Management Plan Development

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A Management Plan is a recommended series of action steps to manage, reduce, or eliminate any actual, potential or perceived FCOIR as it relates to a specific sponsored project and the Investigator’s institutional responsibilities.  The purpose of a Management Plan is to assure that an investigator’s significant financial interests do not affect the research or sponsored activity and that the significant financial interests are not affected by the outcomes of sponsored activity.

Predicated on Research Compliance Service’s initial FCOIR determination, RCS prepares an initial draft of a Management Plan.  Review of this draft Management Plan is conducted during the next scheduled COIR Committee meeting.  The Investigator is notified when the COIR Committee meeting is scheduled.

The Investigator and the Investigator’s Department Head and research Center/Institute Director (if any) are invited to attend the portion of the COIR Committee meeting during which the Investigator’s FCOIR and draft Management Plan will be discussed.  The Investigator is invited to attend in order to provide additional input or perspective on the SFI, related sponsored projects and institutional responsibilities. Investigator attendance is not required.  Meeting attendance by the Investigator’s cognizant Dean/Associate Dean, Department Head and pertinent research Center/Institute Director (if any) is required.

In advance of the COIR Committee meeting, committee members, Investigator and Investigator’s Dean, Department Head and research Center/Institute Director (if any) will receive a copy of the meeting agenda, FCOI Determination Form and draft Management Plans for review.

During the COIR Committee Meeting, the committee will make a recommendation whether the Investigator’s Significant Financial Interest (SFI) related to his/her institutional responsibilities is reasonably perceived to have any effect on the design, conduct, or reporting of sponsored activity OR if the design, conduct, or reporting of the sponsored activity is reasonably perceived to have any effect on the SFI, thereby meeting the definition of a Financial Conflict of Interest in Research.

The COIR Committee will offer input and make additional recommendations for the draft Management Plan.  At this point, the Investigator and the Investigator’s Dean, Department Head and relevant research Center/Institute Director will have the opportunity to offer input for consideration for the draft Management Plan.  During the meeting, the Committee will advise and recommend a final version of the Management Plan, specifying the institutional actions that will be taken to manage, reduce, or eliminate the FCOIR. The COIR Committee will consider an Investigator’s perspective on the FCOI determination and Management Plan elements. The final recommendations will be made at the committee’s sole discretion.  The final determination and authority regarding FCOIR determination and associated Management Plan is held by the Designated Institutional Official.