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, Exhibits A and B which are located on the final pages of the Monitoring Plan Form.

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

Step 2: Submission to ORI

The employee must email the completed Monitoring Plan, Exhibits, Outside Activities/Conflict of Interest Form 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 

ORI will schedule a meeting of the Conflict of Interest Research Committee (COI-RC) to review the documents and the FIU employee will be invited to that meeting to provide information to the committee as needed.   The COI-RC shall provide a recommendation to the Designated Official for each COI matter reviewed by the COI-RC.  If the COI-RC determines that the conflict of interest may be managed, the committee will develop and recommend to the Designated Official a draft monitoring plan to manage the conflict.   The Designated Official shall have the final authorization over the determination of whether the conflict may be managed and if so, of the terms of the final monitoring plan.  The Designated Official may refer a matter back to the COI-RC for further consideration.

Step 4: Monitoring Plan Approval

If a monitoring plan is fully approved, ORI will provide a copy of it to the FIU researcher to whom it applies. 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).  ORI may also notify other FIU units of the monitoring plan, as needed.

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

If the researcher 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 COI after a sponsored project has begun, ORED may suspend the project until the COI-RC has reviewed the matter and it has been concluded as set forth above. Additionally, as set forth in the COI-RC policy, sanctions may be imposed on researchers who do not adhere to that Policy and the University will notify project sponsors if the conflict cannot be managed.

Step 5: Exemption Request Form – Additional Approvals

The final Monitoring Plan approved by the Designated Official and the related Exemption Request, shall be submitted to the University President and the Chair of the University Board of Trustees for authorization, as required by Florida law.

Step 6: Periodic Reviews

The employee who is the subject of a Monitoring Plan 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 COI-RC for those reviews. The COI-RC will make its recommendation to the designated official as to whether the Monitoring Plan should continue in effect, be terminated or be revised.  If a Monitoring Plan is terminated or revised, ORED shall take appropriate action, as needed, including terminating any impacted contract(s) or research projects.