Consistent with the entrepreneurial spirit of innovation at NC State University, the institution encourages the transfer and advancement of knowledge through relationships with outside businesses, scholarly publications, and the creation and licensing of intellectual property.
Nonetheless, the university must also adhere to federal, state and sponsor regulations regarding conflicts of interest (COI) while safeguarding public trust in the integrity and truthfulness of our institution’s research. This requires the establishment of a carefully controlled and monitored process to ensure we meet standards of objectivity that are critical to the preservation and expansion of knowledge.
The management plan is a key component of this process. It is a document that outlines and implements measures to actively reduce, mitigate or eliminate an actual, potential or perceived conflict of interest held by an employee.
SPARCS has developed the COI Management Plan Overview eLearning module, which summarizes the management plan process. We encourage everyone — especially those who suspect their circumstances may require a management plan — to take this module. After viewing the module, you will be able to recognize when a management plan is needed and identify who needs to be involved in the establishment and ongoing oversight of a management plan. You will also understand the key items that are typically included in a management plan.
A management plan is needed when an employee has a financial interest, relationship or other circumstance that has the actual, potential or perceived ability to impair their objectivity while performing university duties or participating in research at the university. Its purpose is to formulate a strategy to mitigate or eliminate risks to the employee’s objectivity. It outlines a plan of the steps that will be taken to manage an employee’s situation so that their objectivity will not be compromised while performing university duties and participating in research at the university.
The information you provide on your annual COI disclosure will help you and the individual who is responsible for reviewing and approving your COI disclosure recognize when your situation requires a management plan. Therefore, it is critical that you complete your annual COI disclosure in a timely manner and ensure that the information disclosed is kept accurate and up to date.
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 (e.g., 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 that: sponsors the employee’s research; or hires an NC State student whom the employee serves in a supervisory or mentoring capacity; or sells merchandise or services to the university while simultaneously working in the university business unit that makes purchasing decisions
- Family members working together on a sponsored project
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, prospective donors
- Scope and nature of permissible activities (e.g., 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 (e.g., 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; Reports 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 (e.g., 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 30, whichever is shorter, and must be updated annually thereafter).
- Conditions under which the plan may be amended
Management Plan Resources
For faculty with interests in an external entity that sponsors research or testing with the university.
Used to ensure that all research workers — including students, fellows, trainees and visiting scientists — engaged in research under the conflicted employee’s supervision are notified of the COI, the existence of the management plan, and the names and contact information of university officials with whom the researchers should address any concerns.
For situations when there is a COI due to family members working on a sponsored project together.
In situations where family members are working together on a research project, this form is used to disclose the relationship to all research workers — including students, fellows, trainees and visiting scientists. It also serves to notify them of the existence of a COI management plan and the names and contact information of university officials with whom they should address any concerns.
In situations where family members are working together on a research project but do not supervise each other, this form is used to disclose the relationship to all research workers — including students, fellows, trainees and visiting scientists. It also serves to notify them of the existence of a COI management plan and the names and contact information of university officials with whom they should address any concerns.
Provides examples of public disclosure statements for use in publications, posters, meetings, symposiums or conferences for reporting financial relationships.