
  • The representative designated by the employee’s Dean’s Office or, if the employee is from an independent center, a representative designated by the Center Director;
  • A representative from ORED.

The foregoing persons shall meet to determine if the conflict may be managed and if so, shall recommend the conditions to be included in the Monitoring Plan to manage the conflict. If any of the above persons has a conflict in relation to the proposed matter or if there is a supervisory conflict between the FIU employee requesting the Monitoring Plan and any of the above personnel, an alternative representative shall be selected by ORED.

ORI shall also include the following personnel at the meeting, who shall attend only for the purposes listed below:

  • The employee who submitted the document(s) shall attend to answer questions from the meeting participants and shall be excused from the meeting when no further questions remain;
  • A representative from the Office of Technology Management and Commercialization (OTMC) if the matter involves FIU intellectual property. The OTMC representative shall attend the meeting only to provide information requested by the participants regarding the intellectual property at issue;
  • A legal representative (generally, Diana Firvida-Oliva) who shall attend to answer any legal questions.

Step 4: Monitoring Plan Approval

At the meeting, if the employee’s chair, the Dean’s (or Center Director’s for independent centers) representative and the ORED representative determine that the conflict may be managed, they shall prepare the recommended Monitoring Plan terms and shall sign it. ORI shall provide that proposed Monitoring Plan to the employee who shall also sign it, reflecting the employee’s agreement to comply with its terms.  Note:  If the employee did not require an Exemption Request Form then once the Monitoring plan has been approved and finalized, proceed to Step 8.

Step 5: Exemption Request Form – First Level Approval

ORI will then provide the signed Monitoring Plan and the Exemption Request to the Vice President for Research and Economic Development (VPR) for review and if approved, signature on the Exemption Request. If the Exemption Request is signed by the VPR, the ORED attorney shall forward the Exemption Request together with the Monitoring Plan to the General Counsel’s Office (OGC) for review.

Step 6: Exemption Request Form – Second Level Approval

If found acceptable, the OGC shall forward the same to the FIU President or his designee for review and if approved, signature.

Step 7: Exemption Request Form – Third Level Approval

If the Exemption Request is approved by the FIU President or his designee, 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. The OGC shall return the final Exemption Request, together with the Monitoring Plan to the VPR.

Step 8: Approval Memorandum

ORI shall forward the final Exemption Request and Monitoring Plan to the employee, and to the College, Department and ORED representatives as well as to the Assistant Vice President for Research and the Director of OTMC. If the Exemption Request and the Monitoring Plan were fully approved, Pre-Award and OTMC may proceed with executing any pending research or IP agreement(s). If the Exemption Request was not fully approved, the agreements may not proceed.

Step 9: Pending Agreements, Projects and/or IP Commercialization

If the applicable contract(s) is/are fully executed, the research project and/or IP commercialization, as applicable may proceed. The processing and maintenance of the research agreement or the IP commercialization agreement, as applicable, shall proceed in Pre-Award or OTMC per each office’s applicable processes. For example, SBIR/STTR research agreements will be executed and maintained in Pre-Award and license agreements will be executed and maintained in OTMC.

Step 10: Periodic Reviews

PI will ensure that the periodic reviews of approved Monitoring Plans are done as required by the approved Monitoring Plans.  ORI will schedule the meetings for those reviews. If, at any of the monitoring meetings, it is determined that the conflict cannot continue to be appropriately managed, then appropriate action shall be taken, including terminating any contract(s), as needed.