Policy on Individual Conflicts of Interest and Commitment

Title

University of North Carolina Chapel Hill Policy on Individual Conflicts of Interest and Commitment

I. Introduction and Purpose

Consistent with the University of North Carolina at Chapel Hill's (the "University's") research, teaching and public service missions, the University encourages faculty, staff, and students to engage in appropriate outside relationships with private industry and the nonprofit sector. While engaging in these relationships, members of the University community are expected to avoid conflicts of interest or commitment that have the potential to directly and significantly affect the University's interests, compromise objectivity in carrying out University responsibilities, or otherwise compromise performance of University responsibilities, unless such conflicts are disclosed, reviewed, and managed in accordance with this Policy. This Policy on Individual Conflicts of Interest and Commitment (hereinafter, the "Policy") describes the University's approach and process for identifying, reviewing, and managing such relationships to help assure the integrity of University academic and administrative endeavors.

A member of the University community - faculty, staff, student, or trainee - may be deemed to have a conflict of interest when he or she or any of that person's family possesses a personal or financial interest related to an activity that involves his or her University responsibilities.

Through this Policy the University seeks to minimize the most obvious and avoidable conflicts of interest that have potential for serious negative effects on performance of its missions. The requirement that an individual's potential conflicts of interest be disclosed and evaluated by others is not a reflection or assessment of the integrity of the individual.

As members of a scientific and intellectual community, we recognize that objectivity about one's own situation and credibility with external observers requires an evaluation external to oneself. Moreover, the fact that an individual may be determined to have a conflict does not imply that the conflict is unethical or impermissible; it means simply that the relation of the conflict to the individual's institutional responsibilities must be carefully examined and in some cases managed, because conflicts - real, potential or perceived - may impair performance of the missions of teaching, research, and public service, as well as jeopardize public trust and support.

II. Definitions of Selected Terms

"Conflict of Interest" (COI) relates to situations in which financial or other personal considerations.circumstances, or relationships may compromise, may involve the potential for compromising, or may have the appearance of compromising a Covered Individual's objectivity in fulfilling their University duties or responsibilities, including research, teaching activities, and administrative duties. The bias that such conflicts may impart can affect many University responsibilities, including decisions about personnel, the purchase of equipment and other supplies, the selection of instructional materials for classroom use, the collection, analysis and interpretation of data, the sharing of research results, the choice of research protocols, the use of statistical methods, and the mentoring and judgment of student work. The University of North Carolina at Chapel Hill utilizes the definition of conflict of interest specified in the University of North Carolina Board of Governor's Policy on Conflict of Interest and Commitment (300.2.2).

"Covered Individual" refers to any University employee, student, or trainee who is performing teaching, research, public service, administration, or business operations of the University. At its discretion for this Policy, the University may include such positions as visiting scientists/scholars, adjunct faculty, or volunteers if these individuals are using University resources for research or other activities under University auspices.

"Executive Position" refers to any position that includes responsibilities for a material segment of the operation, management or oversight of a business or other type of entity, including Board membership.

"Family" of a Covered Individual includes his or her spouse and dependent children. For the purposes of this Policy, "spouse" includes a person to whom one is married or with whom one lives together in the same residence, shares responsibility for each other's welfare and shares financial obligations. Certain sponsors may have an expanded definition of family required for their research Projects and the expanded definition will be applied to those Projects.

"Financial Conflict of Interest" (FCOI) means a Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.

"Financial Interest" means one of more of the following interests of a Covered Individual (and Family) that appear to be reasonably related to a Covered Individual's Institutional Responsibilities.

“Financial Interest” of a Covered Individual includes any of the following:

1. Salary or income external to the University; revenue (including royalties, licensing or tangible property fees, or other distributions to a Covered Individual or his or her Family either through the University or otherwise); interest from loans or bonds; or other payments including awards, consulting fees, or Honoraria (except as excluded below) received by a Covered Individual or his or her Family in the twelve months preceding disclosure or anticipated in the twelve months following disclosure, including any income received for any purpose from a non-United States ("US") entity or organization;
2. Equity interest, including stock options, stock grants or warrants, held by a Covered Individual or his or her Family in publicly-traded or non- publicly traded entities), in the twelve months preceding disclosure or anticipated in the twelve months following disclosure;
3. Intellectual Property rights and interests (including inventorship, authorship, or copyright ownership) held by a Covered Individual or his or her Family in the twelve months preceding disclosure or anticipated in the twelve months following disclosure;
4. Gifts that have been made to the University for the direct benefit of the research or other professional activities of a Covered Individual in the twelve months preceding disclosure or anticipated in the twelve months following disclosure.

"Financial Interest" does not include:

1. Salary or other remuneration (not listed above) from the University;
2. Income from seminars, lectures, or teaching engagements sponsored by a US Federal, state, or local government agency, a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institution that is affiliated with a US institution of higher education;
3. Income from service on advisory committees or review panels for a US Federal, state, or local government agency, a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institution that is affiliated with a US institution of higher education;
4. Income from investment vehicles, such as mutual funds or blind trusts, where a Covered Individual or Family has no control over the selection of holdings.

Note that Financial Interests of an Investigator include Financial Interests of the Investigator's Family, as defined above.

"Honoraria" means a payment made to a person for services rendered in a volunteer capacity where the giver does not have legal obligations, or for services where fees are not traditionally negotiated or expected.

"Human Subjects Research" means any systematic investigation (1) that is designed to develop or contribute to generalizable knowledge and (2) that obtains data through intervention or interaction with living individuals and/or obtains identifiable private information about living individuals, including by means of the observation or recording of behavior. Intervention includes both physical procedures and manipulations of the subject or subject's environment that are performed for study purposes. Interaction includes communication or interpersonal contact between an investigator and a subject. Private information includes information that individuals can reasonably expect will not be made public. This definition also encompasses any experiment that involves a test article and one or more human subjects (i.e., a "clinical investigation" per FDA regulations).

"Institutional Responsibilities" for employees means teaching, research, clinical practice, service and administrative duties for the University. For Students or Trainees, these Institutional Responsibilities mean adherence to the rules or guidelines in their School or Program.

"Investigator" means the principal investigator, project director, key personnel and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of a Project. Investigators may also include research study coordinators, research assistants, graduate students or others. For the purposes of this Policy, research collaborators or independent consultants may also be considered investigators depending upon their activities on the Project.

The term Investigator is not intended to apply to individuals who primarily provide technical support, administrative support, or who are purely advisory, such that these individual have no influence over the research results (e.g. control over its collection, analysis or reporting). Further information is provided in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

"Personal Interest" means an external executive, board position, consulting, volunteer or advisory position related to an activity that involves or is related to a Covered Individual's Institutional Responsibilities. These activities may or may not be uncompensated.

"Project" means any research, testing, evaluation, training, and/or instructional plan conducted under the auspices of the University.

"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 Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration. Funding overseen by the Financial Conflict of Interest (FCOI) regulations is issued by the Department of Health and Human Services (DHHS) and administered by the National Institute of Health (NIH).

"Reimbursed or Sponsored Travel" means any travel that is not covered directly through the University and for which an Investigator either receives direct reimbursement from, or is covered by, an external entity. For the purposes of this Policy, Reimbursed or Sponsored Travel is only applicable to PHS-funded Investigators.

"Senior/Key Personnel" means the Principal Investigator/Project Director and any other person identified as senior/key personnel by the University in a grant application, progress report, or any other report submitted to a PHS awarding component.

III. Applicability

This Policy applies to Covered Individuals, which is defined in this Policy to include any University employee, student, trainee, or others as determined by the University in the performance of the teaching, research, public service, administration, or business operations of the University.

Under this Policy, the interests of a Covered Individual's Family are considered to be the "same as" the Covered Individual and should be disclosed as applicable.

IV. Conflict of Commitment

The term "conflict of commitment" relates to an employee's distribution of effort between University Duties or Institutional Responsibilities (primary and secondary), and external professional activities.

For SHRA employees, the review process is administered by Human Resources through the Secondary Employment Policy.

All EHRA Faculty and EHRA non-Faculty employees of the University are expected to devote their primary professional loyalty, time and energy to their Institutional Responsibilities.

Accordingly, outside professional activities and outside Financial Interests must be arranged so as not to interfere with the primacy of Institutional Responsibilities.

Congruent with the UNC Board of Governor's Policy on Conflict of Interest and Commitment, primary duties consist of assigned teaching, scholarship, research, institutional service requirements, administrative duties, and other assigned employment duties.

Secondary duties may include professional affiliations and activities traditionally undertaken by University employees outside of the immediate University employment context. Secondary duties may or may not entail the receipt of Honoraria, remuneration (see additional regulations, UNC System Office Policy Manual, 300.2.2.2 [R]), or the reimbursement of expenses. A list of these duties would include:

• membership in and service to professional associations and learned societies;
• membership on professional review or advisory panels;
• presentation of lectures, papers, concerts or exhibits;
• participation in seminars and conferences;
• reviewing or editing scholarly publications and books without receipt of compensation;
• service to accreditation bodies.

These 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 employee's primary Institutional Responsibilities or University policies.

EHRA Faculty and EHRA non-Faculty employees of the University may participate in activities for compensation outside of their Institutional Duties, provide such participation is consistent with the University of North Carolina Board of Governors' Conflict of Interest and Commitment and Regulations on External Professional Activities for Pay by Faculty and EHRA Non-Faculty Employees (300.2.2.1[R]). Employees are required to receive approval in advance for any External Professional Activities for Pay (EPAP), except for contract employees, such as 9-month faculty, performing such activities for pay entirely outside the months of their University employment. Any University salary taken during the summer months constitutes employment. External activities during the summer months when salary is being taken are considered EPAPs and must be submitted for review.

Any Covered Individual whose compensation will be equity such as stock, stock options, stock grants, or warrants in the entity must submit an EPAP request if providing consulting services or if the Covered Individual is (1) an officer or director in the entity; (2) is an inventor/author on any intellectual property used by the entity; or (3) the entity has licensed, optioned to license, or otherwise acquired rights to University invention(s) or copyrights.

The University's EPAP policy does not provide that an EHRA faculty or non-faculty employee is entitled to engage in any EPAP for any specific or set percentage of time. EPAP activities for an EHRA faculty or non-faculty employees are limited to no more than twenty percent (20%) of the Covered Individual’s time at 1.0 FTE, consistent with UNC System Office regulations. An employee's supervisor always has the discretion to determine whether a proposed external activity is appropriate in scope or duration or creates a conflict with Institutional Responsibilities, or constitutes excessive time away from Institutional Responsibilities, regardless of the amount of time requested. For any EHRA faculty or non-faculty employee at less than 1.0 FTE, any EPAP request greater than 20% must also be reviewed by the Provost’s Office.

While EPAPs may convey some implied benefit to an employee's position or, in general, to the University, such activities are not considered part of any employee's Institutional Responsibilities; however they may be considered related to Institutional Responsibilities and should be disclosed as Personal or Financial Interests as applicable on any Conflict of Interest disclosure.

EPAP activities, or any contracts signed by a Covered Individual in support of the activity, must be in compliance with University policies, such as the assignment of Intellectual Property. Individual should consult the Office of Technology Commercialization and other applicable University offices for further guidance.

Employees may not use any University resources in support of the EPAP activities except as provided in Section V. C. below. While not inclusive of all resources, some examples of University resources which may not be used as part of, or in support of, an EPAP include an application to the Institutional Review Board (IRB) or the assignment of student work. Please see Section V. C. in this Policy for further guidance.

Required Action

Any potential Conflicts of Commitment between the Covered Individual’s primary and secondary duties and the anticipated EPAP activity are subject to review by the employee's supervisor, department Chair, or Unit head. EPAP requests which include equity will undergo further review by the Office of Technology Commercialization and the Provost or Office of Human Resources, as applicable.

An EHRA faculty or non-faculty employee who intends to engage in an EPAP is required to file a "Notice of Intent for an External Professional Activity for Pay" or EPAP Request through the central AIR website at least ten (10) days before engaging in the activity.

An EHRA faculty or non-faculty employee who is a University inventor seeking to engage in external professional activity, compensated or uncompensated, with an entity that proposes to license, has licensed, or has otherwise acquired rights to his or her invention must include this information in the request so that the supervisor is notified of this relationship and the supervisor can consult with the Office of Technology Commercialization. (See Section V.E. below).

The supervisor, chair, or department head is required to respond with approval or disapproval of the EPAP request within 10 days of the filing of the "Notice of Intent." EPAP requests which include equity will undergo further review by the Office of Technology Commercialization and the Provost or Office of Human Resources may extend the time for review beyond the 10 days. See the University's EPAP Policy for more detailed information.

V. Conflict of Interest

A. Acceptance by Individuals of Gifts, Favors from External Entities

Generally, University employees may neither accept nor offer, either directly or indirectly, any personal gift or favor or loan to or from an organization, entity or person that is conducting or seeking to conduct business with the University, unless the gift is nominal.

A "nominal" gift occurs where the fair market value of all payments, gifts or favors from the same or related source within a single calendar year is less than forty dollars ($40.00). Cash gifts of any size are not considered nominal. Individual schools of the University may adopt stricter polices to which any employee or specified individual of that school must adhere.

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 defacto gifts. However, meals, texts, or customary Honoraria may be provided to EHRA faculty or non-faculty employees in connection with activities allowed under the Policy on External Professional Activities of Faculty and Other Professional Staff.

Any personal compensation a Project sponsor proposes to pay to or for the benefit of a Covered Individual outside of contracted Project support to the University must be submitted in advance and reported by the Covered Individual as applicable under the University's EPAP Policy and this Policy.

University employees also may not accept any financial or other favors in exchange for privileged access by current or potential University vendors to University facilities or employees.

A University employee may not receive compensation from an external source for performance of University work except through a University contract or grant.

B. Gifts to the University or an Affiliated Foundation for the Benefit of a Covered Individual

For purposes of this Policy, 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, even though such gifts or donations are not the legal property of the beneficiary.

Such gifts and donations, where they coincide with University activities undertaken by the beneficiary may create a Conflict of Interest, and they shall be disclosed by that individual as required under this Policy as for any other Financial Interest when the Covered Individual completes an applicable Conflict of Interest Disclosure form. This disclosure of a gift is particularly applicable to research activities, such as support of human research studies or in conjunction with externally sponsored research Projects.

C. Use of University Resources, including Privileged Information

Confidential or privileged information created, developed, or acquired by the University may not be used by a Covered Individual for personal gain, nor may any Covered Individual permit unauthorized access to such confidential or privileged information.

Insider trading is just one form of impermissible use of privileged information for personal gain.

University faculty and staff should be wary of consulting arrangements through which they may risk sharing confidential, non-public, or proprietary information acquired through University supported or externally sponsored Projects.

Covered Individuals may not use for non-University purposes any University-funded or supported resources, including but not limited to University facilities, administrative offices, work product, unpublished research data, results, materials, property records, or information developed with University funding or other University support except as otherwise allowed under University policy.

This prohibition includes the use of the University's name in a manner that may imply that the University is associated in some way with the Covered Individual's external activity or interest. One context in which this situation might occur for a faculty or EHRA non-faculty employee is an External Professional Activity for Pay. Mere identification of the University as one's employer and of one's position at the University is permitted, provided that such identification is not used in a manner that implies sponsorship or endorsement by the University.

Use of University facilities and resources must be in accord with the University's Facilities Use Policy, the Policy on Use of University Resources in Support of Entrepreneurial Activities, the Personal Use Policy, or other applicable University policies. Examples of acceptable use, which include but are not limited to, are minimal use of the telephone, support staff, or computer equipment. Please see the referenced policies for additional details.

Use of University facilities or resources that are governed by a facility use agreement entered into between a third party and the University must be undertaken in accordance with the terms of that Agreement. Such agreements are also subject to a conflict of interest review by the Conflict of Interest Officer. Any Covered Individual who is named in a facility use agreement will be deemed to have a Conflict of Interest under this Policy.

D. Purchasing, Contracting, Other Business Transactions on behalf of the University

A Covered Individual generally may not participate in awarding, negotiating, reviewing, or approving a financial transaction (including but not limited to purchases, contracts, and subcontracts) involving the University and an entity in which the Covered Individual has a Personal or Financial Interest without prior review and approval as described immediately below. Where a Covered Individual is involved in the design, conduct, or reporting of University research related to that person's Financial Interest, that potential Conflict of Interest is governed by the sections below entitled "Intellectual Property Transactions" and "Research and Sponsored Projects." In addition, a Covered Individual may assist in the negotiation of license agreements for University intellectual property only as allowed under the Equity Acquisition in Technology Licensing Arrangements Policy. In all cases, Covered Individuals will conduct University business in keeping with any applicable codes of conduct.

Required Action

Covered Individuals routinely involved in the negotiation, approval or administration of University contracts with external entities must file the applicable Conflict of Interest Disclosure form with the University's Conflict of Interest Officer. See the section below entitled "University Administrative Roles."

If a Covered Individual has not filed an applicable Conflict of Interest Disclosure form disclosing Personal and/or Financial Interests but is prospectively involved in awarding, negotiating, reviewing, or approving a financial transaction involving the University and an entity where there is Personal and/or Financial Interest of that individual, the potential Conflict of Interest must be reported to the person's supervisor. The supervisor shall reassign that transaction to another employee with prior approval and such management as is deemed appropriate through consultation with the Conflict of Interest Officer. Additional University policies governing personal interests and University purchases are administered by the Office of Finance and Operations. Separate reviews for individuals involved in sole source purchasing requests are required and are detailed on the applicable forms available through the Office of Finance and Operations.

E. Intellectual Property Transactions

The University's mission includes fostering the invention and development of new patentable and non-patentable technologies, methodologies, or copyrights. The University attempts to license many of these innovations to commercial entities so that University research results may reach the market for the public good. The University must be protected from both real and perceived inappropriate "pipelining" of University innovations to entities in which University inventors have Personal or Financial Interests. The University's facilities and resources must not be used to the advantage of the licensee entity without advance and specific authorization consistent with applicable University policy and procedures.

Required Action

All Covered Individuals who are University inventors are required to disclose their Personal or Financial Interests and those of their Family in the course of the licensing process as detailed in the University's Patent and Invention Policy or Copyright Policy.

Covered Individuals who are University inventors of technologies licensed or otherwise made available through contract by the University to a third party must complete and submit an applicable Conflict of Interest Disclosure form before execution of the license or other agreement by the Office of Technology Commercialization. Any Covered Individual who is 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 copyrights will be deemed to have a Conflict of Interest under this Policy.

Updated Conflict of Interest Disclosure forms must be submitted to the University's Conflict of Interest Officer promptly when changes arise that may either: (a) give rise to a reportable Personal or Financial Interest; (b) eliminate a previously reported Personal or Financial Interest; or (c) result in an affirmative answer to any question previously answered in the negative.

External consulting relationships between a Covered Individual who is University inventor and the holder of a University license for the inventor's technology are not permitted unless reviewed and approved in advance as detailed in the Conflict of Commitment section above. Additional review by the Office of Technology Commercialization to ensure the integrity of the intellectual property in these relationships may also occur.

F. University Administrative Roles

By virtue of their role, individuals in administrative positions may have substantial influence in professional appointments, promotions, tenure decisions, allocations of space, determinations of salary, staffing decisions, execution of business contracts, etc., and must take particular care to avoid relationships that have the potential to advantage the individual but adversely affect the University's interests or inject inappropriate considerations into administrative decisions. They must be vigilant in ensuring that their exercises of administrative decisions are not, and do not appear to be, colored by their Personal or Financial Interests. Such relationships may also be prohibited under the Policy on Institutional Conflicts of Interest.

Required Action

All University Deans, Vice Chancellors, Directors, Chairs, Department Administrators and Business Managers, Development personnel, and any other employee deemed by his or her supervisor or the Conflict of Interest Officer to be routinely involved in decisions regarding professional appointments, promotions, tenure, allocations of space, determinations of salary, staffing decisions or the review, award, or administration of University contracts must complete an applicable Conflict of Interest Disclosure form. In addition, because of the sensitivity of their positions, employees in the areas of University Counsel, Conflict of Interest, Export Control, Research Compliance, Material and Disbursement Services, Technology Commercialization, and Sponsored Research also must complete an applicable Conflict of Interest Disclosure form pursuant to this section.

Updated Conflict of Interest Disclosure forms must be submitted promptly when changes arise that may either: (a) give rise to a new Personal or Financial Interest; (b) eliminate a previously reported Personal or Financial Interest; or (c) result in an affirmative answer to any question previously answered in the negative.

Further information on disclosure requirements is included in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment, below.

G. University Review Panels

There are also important conflict of interest responsibilities for individuals participating on panels providing administrative review and evaluation on behalf of the University. Such panels include but are not limited to Institutional Review Boards (IRB), Institutional Animal Care and Use Committee (IACUC), Conflict of Interest Review committees, purchase evaluation committees, etc.

Required Action

If any individual member of a University review panel has a Personal or Financial Interest (including Family member interests) in a matter subject to the panel's review, that individual must report the potential Conflict of Interest to the panel's chair. If the panel chair deems the conflict to be material to the matter under review, the panel member shall recuse himself or herself and shall not participate in the related review process. The intent of this process to ensure that the Covered Individual shall not be on both sides of a decision made by a University review panel. The recusal shall be documented in the panel's minutes. The offices which provide oversight over such panels may provide further guidance to their panels.

H. Research and Sponsored Projects

The following sections of this Policy contain requirements applicable to all Projects, regardless of level or source of funding. Certain provisions apply to all Covered Individuals, while others are limited to Investigators, or further limited to Investigators engaged in PHS- funded research. It is the responsibility of each Covered Individual to understand which of the following provisions and associated required actions are applicable in the performance of his or her Institutional Responsibilities.

Regardless of source of funding, independent contractors or consultants will undergo a review through the applicable sponsored research office upon proposal or award to determine if the individual is acting as an Investigator on the related Project. If the individual is determined to be an Investigator and the individual shall be covered by this Policy, all of the following sections are applicable.

Training

Training is required of all Covered Individuals prior to involvement in any Project and at least every four years thereafter. Such training will inform the Covered Individual of the University's Policy, an Investigator's disclosure responsibilities under the Policy and applicable federal regulations on Financial Conflict of Interest (FCOI).

Required Action

All Covered Individuals involved in a Project must complete the COI training modules through the on-line system. Training completion will be reflected in the related campus on-line research system. Funding for any sponsored Project may not proceed until all of the Covered Individuals involved in these activities have completed the COI training.

For Covered Individuals new to the University, training will be completed prior to involvement in any Project. Investigators are also subject to re-training when either of the following circumstances occurs: (1) the University determines that a Investigator is not in compliance with the University Policy or his/her specific management plan; or (2) the University revises its Policy in a manner that affects the requirements of Investigators' responsibilities.

Alternative training options for those Covered Individuals with special circumstances may be proposed by a principal investigator and approved on a case by case basis by the Conflict of Interest Officer. Further information is included in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

Disclosure

Disclosure is required from all Investigators involved in any Project that is submitted through the Office of Sponsored Research or the Office of Human Research Ethics. Investigators are required to complete any applicable Conflict of Interest Disclosure form and provide details regarding their Personal or Financial Interests as necessary in the conflict of interest review process. Disclosure must include any Personal or Financial Interest, regardless of level or type of compensation, and any uncompensated position, board membership, or consultancy with or for an external entity involved in or related to the Project in any way, including as a sponsor, subcontractor, sub-recipient, or as an owner or licensee of any product, process or technology studied or used in the Project, or if the interests of the external entity could be affected by the outcome of the Project.

For the purpose of this Policy, Investigator includes the principal investigator, project director, key personnel and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of a Project. Investigators may also include research study coordinators, research assistants, graduate students, or others. For the purposes of this Policy, research collaborators or independent consultants may also be considered Investigators depending upon their activities on the Project.

The term Investigator is not intended to apply to individuals who primarily provide technical support, administrative support, or who are purely advisory, such that these individuals have no influence over the research results (e.g. control over its collection, analysis, or reporting).

The Principal Investigator on each Project is responsible for ensuring that each individual who qualifies as an Investigator has completed a Conflict of Interest Disclosure form as required under this Policy.

Further information is detailed in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

Required Action

All Investigators are required to complete and submit a Conflict of Interest Disclosure form annually and for each Project when prompted by the online system. Any Investigator new to the University must complete any applicable Conflict of Interest Disclosure form upon request related to a Project submission or an annual form within 60 (sixty) days from the commencement of employment.

For the purposes of this Policy, research collaborators or independent contractors who are determined to be Investigators will need to comply with this Policy if not covered by a Conflict of Interest policy at their own organization or institution which is congruent with the sponsoring organization’s requirements. An assurance signed by an authorized official at their own organization indicating policy coverage must be provided by these individuals to the applicable research office. Investigators are responsible for updating Conflict of Interest Disclosure forms within 30 (thirty) days when changes arise that may either: (a) give rise to a new Personal or Financial Interest; (b) eliminate a previously reported Financial Interest; or (c) result in an affirmative answer to any question on any Conflict of Interest Disclosure form previously answered in the negative.

Review

Conflict of Interest Disclosure forms are submitted through the online system to the University's Conflict of Interest Program and processed as specified in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment. Such review will determine whether there is a Conflict of Interest of any level or type and a specific review to determine if a Financial Conflict of Interest (FCOI) exists.

Potential conflict of interests include any Personal or Financial Interest, regardless of level or type of compensation, and any uncompensated position, board membership, or consultancy with or for an external entity involved in or related to the Project in any way, including as a sponsor, subcontractor, sub-recipient, or as an owner or licensee of any product, process or technology studied or used in the Project.

The review will include an analysis of the Investigator's Personal and Financial Interests and relatedness to his/her Institutional Responsibilities. Whether the interests are determined to be an actual Conflict of Interest will depend upon the nature of the Personal and/or Financial Interests, the relatedness of the responsibilities and the nature of the activities potentially affected by the disclosed Personal or Financial Interest. Specific review will be conducted to determine if the disclosed interests meets the federal definition of being an FCOI.

While certain situations are subject to special provisions regarding particular types of University relationships, the following guidelines are generally applicable:

1. Where an Investigator proposes to be engaged in the design, conduct or reporting of University research other than Human Subjects Research, his or her Conflict of Interest or FCOI may be allowed with University approval and appropriate management.
2. Where an Investigator proposes to be involved in the design, conduct or reporting of University Human Subjects Research, he or she may not have a Personal or Financial Interest of any level or value reasonably judged to be significantly and directly related to the outcomes of such research, absent a showing by the Investigator of compelling circumstances justifying continuation of involvement in the Project notwithstanding the these Interests.
   
   Compelling circumstances are those facts that convince the reviewer that an Investigator who has a Personal or Financial Interest judged to be significantly and directly related to the research should be permitted to conduct Human Subjects Research, taking into account the following factors:
   1. the nature of the research,
   2. the magnitude of the interest and the degree to which it is related to the research,
   3. the extent to which the Financial Interest could be directly and substantially affected by the research,
   4. the degree of risk to the human subjects involved that is inherent in the research protocol,
   5. the extent to which the Investigator is uniquely qualified to perform a research study with important public benefit, and
   6. the extent to which the Personal or Financial Interest is amenable to effective oversight and management.

The training experience and academic progress of University students and trainees must not be subordinated to the Personal or Financial interest of an Investigator or commercial interests of research sponsors.

Where a Conflict of Interest or FCOI poses the risk that University activities may be inappropriately affected, the conflict must be managed, reduced or eliminated.

Required Action

The Investigator will be contacted at the sequential stages of the process to indicate the status of the review. Any Conflict of Interest Disclosure form submitted by an Investigator will be processed as specified in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

When the need for a Conflict of Interest Disclosure form is indicated through the review processes of the Office of Sponsored Research, any of the Institutional Review Boards, or any other University office, the funded Project or other contract for which the form is indicated or the initiation of Human Subject Research may not proceed until the Conflict of Interest Disclosure form has been disclosed, evaluated, and approved or resolved, including any required report to a sponsor. Violation of this provision by any Covered Individual may lead to disciplinary action, up to and including dismissal from employment or enrollment.

SBIR/STTR

Of special concern are federally sponsored SBIR or STTR research Projects that involve association with small business entities. Due to the potential for either the actual or the appearance of a Conflict of Interest, a Covered Individual may not conduct research or administrative activities in conjunction with a SBIR or STTR Project on behalf of both the University and the grantee or sub-grantee company without compelling evidence to support execution of both roles and in accordance with the sponsor guidelines. Approval must be received through the conflict of interest review in accordance with the standards in this Policy prior to the commencement of any activities arising from such collaboration.

Compliance with External Sponsors

The University will be compliant regarding conflict of interest standards as required by the terms of its agreement with external sponsors.

The University will submit reports to federal sponsors as required under applicable federal regulations. As federal agencies may have differing requirements, reporting on these Projects will be responsive to the standards and guidelines set by those agencies.

Reports on FCOIs for those Investigators with PHS funding shall be submitted to the PHS awarding component as required ("FCOI Reports"). FCOI Reports shall be submitted prior to the University's expenditure of funds under the PHS-funded Project and annually thereafter. In addition, the University must submit an FCOI Report within sixty (60) days of the identification of any new FCOIs (e.g., upon the participation of an Investigator who is new to the research). For any previously reported FCOI Report, the University shall provide to the PHS awarding component an Annual FCOI Report that addresses the status of the FCOI and any changes to the management plan. Such Annual Reports shall be provided for the duration of the PHS-funded research Project and in the manner specified by the PHS awarding component (e.g., at the time of the annual progress report or, at time of extension, etc.). For Projects funded by the National Science Foundation ("NSF"), the University will inform the NSF's Office of General Counsel if the University is unable to satisfactorily manage an FCOI.

Required Action

FCOI Reports to PHS shall include a statement that the University has implemented a management plan, as well as key elements of the management plan and other information regarding the nature and value of the Financial Interest as required under PHS regulations. The PHS Annual FCOI report shall specify whether FCOIs previously reported are still under management or explain why the FCOI no longer exists. Further guidance on the information required to be reported pursuant to federal regulations is included in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

Provisions Specific to Research Funded by Certain Federal Sponsors

The following sections contain requirements that apply to research funded by certain Federal sponsors. Accordingly, the following sections have a more narrow application than the prior sections that apply to all Projects.

a) Travel and Paid Authorship​​​​​​

As detailed in the PHS regulations, Investigators who receive PHS research funding are also required to disclose 1) reimbursed or compensated travel and 2) paid authorship. PHS-funded Investigators must disclose any Reimbursed or Sponsored Travel related to their Institutional Responsibilities. The University will determine if any travel disclosure requires further review, including but not limited to the disclosure of the monetary value of the travel. Additionally PHS-funded Investigators must disclose any income received from any paid authorship, including textbooks.

Required Action

PHS-funded Investigators must disclose the occurrence of any Reimbursed or Sponsored Travel, with exclusions, related to their Institutional Responsibilities through a specific Conflict of Interest travel disclosure form which will capture the sponsor or organizer, purpose, destination, and duration of the travel. Generally, exclusions from disclosure include any travel paid directly by the University, a US public government entity, or a US academic institution. All travel internationally must be disclosed, regardless of the type of entity supporting the travel. The Conflict of Interest travel disclosure form should be submitted prior to the travel but must be submitted no later than 30 days after the occurrence of the travel.

Disclosure for paid authorship can be submitted on any applicable Conflict of Interest Disclosure form, and must be submitted no less than annually.

Further information about specific exclusions from the necessary disclosure and processing of the Conflict of Interest Disclosure forms are specified in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

b) Public Accessibility

In accordance with the federal regulations, the University will make information available to the public regarding FCOIs for those Senior/Key Personnel in conjunction with a specifically PHS-funded research Project through responding to a written request. Information concerning FCOIs for Senior/Key Personnel as set forth in this section shall remain available for at least three years from the date that the information is most recently updated.

Required Action

More specific information on public accessibility to the FCOI information is set forth in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

c) Subcontracts

If the University carries out research funded by the PHS or the NSF through sub-recipients, contractors, or collaborators, the University must take reasonable steps to ensure that Investigators working for such entities either (1) comply with this Policy or (2) the entity has its own policy that meets applicable federal requirements on financial conflicts of interest.

Other sponsors, federal or private, may also require that the sub-recipients, contractors, or collaborators be responsive to the sponsor’s Conflict of Interest standards. Such provisions will flow down to the sub-recipients, contractors or collaborators through contracts or forms with the Office of Sponsored Research.

Required Action

For research sponsored by the PHS, the University's Office of Sponsored Research requires that a sub-recipient provides an indication during the application process of contractual assurance of its compliance with PHS' policy on conflict of interest or the intent to comply with the University's Policy.

If the sub-recipient provides assurance of its own policy, there is a contractual obligation that includes a requirement that the sub-recipient report to the University's Office of Sponsored Research the following information for any FCOI of sub-recipient Investigators: (a) sub-recipient contract number; (b) name of the sub-recipient Investigator with the FCOI; (c) name of the entity with which the Investigator has an FCOI; (d) nature of the Financial Interest (e.g., equity, consulting, etc.); (e) value of the Financial Interest; (f) a description of how the Financial Interest relates to the PHS-funded research and the basis for the sub-recipient's determination that the Financial Interest conflicts with the PHS-funded research; and (g) a description of the management plan.

The Office of Sponsored Research will forward a copy of each such sub-recipient report, identified by PHS grant number, with a copy to the Principal Investigator and the Conflict of Interest Program for reporting to the PHS awarding component.

If the sub-recipient chooses to comply with the University's Policy, then a statement to this effect should be included in the letter of intent and will be included in the sub-award contract.

All sub-recipient Investigators known at the time of application must be identified and complete the necessary disclosure process and applicable training as detailed in this Policy. If additional Investigators are identified by the sub-recipient at the time of the sub-award contract, these Investigators must complete the applicable Conflict of Interest Disclosure form and applicable conflict of interest training before the sub-award can be granted. In these instances, the University will report to the PHS-awarding component FCOIs related to sub-recipient Investigators in the same manner as it reports FCOIs related to its Investigators.

I. Other Applicable Situations

Periodically situations may arise in administrative, academic or research areas which could meet the definition of a Conflict of Interest and these scenarios do not meet the parameters of any of the prior sections. If such a situation is raised to the attention of the Conflict of Interest Officer, the Officer will review such situations, including interviewing the Covered Individual, in consultation with the Office of University Counsel and any other applicable University office, maintaining the confidentiality as outlined in this Policy.

VI. Records Confidentiality and Retention

Confidentiality

The Conflict of Interest Disclosure forms, review information and any related management plans containing information that may have a direct bearing on a Covered Individual's employment and are considered to be confidential personnel information that should be maintained in a secure and confidential file. Access to information disclosed in the Conflict of Interest review process, including management plans, will be limited to those with a need to know. This information is available only to individuals duly charged with the responsibility for review, the University's IRB, any central IRB under agreement with the University and other University offices with a business purpose, and may be released only in accordance with and as required by federal regulation, North Carolina law, or lawful court order.

Records Retention

All records relating to the reporting of potential conflicts of interest and commitment, and to the actions taken with respect to those disclosures, reports or plans, shall be maintained for three years following the expiration of their relevance, or as required by applicable government regulations, whichever is greater.

VII. Policy Implementation

The Chancellor is responsible for overseeing the implementation of this Policy. Day-to- day responsibility for such implementation is delegated through the Vice Chancellor in the Division of Institutional Integrity and Risk Management to the Conflict of Interest Officer. The University will make this policy and the Standard Operating Procedures for Individual Conflicts of Interest and Commitment available on its website.

In addition, the Vice Chancellor will appoint a University Conflicts of Interest Advisory Committee, which will be authorized to make recommendations to the Chancellor for appropriate changes to this Policy. The Conflicts of Interest Advisory Committee will include the chairs of any college or school COI review committees, as well as such additional members as the Vice Chancellor shall select upon advice of the Conflict of Interest Officer in order to represent the interests and viewpoints of the members of the University community directly affected by and involved in implementation of this Policy.

VIII. Policy Breaches

Possible sanctions for violation of this Policy, including furnishing false, misleading, or incomplete information, can range from administrative intervention to termination of employment or of enrollment, all in accordance with applicable University policies. The Chancellor, or the Chancellor's delegate, will review all alleged violations of this Policy, including the provisions of the Standard Operating Procedures for Individual Conflicts of Interest and Commitment. Violations may include but are not limited to: (a) failure to comply with the process (by failure to disclose timely Personal or Financial Interests as required, by failure or refusal to respond to requests for additional information, by providing incomplete or knowingly inaccurate information, or otherwise); (b) failure to remedy conflicts; and (c) failure to comply with prescribed management agreement or monitoring plan.

When the University identifies a Financial Interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the University during an ongoing PHS-funded Project (such that it was not timely reviewed or reported by a sub-recipient), the Conflict of Interest Officer will, within 60 days (1) review the Financial Interest, (2) determine whether it is related to the research, and (3) determine whether an FCOI exists. If an FCOI is determined to exist, the University will implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI going forward.

In addition, whenever an FCOI is not identified or managed in a timely manner due to (1) failure by the Investigator to disclose a Financial Interest that is determined by the University to constitute an FCOI, (2) failure by the University to review or manage an FCOI, or (3) failure by the Investigator to comply with an FCOI management plan, the University shall, within 120 days of the University's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research Project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. Such reviews will be in accordance with federal regulation and documented as detailed in the Standard Operating Procedures for Individual Conflicts of Interest and Commitment.

If a determination of bias is made during the retrospective review, a mitigation report will be completed. Mitigation reports will include among other elements, a description of the impact of the bias on the PHS-funded Project and the University's action or actions taken to eliminate or mitigate the effect of the bias. In those instances where the Department of Health and Human Services determines that a PHS-funded Project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not managed or reported by the University as required under PHS regulations, the University will require the Investigator involved to disclosure the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentation.

If an Investigator fails to comply with the provisions of Section V.H. of this Policy as applicable to PHS-funded Investigators or an FCOI management plan developed thereunder and such failure appears to have biased the design, conduct, or reporting of the PHS-funded research, the University shall promptly notify the PHS awarding component of the corrective action taken or to be taken against such Investigator.

The University will be responsive to any inquiries from or requirements by the PHS awarding agency regarding FCOI management, in order to maintain the objectivity of the research. Despite the University’s management of a conflict, the PHS Awarding Component may decide that a particular FCOI will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial Conflict of Interest in accordance with the PHS FCOI Regulation. The PHS Awarding Component may determine that imposition of specific award conditions under 45 CFR 75.207, or suspension of funding or other enforcement action under 45 CFR 75.371, is necessary until the matter is resolved.

In a situation in which the DHHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI that was not managed or reported by the University as required by the federal regulations, the University shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

Standard Operating Procedures for Individual Conflicts of Interest and Commitment

I. Introduction

These Standard Operating Procedures ("SOPs") are based on the University's Policy on Individual Conflicts of Interest and Commitment ("the Policy") and are intended to provide effective and transparent processes for the disclosure, review, management, and reporting of potential conflicts of interest within the University community. The SOPs do not apply to situations arising under the Policy on Institutional Conflicts of Interest or to situations governed by the Ethics in Government Act.

Terms used in these SOPs shall have the meaning as under the Policy unless otherwise noted. The SOPs are maintained and executed, except as noted, by the Conflict of Interest (COI) Officer and the COI staff who are part of the Conflict of Interest Program. In the absence of the COI Officer, the Vice Chancellor of Institutional Integrity and Risk Management shall determine a person to fulfill such functions assigned to the COI Officer. These SOPs are subject to change.

II. Committee Structure

The University currently has five standing individual conflict of interest committees: School of Medicine, School of Dentistry, School of Pharmacy, School of Public Health and the College of Arts & Sciences.

III. Conflict of Commitment

External Professional Activities for Pay (EPAP) requests should be submitted online by the requesting employee ten (10) days prior to the activity through the central AIR website. Any EPAP request will be routed to the designated EPAP approver(s) for review. EPAP approvers can approve or deny the requests. The decision, with any available comments, is automatically routed back to the requesting employee. If a possible COI is indicated in the EPAP request, this form is automatically routed to the COI Program for review only if the EPAP request has been approved.

For further information, please see the University's EPAP Policy..

IV. Conflict of Interest

Conflict of Interest disclosures shall be reviewed under the definition specified in the UNC Board of Governor's Policy on Conflict of Interest and Commitment. The definition of a conflict of interest being situations where a Covered Individual's Personal or Financial Interest:

• may compromise,
• may involve the potential for compromising, or
• may have the appearance of compromising

his or her objectivity in meeting University duties or Institutional Responsibilities, including research activities. The bias that such conflicts may impart can affect many University responsibilities, including decisions about personnel, the purchase of equipment and other supplies, the selection of instructional materials for classroom use, the collection, analysis and interpretation of data, the sharing of research results, the choice of research protocols, the use of statistical methods, and the mentoring and judgment of student work.

University Responsibilities Annual Administrative Role Disclosure

The COI Officer shall create a schedule of required submission dates for University employees specifically required by the Policy to submit a conflict of interest annual form. Such form will be designed by the COI Officer and shall be filed electronically. Any employee who fails to file a required form on or before the date specified by the COI Officer other than for good cause (as determined by the COI Officer) shall be deemed to be in violation of the Policy and subject to disciplinary review by his or her supervisor.

The COI Officer will review all conflict of interest annual forms and determine whether or not the information disclosed in each represents a potential COI. Upon making the determination that there is a potential COI, the COI Officer will forward the applicable disclosure form with a preliminary analysis and recommendation for resolution to the Dean, Vice Chancellor, or other officer with analogous administrative authority ("the reviewing officer") supervising the affected employee.

The reviewing officer shall issue a decision regarding the disclosure within fourteen days of receipt of the conflict of interest annual form, provided that that deadline may be extended by the COI Officer for good cause. Where the reviewing officer agrees with the COI Officer's analysis, the employee will be required to recuse himself or herself from any University activities affected by his or her COI. In situations where recusal of the employee cannot be effected consistent with his or her Institutional Responsibilities, the employee will be required to resolve the COI by divestment of the Personal or Financial Interest causing the COI.

Where the reviewing officer disagrees with the COI Officer's conclusion that a COI exists, he or she shall set out the basis for that decision in a memorandum to the Chancellor, with a copy to the COI Officer and the employee. The Chancellor may accept or reject the reviewing officer's decision and order such further measures to resolve or manage the COI as the Chancellor deems appropriate.

Research and Sponsored Projects Conflicts of Interest

The following sections provide details on the procedures for complying with Section V.H of the Policy.

A. COI Training

As specific in the Policy, all Covered Individuals are required to complete conflict of interest training prior to involvement in a Project. The training requirement applies whether the Project is funded or unfunded. Administrative offices which support the research enterprise are encouraged to take this training as well.

The training modules are on-line via the RAMSES Research website. Except as detailed in the Policy, completion of training is valid for four years. Training status for an individual will be reflected in any appropriate Electronic Administration Research system. The sponsoring department or unit is responsible for ensuring that training has been completed prior to assigning a Covered Individual to a sponsored award account number.

Any principal investigator requesting use of alternative training should submit an email to coi@unc.edu and attach a proposed plan for the alternative training.

B. Disclosures

The University requires that all Investigators involved in a Project submitted through the Office of Sponsored Research ("OSR") or the Office of Human Research Ethics ("OHRE") submit Conflict of Interest Disclosure forms detailing their Personal and Financial Interests. Investigators will also need to complete an annual Conflict of Interest Disclosure form as applicable.

Independent contractors or consultants who have been determined to be “Investigators” are subject to all of the following procedures specific to their sponsored research project.

The requirement to complete a specific Conflict of Interest Disclosure form is communicated through an email notification to the Investigator. The email provides a link to access the form. For Covered Individuals, these forms are always available for access through the central AIR website.

Other Conflict of Interest Disclosures are self-initiated by an Investigator. All Conflict of Interest Disclosure forms can also be accessed through the central AIR website.

A. Paid Authorship Disclosure

Investigators with PHS funding must disclose any compensation received from paid authorship which includes textbooks, book chapters, etc. This information will need to be disclosed in the Conflict of Interest Disclosure form available on the central AIR website. The University will determine if any further information is needed from the Investigator to assess the disclosure.

B. Reimbursed or Sponsored Travel Disclosure Form

Investigators with PHS funding must self-disclose the occurrence of any Reimbursed or Sponsored Travel related to their Institutional Responsibilities. To assist PHS-funded Investigators in submission of this information, Investigators will receive a reminder email to submit travel disclosures if appropriate. Such disclosure will include the sponsor or organizer, the purpose of trip, the destination, and the duration. Disclosure of Reimbursed or Sponsored Travel is done through a specific travel disclosure form, separate from any annual and project-specific disclosures.

PHS-funded Investigators are NOT required to disclose travel that is reimbursed or sponsored:

• directly through the University
• by a US federal, state, or local government agency, or
• by a US institution of higher education, a US academic teaching hospital, a US medical center, or a US research institute that is affiliated with a US institution of higher education.

Reimbursed or Sponsored Travel from all other sources, including private entities, foreign governments, foreign universities, non-profits or NGO's must be disclosed.

The travel disclosure form should be submitted prior to the travel but must be submitted no later than 30 days after the occurrence of the travel. PHS-funded Investigators will receive a reminder email to submit travel disclosures if appropriate. The University will determine if any travel disclosure requires further information, including but not limited to the disclosure of the monetary value.

C. Review

Upon completion of a conflict of interest disclosure by an Investigator, the COI system checks for affirmative answers that might be an indication of a potential COI. If a potential COI is not indicated, the disclosure is finalized in the COI system. Related electronic research systems (such as RAMSeS and IRBIS) are updated automatically indicating the review status of the particular disclosure as complete and may include a "no conflict" designation.

If a potential COI is identified by the system, the disclosure is flagged and reviewed by COI Staff, who will make a threshold determination of whether a potential COI exists, upon consultation with the COI Officer if necessary. The Investigator may be contacted to gather additional or supplemental information necessary to evaluate the disclosure.

If the COI Staff determines that no potential COI exists, the Investigator will be informed of the determination through an electronic notification through the AIR system. RAMSeS and IRBIS will be updated automatically to reflect the determination.

If the COI Staff determines that a potential COI exists, an alert is sent to the COI Committee Chair(s) with jurisdiction over the Investigator indicating that a review is necessary. The COI Committee Chair(s), with input from the COI Staff or COI Officer, will review the disclosure and make a determination regarding whether the case can be handled through expedited review or whether the case should be assigned to an agenda for full committee review. If the Committee Chair determines that expedited review is appropriate, he or she will make recommendations to the COI Staff or Officer on determination and management of the conflict. In schools, centers or departments that have no standing conflict of interest committee, information on potential conflicts of interest will be shared with the appropriate Dean or Unit Head, who will perform the review in conjunction with the COI Staff and Officer.

Taking into account any conclusion reached by a COI Committee Chair (or Dean or Unit Head, as applicable) or a COI Committee, the COI Officer will confirm any determination of whether a COI exists and, if so, whether it can be managed or must be resolved in order for the Project to proceed. The COI Officer may proceed to make a determination regarding the existence of a COI if no advice is provided by the applicable COI Committee Chair (or Dean or Unit Head) or the COI Committee within fourteen (14) days of transmission by the COI Staff of the need for a COI evaluation; this deadline may be extended by the COI Officer for good cause and where doing so will not jeopardize the proposed research relationship.

The COI Officer shall confirm in the COI system one of the following determinations and the COI staff will convey the decision to the Investigator:

Determination Descriptions Table

Determination	Description
No conflict	No conflict was reported or determined.
No evaluation, Declined/Withdrawn	If the IRB or Ramses application is withdrawn or the individual removed from the project.
Rely on External Policy	External to UNC person is part of a UNC-CH study but their employment is with another institution that has a COI Policy congruent with the Federal Regulation. The person must provide an assurance letter to certify compliance.
Acknowledged	Interest disclosed to UNC per COI policy. No additional action required.
Transparency	Request for disclosure in consent, if applicable, and in any public dissemination, not limited to publications and presentations. No management determined.
COI with Administrative Considerations	A COI determined with minimal need for ongoing oversight. Requires disclosure in consent, if applicable, and in any public dissemination, not limited to publications and presentations. Additional management requirements are sometimes included within the context of the project and the disclosed relationships.
FCOI Management	Interests which meet the FCOI definition with the need for ongoing management and monitoring. Request for disclosure in consent, if applicable, and in any public dissemination, not limited to publications and presentations. Change in Roles possible.
Not Manageable	Relationships which have been determined to be either a COI or FCOI and further determined no management is sufficient to effectively counter the actual or potential bias created by the COI/FCOI.
Deferral	A status that states COI or FCOI exists which cannot be managed as presented and changes to the project are required in order for it to proceed.

The COI finalization email letter will contain a determination, an acknowledgement of existing management, or text indicating the need for new (or revised) management to be established. Any management terms, such as public disclosure, are included in the letter and are immediately applicable upon transmission to the Investigator via the email. For human studies, these finalization letters are reflected into the IRBIS system for review by the IRB. Copies of these finalization email letters may be obtained upon request by an Investigator with an email to the COI Program, coi@unc.edu.

When a newly reported relationship is deemed to be a COI with administrative considerations, the COI staff will promptly contact the Investigator with the management details and will secure the Investigator's agreement to such administrative considerations.

Where an FCOI is deemed to be subject to management, the COI Officer will promptly contact the Covered Individual to discuss the Management Agreement and will arrange necessary meetings with the Investigator to resolve any questions he or she may have prior to gaining the Investigator's agreement to abide by the created a Management Agreement.

The IRB retains final jurisdiction over Human Subjects Research and may decline to approve an application on grounds of COI notwithstanding a decision by the COI Officer that there is no COI or that a COI is present but capable of being managed.

V. Management of Conflicts of Interests

Management Principles

The COI Officer is responsible for designing appropriate management mechanisms for conflict of interest activities which have been determined to be capable of being managed. The COI staff will work with the applicable COI Committees and/or Committee Chair(s), Deans or Unit Heads on determining the management plan and tools. The COI Officer may seek advice from individuals outside as well as within the University in proposing such mechanisms.

The University maintains three principles for conflict of interest management:

• Transparency
• Honoring the student/trainee experience
• Protecting the credibility of the individuals doing the work

With transparency being the foundation of conflict of interest management, public disclosure of personal or financial relationships is generally required in any publication, presentation, abstract, poster or human studies’ informed consent, website or other public dissemination as applicable. Notification of such requirements will be detailed in the COI finalization email letter as applicable and samples of such disclosure text are available on the COI Program website.

In addition to public disclosure, possible measures to be taken in managing a COI include, but are not limited to, any of the following:

• Reformulation of the work plan
• Close monitoring of the Project ; independent review committee
• Substituting supervisors and/or any other personnel
• Divestiture of Financial Interests
• Termination or reduction of involvement in the relevant Projects
• Termination of inappropriate student involvement in Projects
• Severance of relationships that pose actual, potential or the appearance of conflicts
• 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.

Other management measures may be determined upon review of the specific case.

Reporting of FCOI for PHS-Funded Investigators

As required by PHS regulations, the University shall report the following information regarding FCOIs related to PHS-funded research to the funding agency through the eRA Commons:

• Project Number
• PD/PI or Contact PD/PI if multiple PD/PI model is used
• Name of the Investigator with the FCOI
• Name of the entity with which the Investigator has a the FCOI
• Nature of the Financial Interest (e.g. equity, consulting fee, travel reimbursement, honorarium)
• Value of the Financial Interest, or a statement that the interest is one whose valued cannot be readily determined through reference to public prices or other reasonable measure of fair market value
• A description of how the Financial Interest relates to the PHS‐funded research and the basis for the University's determination that the Financial Interest conflicts with such research
• A description of key elements of the University's Management Plan including:
  • Role and principal duties of the conflicted Investigator in the research Project Conditions of the Management Plan
  • How the Management Plan is designed to safeguard objectivity in the research Project
  • Confirmation of the Investigator's agreement to the Management Plan
  • How the Management Plan will be monitored to ensure Investigator compliance
  • Other information as needed or requested by the funding agency

Public Accessibility

In accordance with the federal regulations, the University will make certain information available to the public regarding FCOIs for those Senior/Key Personnel in conjunction with a specific PHS-funded research project. Requests must be submitted in writing to the Conflict of Interest Program, 301 Bynum Hall, CB 9103, 222 East Cameron Avenue Chapel Hill, NC 27599-9103, Attention: Public Request, or via email to coi@unc.edu. Requests will be answered within five business days (when the University is open for business) from the date of receipt at the Conflict of Interest Program. The request must identify the specific PHS project number and name for which the information is being requested and must include a named recipient. If the request is in writing, a return address with a physical street address must be included, P.O. Boxes are not acceptable.

The University will note in its written response that the information is current as of the date of the correspondence, and is subject to updates at least annually or within 60 days of the University's identification of a new FCOI, which must be requested under separate cover by the requestor. This information will remain available for request for three years from the date the information was most recently updated.

In accordance with PHS regulations, the following information will be provided:

1. Project Number
2. Name of the Investigator with a conflicted interest;
3. Investigator's title and role with respect to the PHS research Project;
4. Nature of the Financial Interest (e.g. equity, consulting fee, travel reimbursement, honorarium); and Value of the Financial Interest (in ranges), or a statement that the interest is one whose valued cannot be readily determined through reference to public prices or other reasonable measure of fair market value.

VI. Investigation and Resolution of Policy Violations

Any time the COI Officer becomes aware of a potential violation of the Policy or of any other situation that could indicate that University research, education and training may have been affected inappropriately by a Conflict of Interest, the COI Officer shall conduct a preliminary investigation to determine whether the concerns appear to be warranted.

On receipt of such a report, the COI Officer shall notify the Vice Chancellor for Institutional Integrity and Risk Management, and the Research Compliance Officer if a research project is involved. In consultation with those persons, the Conflict of Interest Officer may:

1. Investigate the matter and make a written memorandum of his or her conclusions;
2. Request that the person or committee assigned to monitor the activity conduct an investigation and file a written report of the results of that investigation; or
3. Appoint another faculty member or a committee of faculty members to conduct an investigation and file a written report of the results of that investigation.

Any such investigation should, at a minimum, include a personal interview with the person bringing forth the allegations or concerns, if known, and a personal interview with the Covered Individual, who should be informed with specificity of the allegations or concerns that have arisen. While the Covered Individual has a right to know the identity of a person, if known, making such allegations, he or she should be informed that the University's Whistleblower Policy prohibits retaliation against a person making such allegations in good faith.

Upon determination that a violation of this Policy has occurred or of the existence of a situation that could indicate that University research, education, training, business administration or other performance may have been affected inappropriately by a Conflict of Interest, the COI Officer should take any steps necessary to correct the situation, including and up to disapproval of the conflict of interest being managed. In addition, where appropriate the COI Officer must consider recommending to the relevant officials the imposition of disciplinary or other action under other appropriate University policies, including the Policies and Procedures on Ethics in Research and disciplinary policies for faculty, staff or students. Such possible actions or sanctions could include a letter of reprimand, increased monitoring of the conflict or other appropriate actions. The COI Officer, in consultation with Vice Chancellor for Research and the Vice Chancellor for Institutional Integrity and Risk Management, shall have the authority to direct that the research activities of the Covered Individual affected by the COI be suspended pending conclusion of an investigation or, on conclusion of an investigation, that they be suspended pending amelioration of the Policy violation.

Upon a determination that no violation of the Policy has occurred, or otherwise at the conclusion of any investigation conducted under this Policy, all materials generated in the course of such investigation should be placed with the Covered Individual's personnel file or, if a student, with the Office of the Vice Chancellor for Student Affairs, marked as "confidential" and stored in a secure manner, in order to ensure the confidentiality of these records.

For PHS-funded studies, the University and Investigators are subject to the following procedures when an FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a Financial Interest that is determined by the University to constitute an FCOI; failure by the University to review or manage such an FCOI; or failure by the Investigator to comply with an FCOI Management Plan.

1. The University must implement, on at least an interim basis, a Management Plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward;
2. Within 120 days of the University's determination of noncompliance, the University must complete a retrospective review of the Investigator's activities and the PHS-funded research Project to determine whether any PHS‐funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
3. The University must document the retrospective review and include, at minimum, the following information:
   1. Project number
   2. Project title
   3. PD/PI or contact PD/PI if a multiple PD/PI model is used
   4. Name of the Investigator with the FCOI
   5. Name of the entity with which the Investigator has an FCOI
   6. Reason(s) for the retrospective review
   7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed)
   8. Findings of the review
   9. Conclusions of the review

Based on the results of the retrospective review, if appropriate, the University shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward.

If the retrospective review team members find bias, the University is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research Project and the University's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research Project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research Project is salvageable).

Thereafter, the University will submit to the PHS Awarding Component FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the FCOI, the University may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research Project between the date that the Investigator's noncompliance retrospective review.