Implementing a Monitoring Plan

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 the exhibits which are located on the final pages of this form.  Furthermore, a copy of the Outside Activities and Financial Interest Report from the HR electronic portal 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: Conflict of Interest Research Committee Meeting

ORI will schedule a meeting of the Conflict of Interest Research Committee (COI-RC) to review the requested exemption request and the FIU employee will be invited to that meeting to provide information to the committee as needed.   If the COI-RC determines that the conflict of interest may be managed, the committee will develop a monitoring plan to manage the conflict.   Pursuant to the Florida law requirements, the University President and the Chair of the University Board of Trustees must authorize the proposed transaction and such authorization is reflected by their signature on the Exemption Request.

Step 4: Monitoring Plan Approval

ORI will provide to the FIU employee the Monitoring Plan once it is fully signed by all required University personnel. ORI will also provide the final Monitoring Plan to ORED and to the Office of Technology Management and Commercialization (OTMC) so that ORED, Pre-Award and/or the OTMC may proceed with executing any pending research or intellectual property agreement(s).

The Investigator may not begin work on the project until the COI-RC has either: (1) determined that there is no FCOI in regards to the project; or (2) a monitoring plan has been implemented to manage the FCOI.

If the Investigator is the project PI, ORED will not issue the Project ID until ORED receives notification from ORI that the COI-RC has concluded either item 1 or 2 above and the PI has agreed in writing to comply with the monitoring plan and has provided all additional requirements deemed necessary by the COI-RC or the Designated Official. If the Investigator at issue is not the project PI, then ORED will release the Project ID to the PI once all ORED Pre-Award processes are concluded, and it shall be the responsibility of the PI to ensure that the subject Investigator does not begin work on the project until ORED notifies the project PI that all conflict of interest matters have been resolved, which includes the Investigator agreeing in writing to comply with the monitoring plan.   ORED will withhold the release of sponsored project funding that is associated with the subject Investigator who has the conflict of interest until ORED receives notification from ORI that, as relates to the subject Investigator, the COI-RC has concluded either item 1 or 2 above and the subject Investigator has agreed in writing to comply with the monitoring plan and has provided all additional requirements deemed necessary by the COI-RC or the Designated Official.

If the PI fails to adhere to the above requirements, ORED may suspend the performance of the project until such time as all conflict of interest requirements have been met. Additionally, if ORED identifies a potential FCOI after a sponsored project has begun, ORED may suspend the project until the COI-RC has reviewed the matter and it has been concluded in accordance with item 1 or 2 as noted above. Additionally, as set forth in the COI-RC policy, sanctions may be imposed on Investigators who do not adhere to that Policy and the University will notify project sponsors if the conflict cannot be managed.

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

The Investigator or FIU employee, as applicable, must timely provide to ORI a Monitoring Plan Renewal Request so that an approved Monitoring Plan may be reviewed at the intervals stated in the Plan.  ORI will schedule the meeting for the CIRC for those reviews. If, at any of the renewal meetings, the CIRC determines that the conflict cannot continue to be appropriately managed, then ORED shall take appropriate action, including terminating any impacted contract(s) or research projects, as needed.