A. Charge of Committee
The COI Research Committee (COI-RC) is charged with reviewing instances of potential or actual financial conflicts of interest in research and for developing and reviewing monitoring plans to manage the conflicts that are capable of being managed. When the conflict of interest involves a study that requires the approval of another compliance committee (i.e., IRB, IACUC, IBC) the COI-RC may communicate, as it deems necessary with the other compliance committee concerning the management of the conflict. The other compliance committee shall have final authority to decide the requirements related to any conflicts in regards to the approval or denial of the study within the other committee’s purview.
For example, the IRB shall have final authority over whether to approve the subject human subject protocol and the conditions that may be imposed therein, and such conditions may vary from the conditions imposed by the COI-RC in the monitoring plan. The COI-RC shall make recommendations to the Vice President for Research as it deems appropriate.
The COI-RC shall consist of at least five (5) members comprised of the following individuals who shall all be voting members:
- A designee of the Vice President for Research (who shall be the Committee Chair and shall have responsibility for running the Committee meetings)
- A minimum of three (3) faculty members selected by the Vice President for Research
- The Dean (or the Dean’s designee) of the subject Investigator’s college
- Ad-Hoc member(s) as determined necessary by the Vice President for Research depending on the research project involved or if needed when it is anticipated that the number of voting members in attendance will not constitute a quorum
Recusal of a member is required when a member has an actual or apparent conflict of interest with regard to any matter under review. If the FIU employee whose conflict of interest is under review holds a senior position at FIU (e.g., the Provost or the President) such that the Vice President for Research determines that one of more independent monitor(s) is/are needed to review the matter, then such independent monitor(s) may be retained to serve on the COI-RC for the matter at issue. In that case, the COI-RC shall be constituted in a way that allows for the review of the senior FIU official’s conflict in the most transparent and unbiased manner reasonably possible.
Committee meetings will be convened and actions may be taken only when a quorum has been reached. A quorum consists of a majority of voting members of the Committee. A member of the COI-RC may not vote on a project, and is not counted towards a quorum, if the member has a conflict of interest in relation to the matter that is under review.
Minutes are generated that record the following information from each COI-RC meeting:
- Attendance at each meeting;
- Actions taken by the Committee at the meeting;
- The vote on actions taken including the number for, against and abstaining;
- The basis for requiring the conditions included in monitoring plans or the reason why a monitoring plan was disapproved;
- A written summary of the discussion of issues and their resolution.
E. ORI Administrative Support
ORI provides administrative support to the COI-RC as follows:
- Schedules the Committee meetings and distributes documentation for such meetings to all Committee members in advance of the meetings;
- Maintains files for each matter reviewed by the Committee and on Committee minutes;
- Assists with preparation of meeting minutes;
- Screens documentation submitted by FIU employees for completeness and communicates with such personnel, as needed, to request any omitted information;
- Acts as a resource for the FIU community on inquiries on general regulatory information and guidance on forms related to the conflict of interest in research process;
- Provides staff support to the Committee for all written correspondence;
- Sends notices of Committee actions to affected University personnel, including monitoring plan approvals, rejections and renewals;
- Generates and sends reminder notices to FIU personnel of upcoming meetings and any information required from such FIU personnel for those meetings.