Conflicts of Interest
The University has not attempted to develop an exhaustive list of fixed rules on potential conflicts of interest, because each situation depends on its specific facts. The following examples are intended to illustrate the principles underlying the University policy. Individuals who have questions about how this policy applies to a particular activity should seek advice from the Office of the Provost. (Note that some of the activities in these examples may also represent conflicts of commitment.)
The activities described in examples 1 through 6 below represent actual conflicts of interest that are inconsistent with University policy and may not be undertaken.
- A researcher uses his laboratory at Yale to do product-testing research, paid for by a company in which he is a 20% owner and founder, which seeks to validate advertising claims made about a product sold by that company.
- A clinician makes patient referrals to a diagnostic company in which she or her immediate family has a significant ownership interest.
- An employee directs the purchase of supplies for the University toward a business in which he or his immediate family has a significant financial interest.
- An employee managing a design and construction project participates in the selection of an architectural firm in which her spouse is a partner.
- A faculty member acts as the thesis or dissertation advisor to a graduate student for a research project, suggested by the faculty member, that the faculty member expects to substantially enhance the value of a company in which the faculty has a significant interest.
- A researcher conducts clinical research on a product developed by her and licensed to an external organization in which she owns equity or has other direct relations including consulting.
Activities such as those in examples 7 through 10 below may represent conflicts of interest, but in many cases would be permitted to go forward after disclosure with appropriate safeguards against bias of University activities and with continuing oversight. Example 9 would be permitted only if no federal funds were involved.
- A researcher conducts federally- or foundation-sponsored non-clinical research on a product developed by a company for which he is a consultant.
- A researcher who is a member of a company's scientific advisory board conducts non-clinical research sponsored by that company.
- An employee manages a design and construction project involving an architectural firm in which his spouse is a partner, when the Yale employee did not participate in the selection of the firm for the project.
- A researcher conducts federally- or foundation-sponsored basic research on a University invention that has been licensed to a company for which he consults, and on which he receives a share of University royalties.
It is important to understand that the above examples are meant to be only that - examples - and that there are many other situations different in nature and kind from the above. It is assumed that individuals who have questions about how this policy applies to a particular activity will seek advice from the Office of the Provost.
Yale University School of Medicine - Yale New Haven Medical Center
Human Investigation Committee
Protocol-Related Conflict of Interest (COI) Policy
All members of the Yale University research community should be sensitive to the potential impacts of financial interests and/or non-financial relationships with commercial sponsors or other external entities on the conduct of research and the participation and protection of human research subjects. In compliance with federal regulations and guidance, and University policy, the HIC considers such relationships and determines whether they might influence of appear to influence the outcome of a research project involving human subjects, the objectivity of the investigator during the performance of such a project, or the investigator's interactions with research subjects who participate in the project. Accordingly, the HIC solicits and reviews relevant information regarding the financial interests of all investigators and key study personnel participating in a protocol involving human research subjects prior to approving or re-approving that protocol.
"Key study personnel" means those persons involved in the design, conduct, and/or the data analysis of the research involving human subjects.
"Financial interests" that may be considered to be conflicts include, but are not limited to, the following: ownership of stocks, bonds, options, patent or royalty interests, receipt of consulting, honoraria or speaking fees, salary, subject accrual rewards and/or penalties, loans, lectureships, memberships on boards of directors or scientific advisory boards.
The Role of the HIC
The HIC is the primary authority at the Yale School of Medicine responsible for ensuring that human research subjects are protected in accordance with federal regulations, University policies, and ethical principles. One of the primary responsibilities of the HIC is to ensure that human research subjects receive all information needed to provide informed consent. The HIC's consideration of the investigators' financial interests is intended to ensure 1) that the informed consent process provides the subjects with the facts necessary to make a knowledgeable and sound decision as to whether they wish to participate in the study, and 2) that no conflict exists that would otherwise compromise the protection of human subjects.
The HIC's consideration of investigators' financial interests as they relate to human subject research complements, but does not supplant, the deliberations of the Provost's Committee on Conflict of Interest (the "COI Committee"), which is responsible for reviewing the financial disclosures of all faculty members in accordance with the University Policy of Conflict of Interest and Conflict of Commitment.
Role of Investigators and Key Study Personnel
For all protocols submitted to the HIC, including new protocols and those submitted for reapproval, each participating investigator and key study person must read this Protocol-Related Conflict of Interest policy. Each participating investigator and key study person who answers "no" to all of the questions below must sign the Protocol for Research Application Form or the Request for Reapproval Form in the space noted on the form as "COI signature." A signature in this space indicates that no actual or perceived COI exists. Individuals who answer "yes" to any of the questions listed below are required to complete and sign a Protocol COI Form and submit it to the HIC as part of the application package or request for reapproval. Investigators and key study personnel affiliated with Yale are reminded of the separate obligation to complete the annual disclosure form required by the University Policy on Conflict of Interest and Conflict of Commitment.
Before the HIC meeting at which a protocol is scheduled for consideration, the HIC Chair will review the Protocol COI Form, if one is submitted, to determine if there are related actual or potential conflicts. The Chair will evaluate such conflicts and, if necessary, provide a summary to the Committee. The Committee will determine (1) whether the conflict is permissible in the context of the protocol, and, if so, (2) whether the conflict warrants disclosure to potential subjects as part of their informed consent process. The HIC Chair will share relevant information with the Provost's Committee on Conflict of Interest, which may make additional findings and recommendations regarding actual and potential conflicts of interest. Note again, however, that completion and submission to the HIC of this protocol-specific form does not relieve investigators of their responsibility to make disclosures to the COI Committee as outlined in the University Policy.
Note: In the Protocol-Related COI process, the confidentiality of investigators and key study persons will be respected. Financial disclosure forms will be kept in confidential files, and information will be shared only on a need-to-know basis.
July 26, 2002
Conflict of Interest Principles Applicable to Faculty with Relationships with Startup Companies
Faculty relationships with "startup" ventures - relatively newly formed, privately held, for-profit companies that are based on intellectual property developed at Yale - present opportunities for development and commercialization of inventions but may also create conflicts of interest and commitment. The following policy guidelines govern faculty relationships with such ventures.
- Equity interests. Faculty may hold equity interests in startups that license intellectual property developed at Yale. Such equity ownership must be promptly disclosed to the Provost. Faculty accepting equity in such ventures should recognize that their ability to conduct research sponsored by that venture - especially research involving human subjects - will be restricted because of the conflict created by their ownership interest in the sponsoring entity.
Membership on Boards of Directors. Faculty may be permitted to serve on the Board of Directors of a startup. In accordance with the policy stated in the Faculty Handbook with respect to all for-profit companies, the prospect of Board membership must be disclosed in advance to the Provost's Office, and a Board seat may be accepted only with permission of the Provost, because of the fiduciary obligation that the seat creates and its potential for conflict with the faculty member's Yale duties and obligations. The Provost may seek the advice of the Committee on Conflict of interest before acting on such a request. A faculty member who has assumed a Board seat should recognize that his or her ability to conduct research at Yale that is sponsored by the venture - especially research involving human subjects - will be restricted because of the conflict created by the fiduciary relationship with the venture. Faculty members who assume Board seats on startups should also be sensitive to the need to recuse themselves from all Board decisions that involve conflicting duties to the startup and to the University.
Service as an Operating Officer. A full-time faculty member should not serve as an operating officer of a startup (or, as the Faculty Handbook provides, of any company) while not on leave. If a faculty member believes it is essential for the success of the venture to serve as an operating officer, he or she should request a full or partial leave from the Provost for a specified period of time, consistent with policies on leave in the Faculty Handbook. Such a leave would be without compensation by the University. The Provost may seek the advice of the Committee on Conflict of Interest before acting on such a request.
Consulting relationships, including Scientific Advisory Board membership. Consulting agreements (including scientific advisory board memberships) between a faculty member and a startup in which the faculty member holds equity or has a Board seat should receive prior review and approval from the Provost's Committee on Conflict of Interest, which may recommend restrictions on the proposed agreement.
Student employment by a startup. Except in special and unusual circumstances, students under a faculty member's direction, paid for by a faculty member's grant, or in a faculty member's research group, may not be employed part- or fulltime by a startup in which the faculty member has an equity interest. Such special circumstances might exist, for example, where the student sought summer employment with the startup and planned to work in a field unrelated to his or her academic program.
Employment of postdoctoral fellows and associates by a startup. Postdoctoral fellows and associates under a faculty member's direction, paid for by a faculty member's grant, or in a faculty member's research group, should not be employed by a startup, in which the faculty member has an equity interest, to conduct research that overlaps with the fellow's university research or is to be conducted on University premises. Any proposed employment of a post-doctoral fellow or associate by a startup should be reviewed in advance by the Committee on Conflict of Interest.
Use of Yale space. Use of Yale space by a startup should not be permitted.
Use of Yale equipment or laboratory training. A startup may use Yale equipment or laboratories only subject to a written agreement with the University, and with strict limitations as to time and extent and only after review and approval by the Committee on Conflict of Interest.
- Research funding from a startup and testing of faculty-generated intellectual property licensed to a startup. There is a strong presumption against accepting research funding in the form of grants, subcontracts, or gifts, from a startup in which the faculty member proposing the research has an equity interest or a Board seat (or other significant financial interest as defined below), if the research is to be done in the faculty member's research group, or the faculty member's students or postdoctoral fellows or associates would participate in the funded research projects. Rigorous restrictions also apply to human subjects research and non-human subjects research that involves testing, when the faculty member has a related financial interest. The presumption is applied as follows:
- Human subjects research. Where the proposed research involves human subjects, the presumption against permitting a related startup to sponsor the research is particularly strong. Any equity interest in the startup company (including stock options, warrants and instruments convertible into equity), or a non-equity financial interest of over $10,000 in a year (whether derived from consulting fees, honoraria, royalties, or in some other vehicle), will almost always preclude the financially interested faculty member from conducting human subjects research sponsored by the startup. The presumption may be overcome only in rare and compelling circumstances, as judged by the Conflict of Interest Committee and the cognizant Institutional Review Board (IRB), and where the Committee and IRB are satisfied that effective controls to mitigate any possible effects of the conflict can and will be implemented. Such circumstances might include, for example, that the researcher is uniquely qualified to perform the experimental procedure. In such circumstances, the Conflict of Interest Committee will consider whether the researcher should divest himself or herself of the equity interest, or place the equity in a blind trust for an appropriate period of time. The presumption is less likely to be rebutted when the object of the conflicted research is testing of a device or compound for public validation or other similar purpose.
Research not involving human subjects. When a startup proposes to sponsor research to be conducted by a faculty member who holds equity or a Board seat in the company, and which involves neither human subjects nor validation testing, the presumption may be rebutted if, in the judgment of the Conflict of Interest Committee appropriate controls are in place (see C, below), and one of the following sets of conditions is met:
Except in extraordinary circumstances, the presumption may not be rebutted when the research in question has as its object the testing of an invention in which the faculty member has a royalty or other interest in a startup, or a Yale invention that is licensed to a startup in which he or she has an equity interest. For purposes of this proviso, "testing" is intended to describe doing research designed to validate to the public or perform a similar function regarding an invention created at Yale and licensed to a startup company. (The same restrictions would generally apply to testing undertaken for a publicly held company holding a license from Yale.)
- the research is of a fundamental or basic nature; the research is not directly related to the financial success of the startup; and the faculty member's relationship with the company is otherwise limited (i.e., does not involve multiple additional entanglements such as consulting agreements and scientific advisory board membership); so that the likelihood of any distortion of the research endeavor is minimal; or, the faculty member's equity interests in a venture are so diluted that his or her control or influence over the firm's decisions and the possible benefit from Yale-based activity are negligible, and the faculty member's relationship with the company is otherwise limited (see above); or
- the research is essential to maintain the continuity of a research effort related to the licensed intellectual property during a short interval of time (normally under six months), while the research activity is being established in the startup; and during this period it is subject to oversight of non-interested peers appointed by the COI Committee.
- Controls. In each case in which the Conflict of Interest Committee recommends that research be permitted to proceed despite the presumption against such research, it shall ensure, in addition to measures adopted by the Committee or (for human subjects research) the cognizant IRB, and complete compliance with the other strictures of this policy on startups, the following:
- The research agreement contains no restrictions on publication other than those sanctioned by the Faculty Handbook; all individuals working on the research project are provided a written notice that the research is being sponsored by a venture in which the faculty member has an ownership interest or fiduciary relationship; before the Committee makes a recommendation that the research be allowed to proceed, the faculty member provides the Committee a written description of the proposed research and an assurance of his or her compliance with the restrictions set forth above; and thereafter, provides the Committee written reports on the progress of the research, listing related peer-reviewed publications and grants, no less frequently than annually; and
- all other management measures deemed appropriate by the Committee and cognizant IRB are in place. Examples of such measures are requirement of a data safety monitoring board, in the case of human subjects research; an oversight committee to review data, publications and other issues; requirement of disclosure in publications; and commitment of equity to a blind trust for a period of time.
Policy on Interactions between Clinical Personnel of the Yale Medical Group and Industry
Date Approved: August 17, 2010
Date Effective: September 1, 2010
The Yale Medical Group (YMG) strives to provide the highest quality health care to its patients. Through its clinical activity, YMG also supports the medical education, training, and clinical research missions of the Yale School of Medicine (YSM). In some cases, interactions between YMG clinicians and industry1 can promote these missions and have a positive impact on patient care. Indeed, Yale University encourages its faculty “to consult widely, and to engage in other activities that may benefit not only the participants but also the University itself, and the larger public.”2 These interactions with industry, however, must adhere to the highest ethical and professional standards and must be intended and designed to enhance patient care, to improve the practice of medicine, or to support medical education.
The purpose of this Policy is to increase the awareness of YMG clinicians about the potential for conflicts of interest arising from relationships with industry and to establish parameters for these relationships so that actual or potential conflicts may be avoided or properly managed.
II. Policy Statement
It is the policy of the Yale Medical Group to promote principled interactions with industry that support the clinical and educational missions of the School of Medicine and to protect these missions from interactions that create actual or perceived conflicts of interest. The complexities of relationships with industry preclude YMG from identifying all circumstances in which a conflict of interest may arise or in which an interaction may be inappropriate. The principles outlined in this Policy should guide all relationships or interactions between YMG clinicians and industry. For additional guidance or clarification on this Policy, YMG clinicians should consult with their Department Chair or Section Chief, or with the YMG Chief Medical Officer.
III. Scope of the Policy
- This Policy applies to all physicians, PAs, APRNs, RN’s, midwives, or other clinicians who practice in the Yale Medical Group (hereinafter “Clinical Personnel”).
- This Policy supplements the University’s policies on conflict of interest. While this Policy addresses many aspects of industry relationships, Clinical Personnel are expected to comply with all other University policies and principles relating to interactions with industry including, but not limited to:
- University Policy on Conflict of Interest and Conflict of Commitment;
- Policy 2201: Gifts from External Parties to Employees;
- Policy 3201: General Purchasing;
- Policy 3205: Vendor Selection; and
- Standards of Business Conduct.
- Clinical Personnel shall not accept personal gifts from industry representatives3 under any circumstances.
- In this Policy, the term “gift” means any item, product, or service, regardless of the nature, purpose, or value, except in the limited circumstances described below. The term includes, but is not limited to, pens, pads, and other promotional items; cash; food and drink, except in the limited circumstances described in Section V of this Policy; entertainment such as tickets to events, golf, and other sports outings; hotels, transportation, and other travel expenses, except in the limited circumstances described in Section XI of this Policy; stock, equity, and other ownership interests; discounts on products or services.
- The following are not considered “personal gifts” under this Policy:
- Books, charts, or other materials used for patient care or for training purposes may be accepted if distributed through the relevant department;
- Payments for contractual services may be accepted if the engagement complies with this policy (see the Consulting and Industry-sponsored Educational Programs sections below); and
- Unrestricted educational funds provided to a School of Medicine department.
- Industry-supplied or supported food or drinks are considered personal gifts and may not be accepted by Clinical Personnel on-campus or off-campus, except in the limited circumstances discussed below.
- Industry-supplied food or drinks may only by accepted:
- if provided in connection with attendance at programs compliant with the Accreditation Council on Continuing Medical Education (ACCME) Standards for Commercial Support;
- as a reasonable and necessary travel expense associated with services rendered in accordance with Section XI of this Policy (e.g., approved consulting activity); or
- if provided in connection with attendance at scientific or professional society meeting events open to all meeting attendees.
- Clinical Personnel may consult with industry subject to the following requirements:
- the engagement must be governed by a written agreement specifying the service(s) to be provided and the compensation to be paid;
- payment must be at fair market value and must be commensurate with the time and effort for the contractual services; and
- Clinical Personnel consulting for industry must disclose the engagement as required under this Policy and the Policy on Conflict of Interest and Conflict of Commitment.
- Consulting engagements involving compensation without commensurate time and effort are considered personal gifts and are prohibited under this Policy.
VII. Drug Samples
- Clinical Personnel may accept free drug samples from industry for distribution to patients, particularly those who lack financial access to the medications, with the following limitations:
- Clinical Personnel should be cautious in distributing medications that are not on formulary since distribution of non-formulary drugs to patients may encourage use of costlier medications;
- Free drug samples may never be sold; and
- Free drug samples may never be used by Clinical Personnel for themselves or family members, except when prescribed and/or dispensed by a physician.
VIII. Site Access by Industry Representatives
- Industry representatives are permitted in non-patient care areas by appointment only. Appointments will be permitted only on the invitation of Clinical Personnel.
- Industry representatives are strictly prohibited from entering patient care areas except in the limited circumstances described below:
- The purpose of the industry representative’s presence must be to provide in-service training or assistance to Clinical Personnel on devices or equipment;
- Clinical Personnel must be present at all times during the patient care interaction; and
- Disclosure must be provided to the patient (or to his/her family) that industry representative(s) may be present in the procedure area.
- For the purpose of this Policy, in-service training and interactions with industry to evaluate devices or equipment are not considered “educational programs” and are not subject to the requirements in the sections pertaining to education (below).
IX. Industry Support of Continuing Medical Education
- All industry-sponsored continuing medical education (CME) events on the Yale campus must be compliant with the Accreditation Council on Continuing Medical Education (ACCME) Standards for Commercial Support in effect on September 1, 2010. The following is a summary of selected ACCME Standards (last revised in 2007):
- All decisions concerning educational needs, objectives, content, methods, evaluation and speaker must be free of commercial influence (ACCME Standard 1.1);
- All persons in a position to control the content of an educational activity must disclose all relevant financial relationships to the provider of the CME and to the audience at the beginning of the educational activity (ACCME Standards 2.1, 6.1);
- All conflicts of interest must be identified and resolved prior to the educational activity being delivered (ACCME Standard 2.3);
- Product-promotion material or product-specific advertisements of any type are prohibited in or during CME activities (ACCME Standard 4.2);
- Educational materials that are part of a CME activity, such as slides and handouts, may not contain any advertising, trade name, or a product-group message (ACCME Standard 4.3);
- The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial entity (ACCME Standard 5.1); and
- The CME provider may not use commercial support to pay for travel, lodging, or other personal expenses of attendees (ACCME Standard 3.12).
(The full text of the Standards is available at http://www.accme.org/)
- In addition to the aforementioned ACCME Standards, industry-sponsored CME events on the YSM campus must also comply with the following provisions:
- Gifts or compensation may not be provided solely for attendance at the meeting or lecture; and
- Industry funds to support the specific educational activity must be given directly to the University in accordance with University policy and may not be provided directly to Clinical Personnel.
- The YSM Center for Continuing Medical Education (Yale CME) is the exclusive provider of accredited continuing professional development for Clinical Personnel.
X. Industry-sponsored Educational Programs (off-campus)
- Clinical Personnel Participation in Off-campus Educational or Training Programs (Organizer, Author, Speaker)
Clinical Personnel may actively participate (e.g., by giving a lecture, organizing the meeting) in industry-sponsored meetings or lectures only if all of the following requirements are met:
- Financial support by industry must be fully disclosed at the meeting by the sponsor;
- The meeting or lecture’s content, including slides and written materials, must be determined solely by the participating Clinical Personnel with no influence from the sponsor;
- The lecturer must promote objective scientific and educational activities and discourse;
- Clinical Personnel must not be required by the industry sponsor to accept advice or services concerning teachers, authors, or other educational matters including content as a condition of the sponsor’s contribution of funds or services;
- If Clinical Personnel are organizing the meeting, then they must ensure that attendees in the audience are not compensated or otherwise materially rewarded for attendance (e.g., through payment of travel expenses, or provision of food or gifts);
- If Clinical Personnel are organizing the meeting, then they must ensure that gifts of any type are not distributed to attendees before, during, or after the meeting or lecture;
- The engagement must be governed by a written agreement or memorandum specifying the service(s) to be provided. Compensation must be limited to reimbursement of reasonable and necessary travel expenses as described in Section XI of this Policy, and an appropriate honorarium;
- The lecturer must explicitly describe all of his or her relevant financial interests (recent, existing, or planned) to the audience prior to the lecture; and
- Clinical Personnel actively participating in industry-sponsored meetings or lectures must disclose the engagements and total annual compensation as required under the University Policy on Conflict of Interest and Conflict of Commitment
- Clinical Personnel Attendance in Off-campus Educational or Training Programs
Clinical Personnel may attend off-campus industry-sponsored programs only if all of the following requirements are met:
- The program must be primarily educational and designed to provide evidence-based medical or scientific information or to promote evidence-based clinical care and/or to advance scientific research;
- The industry sponsor may not reimburse the travel expenses of attendees; and
- Attendees may not receive gifts or other compensation for attendance.
- Clinical Personnel should not attend or participate in industry-sponsored off-campus events for primarily promotional/marketing purposes.
XI. Travel Expenses
- Clinical Personnel may not accept travel funds from industry, except for legitimate reimbursement of reasonable and necessary travel expenses in the following circumstances:
- to provide services rendered in accordance with the terms of a written agreement (e.g., approved consulting activity); or
- for in-service training or on-site inspection and demonstration of capital equipment or devices.
- Clinical Personnel are prohibited from being listed as an author on an article unless they make a substantive contribution to the content of the article. Industry representatives or others retained by industry that contribute to an article on which Clinical Personnel appear as authors must be listed as contributors or authors on the article and their industry affiliation must be disclosed in the published article.
- The practice of being named as an author on an article that contains substantial portions written by someone who is not listed as an author (i.e., ghostwriting) is unacceptable under all circumstances.
XIII. Scholarships/Fellowships/Other Educational Funds for Trainees
- Industry support for scholarships, fellowships, or other educational programs for trainees must comply with all of the following:
- The funds must be given directly to the School of Medicine Department or Section in accordance with University policy and may not be provided directly to the trainee;
- The Department, Section, or Program must determine that the conference or training has educational merit;
- The industry donor may not have any input or involvement in the selection of the individual(s) that will receive the funding; and
- The recipient of the funds may not be subject to any implicit or explicit quid pro quo (i.e., “no strings are attached”).
- In situations where a scholarship for participation in an educational program is administered by the industry sponsor, the application must be approved in advance by the Department Chair or Section Chief.
XIV. Disclosure of Industry Relationships
- Clinical Personnel must disclose industry relationships in accordance with the University Policy on Conflict of Interest and Conflict of Commitment (view the policy at http://provost.yale.edu/conflict-policy).
- Disclosure in publications: For articles submitted for publication in a professional journal, Clinical Personnel must adhere to the financial interest disclosure requirements of the journal. In the event that the journal does not have a disclosure requirement, Clinical Personnel must adhere to the disclosure requirements recommended by the International Committee of Medical Journal Editors in effect on September 1, 2010.
- Disclosure in presentations: For presentations given in connection with a meeting of a professional society, Clinical Personnel must adhere to the financial interest disclosure requirements of the society. In addition to any requirements of the society, the disclosure must comply with the ACCME Standards and the presentation must include a slide with the disclosure information.
- Disclosure to patients: Clinical Personnel must disclose all relevant financial interests to patients. The timing, method, and content of the disclosure shall be determined by the individual program.
- Disclosure to students/trainees: Clinical Personnel must disclose all relevant financial interests to students and trainees. The timing, method, and content of the disclosure shall be determined by the individual program.
- Disclosure to the public: The University will disclose to its patient communities information regarding the industry relationships of Clinical Personnel that relate their University responsibilities. The format and mechanism for such disclosures remain to be determined, but may include public websites, informational brochures, etc.
- Suspected violations of this Policy shall be referred to the relevant Department Chair and/or the Dean’s Office for review. Depending on the nature of the alleged violation, the Department Chair or Dean’s Office, as applicable, may coordinate with other appropriate University committees or offices in the review.
- Violations of this Policy will be subject to corrective or disciplinary action by the School of Medicine. The corrective or disciplinary action(s) imposed will in each case depend on several factors, including:
- The seriousness of the violation;
- Whether the violation was a first or repeat offense;
- Whether the violation was inadvertent or deliberate; and
- The magnitude of the harm caused to the School of Medicine and Yale University.
- Potential corrective and disciplinary actions that may be imposed, singly or in any combination, for a violation of this Policy include, but are not limited to:
- Further education or training for the individual on the requirements of this Policy and/or on conflict of interest principles;
- Written reprimand;
- Correction of disclosure information published by the individual;
- Restrictions on the individual’s external professional relationships;
- Restrictions on the individual’s supervision of other faculty, staff, students, and/or trainees;
- Restrictions on the individual’s research or clinical activities;
- Removal of the individual from University administrative positions; or
- Other corrective and disciplinary actions available under applicable University policies, up to and including termination.
1 In this Policy, the term “industry” means biomedical, pharmaceutical, and medical device companies and any other companies that make products used in the treatment of patients or the provision of medical care.
2 Yale University Policy on Conflict of Interest and Conflict of Commitment, May 2004.
3 In this Policy, the term “industry representatives” means all sales, marketing, or other personnel who promote industry products.