Management Plan FAQ

If a COI Official determines that a FCOI exists, the COI Official or designee must notify the investigator in writing and work with the investigator to develop a management plan specifying the steps to be taken to manage, reduce or eliminate the FCOI.

A management plan must include a description of the following key elements:

• The research affected by the FCOI, including, if available, the project number;
• The role and principal duties of the investigator who has the FCOI;
• The conditions or restrictions to be implemented to manage, reduce or eliminate the FCOI;
• A statement explaining how the management plan will protect the research from bias resulting from the FCOI;
• Confirmation of the investigator’s agreement to abide by the management plan;
• A statement explaining how the management plan will be monitored to ensure compliance and who is responsible for monitoring compliance with the management plan; and
• Any other information as needed.

Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate an investigator’s FCOI include, but are not limited to:

• Public disclosure of the FCOI;
• For research projects involving human subjects, disclosure of the FCOI to the participants;
• Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of research against bias resulting from the FCOI;
• Modification of the research plan or research activities;
• Requiring a change in personnel and/or responsibilities for all or a portion of the research activities;
• Disqualification of personnel from participation in that portion of the research activities that would be affected by the FCOI;
• Reduction or elimination of the financial interest (e.g., sale of an equity interest); and
• Severance of relationships that create an FCOI.

Examples of circumstances that require disclosure and a management plan include, but are not limited to:

• Participating in University research involving Intellectual Property (IP) owned by or contractually obligated to a business in which the individual or their immediate family has a consulting relationship, has a Significant Financial Interest, or holds an executive position (for example, startup companies);
• Requiring students to purchase the textbook or related instructional materials of the employee or members of their immediate family, which produces compensation for the employee or family member;
• Serving on the board of directors or scientific advisory board of an enterprise that provides financial support for the employee or their immediate family to conduct University research;
• Having a Significant Financial Interest in a business which sponsors the employee’s research;
• Family members working together on a sponsored project;
• Having a Significant Financial Interest in a business that hires an NC State student whom the employee serves in a supervisory or mentoring capacity; or
• Having a Significant Financial Interest in a business which sells merchandise or services to the University while simultaneously working in the University business unit that makes purchasing decisions.

Issues that may be addressed in a management plan include but are not limited to:

• Disclosing future developments in the external relationship to the institution
• Disclosing certain aspects about the relationship to third parties such as sponsors, journals, or prospective donors
• Scope and nature of permissible activities (such as hiring University students in the outside endeavor or serving as principal investigator on projects funded by the external concern)
• Identification of the approvers of covered activities
• Acknowledgement of compliance with law, regulation, and institutional policy
• Communication with government regulators (such as the FDA, EPA, USDA, or CDC)
• Definition of key terms used in, or necessary to understand and follow, the management plan
• If an oversight committee will be used, specification of its:
  • Membership
  • Functions
  • Frequency of reports
  • Report contents
  • Frequency of meetings
  • Reporting delegation (i.e., to whom do reports go)
  • Scope of its authority (e.g., decide, recommend)
  • Method for receipt of complete, accurate and timely information
• Assignment of students and trainees to research or other scholarly activities, sponsored or not sponsored (such as Analysis and Testing Agreements, Service Center Work, Sponsored Activities, etc.)
• Conditions for the sale or transfer of equity when the institution has an equity interest
• Use of institutional name in commercial activity
• Use of institutional facilities and resources for consulting activities
• Participation in institutional decisions on transactions with outside entities in which the employee has a Significant Financial Interest
• Term of the plan (Generally, plans are valid for one year from filing or from the filing date until June 30th, whichever is shorter, and must be updated annually thereafter)
• Conditions under which the plan may be amended