Regulation on Conflicts of Interest, Commitment, and External Professional Activities

1. PURPOSE

• 1.1 It is the policy of East Carolina University (herein referred to as “ECU” or “University”) that activities undertaken by its faculty, staff, postdoctoral scholars, visiting scholars, and students in furtherance of the mission of the University shall be conducted in an ethical and transparent manner, consistent with federal and state law and University policy. This Regulation sets forth procedures for implementation of the UNC Board of Governors’ policies concerning Conflicts of Interest (COI), Conflicts of Commitment (COC), and External Professional Activities (EPAs) that may affect a Covered Individual’s University employment. All members of the ECU community are expected to avoid Conflicts of Interest and Conflicts of Commitment that have the potential to directly and significantly affect ECU’s interests or compromise the objectivity in carrying out their University Employment Responsibilities, unless such conflicts are disclosed, reviewed, and appropriately managed in accordance with the provisions of this Regulation. Every individual has an obligation to become familiar with, and abide by, the provisions of this Regulation.
• 1.2 All Covered Individuals and Senior/Key Personnel (as defined in Sections 3.5 and 3.21, respectively) must abide by this Regulation and complete specific disclosure requirements, including those who are on leave if the leave is funded at least partially from University sources.
• 1.3 The scope of this Regulation includes conflicts that may arise from business or financial relationships, investment relationships, employment relationships, and service to other  organizations.
• 1.4 ECU REG10.45.02, Objectivity in Research Under Public Health Service Grants, Cooperative Agreements, or Contracts, identifies other University processes, in addition to this Regulation, governing the reporting of conflicts arising in the context of Public Health Service (PHS)-funded research as well as those sponsor organizations that have adopted the PHS policy.

2. RESPONSIBILITIES FOR COMPLIANCE

• 2.1 The responsibility for compliance with applicable laws, policies, and regulations on Conflicts of Interest, Conflicts of Commitment, and External Professional Activities resides with faculty, staff, postdoctoral scholars, visiting scholars, and students at ECU. If a situation raising questions of Conflicts of Interest or Conflicts of Commitment arises, individuals should discuss the situation with their Supervisor and the Conflicts of Interest Officer.
• 2.2 Covered Individuals and Senior/Key Personnel are responsible for being transparent and disclosing relevant financial and personal information that has the potential to affect ECU’s interests or compromise their objectivity in carrying out their University Employment Responsibilities. This includes a responsibility to timely update their disclosures if their financial or personal interests change after their disclosure. Disclosure is key to managing conflicts. Individuals with a COI/COC management plan are responsible for complying with the terms set forth in the fully executed management plan.
• 2.3 The Director of the Office of Research Integrity and Compliance (ORIC) functions as the Conflicts of Interest (COI) Officer and serves as the designated official to provide guidance related to this Regulation; solicit, review, and determine the disposition of annual and project specific disclosures in accordance with the requirements set forth herein; and administer the University’s program to manage conflicts of interest and conflicts of commitment.
• 2.4 The Chief Research Officer is the Institutional Official (IO) and is responsible for ensuring implementation of this Regulation. The Director of ORIC has the delegation of authority to implement the requirements of this Regulation on behalf of the Institutional Official, but the Chief Research Officer remains ultimately responsible for enforcement of this Regulation at ECU.
• 2.5 The Supervisor of the Covered Individual is responsible for reviewing and either approving or denying requests for External Professional Activities. Supervisors maintain responsibility when a management plan is implemented for a Covered Individual and/or Senior/Key Personnel. Note: Some External Professional Activities require an additional review by a second-level Supervisor. See Section 13.1.1 for details.
• 2.6 The Dean or other applicable administrator is responsible for performing a second-level management review for External Professional Activities of Covered Individuals, when applicable. The Dean or other applicable administrator shares in oversight responsibility with the Supervisor and the COI Officer when a management plan is created for Covered Individuals and Senior/Key Personnel. See Sections 13.1.1 and 9.4, respectively, for details.
• 2.7 The Department for People Operations, Success, and Opportunity (POSO) is responsible for providing support to Supervisors in reviewing External Professional Activities (EPA). This includes partnering with ORIC to develop targeted training for Supervisors on the procedures and requirements related to EPAs, particularly in identifying and addressing potential conflicts of commitment. Upon request, POSO will assist Supervisors in evaluating whether proposed EPAs may conflict with university responsibilities. Additionally, POSO will provide consultative support when a Supervisor suspects a conflict of commitment but is uncertain about the appropriate next steps.nt.

3. DEFINITIONS

• 3.1 “Conflict of Commitment” (COC) relates to situations in which a Covered Individual engages in activities external to the University, or assumes commitments external to the University that compromise, may appear to compromise, or have the potential to compromise their ability to fulfill their University Duties.
• 3.2 “Conflict of Interest” (COI) relates to situations in which a Covered Individual’s or Senior/Key Personnel’s financial or other personal interests or relationships may compromise, may involve the potential for compromising, or may have the appearance of compromising the person’s objectivity in fulfilling their University Duties or University Employment Responsibilities, including research, service, clinical and teaching activities, and administrative duties. A Covered Individual or Senior/Key Personnel may have a Conflict of Interest when they, or any member of their Immediate Family, has a financial or personal interest in an activity that may affect decision making with respect to their University Employment Responsibilities.
• 3.3 “Conflict of Interest Committee” (COI Committee) is a university-wide, standing advisory committee with representation from a broad cross section of academic disciplines. The COI Committee functions as an independent and objective party to provide advice and counsel on the University’s conflict of interest management process.
• 3.4 “Conflict of Interest Officer” (COI Officer) means the individual within the Office of Research Integrity and Compliance who is delegated responsibility from the Institutional Official to implement this Regulation and associated operating procedures, including the day-to-day operations of COI/COC management.
• 3.5 “Covered Individual” is defined as any faculty, postdoctoral scholar, Senior Academic and Administrative Officer (SAAO), and Exempt Professional Staff (EPS) employed by ECU.
• 3.6 “Department” means an academic department, a professional school without formally established departments, or any other administrative unit designated by the Chancellor for the purposes of implementing this Regulation.
• 3.7 “Disclosure” refers to a formal statement made in response to questions about Conflicts of Interest or Commitment. The process for making a Disclosure and the review thereof are described in Sections 6, 7, and 8.
• 3.8 “University Employment Responsibilities”, or “University Duties,” consist of assigned teaching, scholarship, research, institutional service requirements, clinical, administrative duties, and other assigned employment duties. University Employment Responsibilities may include professional affiliations and/or activities traditionally undertaken by Covered Individuals outside of the immediate University employment context. Such professional affiliations or activities may or may not entail the receipt of honoraria, remuneration for time, or the reimbursement of expenses, and include but are not limited to:
  • 1. Membership in and service to professional association and learned societies;
  • 2. Membership on professional review or advisory panels;
  • 3. Presentation of lectures, papers, concerts or exhibits;
  • 4. Participation in seminars and conferences;
  • 5. Reviewing or editing scholarly publications and books without receipt of compensation;
  • 6. Service to accreditation bodies.
• Professional affiliations and/or activities which demonstrate active participation in a profession, are encouraged provided they do not conflict or interfere with the timely and effective performance of the individual’s University Duties or University policies.
• 3.9 “External Professional Activity” (EPA) is defined as any activity performed by a Covered Individual that:
  • 1. Is performed for any entity other than ECU; and
  • 2. Is based upon the professional knowledge, experience and abilities for which ECU employs the individual; and
  • 3. Is not included within the individual’s University Employment Responsibilities (except as identified in 3.9.1 below); and
  • 4. Is undertaken for compensation (except as identified in 3.9.1 below).
  • 3.9.1 External Professional Activities involving a foreign entity. An External Professional Activity also includes the following activities with a foreign entity which require screening by the Office of Research Integrity and Compliance and prior approval by the Covered Individual’s Supervisor:
  • 1. Any formal title, appointment, affiliation, career advancement opportunity, position or other recognition or status outside of ECU with a foreign government or non-U.S. entity, whether paid, unpaid, or honorary.
  • 2. Participation with any Foreign Talent Recruitment Program whether paid, unpaid, or honorary.
  • 3.9.2 Except to the extent Section 3.9.1 applies, Covered Individuals who engage in external activities that do not involve professional knowledge, experience, and abilities are not required to follow the advance disclosure and approval requirements of Sections 11 and 12 of this Regulation for such external activities. However, Covered Individuals and their Supervisors shall ensure that any such activities do not result in the neglect of their University Duties, create unmanageable Conflicts of Interest in accordance with this Regulation, create unmanageable Conflicts of Commitment in accordance with this Regulation, involve inappropriate uses of the University name or resources, or include claims of University responsibility for the activity.
  • 3.9.3 External Professional Activities performed for another UNC constituent institution or agency of the State of North Carolina also must comply with applicable State policies governing dual employment and compensation, unless an exception to those State policies is expressly authorized by the Chancellor of the primary employing institution or the President of the UNC System.
  • 3.9.4 Secondary employment for staff subject to the North Carolina Human Resources Act is addressed separately from this Regulation in the Office of State Human Resources Manual under Employment and Records, Secondary Employment Policy.
• 3.10 “Financial Interest” is defined as one or more of the following interests held by the Covered Individual and/or members of the Covered Individual’s Immediate Family.
  • 1. Income received, such as salary, dividends, royalties, payment for services, consulting fees, honoraria (except as excluded below under 3.10.1), and paid authorships from an entity other than ECU.
  • 2. Equity or other ownership interest in publicly-traded or non-publicly traded entities (e.g., stock, stock options, warrants, or other ownership interest); or
  • 3. Intellectual property rights and interests (e.g., inventorship, patents, copyrights) upon receipt of income related to such rights and interests. This includes intellectual property rights assigned to ECU and subject to a share in royalties related to such rights.
  • 3.10.1 The definition of “Financial Interest” does not include:
    • 1. Salary from ECU.
    • 2. Income from investment vehicles, such as mutual funds or retirement accounts, in which the Covered Individual or a member of their Immediate Family do not directly control the investment decisions.
    • 3. Income from seminars, lectures, or teaching engagements sponsored by U.S. federal, state, or local government agencies, U.S. institutions of higher education, U.S. academic teaching hospitals, U.S. medical centers, or U.S. research institutions that are affiliated with a U.S. institution of higher education.
    • 4. Income from service on advisory committees or review panels for U.S. federal, state, or local government agencies, U.S. institutions of higher education, U.S. academic teaching hospitals, U.S. medical centers, or U.S. research institutions that are affiliated with a U.S. institution of higher education.
• 3.11 “Financial Conflict of Interest” (FCOI) means a financial interest that could directly and significantly affect the design, conduct, or reporting of sponsored research or influence other University Employment Responsibilities of a Covered Individual or Senior/Key Personnel.
• 3.12 Per the National Institute of Standards and Technology (NIST), “Foreign Government Talent Recruitment Program” (FGTRP) or “Foreign Talent Recruitment Program” (FTRP) is defined as an effort organized, managed, or funded by a foreign government, or a foreign government entity, to recruit science and technology professionals or students (regardless of citizenship or national origin, or whether having a full-time or part-time position), or as may be defined by an applicable government or funding agency.
• 3.13 “Honorarium” means a gratuitous payment of money or anything of value made to an individual for services rendered for which fees cannot be legally or are not traditionally paid. Such remuneration is distinguished from hire or compensation for service. An example of Honorarium includes, but is not limited to, a payment made by an agency of the federal government or a private entity to offset costs incurred by that Covered Individual (such as travel, lodging, and food for serving as a guest speaker) for services rendered incident to performance of that service.
• 3.14 “Immediate Family” of a Covered Individual is defined to include the Covered Individual’s spouse and dependent children.
• 3.15 “Inappropriate Use or Exploitation of University Resources” means using any services, facilities, equipment, supplies or personnel which members of the general public may not freely use for any purpose other than to conduct University Employment Responsibilities. A Covered Individual engaged in an External Professional Activity shall not use University Resources in the course and conduct of external activities, except as allowed by this Regulation. Under no circumstances may any employee use the services of another employee during University employment time to advance an employee’s External Professional Activities.
• 3.16 “Industry” or “Vendor” refers to any person or company that sells goods or services. It includes a person or company seeking to do or doing business with ECU.
• 3.17 “Institutional Official” (IO) means the individual responsible for implementation of this Regulation and is the University’s Chief Research Officer. The IO may delegate this authority to the COI Officer but remains ultimately responsible.
• 3.18 “Malign Foreign Talent Recruitment Program” (MFTRP) means any Foreign Talent Recruitment Program that:
  • 1. Is sponsored by, affiliated with, or based in a foreign country of concern or sponsored by an entity of concern; and
  • 2. Requires the Covered Individual or Senior/Key Personnel to engage in activities that violate their obligations to ECU and/or to an applicable research sponsor, creating an unmanageable Conflict of Interest or Conflict of Commitment.
• 3.19 “Notice of Intent” (NOI) is a form submitted by a faculty, postdoctoral scholar, EPS, or SAAO through the electronic COI disclosure system for the purpose of requesting permission from their Supervisor to engage in an external professional activity (EPA). Filing a NOI is a requirement that protects the individual and ECU from Conflicts of Interest or Conflicts of Commitment, which occur when the pursuit of an external activity involves an investment of time that interferes with an employee’s work obligations.
• 3.20 “Project” means any research, creative activity, testing, evaluation, service, training, and/or instructional plan conducted under the auspices of the University.
• 3.21 “Public Health Service” (PHS) means the section of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include but are not limited to: the National Institutes of Health; Centers for Disease Control and Prevention; Food and Drug Administration; and Health Resources and Services Administration. Funding overseen by the Financial Conflict of Interest regulations is issued by the Department of Health and Human Services (DHHS) and administered by the National Institutes of Health (NIH).
• 3.22 “Senior/Key Personnel” means the principal investigator, project director, key personnel, and any other individual, regardless of title or position, who is responsible for the design, conduct, or reporting for a Project or sponsored research.
• 3.23 “Supervisor” refers to the person with supervisory responsibility for the Covered Individual, or Senior/Key Personnel, whether in an academic or non-academic department.

4. CONFLICTS OF INTEREST

• 4.1 Categories of Potential Conflicts of Interest.
• Activities that may involve Conflicts of Interest can be categorized under four general headings:
  • 1. Activities that are allowable and are disclosed;
  • 2. Activities requiring disclosure for further administrative review and analysis;
  • 3. Activities or relationships that are generally not allowable or permitted unless an approved Conflict of Interest/Conflict of Commitment Management Plan is in place; and
  • 4. Activities that are not allowable under any circumstances.
    The following examples are merely illustrative and do not purport to include all possible situations within the four categories:
  • 4.1.1 Activities that are allowable and are disclosed.
    The examples cited below involve activities external to University employment, and thus, may give the appearance of a Financial Conflict of Interest but have little or no potential for affecting the objectivity of the Covered Individual’s performance of University Employment Responsibilities; these situations are more likely to prompt questions of Conflicts of Commitment.
    Provided all other University policies, regulations, and rules are followed, the following activities, standing alone, would generally be permitted:
  • 1. A Covered Individual receiving royalties from the publication of books or for the licensure of patented inventions subject to ECU Patent and Copyright Policies.
  • 2. A Covered Individual receiving compensation in the form of honoraria or expense reimbursement, in connection with service to professional associations, service on review panels, presentation of scholarly works, and participation in accreditation reviews.
  • 4.1.2 Activities requiring disclosure for further administrative review and analysis.
  • The examples cited below suggest a possibility of conflicting interests that can impair objectivity, but disclosure and resulting analysis of relationships may render the activity permissible and may result in the establishment of an approved management plan.
  • 1. A Covered Individual requiring students to purchase the textbook or related instructional materials authored by the Covered Individual or members of their Immediate Family, which produces compensation for the employee or family member.
  • 2. A Covered Individual receiving compensation or gratuities from any individual or entity doing business with the University. Nothing in this subsection authorizes accepting compensation or gratuities where prohibited by federal or state law.
  • 3. A Covered Individual serving on the board of directors or scientific advisory board of an enterprise that provides financial support for University research where the employee or a member of their Immediate Family may receive such financial support.
  • 4. A Covered Individual or a member of their Immediate Family having an equity or ownership interest in a publicly or non-publicly-traded entity or enterprise.
  • 5. A Covered Individual accepting support for University research under conditions that require research results to be held confidential, remain unpublished, or inordinately delayed in publication. Research conducted by faculty or students under any form of sponsorship must maintain the University’s open teaching and research philosophy and must adhere to a policy that prohibits secrecy in research. Such conditions on publication must be in compliance with UNC Policy Manual, 500.1 and 500.2, and with campus Intellectual Property policies.
  • 6. A Covered Individual participating in External Professional Activities governed by this Regulation and UNC Policy Manual Section 300.2.2.1[R].
  • 7. A Covered Individual participating in any Foreign Government Talent Recruitment Program or Foreign Talent Recruitment Program.
  • 4.1.3 Activities or relationships that are generally not allowable or permitted unless an approved Conflict of Interest Management Plan is in place.
  • The examples cited below involve situations that are not generally permissible because they involve potential Financial Conflicts of Interest, or they present obvious opportunities or inducements to favor personal interests over University interests. Before proceeding with any such endeavor, a Covered Individual or Senior/Key Personnel would have to demonstrate that in fact their objectivity would not be affected and agree to only engage in the endeavor once an approved Conflict of Interest Management Plan is fully executed. An approved Conflict of Interest Management Plan is required if the conflict can be managed, mitigated, or eliminated. The activity may, however, be deemed to be impermissible.
  • 1. A Covered Individual or Senior/Key Personnel participating in University research involving a technology owned by or contractually obligated (by license, option to license, or otherwise) to an enterprise or entity in which the individual or a member of their Immediate Family has a consulting relationship, is engaged in an External Professional Activity, has an equity or ownership interest, or holds an executive position.
  • 2. A Covered Individual or Senior/Key Personnel participating in University research that is funded by a grant or contract from an enterprise or entity in which the individual or a member of their Immediate Family has an equity or ownership interest.
  • 3. A Covered Individual or Senior/Key Personnel assigning students, postdoctoral scholars, or other trainees to University research projects sponsored by an enterprise or entity in which the individual or a member of their Immediate Family has an equity or ownership interests.
  • 4.1.4 Activities that are not allowable under any circumstances.
  • 1. A Covered Individual making referrals of University business to an external enterprise in which the individual or a member of their Immediate Family has a financial interest.
  • 2. A Covered Individual associating their own name with the University in such a way as to profit financially by trading on the reputation or goodwill of the University.
  • 3. A Covered Individual making unauthorized use of privileged information acquired in connection with one’s University responsibilities.
  • 4. A Covered Individual signing agreements that assign Institution patent and other intellectual property rights to third parties without prior University approval.
  • 5. A Covered Individual benefitting from a public contract in violation of G.S. 14-234, accepting gifts or favors from vendors or contractors in violation of G.S. 133-32, or engaging in activities prohibited under G.S. Chapter 138A.
  • 6. Any activity otherwise prohibited by law or University policy.
• 4.2 Honoraria
  • 4.2.1 Covered Individuals who engage in activities related to their University Responsibilities where travel expenses are paid for or reimbursed by ECU, occur during normal work time, or when University resources are used, shall not receive any financial compensation, including honoraria. In these instances, the employee may request that the Honorarium be paid to the University.
  • 4.2.2 A Covered Individual may be invited to speak at an event unrelated to the University, unrelated to research or field of study, and unrelated to that employee’s University Duties. In this case a Covered Individual may retain an Honorarium only if the activities are performed outside of normal working hours, as defined by the University, or while the employee is on earned paid or annual leave, and all travel or related expenses are the responsibility of the employee or a third party that is not a State entity.
  • 4.2.3 Covered Individuals who are SAAO employees who pursue external activities that are not a part of their University Responsibilities are required to take annual or personal leave if external income is earned and the activities take place within the conventional work week (i.e., between 8:00 a.m. and 5:00 p.m., Monday through Friday). See Section 14, Special Provisions.
• 4.3 Gifts
  • 4.3.1 Generally, University employees charged with the duty of (1) preparing plans, specifications, or estimates for public contract, (2) awarding or administering public contracts, or (3) inspecting or supervising construction may not accept any gifts from a vendor or potential vendor associated with doing business with the University. Exceptions are the following:
  • 1. Non-cash gifts less than forty dollars ($40).
  • 2. Gifts and/or meals that are provided to all conference or seminar attendees.
  • 3. Employee discounts that are provided to all state employees.
    • 4.3.1.1. Other areas of the University may further define gifts to include additional requirements and prohibitions. See, for example, the Brody School of Medicine Standard Operating Procedure, Conflicts of Interest Regarding Interactions with Industry.
  • 4.3.2 In accordance with N.C. Gen. Stat. § 14-234(a)(1), no University employee may solicit or receive any gift, favor, reward, service, or promise of reward, including a promise of future employment, in exchange for recommending, influencing, or attempting to influence the award of a contract by the University. Violation of this law is a criminal offense.
  • 4.3.3 Pursuant to N.C. Gen. Stat. § 14-234(a)(1), no University employee who will derive a direct benefit from a contract with the University may attempt to influence any person who is involved in making or administering the contract. This includes, but is not limited to, contracts for employment of an employee’s spouse. Violation of this law is a criminal offense.
  • 4.3.4 Although customary honoraria and reimbursement for actual costs generally are not considered to be gifts, if reimbursements or honoraria are significantly in excess of fair market value or customary amounts (e.g., expensive resort sojourns, coverage of family member expenses, etc.), they are de facto gifts and must be disclosed as such. Receipt of honoraria or reimbursement is conditioned upon such being in compliance with all applicable laws and University policies.
  • 4.3.5 University employees may not accept any financial or other favors in exchange for privileged access by current or potential University vendors to University facilities or employees.
  • 4.3.6 A University employee may not receive compensation from an external source for performance of University work except for compensation received from the University as a result of a University contract or grant. Employees must report any personal compensation a project sponsor pays to or for the benefit of an individual outside of contracted project support to the University through the External Professional Activity process.
  • 4.3.7 For purposes of this Regulation, gifts and donations that have been made to the University or to a University-affiliated foundation for the benefit of the professional activities of a Covered Individual, are considered to be a financial interest of the intended beneficiary and must be disclosed.
• 4.4 Intellectual Property Transactions
  • 4.4.1 In the course of the licensing process, individuals who are University inventors are required to disclose their personal or financial interests related to the invention, as well as those of their Immediate Family members.
  • 4.4.2 Individuals who are inventors of technologies licensed or otherwise made available by the University to a third party must complete and submit an applicable Conflict of Interest Disclosure before execution of the license or other agreement by the Office of Licensing and Commercialization. Any employee who is an inventor and who holds equity in, is an officer or director of, or provides consultative services to an entity that has licensed or otherwise acquired rights to University invention(s) or copyright(s) will be deemed to have a Conflict of Interest under this Regulation.
  • 4.4.3 External consulting relationships between an employee who is an inventor, and the licensee of that invention are permitted only when reviewed and approved in accordance with this Regulation.

5. TRAINING REQUIREMENTS

• 5.1 All Covered Individuals must complete the University’s COI training modules within thirty (30) days of beginning employment and every four (4) years thereafter. Employees receive an email notification of these requirements.
• 5.2 All Senior/Key Personnel, including those new to ECU, must complete ECU’s COI training and training on the Financial Conflicts of Interest regulations for federally funded research prior to engaging in research funded by the PHS or other federal agencies. For purposes of this Regulation, all federally sponsored investigators must complete COI training made available through the Collaborative Institutional Training Initiative (CITI) program and complete CITI program COI refresher training at least every four (4) years thereafter.
• 5.3 Senior/Key Personnel also must complete training in the event that this Regulation is substantively amended in a manner that affects the requirements related to sponsored research programs, or if it is determined that the Senior/Key Personnel has not complied with this Regulation or with a management plan related to their activities.
• 5.4 The Institutional Official may specify an appropriate timeframe for training where immediate training is required.
• 5.5 Subrecipient investigators on federally sponsored projects when ECU is the prime awardee must comply with ECU’s training requirements outlined herein or complete training that is commensurate with ECU’s requirements.

6. ANNUAL COI DISCLOSURE REQUIREMENTS

• 6.1 All Covered Individuals are required to submit an annual conflicts of interest disclosure through the electronic COI disclosure system no later than April 30th of each fiscal year. (Note: This is the only acceptable method for submitting a COI disclosure.)
• 6.2 Disclosures must be updated within thirty (30) days upon acquiring a new financial or personal interest or when assuming a fiduciary responsibility with an external agency that is related to the employee’s ECU job responsibilities.
• 6.3 New Covered Individuals must submit a COI disclosure within thirty (30) days of beginning employment with ECU.

7. PROJECT SPECIFIC COI DISCLOSURE REQUIREMENTS

• 7.1 When University research or another activity is funded by an external sponsor, a project specific COI disclosure is required prior to the submission of the proposal to the agency and any conflict must be eliminated or managed prior to the disbursement of external funds.
• 7.2 All Senior/Key Personnel must submit a project specific COI disclosure prior to the submission of the proposal and disclose any financial interest that would reasonably appear to be affected by the research. In addition, all Senior/Key Personnel added to a project at time of award must submit a project specific COI disclosure and disclose any financial interest that would reasonably appear to be affected by the research. All financial disclosures must be updated during the period of the award on an annual basis, and within thirty (30) days of obtaining a new reportable financial interest. Disclosures must also include participation in any Foreign Talent Recruitment Program.
• 7.3 In the event federal agencies or other external sponsors impose additional disclosure requirements, disclosure to the sponsor must also include disclosure to the University.
• 7.4 The Office of Research Administration (ORA) shall certify in each application for funding that the University has in effect an up-to-date written and enforced administrative process to identify and manage Financial Conflicts of Interest with respect to all research projects for which funding is sought or received from the PHS. Additionally, ORA shall ensure that any subrecipient agreements comply with the requirements of 42 CFR 50.604(c).
• 7.5 In accordance with the CHIPS Act of 2022, all Senior/Key Personnel involved in research or development awards funded by the U.S. federal government are prohibited from participating in any Malign Foreign Talent Recruitment Program.

8. PROCESS FOR REVIEW AND RESOLUTION OF ANNUAL COI AND PROJECT SPECIFIC COI DISCLOSURES

• 8.1 The Director of ORIC functions as the COI Officer and is responsible for soliciting, reviewing, and determining the disposition of annual and project specific disclosures in accordance with the requirements set forth herein.
• 8.2 The Director of ORIC may delegate the review and resolution of disclosures to other staff members in ORIC as deemed appropriate.
• 8.3 Reviews of project specific COI disclosures may also be performed by the COI Committee if a significant financial interest exists related to the research and/or sponsored projects.

9. MANAGING CONFLICTS OF INTEREST AND COMMITMENT

• 9.1 The COI Officer will work with the Covered Individual, Senior/Key Personnel, the Covered Individual’s or Senior/Key Personnel’s Supervisor, other appropriate administrators, and when appropriate, the Conflicts of Interest Committee (COI Committee), to define and implement management mechanisms for identified COI/COC or to determine that a COI/COC may not be managed. Possible measures to be taken in managing COI/COC include, but are not limited to:
  • 1. Public disclosures of Financial Interests (to include disclosure to research subjects, if applicable);
  • 2. Reduction or elimination of the Financial Interest (e.g., sale of an equity interest);
  • 3. Modification of the work or research plan;
  • 4. Substituting supervisors and/or other personnel;
  • 5. Termination or reduction of involvement in the project where a COI/COC cannot be managed;
  • 6. Termination of inappropriate student involvement in projects;
  • 7. Severance of relationships that pose actual, potential, or the appearance of conflicts;
  • 8. Separation of the Covered Individual from involvement in Human Subjects Research in the critical areas of recruitment, inclusion/exclusion evaluation, enrollment, and adverse event evaluation and reporting;
  • 9. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest.
• 9.2 A Financial Conflict of Interest (FCOI) exists when ECU’s designated official(s) reasonably determines that an employee’s financial interest could directly and significantly influence their University Employment Responsibilities or a Senior/Key Personnel’s design, conduct, or reporting of externally funded research.
• 9.3 Employees shall comply with management mechanisms established by the COI Officer or COI Committee, including the COI Officer’s or COI Committee’s determination that conflicts cannot be managed for a particular activity/activities.
• 9.4 The typical oversight responsibility for any COI requiring a management plan is the next two levels in the Covered Individual’s or Senior/Key Personnel’s reporting chain. For a faculty member this would typically be the Department Chair and Dean, or in the case where a Department Chair has a conflict, the Dean and applicable Vice Chancellor/Provost. ORIC will determine the appropriate management officials in unique or unusual situation.
• 9.5 ORIC is responsible for monitoring management plans and updating them when informed of changes to financial or personal interests. Additional monitoring may be conducted by other offices in collaboration with ORIC. For-cause audits of compliance with COI Management Plans will be completed as necessary. Compliance deviations will be reported to ORIC for resolution.
• 9.6 Appeal Process for Management Plan
  • 9.6.1 If a Covered Individual or Senior/Key Personnel disagrees with the COI Officer’s or COI Committee’s management mechanisms or determination that conflicts cannot be managed for a particular activity/activities, the Covered Individual or Senior/Key Personnel may appeal to the Institutional Official. The Institutional Official will consult with the appropriate Vice Chancellor/Provost and/or the applicable Dean or other administrator, as needed when considering the appeal. The decision of the Institutional Official is final.

10. CONFIDENTIALITY OF DISCLOSURES AND MANAGEMENT PLANS

• 10.1 COI disclosures, review information, and any related management plans containing information having direct bearing on an employee’s employment are considered, generally, to be a part of that employee’s Personnel File and shall be maintained as confidential to the extent provided by N.C. Gen. Stat. § G.S. 126-22. In certain circumstances, federal or state law may require or permit the University to disclose such information to third parties.
• 10.2 As required by federal law, the University may make such information available to an agency funding research of the faculty member, to a requestor of information concerning Financial Conflict of Interest related to sponsor funding, or to the primary entity who made the funding available to the University, if requested or required. If the University is requested to provide disclosure forms, conflict of interest management plans, and related information to an outside entity, the Covered Individual or Senior/Key Personnel will be informed of this disclosure.

11. CONFLICTS OF COMMITMENT AND EXTERNAL PROFESSIONAL ACTIVITIES

• 11.1 Conflicts of Commitment relates to a faculty, postdoctoral fellow, SAAO, and EPS employee’s distribution of time and effort between their University employment obligations and participation in external activities, compensated or uncompensated, that are related to an employee’s professional obligations to the University. This may include such generally encouraged extensions of professional expertise as professional consulting (e.g., External Professional Activity). Such activities promote professional development and enrich the individual’s contributions to ECU, to the profession, and to society. However, a Conflict of Commitment occurs when the pursuit of such outside activities involves an inordinate investment of time or is conducted at a time that interferes with the employee’s fulfillment of University Employment Responsibilities.
• 11.2 Faculty, SAAOs, postdoctoral scholars, and EPS employees may only engage in an External Professional Activity when it does not interfere with the individual’s University Employment Responsibilities and with approval from the appropriate Supervisor, as stated below.
• 11.3 External Professional Activities are to be undertaken only if they do not:
  • 1. Create a Conflict of Commitment by interfering with the obligation of the individual to carry out all University Employment Responsibilities in a timely and effective manner;
  • 2. Create an unmanageable Conflict of Interest;
  • 3. Involve any Inappropriate Use or exploitation of University Resources. See Appendix I for details.
  • 4. Make any use of the name of ECU for any purpose other than professional identification; or
  • 5. Claim, explicitly or implicitly, any University responsibility for the conduct or outcome of the External Professional Activity.
• 11.4 External Professional Activities should be arranged to avoid interfering with the Covered Individual’s fulfillment of their University Employment Responsibilities. External Professional Activities should generally be limited to no more than the equivalent of twenty percent (20%) of the Covered Individual’s contracted time, during the appointment, and a Covered Individual in a leave-earning position must use vacation or personal leave for the time spent on the External Professional Activity during normal working hours. Using sick leave for an External Professional Activity is prohibited.
• 11.5 Covered Individuals may not engage in activities outside of ECU that directly compete with the interests of ECU or are in conflict with their University Responsibilities, regardless of the time they require.
• 11.6 Political Activities. The Board of Governors has established rules for monitoring and regulating the involvement of University employees in political candidacy and office holding that could interfere with fulltime commitment to University duties. Refer to UNC Policy Manual 300.5.1, Political Activities of Employees, for specific policy details.

12. EXTERNAL PROFESSIONAL ACTIVITY REPORTING REQUIREMENTS

• 12.1 All faculty and EPS employees with a Full-Time Equivalent (FTE) workload of 0.5 or greater, all postdoctoral scholars, and all SAAOs must submit a Notice of Intent through the electronic COI disclosure system to request to take part in an External Professional Activity.
  • 12.1.1 Faculty and EPS employees serving on academic year (9-month) contracts are not required to comply with Section 12 if the External Professional Activity is wholly performed and completed outside of the contract service period for teaching, research, clinical, or other services to ECU during a summer session, provided the Faculty or EPS employee does not engage in sponsored research or teach during the summer session, and the activity does not conflict with the policies of ECU or the UNC Board of Governors.
• 12.2 A Notice of Intent request must be submitted at least ten (10) calendar days in advance of the date the proposed External Professional Activity is to begin. The Covered Individual shall not engage in the proposed External Professional Activity until the Covered Individual has received the approval(s) required in this Regulation.
• 12.3 A separate Notice of Intent shall be filed for each External Professional Activity for which the Covered Individual proposes to engage.
• 12.4 The Covered Individual must include the following elements in the Notice of Intent request:
  • • Name and address of contracting organization/entity
  • • Nature of the proposed activity
  • • Beginning date and anticipated duration of the activity
  • • Average number of hours per week to be devoted to the activity within the fiscal year for 12-month employees and within the academic year for 9-month employees who do not have a summer contract with ECU for teaching, research, clinical work, or service
  • • Total number of hours to be devoted to the activity
  • • Identification of classes, meetings, or other University Duties that will be missed because of involvement in the proposed activity and identification of what arrangements have been made to cover such duties
  • • Identification of any University Resources to be used for the activity or affirmation that University Resources are not being used for the activity
  • • Determination if the contracting organization/entity is providing funding which directly supports the individual’s University Duties
  • • Determination if the individual has any financial interests in the contracting organization/entity beyond that which is being disclosed, including determination if the individual or member of their Immediate Family owns an equity interest in the contracting organization/entity, and determination if the individual holds an office in the contracting organization/entity
  • • Certify that the information disclosed is consistent with the Board of Governor’s policy on Conflict of Interest and Commitment (Section 300.2.2 of the UNC Policy Manual)
• 12.5 The Notice of Intent will be routed to the individual’s immediate Supervisor for review.
• 12.6 If the External Professional Activity is approved, the individual must update their annual COI disclosure within thirty (30) calendar days of the approval.

13. EXTERNAL PROFESSIONAL ACTIVITY REVIEW REQUIREMENTS

• 13.1 The Covered Individual’s Supervisor shall review the Notice of Intent and determine if the proposed activity is allowable under conditions stated in Sections 11 and 12. The Supervisor must either approve or deny the activity and must notify the individual of the approval or denial in writing within ten (10) calendar days of the date the Notice of Intent is filed.
  • 13.1.1 In the event the Notice of Intent discloses either of the following External Professional Activities, the Supervisor’s decision to approve the proposed activity shall be reviewed promptly by the administrative officer to whom the Supervisor reports, or the administrative officer’s designee:
  • • The proposed activity is for an entity that provides funding that directly supports the Covered Individual’s University Employment Responsibilities or Duties, or
  • • The proposed activity is for a private entity in which the Covered Individual or member of their Immediate Family holds an equity or ownership interest or holds an office.
    • 13.1.1.1 The second-level administrative officer, or their designee, must notify the individual of the approval or denial in writing within ten (10) calendar days of receipt of the approval from the individual’s Supervisor.
• 13.2 Approval is granted for remainder of the fiscal year for 12-month employees and 9-month employees with a summer session contract at ECU. Approval is granted for the remainder of the academic year for 9-month employees who have no summer session contract with ECU. If the approved activity will continue beyond the relevant fiscal or academic year in which it began, the individual must file an additional Notice of Intent at least ten (10) calendar days before engaging in such activity in the succeeding relevant year.
• 13.3 The Supervisor, in consultation with the appropriate Vice Chancellor/Provost’s Office, may revoke approval of the External Professional Activity and provide the employee an opportunity to wind down the activity.
• 13.4 If the Supervisor or administrative officer denies the request in writing, the individual shall not proceed with the proposed activity but may appeal the decision, in accordance with Section 13.5.
• 13.5 Notice of Intent Appeal Requirements:
• 13.5.1 If the individual’s Supervisor denies the proposed activity in writing after a review pursuant to Section 13.1, the individual may appeal the denial to the administrative officer (e.g., the Dean) to whom the Supervisor reports. An appeal to the administrative officer must be made in writing within ten (10) calendar days from the date on which the Supervisor’s denial is issued. The administrative officer shall issue a decision on any such appeal in writing to the individual within ten (10) calendar days of the date on which the appeal is received.
  • 13.5.2 If the administrative officer denies the appeal, the individual may then appeal to the Chancellor or the Chancellor’s designee. An appeal to the Chancellor or the Chancellor’s designee must be made in writing within ten (10) calendar days from the date on which the administrative officer’s denial is issued. The Chancellor or the Chancellor’s designee shall issue a decision on any such appeal in writing to the individual within ten (10) calendar days of the date on which the appeal is received.
  • 13.5.3 The decision of the Chancellor or the Chancellor’s designee shall be final.

14. SPECIAL PROVISIONS

• 14.1 External Professional Activities performed for another UNC institution should be established through a written agreement. In such situations, the parent institution of the employee shall provide any compensation to the employee through its payroll and financial systems and shall invoice the borrowing institution for the expense. Exceptions to this must be approved by the appropriate authorized officer of both institutions. External Professional Activities performed for an agency of the State of North Carolina also must comply with State policies governing dual employment and compensation, unless an exception to those State policies is expressly authorized by the Chancellor or the Chancellor’s designee (or, at the UNC System Office, to the President or the President’s designee).
• 14.2 When a Senior Academic and Administrative Officer (SAAO) who engages in external professional activities, such as sitting on boards of directors of various private corporations, pursues opportunities that fall within the Board of Governor’s definition of external professional consulting, or conducts official duties as a state employee for which an Honorarium is received, the following shall apply:
  • 1. Pursuit of Private Interests in Which Activities are Compensated. For SAAOs who pursue external activities that are not a part of their University employment, it is important that overlapping compensation be avoided. If an SAAO engages in an activity from which external income is earned, that is not a part of their University employment, annual leave must be used if such activities take place within the conventional work week (i.e., between 8:00 a.m. and 5:00 p.m., Monday through Friday). SAAOs must also file appropriate disclosures of financial interests and Notices of Intent in accordance with Board of Governors’ policies and ECU’s policies and procedures to provide satisfactory assurances that such activity will not interfere with University employment obligations.
  • 2. Activities for Which an Honorarium is Received. SAAOs may engage in employment-related activities for which an Honorarium is received. In those instances when State-reimbursed travel, work time, or resources are used or when the activity can be construed as related to the employee’s State position or official duties on behalf of the State, the employee shall not receive an Honorarium. In these instances, the employee may request that the Honorarium be paid to the University. The Honorarium may be retained by the employee only for activities performed during non-working hours or while the employee is on annual leave, if all expenses are the responsibility of the employee or a third party that is not a State entity and the activity has no relation to the employee’s State duties.

15. ENFORCEMENT OF REGULATIONS AND SANCTIONS

• 15.1 Possible sanctions for violation of this Regulation and associated COI/COC standard operating procedures can range from administrative intervention to termination of employment in accordance with applicable University policies.
• 15.2 Violations may include, but are not limited to:
  • • Failure to timely disclose personal or financial interests as required;
  • • Failure or refusal to respond to requests for additional information;
  • • Providing incomplete, misleading, or inaccurate information;
  • • Failure to comply with a prescribed management or monitoring plan;
  • • Engaging in a Professional External Activity without receiving prior approval.
• 15.3 Violations will be reported by the Director of ORIC to the Covered Individual’s Supervisor and second-level Supervisor, with an optional copy to the Department for People Operations, Success, and Opportunity. Responsibility for administrative enforcement of such violations rests with the Covered Individual’s Supervisor/second-level Supervisor, who may consult with the Department for People Operations, Success, and Opportunity to determine and implement appropriate actions in accordance with University policies.

APPENDIX I. INNAPPROPRIATE USE OR EXPLOTATION OF UNIVERSITY RESOURCES

• 1. A Covered Individual engaged in an External Professional Activity may not use University Resources in the course and conduct of external activities, except as allowed by this Regulation. Under no circumstances may any employee use the services of another employee during University employment time, or a student, to advance the employee’s External Professional Activity. Use of University Resources must also be in accord with ECU’s REG07.30.08, Use of University Property, and other applicable Universities policies related to facilities or resources.
• 1.1 Examples of such resources include, but are not limited to, offices, laboratories, classrooms, athletic facilities, materials, property, equipment, scientific instruments, software, databases, IT resources, or the services of another University employee.
• 2. The use of resources must comply with all laws, regulatory requirements, applicable University policies, and the terms and conditions of University contracts. For example, if a software license states that software may only be used by the University for its business use, said software may not be used by a Covered Individuals in their conduct of an External Professional Activity. Note: This includes compliance with all applicable Export Control laws and regulations.
• 3. The Covered Individual is responsible for the use of the University resource(s) and shall indemnify and hold harmless the University for any damages, losses, costs, or other injuries sustained by the University, as a result of third-party claims or otherwise, that result from or are related to such use. A Covered Individual shall always exercise reasonable care and use University resources in a safe and professional manner. In its sole discretion, the University may require a Covered Individual to purchase insurance coverage in connection with their use of University Resources for an External Professional Activity, naming the University as an insured party, if the University determines at any time that the institution has any material risk of liability because of the employee’s activity. The amount and other requirements of such a policy shall meet or exceed any parameters the University deems appropriate for the situation.
• 4. The overall cost to the University must be negligible, i.e., the marginal cost of the use is nearly zero. There should be no financial consequence to the University for use of a University resource by a Covered Individual in the conduct of an External Professional Activity.
• 5. The use must not interfere with a Covered Individual’s ability to carry out University Employment Responsibilities in a timely and effective manner. Time spent engaged in the use of a University resource for the conduct of an External Professional Activity is not considered to be University work time.
• 6. The use must in no way interfere with the use of University resources for University purposes. The use of such resources in the support the University’s teaching, research, clinical, and service missions will at all times take priority.
• 7. The use neither expresses nor implies sponsorship or endorsement by the University of the Covered Individual’s conduct of the External Professional Activity. Mere identification of the University as the Covered Individual’s employer is permitted, provided that such identification is not used in a manner that implies sponsorship or endorsement by the University. Any other use of the University’s name, marks, or other indicia by the Covered Individual is prohibited.
• 8. Employees do not have any expectation of privacy in the use of University Resources for the conduct of External Professional Activities. Employees are prohibited from storing confidential information associated with their External Professional Activity on any University device or in any University facility, including but not limited to, computer hard drives, remote storage, or campus office space. The ECU Office of Internal Audit and Management Advisory Services, the State Auditor, and others (including government regulatory agencies) may examine uses of University resources, including reviewing any and all information related to an External Professional Activity that may be found in or on any University facility or device, and the Covered Individuals should not expect notification of such reviews.
• 9. The use of specialized equipment and/or facilities by a Covered Individuals requires advance approval, in writing by:
  • 1. The administrator with the appropriate authority to approve External Professional Activity use of a facility or site;
  • 2. The Covered Individual’s immediate Supervisor or Department Chair;
  • 3. The Covered Individual’s next highest University Administrator; and
  • 4. Final Approval from the Chief Research Officer.
• 10. Documentation that the Covered Individuals has received any specialized training necessary to appropriately conduct activities with said equipment, facilities, or site must be provided as part of a Covered Individual’s request to use specialized equipment or facilities.
• 11. Employees must consult their supervisors and the COI Officer, in advance, regarding use of University resources for External Professional Activities to ensure that said use is appropriate under University policy and applicable law.
• 12. The University may require a Covered Individual, or his or her affiliated legal entity, to enter into a Facility Use Agreement with the University that specifies the terms and conditions under which the Covered Individuals may use University facilities, which may include payment of use fees and other charges. For example, such an agreement would be required where an Athletic Coach or a faculty member may wish to operate a for-profit summer camp on University property.
• 13. Confidential information in the possession of the University, including that to which the Covered Individual may otherwise have access to in the performance of University Employment Responsibilities, may never be used by a Covered Individuals for the conduct of an External Professional Activity. Such information includes, but is not limited to, education records, protected health information, personally identifiable information (such as social security numbers and credit card information), personnel file materials, university research records and information relating to University owned intellectual property, generally, and any other information that is made confidential by law.
• 14. Under no circumstances may any employee use the services of another employee during University employment time to advance the externally compensated employee’s External Professional Activities.
• 15. Covered Individuals acknowledge that violation of these requirements is grounds for disciplinary action, up to and including, termination of University employment.