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THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL POLICY ON INDIVIDUAL CONFLICTS OF INTEREST AND COMMITMENT
Revised September 12, 2012
I. INTRODUCTION AND PURPOSE
II. DEFINITIONS OF SELECTED TERMS
III. APPLICABILITY
IV CONFLICT OF COMMITMENT
V. CONFLICT OF INTEREST
A. Acceptance by Individuals of Gifts, Favors from External Entities
B. Gifts to the University or an Affiliated Foundation for the Benefit of a Covered Individual
C. Use of University Resources, including Privileged Information
D. Purchasing, Contracting, Other Business Transactions on behalf of the University
E. Intellectual Property Transactions
F. University Administrative Roles
G. University Review Panels
H. Research and Sponsored Projects
VI. RECORDS CONFIDENTIALITY AND RETENTION
VII. POLICY IMPLEMENTATION
VIII. POLICY BREACHES
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. But 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
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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, and 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.
“Covered Individual” refers to any University employee, student or trainee who is performing teaching, research, public service, administration and business operations of the University.
“Executive Position” refers to any position that includes responsibilities for a material segment of the operation, management or oversight of a business, 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.
“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:
(1) Salary external to the University, royalties (including royalties distributed to a Covered Individual or his or her Family through the University), or other payments, including
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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;
(2) Equity interest held by a Covered Individual or his or her Family in publicly-traded or non-publicly traded entities), in the twelve months preceding or anticipated in the twelve months following disclosure;
(3) Intellectual Property rights and interests (including inventorship) held by a Covered Individual or his or her Family in the twelve months preceding or anticipated in the twelve months following disclosure; and
(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 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 Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institution that is affiliated with an institution of higher education;
(3) Income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institution that is affiliated with an 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, or situations 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
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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, consulting 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 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.
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III. APPLICABILITY
This Policy applies to Covered Individuals, which is defined in this Policy to include any University employee, student or trainee in the performance of the teaching, research, public service, administration and 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 SPA employees, the review process is administered by Human Resources through the Secondary Employment Policy.
All EPA Faculty and EPA 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 BOG 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.
In accordance 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 Non-Faculty EPA Employees, all EPA Faculty and EPA non-Faculty employees of the
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University may participate in activities for compensation outside of their Institutional Duties. Employees are required to receive approval in advance for External Professional Activities for Pay (EPAP), except for contract employees performing such activities for pay entirely outside the months of their University contract employment.
University policy does not provide that an EPA faculty or non-faculty employee is entitled to engage in any EPAP for any specific or set percentage of time. Rather, an employee’s supervisor always has the discretion to determine whether a proposed external activity is appropriate in scope and duration or constitutes excessive time away from Institutional Responsibilities.
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.
Employees may not use any University resources in support of these type of 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., Use of University Resources, in this Policy for further guidance.
Required Action:
Any potential Conflicts of Commitment between primary and secondary duties are subject to review by the employee’s supervisor, department Chair or unit head.
An EPA 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 online system at least ten (10) days before engaging in the activity.
An EPA 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 should 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 Development. (See section “Intellectual Property Transactions” 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.” See the Policy on External Professional Activities of Faculty and Other Professional Staff 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
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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 of that school must adhere.
However, meals, texts, or customary honoraria may be provided to EPA faculty or non-faculty employees in connection with activities allowed under the Policy on External Professional Activities of Faculty and Other Professional Staff. 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.
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. Any personal compensation a Project sponsor pays to or for the benefit of a Covered Individual outside of contracted project support to the University must be reported by the Covered Individual as applicable under the Policy on External Professional Activities of Faculty and Other Professional Staff and this Policy.
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 that relate to the entity making the gift or donation, 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.
C. Use of University Resources, including Privileged Information
Confidential or privileged information 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 proprietary
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information acquired through 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, 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 EPA 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 Policy on Use of University Facilities for Noncommercial and Commercial Purposes, the Use of University Resources in Support of Entrepreneurial Activities Policy and the Personal Use Policy. 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 University employee 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 employee has a personal financial interest without prior review and approval as described immediately below. Where an employee is involved in the design, conduct or reporting of University research related to that employee’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, an employee may assist in the negotiation of license agreements for University intellectual property as allowed under the Policy on Equity Acquisition.
Required Action:
University employees 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 “Exercise of University Administrative Responsibilities.”
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If a University employee 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 employee’s supervisor. The supervisor shall reassign that transaction to another employee with prior approval and such management as is deemed appropriate by the Conflict of Interest Officer. (See also the University’s Business Manual, Material and Disbursement Services Policies No 17 and No. 22 and Appendix 12 http://www.ais.unc.edu/busman/msd/msdpol17.html.)
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 Patent and Copyright Policies and Procedures.
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 Development. 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.
Additionally, 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 both as detailed in the Conflict of Commitment section above.
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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 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 Office of University Counsel, Office of Research Compliance, Office of Material and Disbursement Services, Office of Technology Development, and Office of 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.
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 financial or personal 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
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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 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.
1) 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 and federal regulations on financial conflict of interest.
Required Action:
All Covered Individuals involved in a Project will need to 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.
2) 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
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or for an external entity involved in the Project in any way, including as a sponsor, subcontractor, subrecipient, or as an owner or licensee of any product, process or technology studied in 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. A letter of assurance signed by an authorized official at their own organization indicating policy coverage must be provided by these individuals.
Investigators are responsible for updating their Conflict of Interest Disclosure forms within 30 (thirty) days when changes arise that may either: (a) give rise to a 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.
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3) Review
Conflict of Interest Disclosure forms are submitted through the online system to the University’s Conflict of Interest Officer 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 Financial or Personal Interest, regardless of level or type of compensation, and any uncompensated position, board membership, or consultancy with or for an external entity involved in the Project in any way, including as a sponsor, subcontractor, subrecipient, or as an owner or licensee of any product, process or technology studied 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 a FCOI.
Subject to special provisions regarding particular types of University relationships (such as SBIR or STTR Agreements, see below), the following guidelines are generally applicable:
(A) 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.
(B) 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
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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.
(C) 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 research 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. Violation of this provision by any Covered Individual may lead to disciplinary action, up to and including dismissal from employment or enrollment.
4) 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. 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.
5) 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. Reports on FCOIs for those Investigators with PHS funding shall be submitted to
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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 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 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. 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.
6) 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 entity or a US academic institution. 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.
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Further information about specific exclusions from the necessary disclosure and processing of the COI 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 either through responding to a written request or web posting.
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.
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 a 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 Officer 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.
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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.
VI. RECORDS CONFIDENTIALITY AND RETENTION
A. 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 COI 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.
B. 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 Research Compliance Director 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 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, along with such other recommendations regarding the disclosure, evaluation, approval and management of conflicts of interest as the Committee deems appropriate. 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 Chancellor shall select upon advice of the Conflicts 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.
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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 a 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 subrecipient), 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 a FCOI exists. If a 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 a 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 a FCOI, (2) failure by the University to review or manage a FCOI, or (3) failure by the Investigator to comply with a 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 a 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.