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policy BEH-002 : Conflict of Interest and Conflict of Commitment

Team Members have an obligation to be objective and impartial in fulfilling their responsibilities to the Health System; this policy is intended to promote awareness of Health System requirements concerning gifts, gratuities, funds for the support of educational activities or stipends, conflicts of interest, and conflicts of commitment.

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  1. effective date:

    October 1, 2016
  2. content:

    Applies To:                         The Medical Center, the School of Medicine, the School of Nursing, Claude Moore Health Sciences Library, Transitional Care Hospital, the Health System Development Office/UVA Health Foundation (“Health System Development Office”), and the University of Virginia Physicians Group (“UPG”)

    Reason for Policy:           Team Members have an obligation to be objective and impartial in fulfilling their responsibilities to the Health System; this policy (“Policy”) is intended to promote awareness of Health System requirements concerning gifts, gratuities, funds for the support of educational activities or stipends, conflicts of interest, and conflicts of commitment.

    Table of Contents:               

    Definitions: 

    Overall Policy Statement: 

    Topics Addressed:

    1.  Gifts and Gratuities; General; Prohibitions
    2.  Interactions with Industry: (Gifts, Meals, and Travel)
      1. Gifts and Gratuities, Generally, including Meals
      2. Exceptions: When Meals are permitted
      3. Industry Paid Travel
      4. Accepting Meals and/or Travel from Industry (under exceptional circumstances)
      5. Proposals from Industry; where funds may be directed
    3.  Industry Use of Health System Resources
    4.  Industry Compensation
      1. Outside Consulting Speaking and Training for Industry
      2. Speaking and Training for Industry
      3. Formulary Review and Purchasing Committees
      4. Endorsements
    5.  Industry Access to Health System Facilities
    6.  Industry Support for Graduate Medical Education
      1. GME Stipends
    7.  Industry Provision of Scholarships and Other Educational Funds to Participants in School of Medicine UME Programs
    8.  Continuing Medical Education and Other Continuing Education
    9.  Outside Activities
    10. Publishing
    11. Reporting Requirements/Disclosures
      1. University Employees: Disclosures to the University and Commonwealth under the Virginia State and Local Government Conflict of Interests Act
      2. Special Requirements for School of Medicine Faculty
      3. Special Requirements for the School of Nursing Faculty and Investigators
      4. Disclosures to the Institutional Review Board
    12. Enforcement

     Definitions:                

    Compensation - Includes, but is not limited to, payment in currency, royalties, shares of stock, partnerships, equity interests, and travel/meal expenses (both reimbursement for out-of-pocket expenses and any travel arrangements made directly for the Team Member). 

    Conflict of Interest (COI) - A conflict of interest occurs when a person to whom the Health System has entrusted Institutional Responsibilities has financial or other personal interests that may conflict with or compromise the proper exercise of these responsibilities. A COI may adversely impact, or interfere with, health care delivery (including but not limited to available and appropriate diagnostic or therapeutic options) the design, conduct or reporting of research, teaching and training activities; the utilization of available resources; business operations; appropriate decision-making; and/or institutional policies. 

     Conflict of Commitment - A conflict arising when time expended on Outside Activities such as consulting or entrepreneurial activities interferes with a Team Member’s ability to meet his or her Institutional Responsibilities.

     Employer – for purposes of this policy, the Medical Center, the University of Virginia, and UPG.

     External Entity – A person, company, association, organization, institution, or any other type of entity with a separate legal identity, including a for-profit, not-for-profit, or an organization of higher education. The term “External Entity” includes, but is not limited to, any person or company seeking to do, or doing business with, the Health System, including but not limited to any person or company that produces, sells, and/or distributes health care goods and services, including any pharmaceutical, medical device, medical publishing, or medical equipment company (see also the definition below of “Industry”).

     Financial Interest - Anything of monetary value including, but not limited to: remuneration for participation in Outside Activities (e.g., salary, consulting and other fees, gifts, honoraria, etc.)ownership of stocks, bonds, stock options, partnership or other equity interests, rights to patent or royalty payments, consulting fees, speaking fees, salary, loans, gifts, lectureship fees, compensation for serving on boards of directors, scientific and other advisory boards. Financial Interests do not include stock owned through mutual funds.

     Grounds – the University of Virginia campus located in Charlottesville, Virginia.

     Health System - The Medical Center, the School of Medicine, the School of Nursing, Claude Moore Health Sciences Library, Transitional Care Hospital, the Health System Development Office, and UPG (hereinafter referred to collectively as “Entities” or each individually as an “Entity”).

     Health System Facilities –All facilities operated by, or otherwise under the control of, the Medical Center, the School of Nursing, the School of Medicine, the Transitional Care Hospital, and UPG, including those facilities leased by an Entity from the University of Virginia or UPG.

     Immediate Family - One’s spouse and dependent children.

     Industry - An External Entity seeking to do, or doing business with, the Health System, including but not limited to an External Entity that produces, sells, and/or distributes health care goods and services, including any pharmaceutical, medical device, medical publishing, or medical equipment company.   

    Institutional Responsibilities - A Team Member’s professional activities, which may include clinical care, teaching, research, financial/administrative support services, committee memberships, and service on panels such as an Institutional Review Board (IRB) or data and quality monitoring committees.

     Investigator - The principal investigator and any other person who is responsible for the design, conduct, or reporting of sponsored research, or for a proposal seeking such funding.

     On Site – As used in this Policy, “On Site” refers to activities occurring within, or in the immediate vicinity of, any Health System Facility, and anywhere on the Grounds of the University of Virginia in Charlottesville, Virginia.

     Off Site - As used in the Policy, “Off Site” refers to activities conducted at any location that is not On Site.   

     Outside Activities - Self-employment, or employment by a person or business not affiliated with the Health System; participation in the business or activities of External Entities, or employment, including but not limited to Outside Consulting, with External Entities that requires the use of knowledge, skills or expertise also required to carry out Institutional Responsibilities. Outside Activities may be compensated or uncompensated. 

     Outside Consulting - A relationship between a Team Member and an External Entity for services including, but not limited to, scientific advisory boards, data safety monitoring boards, other advisory/scientific boards, and product evaluation/development; payment is made directly to the Team Member. Health System resources are not utilized to do the work.  Neither the University nor the Health System is a participant in the consulting relationship.   

     Professional Public Service Activities - Activities related to University or public service including service on national commissions, governmental agencies and boards, granting agency peer-group review panels, visiting committees or advisory groups to other universities, professional associations, and analogous bodies. The fundamental difference between these activities and Outside Consulting is that they are public or University service. Although an honorarium or equivalent may be received, these Professional Public Service Activities are not undertaken for personal financial gain. Professional Public Service Activities are considered neither Outside Consulting nor Institutional Responsibilities for purposes of this Policy.

     Representative -A person employed by, or acting as an agent of, Industry.

     Research - A systematic investigation designed to develop or contribute to generalizable knowledge, including basic and applied science, clinical trials, and product development.

     SOM Faculty - With respect to the disclosure of Financial Interests, all faculty with primary appointments in the University of Virginia School of Medicine (appointments with rank of Lecturer or above including: Instructors, Assistant Professors, Associate Professors and Professors). The Financial Interest of the individual SOM Faculty includes his or her Immediate Family.

     SON Faculty - With respect to the disclosure of Financial Interests, all faculty with primary appointments in the University of Virginia School of Nursing (appointments with rank of Lecturer or above including: Instructors, Assistant Professors, Associate Professors and Professors).The Financial Interest of the individual SON Faculty includes his or her Immediate Family.

     Speakers Bureau - A situation where a Team Member provides services as a speaker for Industry, where the arrangement has any of the following characteristics:

    • the company has the contractual right to dictate or control the content of the presentation or talk;
    • the company creates the slides or presentation material that is not otherwise publicly available;
    • clinical data is available from company statistician; and/or
    • the Team Member is expected to act as the company’s agent or spokesperson for the purpose of disseminating company or product information or endorsing the company’s product.

     Team Members – All persons providing clinical, educational, research, administrative, or other services within or for the benefit of the Health System, regardless of Employer. 

     Policy Statement:  

    Team Members shall conduct Health System business, training, patient care, or research only under circumstances in which a reasonable person would conclude that the integrity of their performance of these activities has not been compromised by a Conflict of Interest or a Conflict of Commitment. 

    Because accepting gifts and gratuities can create a perception of bias and engender a sense of obligation to reciprocate (by, for example, prescribing more of a company’s products), the receipt of gifts and gratuities, as well as the limited circumstances under which they can be accepted, regardless of their source, falls within the scope of this policy and is treated as a potential Conflict of Interest.  

    Outside Activities, private Financial Interests, or the receipt of benefit from third parties, particularly Industry and Representatives but including the receipt of gifts from any source, can cause an actual or perceived conflict between Health System interests and an individual’s private interests, which must be avoided or formally managed under an institutionally approved plan. 

    Team Members who are employed by the Medical Center or the University are subject to the State and Local Governmental Conflict of Interests Act and the Ethics in Public Contracting Section of the Virginia Public Procurement Act of the Code of Virginia.  Those Team Members who hold dual employment by both the University and UPG (i.e., physicians) are state employees and shall also be governed by the requirements of state laws.  This policy incorporates the requirements of these Acts for those Team Members, and in some instances, imposes more stringent requirements. To the extent that this policy exceeds the requirements of state law or other codes of conduct, this policy shall control.  As relevant, this policy is also applicable to Team Members who are employed exclusively by UPG (“UPG Employees”) and who are therefore not state employees. 

    Team Members shall participate, in educational programs offering guidance on avoiding or resolving actual or perceived Conflicts of Interest and Conflicts of Commitment, as well as relationships with Industry, as may be required by an Employer.

     For additional guidance specific to researchers, see RES-005 Financial Conflicts of Interest for Research Investigators

     Any concerns about possible conflicts of interest or conflicts of commitment shall be referred as appropriate, to the Office of University Counsel, the Vice Provost for Research, the School of Medicine Senior Associate Dean for Research, or UPG Legal Affairs or UPG Compliance.                   

    Specific topics falling under this Policy are addressed in greater detail below:

    1. Gifts and Gratuities; General Prohibitions:  Except as otherwise permitted under this policy, Team Members, shall not directly or indirectly: 
        1. Solicit or accept Compensation, loans, advances, favors, special discounts, services, or gifts of any kind (including meals) and regardless of value, for services performed within the scope of their official duties except for compensation, expenses (including without limitation, payments for travel and stipends for educational activities), or other remuneration paid directly to them, or approved for them, by their respective employers;
        2. Solicit or accept Compensation, or anything else of value for or in payment of employment, an appointment, a promotion or a privilege within the Health System, except for compensation, expenses or other remuneration paid directly to them or approved for them by their respective employers;  
        3. Exceptions: 
          1. Team Members may accept unsolicited non-monetary gifts (for example, food or flowers) of nominal value (less than $25) from patients or patients’ families provided such gifts are offered as expressions of gratitude or appreciation for care or treatment rendered.  Patients and family members interested in making more substantial gifts or donations should be encouraged to contact the Health System Development Office.
          2. Team Members may accept items of nominal value having a legitimate educational purpose (i.e., brochures, pamphlets, training videos or similar items) for use by Team Members, patients or students.  
    2. Interactions with Industry (Gifts, Meals and Travel) 
      1. Gifts and Gratuities Generally, including Meals.  Unless otherwise permitted under this policy, Team Members shall not, directly or indirectly, solicit or accept from Industry or a Representative: 
        1. any Compensation, loans, advances, favors, special discounts, services, or gifts of any kind and regardless of value;
        2. promotional items (i.e., pens, note pads, cups or similar items), of any kind and regardless of value.  Team Members may accept items of nominal value having a legitimate educational purpose (i.e., brochures, pamphlets, training videos or similar items) for use by Team Members or patients. 
        3. food or beverage, of any kind and regardless of value, from any Representative On Site;  food and beverage offered Off Site is addressed in other sections of this Policy;
        4. meals, gifts or compensation, of any kind and regardless of value (including reimbursed or sponsor paid  travel expenses), for listening to a Representative presentation, or a presentation directly sponsored by a Representative, whether occurring On Site or Off Site;
        5. any product samples, for personal or family use, including but not limited to medication samples or ancillary product samples such as infant formula, lotions, etc.
      2. Exceptions: When Meals are permitted:  
        1. Team Members may accept meals or beverages from Industry when offered Off Site to a large group of people at a trade show, conference, exhibit or other professional meeting attended by, and open to, persons from a variety of organizations or institutions. NOTE: this exception does not apply to circumstances where, while attending an Off Site event, a Team Member, or group of Team Members, or a small group which includes a Team Member or Team Members, is/are invited by Industry, directly or indirectly, to attend a more select gathering at which food is provided by Industry and Industry Representatives; under these circumstances, the prohibitions articulated in Section 2.a above would apply. 
        2. Meals may be accepted Off Site if reasonably associated with travel in connection with product inspection, training, or procurement (See Section 2.c below). 
        3. Funds that are given to the University or Health System through the Health System Development Office, without restrictions on their use (“unrestricted gifts”), may be applied to provide food or beverage at an educational event or function, On Site or Off Site.  

                        Examples of when meals can be accepted under this Section 2 are contained in the attached FAQs.

      3. Industry Paid Travel:  
        1. Subject to the limitations of Section 2.c.ii below, a Team Member (other than a GME Trainee—for policy applicable to GME Trainees see Section 6 below) may accept Representative paid travel, including meals, provided such travel is approved in advance by a senior executive with overall responsibility for the area in which the Team Member is employed (e.g., a faculty member in the SOM would seek approval from the Department Chair; a Department Chair would seek approval from the Dean).
        2. For  travel conducted in connection with a procurement for the benefit of the Medical Center,  Medical Center Procurement must confirm  that the travel is: 
          1. in conjunction with a procurement process for the benefit of the Health System; or
          2. for purposes of product inspection by a Team Member; or
          3. necessary for the training and education of a Team Member               

         

        Examples of when travel can be accepted under this Section 2 are contained in the attached FAQs. 

         

      4. Accepting Meals and/or Travel from Industry may be deemed acceptable with senior executive approval under exceptional circumstances.   
        1. As noted elsewhere herein, Team Members must, in all instances, comply with the requirements of this policy that prohibit the acceptance from Industry of meals, travel and other compensation for services performed within the scope of Team Members’ official duties.  Team Members may not accept any favor, loan, service, business or professional opportunity from anyone knowing (or when it should be known) that it is offered in order to improperly influence the performance of their public duties, or when acceptance thereof may reasonably be perceived as an impropriety in violation of Health System or University policy, or of state law.
        2. In exceptional circumstances, the acceptance of meals and/or travel expenses may be an integral part of, or may facilitate, ongoing discussions between the Health System and Industry concerning Industry’s need for Health System services, or of collaborative relationships between the Health System and Industry such as research partnerships.   In such circumstances, the acceptance of meals and/or travel expenses may be permissible, provided a senior executive (defined in Section 2.d.3 below) with overall responsibility for the area in which the Team Member is employed has confirmed in advance that: 
          1. the proposal, initiative or collaborative relationship with Industry is in the best interests of the Health System, based upon, but not limited to, such factors as: 
            1. the nature and purpose of the proposed collaboration or relationship
            2. any historical or existing relationships with the Industry entity;
            3. whether the Industry entity is a vendor or potential vendor of the Health System and/or the University;
            4. the potential impact of the proposed collaboration or relationship upon existing or potential relationships with other Industry entities;                                                            
          2. acceptance of a meal and/or travel expenses in furtherance of this relationship would not involve any conduct on the part of the Team Member which violates Sections 1 or 2.a of this Policy or state law; 
          3. the value of the meals and/or travel reimbursement shall not exceed lodging and meal limits set forth at:  http://www.procurement.virginia.edu/main/departments/LodgingAndMealLimits.html.        
        3. Senior executives:  The following are the only individuals who shall approve exceptions under this Section 2.d: 
          1. The Executive Vice President of the Health System (for all entities, and specifically for TCH and the UVA Health Foundation);
          2. The Dean of the School of Medicine or designee (for SOM department chairs/center directors and the Claude Moore Library);
          3. Department Chairs or Center Directors in the SOM may approve requests from SOM faculty, with notification to the Dean or designee;
          4. The Dean of the School of Nursing or designee;
          5. The Chief Executive Officer of the Medical Center or designee;
          6. The Chief Executive Officer of UPG;
          7. The Designated Institution Officer (for GME Trainees) 
        4. This Section 2.d shall not apply to Outside Consulting or Outside Activities. 
        5. Physicians should be aware that under the “sunshine provisions” of the Patient Protection and Affordable Care Act, manufacturers of medical drugs and devices are required to report to the Centers for Medicare and Medicaid services payments, including meals and travel expenses, made to physicians and teaching hospitals. These reported payments will be published on a public website.
      5. Proposals from Industry; where funds may be directed:  Proposals from Representatives for any interactions described in this policy shall be referred to the appropriate office for review, evaluation and approval, with documentation as required.  The following may be used as a referral guide:
        1. Research grants, and contracts in which University personnel provide consulting and other services to a Representative; for School of Medicine: Office of Grants and Contracts; School of Nursing: Office of Nursing Research.
        2. Representative’s offer of a service or product – Medical Center Procurement (Medical Center); University Procurement Services (Schools of Medicine and Nursing, Health Sciences Library).
        3. Gifts to the Medical Center/TCH and/or University – Health System Development Office.
        4. Sponsorships of educational conferences, programs and events – Medical Center Procurement (Medical Center); University Procurement Services (Schools of Medicine and Nursing, Health Sciences Library); Continuing Medical Education Office; Graduate Medical Education Office.
        5. Industry grants to support the stipend and benefits of Graduate Medical Education trainees or the training programs in which they enroll – Graduate Medical Education Office.
        6. Unrestricted gifts in association with a specific educational activity or other purpose as permitted – Medical Center Procurement (Medical Center); University Procurement Services (Schools of Medicine and Nursing, Health Sciences Library); Continuing Medical Education Office; Graduate Medical Education Office.

    3.  Industry Use of Health System Resources:  Use of Health System resources (e.g., e-mail, messenger mail, or mailing lists, facilities) for the benefit of Industry, or to advertise or disseminate information about Off-Site educational or promotional events that are directly sponsored, funded or organized by Industry (See Medical Center Policy No. 0193 “Electronic Mail (E-mail)” and Health System Policy IT-002 Use of Electronic Information and Systems"  is prohibited.  See also UVA Policy re: use of University resources and HS policy re: use of resources. 

    4.  Industry Compensation 

      1. Outside Consulting 
        1. These arrangements (including, but not limited to, scientific advisory boards, data safety monitoring boards, other advisory/scientific boards, and product valuation/development) must be accompanied by a time-limited contract or letter of invitation/agreement that outlines specific deliverables, tasks, responsibilities, and Compensation that is consistent with the expertise provided ("Consulting Agreements"). 

          Compensation must be at fair market value for the services provided, and must be consistent with the patient care, research, service and educational missions of the institution. 

          Examples of activities which might be approved for Consulting Agreements, subject to the requirements of this Policy and other applicable University and Health System policies, include:  

          1. Assistance in designing and overseeing clinical trials.
          2. Technical assistance in creating or improving medical devices.
          3. Advice on potential avenues for future scientific research.
        2.  Team Members may not accept payment, gifts, honoraria, or other benefits, in return for completing evaluations or surveys developed by Industry, unless this activity meets the requirements for Consulting Agreements as set forth in the preceding paragraph, and otherwise meets the requirements of this Policy.

        3. Outside Consulting may not create a Conflict of Interest or Conflict of Commitment.
        4. Prior to executing a Consulting Agreement (including contract renewals and amendments) and engaging in the Outside Consulting activity, the Team Member must submit the agreement to the following offices/individuals/entities (the “Approving Official”), for approval, including the Compensation to be received as may be applicable.
        5. Approving Officials are:
          1. SOM Faculty: Department Chair, Office of Grants and Contracts on behalf of the Dean
          2. SON Faculty: Office of Nursing Research on behalf of the Dean
          3. Medical Center (including GME Trainees)/TCH: Medical Center Procurement, the Designated Institutional Officer (DIO) or designee for GME Trainees, and Administrators of an area where a Team Member is employed
          4. UPG: Chief Executive Officer

         

        Approving Officials shall review proposed consulting activities to ensure that they do not involve endorsement or promotion of the sponsor’s products or services.

         

         

        NOTE: The Team Member assumes full liability for the activity outlined in the agreement, is not protected by the University’s insurance coverage, and may not use the services of the University Counsel.  Additional requirements specific to SOM Faculty are contained in School of Medicine Policy No. 2.000 External Consulting and Professional Activities.

         

      2. Speaking and Training for Industry 

        1. Team Members may not participate on Speakers’ Bureaus.
        2. Team Members shall not provide presentations or training for which the primary purpose is to promote or endorse Industry products, or that occur in the context of a promotional event.  This proscription does not apply to Outside Activities of, or Outside Consulting by, a Team Member.
        3. The trainer/educator must control the content of training or educational presentations, which must be their original work. 
        4. A Team Member’s participation on informal or loosely defined 'advisory boards' must comply with the requirements for Consulting Agreements.
        5. Team Members shall also comply as applicable, with requirements of Medical Center Policy No. 0013 “Vendors, Sales, and Service Representatives at the Medical Center”
      3. Formulary Review and Purchasing Committees: Team Members are not eligible to participate in Medical Center Pharmacy and Therapeutics or product evaluation committees if they or members of their Immediate Family have, or have had within the prior five years, a Financial Interest in or research sponsored by a related pharmaceutical or medical device company that is under consideration by an entity within the Health System.
      4. Endorsements 
        1. A Team Member’s apparent or actual endorsement of an Industry product or business, whether commercial or non-profit, must not be associated with any indication of a real or implied similar endorsement by the University of Virginia, the Health System or any components of the University or the Health System. Therefore, no endorsement may contain reference to the Team Member’s official University title(s) or the University’s (or School’s) name, logo, and/or identifiable visual images of the University (such as faculty photos in front of the Rotunda or use of University letterhead). Team Members should evaluate carefully, in consultation with their legal counsel, any proposal involving real or implied endorsement, because of the potential for conflict of interest and other compliance concerns.
        2. As noted in Section 4.A above, Approving Officials shall review proposed consulting activities to ensure that they do not involve endorsement or promotion of the sponsor’s products or services.
        3. This policy does not apply to formal marketing agreements approved by the EVP for Health Affairs, the Clinical Strategy Group, the SOM Dean, the Medical Center CEO, and/or the UPG CEO.   This policy also does not apply to descriptions of University-corporate research or development activities for inclusion in corporate marketing materials, if approved by an Approving Official (see also Medical Center Policy No. 0030 “The Use of Cameras and other Electronic Devices and Media”)

     5.   Industry Access to Health System Facilities

      1. Representatives are not permitted in any patient care areas except to provide in-service training on devices and other equipment and then only by appointment and in full compliance with all Health System and Medical Center policies regarding identification and facilities access (See, e.g., ACC-001 “Health System Identification”; ACC-002 “Access Control to Health System Facilities”)
      2. Representatives shall not participate in any quality review, root cause analysis, BeSafe review or any other quality improvement or peer review activity that is privileged under Virginia Code § 8.01-581.17.
      3. Representatives are permitted in non-patient care areas by appointment only. Appointments will normally be made for such purposes as:
        • In-service training on research or clinical equipment or devices already purchased.
        • Evaluation for purchases of equipment, devices, or related items.
        • Calibration or certification of instrumentation, under contract with the University or Medical Center.
      4. Appointments for these purposes may be made on a per visit basis or as a standing appointment for a specified period of time, at the discretion of the SOM or SON faculty member, his or her division or department, or an authorized designee of the individual issuing the invitation.  (See also Medical Center Policy No. 0013 “Vendors Sales and Service Representatives at the Medical Center” for further information about managing Industry Interaction at the Medical Center)   

    6.    Industry Support for Graduate Medical Education 

     

      1. Industry representatives or vendors may provide support to the department chair or division chief of the GME Trainee’s program for the stipend and benefits or travel or registration for an educational conference attended by a GME Trainee under the following conditions:
        1. The funding cannot be linked to the training of an individual trainee, nor should any trainee have knowledge that funding is being accepted for his or her education and training.
        2. The department, division, or program selects the trainee.
        3. The GMEC has determined that the funded conference or program has educational merit.
        4. The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a “quid pro quo.”
        5. Applications to industry for funding of educational activities must be reviewed and approved in advance by the Graduate Medical Education Committee (GMEC) or appropriate subcommittee.  Educational activities must meet all applicable CME requirements.
        6. Applications to Industry for funding for the stipend and benefits of a GME trainee must be approved in advance by the GMEC and must comply with all necessary requirements of the School of Medicine Office of Grants and Contracts. If the application is approved and funded, a PTAO must be provided to the GME Office so that such funds can be tracked. A specific trainee must not be named in in the application.
        7. Any application for industry sponsored educational activities, stipend and benefits, or support for a GME trainee must name the department chair or division chief as the recipient; the chair must acknowledge that he or she may be publicly reported for accepting such funds under the Sunshine Act.

     7.  Industry Provision of Scholarships and Other Educational Funds to Participants in SOM and SON Programs

     Industry support of students and trainees in the SOM and SON educational programs shall be free of any actual or perceived conflict of interest, must be specifically for the purpose of education and must comply with all of the following provisions:

        1.  The SOM or SON department, program, division or institute selects the student or trainee.
        2. The funds are provided to the SOM/SON, department, program, division or institute and not directly to any individual.
        3. The department, program, division or institute has determined that the funded conference or program has educational merit.
        4. The recipient is not subject to any implicit or explicit expectation of providing something in return for the support.
        5. At the time Industry support is received, the department chair or unit head shall notify the applicable dean.
        6. This provision does not apply to national or regional merit-based awards.
        7. Stipulations Regarding Support:
          1.  Industry support for education must be spent exclusively on education.
          2. Industry support may not influence curriculum in any way. The SOM or SON must lead the identification of needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that control the content, selection of educational methods, and evaluation.
          3. Industry exhibits associated with educational activities are prohibited both On Site and Off Site.
          4. Industry promotion or marketing (e.g., corporate logos, slogans, signs, brochures) are not allowed in the educational space.
          5. Acknowledgement of funding or in-kind support may be made on promotional materials for educational activities.
          6. Industry employees will normally not serve as educators at educational activities.
          7. When a faculty member has a Financial Interest that poses a Conflict of Interest, this shall be disclosed to the learners both verbally and on a slide at the beginning of the presentation. Any individual who receives Industry support for educational activities for UVA medical, nursing and graduate students and postdoctoral fellows and trainees must report this support to the appropriate individual in the dean’s office at the time of receipt.
          8. Meals or other types of food funded by Industry may not be provided during these educational activities

    8.  Continuing Medical Education and Other Continuing Education 

    All CME activities sponsored by SOM must be in compliance with ACCME regulations, requirements, standards, and guidelines. Industry employees who are approved to participate in CME activities must abide by ACCME requirements. For non-CME activities, those responsible for the activities must ensure that presentations are free of commercial bias. 

      1. All educational grants (CME, CNE, etc.) must be accompanied by a written letter of agreement and signed prior to the event by an authorized representative from the University of Virginia accredited provider signatory as well as the industry representative providing the grant.
      2. Continuing education programs provided by the SON must be in compliance with ANCC standards for providers of continuing education contact hours.
      3. Continuing education efforts within other Health System schools and departments (e.g. SON, pharmacy, social work etc.) shall adhere to the guidelines of their accrediting bodies and to the requirements of this Policy.
      4. Team Members shall comply with the CME/CNE/CE accreditation requirements at other institutions when invited to make presentations at other institutions.
      5. Industry exhibits must conform to all ACCME and ANCC requirements.

     9.  Outside Activities

      1. Team Members shall not conduct Outside Activities that interfere with their Institutional Responsibilities and thereby create a Conflict of Commitment.
      2. Team Members shall not use Health System/University resources (e.g., facilities, equipment, computer networks, and personnel) for the financial benefit of External Entities, unless authorized by the Health System leadership. The incidental use of internet and phone systems is permitted as governed by the Virginia Department of Human Resource Management Policy on Use of Electronic Communications and Social Media).  See, e.g., Medical Center Policy No. 0030 “The Use of Cameras and other Electronic Devices and Media”).
      3. The right or responsibility of a Team Member to freely publish or present publicly his/her research findings shall not be constrained as a result of a financial incentive   or contractual agreement with a non-University of Virginia party.
      4. Team Members, including GME Trainees, must comply with the requirements of this Policy and all other applicable policies in connection with any services they perform within or for the benefit of the Health System. 

      Exempt activities:

      The following activities are not considered Outside Activities: 

          1. The following Professional Public Service Activities
            1. Activities related to University or public service including service on national commissions, governmental agencies and boards, granting agency peer-group review panels, visiting committees or advisory groups to other universities, professional associations, and analogous bodies;
            2. The review of grant/contract proposals or advisory panels on behalf of a federal, state, or local government, or an institution of higher education/academic medical center/academic research institute; 
          2. Reimbursed or sponsored travel paid by a federal, state, or local government, or an institution of higher education/academic medical center/academic research institute;
          3. income from agreements to which the University of Virginia is a party (including sponsored awards);
          4. income from the University of Virginia Licensing & Ventures Group or UPG;
          5. Holding office in, or undertaking an editorial office or duties for a scholarly journal; academic press, or professional organization;
          6. Serving as a referee for a scholarly journal or an academic press;
          7. Serving on the board or in other leadership roles of a professional organization;

      10.  Publishing

        1.  Team Members shall not participate in ghost authorship, either as the writer or as the individual on whose behalf the writing is made. Ghost authorship is the failure to name, as an author, an individual who has made substantial contributions to a manuscript.
        2. When submitting manuscripts, Team Members must disclose all relevant Financial Interests to journal editors.
        3. Further information on appropriate publishing practices can be found at: https://med.virginia.edu/school-administration/wp-content/uploads/sites/304/2015/11/Authorship-of-Scholarly-Publications.pdf; see also the International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals at: http://www.icmje.org/icmje-recommendations.pdf                     

      11.  Reporting Requirements/Disclosures 

        1. University Employees: Disclosure to the University and Commonwealth under the Virginia State and Local Government Conflict of Interests Act:   Team Members employed by the University of Virginia who have received a waiver of conflict of interest under the state COI statute, and are SOM Faculty or SON Faculty, and/or are Health System leaders as identified by Medical Center HR, must disclose their current Financial Interests to the Commonwealth periodically, as required by law. These financial reports are required by law and are subject to the Freedom of Information Act.  Also required by law is the disclosure of Financial Interests in companies that may contract with the University. Neither of these statutory requirements replaces the financial disclosures required by this policy, nor are they described further in this document.
        2.  Special Requirements for SOM Faculty and Investigators
          1.  All SOM Faculty and Investigators and SOM research core directors are required to disclose annually all Financial Interests that relate to their Institutional Responsibilities using the SOM on-line disclosure system (https://coi.sites.virginia.edu/). New Financial Interests must be disclosed within 30 days.  Newly appointed SOM Faculty must disclose their Financial Interests within 30 days of their initial appointment. Whenever an application for external research funding is submitted, the principal investigator must certify on the Proposal Approval Form that he or she and all project Investigators, including subcontractors, have disclosed their Financial Interests.
          2. SOM Faculty and Investigators shall disclose the following Financial Interests in organizations outside of the University that relate to their Institutional Responsibilities:
            1. any reimbursed or sponsored travel related to Institutional Responsibilities during the previous year;
            2. $5,000 or more in total remuneration plus equity interest (i.e. stock ownership) in a publicly traded entity;
            3. $5,000 or more in remuneration from a non-publicly traded entity during the previous year; and
            4. any equity interest in a non-publicly traded entity, including a University of Virginia Start-up Company
          3. Public Disclosures:  Information pertaining to financial interests disclosed by SOM Faculty under this Policy will be published on a public web site.
          4. Review of SOM Financial Disclosures for Conflicts of Commitment:  SOM department chairs will review the financial disclosures of their Faculty and Investigators for potential Conflict of Commitment. The dean or designee will review the disclosures of chairs. If the review suggests that a Conflict of Commitment exists, the reviewer shall discuss the conflict with the faculty member and take steps to assure either elimination or management of the conflict. If the reviewer is unable to guarantee its elimination or management, he or she should consult with the dean’s designee. The Dean will make a final determination on the disposition of all Conflicts of Commitment.
          5. SOM and institutional review of Conflicts of Interest:  Disclosures of Financial Interests will be reviewed by staff of the SOM Conflict of Interest Committee (“SOM COI”).  Financial Interests that are considered de minimis will not be pursued further. SOM COI staff will determine which Financial Interests relate to newly funded or ongoing research projects on which that individual participates (such that the Financial Interest could be affected by the research or is in an External Entity whose Financial Interest could be affected by the research), or to the individual’s clinical or training activities.  Any related Financial Interests will be referred to the UVA COI Committee for further review under the state COI statute, federal COI policy  (see, for example, http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf), or  UVA COI policy.
          6. Research
            1. Financial Interests related to research activities will be referred to and reviewed by the University of Virginia Conflicts of Interest Committee (“UVA COI”), which will determine whether a Conflict of Interest exists.
            2. The SOM faculty member should first meet with SOM COI staff to identify the sources of the Financial Interest, confirm the relationship between the Financial Interest and the individual’s research, determine whether the Financial Interest could directly and significantly affect the design, conduct, or reporting of that research, and develop an appropriate management plan to be presented to the UVA COI staff.
            3. SOM COI may gather additional information to inform this process and the deliberations of the UVA COI.  The UVA COI will forward its recommendations to the Provost for Research, per University of Virginia Conflict of Interest policy.  The UVA COI will coordinate with the Institutional Review Board concerning Financial Interests associated with human subjects’ research. For financial Conflicts of Interest that involve federal research awards, the UVA COI will notify the Vice Provost for Research, Office of Sponsored Programs, and Office of Grants and Contracts that potential conflicts have been reported and addressed.   Follow up with research sponsors, including required reports, will be submitted through one or more of these offices.
          7. Other Activities
            1. For institutional activities not listed above, the SOM COI shall review financial disclosures, identify the sources of actual and potential conflicts, and develop written plans to eliminate, reduce, or manage those conflicts.
            2. The SOM COI may request additional information from the faculty member involved and may also consult with others who might have relevant information. In making its determinations, the SOM COI will be guided by the principles discussed herein and the policies referenced below.
            3. The SOM COI shall deliver to the dean a written recommendation describing how the conflict should be managed.
            4. The dean will make a final determination on the case. SOM COI staff will communicate the Dean’s decision to the faculty member and the entire SOM COI.
            5. If the dean requires that the Conflict of Interest be managed, he or she will describe the specifics of the management plan, including oversight and reporting requirements.
          8. Reconsideration
            1. The University of Virginia Policy RES-005 “Financial Conflicts of Interest for Research Investigators,” describes reconsiderations of UVA COI decisions concerning Conflicts of Interest in research.  The procedure below describes reconsideration of all other Conflict of Interest determinations.
            2. Within two weeks of notification of the SOM COI’s original determination, the faculty member may request that the dean reconsider the original determination, by submitting to SOM COI staff a detailed, written description of why that determination should be modified.
            3. The dean may rule on the request directly or with input from SOM COI or others and will respond to the faculty member after such review; this response will ordinarily occur within three weeks of receipt of the request. A single such request will be allowed for any case.
          9. Management of conflicts of interest:  Management plans may include, but not be restricted to, one or more of the following elements:
            1. creation of an oversight committee to review the integrity of data, manuscripts, and reports resulting from a project where faculty members have a financial Conflict of Interest;
            2. appointment of a faculty advocate to ensure that the career development of GME Trainees or junior faculty is placed ahead of their supervisor’s Financial Interests;
            3. requirement to disclose the Financial Interest in publications and public presentations;
            4. requirement that project personnel be notified of the nature of the Financial Interest.
          10. Special considerations for research with human subjects – the “rebuttable presumption”:  SOM Faculty who have an existing (over the past 12 months) or anticipated (over the coming 12 months) Financial Interest in interventional research involving human subjects that exceeds $10,000 in annual income or 3% ownership may participate in its conduct only upon requesting and receiving institutional approval. The UVA COI and IRB shall consider the following in reviewing such a request:
              1.       The nature of the research and potential risks for study participants
              2.       Unique qualifications of the individual to perform the study
              3.       The nature of the Financial Interest and how it is related to the research
              4.       The extent to which the investigator may benefit financially
              5.       The potential to reduce or effectively manage the Financial Interest
          11. Confidentiality of Financial Disclosures
            1. The SOM posts on a publicly accessible web site the following information on Financial Interests of SOM Faculty who disclose external interests above the required thresholds: name; outside entity name; basis of Financial Interest (e.g., consulting, ownership).
            2. Financial Conflicts of Interest associated with Public Health Service funded research projects, as defined in that agency’s Objectivity in Research policy, must be posted on a publicly accessible web site or be made available by the University in response to any request for that information.
            3. The confidentiality of other information contained within these financial disclosures shall be maintained securely.
            4. The following individuals and groups are provided access to disclosures made by Faculty Members to assess actual or potential Conflicts of Interest and compliance with this policy.  These individuals are responsibility for maintaining confidentiality.
              1.       The disclosing faculty member’s chair.
              2.       The dean’s representative may access information for chairs who disclose.
              3.       SOM COI and its staff.
              4.       UVA COI, its staff, and the Vice Provost for Research.
          12. Other Internal Disclosures
            1. Medical Center Procurement - shall review financial disclosures of individuals who serve on the Procurement-Related Selection Committees or the Pharmacy and Therapeutics Committee to ensure that its procurements are not influenced by financial conflicts. (see, for example, Medical Center Policy 0189 Medical Center Procurement)
            2. The Director of SOM Office of Grants and Contracts or his/her designee(s) – to ensure compliance with sponsor requirements for conflicts of interest in research.
            3. Institutional Review Board - for conflicts involving human subjects research, IRB staff and members may review financial disclosures. The disclosures may be provided to other individuals as required by law.
          13. “Sunshine Provisions” of PPACA:  Under the “sunshine provisions” of the Patient Protection and Affordable Care Act, manufacturers of medical drugs and devices are required to report payments to physicians and teaching hospitals to the Centers for Medicare and Medicaid services. These reported payments will be published on a public website. SOM faculty members should be aware that it is likely any consulting payments will be reported as direct payments to the individual, made to the faculty member or the University.
        3. Special Requirements for the  School of Nursing Faculty and Investigators
          1. All SON Faculty are required to disclose annually all Financial Interests that relate to their Institutional Responsibilities using a SON on-line disclosure system. New Financial Interests must be disclosed within 30 days. Newly appointed Team Members must disclose their Financial Interests within 30 days of their initial appointment.
          2. Whenever an application for external research funding is submitted, the principal investigator must certify on the Proposal Approval Form that he or she and all project Investigators, including subcontractors, have disclosed their Financial Interests.
          3. Review of conflicts of commitment. The Office of Nursing Research on behalf of the dean will review the financial disclosures of faculty for potential Conflict of Commitment. If the review suggests that a Conflict of Commitment exists, the reviewer shall discuss the conflict with the faculty member and their respective chair to take steps to assure either elimination or management of the conflict. If the reviewer is unable to guarantee its elimination or management, he or she should consult with the dean. The dean will make a final determination on the disposition of all Conflicts of Commitment.
          4. SON and institutional review of conflicts of interest.  Disclosures of Financial Interests will be reviewed by members of the SON Dean’s Council. Financial Interests that are considered de minimis will not be pursued further. SON Dean’s Council members will determine which Financial Interests relate to newly funded or ongoing research projects on which that individual participates (such that the Financial Interest could be affected by the research or is in an entity whose financial interest could be affected by the research), or to the individual’s clinical or training activities.
        4. Disclosure to the Institutional Review Board  In addition to any other disclosures required by this Policy, Principal investigators engaging in human subjects research at the University of Virginia are required to ensure disclosure of the Financial Interests of all study personnel to the Institutional Review Board when proposing a new protocol or when a new Financial Interest arises during the course of an IRB-approved study that might be perceived to influence the outcome of that study. These reports are required in addition to the annual disclosures described elsewhere in this Section 11.

       12.  Enforcement  Corrective action for violations of this Policy will be taken by the applicable employer of the Team Member.

    1. related or referenced content:

      Provost Office: http://provost.virginia.edu/conflict-interest-faculty
      Medical Center: http://www.medicalcenter.virginia.edu/intranet/ccpo/corporate-compliance
      University: http://www.virginia.edu/vprgs/objectivity.html
      School of Medicine: https://med.virginia.edu/school-administration/wp-content/uploads/sites/304/2015/11/Code-of-Conduct.pdf
      University: Policy XV.A.1, Conflict of Interests (University of Virginia Manual of Financial and Administrative Policies and Procedures)             
      Medical Center Policy No. 0235 “Compliance Code of Conduct” 
      State and Local Governmental Conflict of Interests Act and the Ethics in Public Contracting Section of the Virginia Public Procurement Act of the Code of Virginia.      
      UPG: The University of Virginia Physicians Group Conflict of Interest/Conflict of Commitment Policy;
      Medical Center Policy No. 0193 “Electronic Mail (E-mail)

      Medical Center Policy No. 0013 “Vendors, Sales, and Service Representatives at the Medical Center”.

      Medical Center Policy No. 0030 “The Use of Cameras and other Electronic Devices and Media”
      Transitional Care Hospital  Policy No. 0235 “Compliance Code of Conduct” 
      Transitional Care Hospital Policy No. 0193 “Electronic Mail (E-mail)”

      Transitional Care Hospital Policy No. 0013 “Interactions with Vendors, Sales, and Service Representatives”  
      Transitional Care Hospital Policy No. 0030 “The Use of Cameras and other Electronic Devices and Media”
      Health System: ACC-001 “Health System Identification”; ACC-002 “Access Control to Health System Facilities”
      University: Policy RES-005 “Financial Conflicts of Interest for Research Investigators,”

      University: Policy HRM-045 Faculty External Consulting and Internal Overload

    2. signature(s):

      Richard P. Shannon, MD, Executive Vice President for Health Affairs, UVA Health System