Yale University Policy on Conflict of Interest and Conflict of Commitment

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PRINCIPLES

Yale University believes that a great university should reach out to the world. Accordingly, the University encourages its faculty to seek and participate in sponsored research, 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. In many cases, non-faculty employees also consult or engage in other outside activities. While Yale recognizes the benefit of such activities, it is also committed to ensuring that they are conducted properly and consistently, in accordance with the principles of openness, trust, and free inquiry that are fundamental to the autonomy and well-being of a university and with the responsible management of the University's business.

The number of faculty and staff engaged in sponsored research, in consulting, or in other interactions with external organizations is substantial. The interests and commitments of the various parties engaged in such activities or affected by them - the individual, the University community, industry, the government, and the public - are complex and not necessarily coincident; occasionally, these interests may conflict with and threaten to compromise the University's core missions and the atmosphere of free inquiry that Yale considers vital. It is sometimes difficult to draw the line between the responsibilities of a faculty or staff member to Yale and to external organizations. Under these conditions the possibility of perceived or real conflict of interest or conflict of commitment is significantly heightened.

In pursuit of its own mission, and consistent with the requirements of external agencies, particularly the federal government [1], Yale University has formulated the following policy to identify and address potential, actual and apparent conflicts of interest and commitment. The fundamental premise of this policy is that each member of the Yale community has an obligation to act in the best interest of the University and in furtherance of the University's mission, and must not let outside activities or outside financial interests interfere with those obligations. This policy is intended to increase the awareness of faculty, staff and students to the potential for conflicts of interest and commitment, and to establish procedures whereby such conflicts may be avoided or properly managed.

CONFLICT OF COMMITMENT AND CONFLICT OF INTEREST

Recognizing Conflict of Commitment

A conflict of commitment occurs when the commitment to external activities of a faculty or staff member adversely affects his or her capacity to meet University responsibilities. This form of conflict is easily defined and recognized since it involves a perceptible reduction of the individual's time and energy devoted to University activities.

Yale's Faculty Handbook provides guidance about the amount of time that may be given by faculty members to outside activities; it stipulates, for example, that a faculty member may not accept salaried employment at another institution while a full-time employee of Yale, that faculty may not spend more than one day in a seven-day work week on consulting activities, and that faculty ownership or management of private enterprises is subject to review and to limitations. It is important to recognize, however, that the obligations of Yale faculty move beyond the letter of these obligations to their spirit. The University requires that its faculty will meet their classes, but it also expects that they will be available to students outside of the classroom, will carry their share of committee responsibilities, will remain productively involved in their research and other scholarly pursuits, and, where applicable, will meet their clinical obligations. External activities that compromise or diminish a faculty member's capacity to meet these obligations represent a conflict of commitment.

Full-time non-faculty employees are expected to satisfy all of the requirements of their jobs, and should not permit outside activities to interfere with the performance of their Yale obligations. Some departments prohibit staff employees from consulting or engaging in other outside employment because of the likelihood of such interference. Other departments may permit certain outside activities, with appropriate notice to and written approval by the employee's supervisor, so long as they do not interfere with employees' Yale obligations. The Yale Personnel Policies and Practices Manual sets forth the University's general expectations about staff and the avoidance of conflicts in performance of their duties in its Section 505. (http://www.yale.edu/ppdev/PersPracWeb/505.html)

Recognizing Conflict of Interest

A conflict of interest exists when an individual [2] has an external interest that affects or provides an incentive to affect the individual's conduct of his or her University activities. Conflicts of interest can arise naturally from an individual's engagement with the world outside the University, and the mere existence of a conflict of interest does not necessarily imply wrongdoing on anyone's part. When conflicts of interest do arise, however, they must be recognized, disclosed and either eliminated or properly managed.

Conflicts of interest may exist with respect to University financial decisions in which the individual is involved, for example, regarding investments, loans, purchases or sales of goods or services, and financial accounting decisions. They may also exist with respect to non-financial University matters, including in particular the conduct of research, the care of patients, the protection of human research subjects, and the treatment of students and faculty colleagues. Conflicts may also exist with respect to matters with both financial and non-financial implications, such as decisions about the use of University equipment and facilities and the negotiation of research agreements and license agreements.

For purposes of this policy, an individual's economic interests include his or her interest in obtaining, maintaining or increasing the value of relationships such as employment, independent contractor or consultant; management positions, board memberships and other fiduciary relationships with for-profit organizations; ownership of stock or other securities and other financial interests such as loans or royalties; and any other activity from which the individual receives or expects to receive remuneration. They also include such interests on the part of the individual's spouse and his or her financially dependent children.

External economic interests are those economic interests that do not involve the University as an institution. For example, although employment is an economic interest, an individual's employment by the University is not an external economic interest; hence, the incentives that derive from the individual's Yale employment do not create conflicts of interest for purposes of this policy. Some external economic interests do not create actual conflicts of interest because they do not affect Yale research, Yale financial decisions or other Yale activities. For example, there is not a conflict of interest with respect to a Yale financial decision by an employee where the external economic interest consists of a very small investment interest and the effect of the Yale decision on the organization is very small, e.g., ownership of 50 shares of IBM stock in the context of a Yale decision to buy ten IBM personal computers. There would also be no conflict of interest where the Yale employee who has the interest is not in a position to affect the Yale decision, e.g., an employee who does not in fact arrange or make recommendations for equipment purchases has no conflict of interest with respect to such purchases even if he or she has a significant economic interest in an equipment vendor.

As these examples indicate, external economic interests create conflicts of interest when they provide an incentive to the individual to affect a University decision or other activity (for example, because of the possibility of personal gain), and when the individual has the opportunity to affect the University decision or other activity (for example, because he or she is the decision-maker or the principal investigator for a research project). In the first example cited above, there was opportunity but no significant incentive, while in the second example, there was incentive but not opportunity.

Fundamental Principles

The following principles are among those that underlie the University's policy on conflicts of interest and commitment:

External activities should not compromise an individual's ability to perform all the activities expected of him or her as a Yale employee.An individual should not receive remuneration for the conduct of his or her research or clinical activity at Yale or other Yale activity except through University channels (such as salary).An individual should not conduct research or clinical activity at Yale or carry on other Yale business under circumstances in which a reasonable person would infer that the Yale activity could have been distorted by the desire for or expectation of direct or indirect external economic advantage.Yale researchers, including students and postdoctoral appointees, must not be precluded from publishing their work by agreements with external sponsors or on account of the interest of an external organization in which a faculty mentor or supervisor has an economic interest.Graduate students must not be held to non-disclosure of any aspect of their work in their meetings with individuals at Yale (including members of their dissertation advisory committees).Yale facilities, equipment, and personnel should be used only for Yale activities and purposes, except when other uses are specifically authorized by the University.An individual should not participate directly in the negotiation of research agreements, license agreements, equipment purchases or other arrangements between the University and an organization in which the individual has a significant financial interest.Research involving human subjects should receive especially rigorous review, and should be subject to a strong presumption against permitting the participation of any individual holding a related significant financial interest. (See below).
The University will apply a rebuttable presumption against accepting research that is proposed to be sponsored by a small, privately-held entity in which the faculty member who would conduct such research has an equity interest or Board seat or other significant financial interest. (See below).

Conflicts of interest related to research involving human subjects pose special concerns. The University and its researchers have ethical obligations to honor the rights and protect the safety of persons who participate in research conducted at the University. Financial interests held by those conducting the research or the research's sponsor may compromise or appear to compromise the fulfillment of those ethical obligations and the well-being of the research subjects, as well as the integrity of the related research. Accordingly, there is a strong presumption against permitting any person with related significant financial interests to participate in the conduct of such research, particularly if the protocol involves more than minimal risk. Only in rare and compelling circumstances might an exception be made. The University's Human Investigation Committee, which is charged with reviewing and monitoring human subjects research conducted at the School of Medicine, has established a rigorous policy and procedure for review of financial interests related to human subjects research performed at the University or by University researchers. These policies and procedures are intended to supplement the Yale University Policy on Conflict of Interest and Conflict of Commitment. Relevant excerpts of the policy are included as an appendix to this document. The Human Investigation Committee works closely with the Provost's Committee on Conflict of Interest to identify and address all such conflicts. Similar policies are in place at the University's other institutional review boards, which primarily review research involving no more than minimal risk to human subjects.

Faculty relationships with startup companies - newly-formed, privately-held, for-profit companies based on Yale intellectual property -frequently present multifaceted conflicts of interest and commitment. Policy guidelines specific to faculty relationships with such ventures appear as an appendix to this general policy statement. These are related to and in part derived from longstanding policies, set forth in Section X.D.4 of the Faculty Handbook, with respect to faculty relationships with any private enterprise.

The Appearance of Conflict of Interest

There are certain cases in which the appearance of conflict of interest is present even when no conflict actually exists. Such apparent conflicts can do almost as much damage as actual ones, undermining the credibility of research and scholarship as well as University financial decisions and calling into question the integrity of an individual or the University or both. For this reason, it is important for an individual, in evaluating a potential conflict of interest, to consider how it might be perceived by others. Apparent conflicts of interest must be avoided, and the same rigorous evaluation must be applied to situations in which there is a potential for such misunderstanding as is applied to situations in which there is the potential for actual conflict.

PROCEDURE

Disclosure

The responsibility for avoiding conflict of interest or commitment rests, in the first instance, with the individual. An essential step in addressing an actual or apparent conflict of interest or commitment is for the individual involved to make full disclosure of relevant information to the appropriate supervisor. As described in greater detail below, certain individuals are required to make regular, annual disclosures, with updates as needed; others need only disclose on an ad hoc basis. When a disclosure is received, the supervisor will review it and forward it to the Provost's Office for review by the Provost's Committee on Conflict of Interest and Conflict of Commitment (the "Committee"), and/or other cognizant office, which will determine what should be done to avoid or manage the conflict appropriately. (See below.) For certain senior administrators, the review will be conducted by the Office of the Vice President and General Counsel.

Required annual disclosures
All faculty members with University appointments of greater that 50% time; all faculty who hold administrative positions; and all faculty and non-faculty personnel who are responsible for the design, conduct or reporting of research (being "engaged in research") are required annually to submit a conflict of interest/conflict of commitment disclosure describing their external activities and significant financial interests. The annual disclosures must be in writing, on the forms approved by the Provost.[3] Faculty members, investigators, and non-faculty personnel who are engaged in research must submit the annual disclosure forms to their departmental chair, who will then review them and forward the forms to the Provost's Office as provided below. When the disclosing individual is a departmental chair in the School of Medicine, the disclosures go to the Dean, who will then review them and forward the forms to the Provost's Office. Where the individual is a Dean or departmental chair in the FAS, the disclosures should be submitted directly to the Provost.

Certain senior, non-faculty administrators designated by the President are also required to submit annual disclosures of outside activities and financial interests. These disclosures must be prepared on the Conflict of Interest Disclosure Form for Senior Administrators and submitted to the Office of the Vice President and General Counsel. The form will be provided to those administrators who are designated to submit them.
Required disclosures other than in annual disclosure process

Material change from annual disclosure. Whenever significant financial interests, external activities, or internal responsibilities change materially from those described in the annual disclosure, the disclosure is to be updated as soon as possible [4], in writing. Updates should be submitted according to the same procedure as the annual disclosures, described above. Whenever possible, individuals should attempt to disclose expected changes or newly anticipated conflicts before they occur, and seek advice from the Committee on the restrictions that may result from any anticipated new significant financial interest, before accepting such a financial interest. Whenever an application for funding of a new research project is submitted, the investigator will be required to certify that he or she has submitted a complete and accurate annual disclosure, and that the new research project does not present the potential for any actual or apparent conflicts of interest not already identified in the annual disclosure.
Human subjects research protocols. Principal investigators and key research personnel involved in human subjects research at the School of Medicine are required to complete and submit Protocol-Related Conflict of Interest Disclosure forms or related screening forms to the Human Investigation Committee ("HIC") at the time of the submission of each protocol to the HIC. These disclosures are intended to supplement, not replace, the annual disclosure described above.
Ad hoc disclosures by those not required to file annual disclosures. Postdoctoral appointees, non-faculty employees other than designated senior administrators, and students are not required to submit annual disclosure forms unless they are responsible for the design, conduct, or reporting of research. They are required, however, on an ad hoc basis, to disclose potential and actual conflicts of interest relating generally to University research (including, for example, the use of research facilities and involvement of students in startup-company sponsored research), University financial decisions, and other matters whenever they arise. If there is any doubt about the existence of an actual or apparent conflict of commitment or conflict of interest, the individual should submit a disclosure for review by his or her supervisor, a senior administrator in the department, the Dean of the School, the Office of the Vice President and General Counsel, or the Provost's Committee on Conflicts of Interest and Conflicts of Commitment.

The confidentiality of the disclosures will be respected as far as possible. In particular, the information on the forms will not be shared except with those who have a need to know.

Initial Review of Disclosures

The chair, senior administrator, supervisor, or other recipient of an annual or other disclosure [5] (the "initial reviewer") should review the information in the disclosure to determine if a conflict of commitment exists. The initial reviewer may, but is generally not required to, review the disclosure to identify any apparent conflicts of interest, before forwarding it to the Provost's Office.

Conflict of Commitment. If the initial review suggests that a conflict of commitment exists, the initial reviewer should discuss the conflict with the individual, and take steps to assure that any actual conflict is eliminated. If the initial reviewer is unable to assure the elimination of the conflict of commitment, he or she should consult with the appropriate dean or director (or in the case of an FAS chair, with the Provost's Office); if the dean or director is unable to assure the elimination of the conflict of commitment, he or she should consult with the Provost's Office.

Conflict of Interest. When the disclosure relates to research activities, the initial reviewer (the chair, dean or supervisor) is not required to review the substance of the disclosure for possible conflict of interest; he or she may instead merely note that the disclosure was received and forward it to the Provost's Office. The initial reviewer is encouraged, however, to assist in the review process by commenting on the substance of the disclosure based on his or her knowledge of the circumstances. In some cases, the initial reviewer's clarification of the facts will significantly speed up the review of a potential conflict of interest.

When the disclosure relates to University financial decisions or other non-research activities, the initial reviewer shall review the disclosure, identify actual and apparent conflicts, and develop a written plan that would eliminate or manage the identified conflicts. This plan could, among other possibilities, (i) authorize the individual to participate, under the reviewer's oversight, in a matter as to which the conflict exists, or (ii) instruct the individual not to participate in the decision or other matter relating to the conflict. The plan and disclosure shall be forwarded for a final decision to the Provost's Office, in the case of a faculty member or researcher, or to the University Officer responsible for the reviewer's school or department in the case of non-faculty personnel who are not responsible for the design, conduct or reporting of research.

Whether or not the initial review indicates that an actual or apparent conflict of interest exists, the initial reviewer will forward the disclosure form (or a written record of an oral disclosure), together with any comments by the initial reviewer, to the Provost's Office.

Review by the Provost's Office

Review of disclosures forwarded to the Provost's Office will be conducted by the Provost's Committee on Conflict of Interest and Conflict of Commitment. This Committee consists of one or more members of the Provost's staff and one or more faculty members selected by the Provost, together with additional individuals selected by the Provost. The Committee may delegate review of routine matters to one of its members from the Provost's staff. If necessary, the Committee will discuss disclosure- related matters with the individual involved and may also consult with others who may have relevant information. The individual in entitled to meet with the Provost's Committee if he or she wishes.

The Provost's Committee will determine whether an apparent or actual conflict of interest exists, and, if so, by what means - such as the individual's abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee - the conflict should be avoided or managed. In making those determinations, the Provost's Committee will be guided by the principles discussed in this statement and in the Faculty Handbook and will be informed by the relevant deliberations of the HIC.

If the Committee determines that a conflict exists, it will communicate this determination and the means it has identified for eliminating or managing the conflict, in writing, to the individual, the initial reviewer who referred the case, and the appropriate dean or department chair. The Provost's Committee will also communicate to the appropriate Office of Grant and Contract Administration the fact that the disclosure has been reviewed (or, if applicable, referred for further review as described below) and its summary determination (e.g., "no conflict," "conflict managed"), but not the substance of the disclosure.[6] The Provost's Committee will keep a record of the disclosure and other relevant information for at least three years.[7] If the Provost's Committee prescribes monitoring of the activity, it will describe specifically how the monitoring shall be performed and what records are to be kept.

If the individual is not satisfied with the decision of the Provost's Committee, he or she may request that the matter be referred to the Provost for a decision. Any matter referred to the Provost in this way shall be accompanied by a written statement of the findings and recommendations of the Provost's Committee, with copies to the individual, and the appropriate Dean. The Provost will notify the individual, the Provost's Committee, and the Dean of his or her decision, ordinarily within three weeks after receiving the Committee's report.

The Provost's decision will be final, and any failure by the individual to adhere to the decision will be cause for disciplinary action, including, in severe cases, termination.
Revised, May 2004

Notes:

[1] A number of external organizations have developed policies requiring disclosure of potential conflicts of interest. In particular, the Public Health Service ("PHS") and the National Science Foundation ("NSF") have issued proposed or final rules on this subject. Research sponsored by PHS, NSF or any other Federal agency must be conducted in accordance with applicable Federal regulations.

[2] This policy applies to all faculty, staff and students, as well as to postdoctoral appointees, visiting faculty and others working at Yale who may technically be neither employees nor students of the University.

[3] The Provost may set the dates for submission of annual disclosures by the various Schools and Departments, so that all disclosures are not submitted at the same time.

[4] In the case of faculty members engaged in federally-sponsored research, the disclosure should be updated within 30 days of any change if it is not possible to provide an updated disclosure in advance of assuming any such related interest.

[5] All such disclosures should be in writing. If a disclosure is made orally, it should be reduced to writing as soon as possible.

[6] For federal grants and contracts, the University will be required to certify that potential conflicts of interest have been disclosed and addressed.

[7] Records of disclosures by investigators involved in federally-sponsored research that are used as the basis for the University's certification to federal sponsors that it has addressed any potential conflicts of interest with respect to the funded research must be kept for at least three years beyond the termination or completion of the research.

APPENDIX I

CONFLICTS OF INTEREST

Examples

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.

1. 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.

2. A clinician makes patient referrals to a diagnostic company in which she or her immediate family has a significant ownership interest.

3. 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.

4. An employee managing a design and construction project participates in the selection of an architectural firm in which her spouse is a partner.

5. 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.

6. 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.

7. A researcher conducts federally- or foundation-sponsored non-clinical research on a product developed by a company for which he is a consultant.

8. A researcher who is a member of a company's scientific advisory board conducts non-clinical research sponsored by that company.

9. 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.

10. 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.

APPENDIX II

Yale University School of Medicine
- Yale New Haven Medical Center
Human Investigation Committee
Protocol-Related Conflict of Interest (COI) Policy
(Excerpts)

Introduction:

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.

Definitions:
"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

APPENDIX III

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:
1. 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:
  1. 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
  2. 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.
  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.)
2. 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:
  1. 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
  2. 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.

APPENDIX IV

May 17, 2005

GUIDELINES FOR INTERACTIONS AMONG YALE MEDICAL GROUP
PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY

Introduction

The faculty in clinical departments of Yale School of Medicine (YSM) have developed the following Guidelines for interactions among the physicians of Yale Medical Group and the pharmaceutical industry. These guidelines have been formally endorsed by the Board of Governors of Yale Medical Group (YMG) and apply to all those full-time faculty of YSM who practice in Yale Medical Group (YMG physicians). The guidelines supplement Yale University’s policies on conflict of interest.

The pharmaceutical industry plays a vital role in drug discovery and in improving the public health. The physicians of YMG are eager to promote a mutually beneficial relationship with industry that facilitates drug discovery and evidence-based use of medications, and that is characterized by the highest professional standards of rigor and integrity. The Guidelines are intended to meet these goals by setting standards for the interactions among YMG physicians and the pharmaceutical industry. The Guidelines specifically seek to preserve and fortify the independence of our faculty; ensure that we incorporate the most objective information in the care of our patients; slow the rising cost of healthcare; reduce the potential for real or perceived bias in our programs of clinical care and education; and ensure compliance with the law. The complexities of relationships with industry preclude us from identifying all circumstances in which a financial conflict of interest may arise or in which an interaction may be inappropriate. We believe that the guiding principles in unclear situations should be to protect the interests of our patients and the independence of the faculty. The overriding goal of these Guidelines is to ensure as much as possible that the integrity of clinical decision-making is not compromised by financial or other personal relationships with industry.

The Guidelines are not technically binding on YMG Physicians, except in certain areas cited in the Guidelines that are legally prohibited. Adherence to the Guidelines is strongly encouraged, however, to avoid both conflict of interest in clinical practice and violation of the federal anti-kickback statute and other laws. For example, receipt of compensation from the pharmaceutical industry by a YMG physician may be scrutinized by regulators to determine whether the payment was made or received with unlawful intent to influence prescribing or referral practices. Although some such transactions addressed by the Guidelines have not been explicitly prohibited, they have been characterized by the HHS Office of Inspector General (OIG) as having a significant potential for abuse. They can also create an appearance of unlawful intent. The OIG’s views on these subjects can be expected to reflect the federal government’s general approach to assessing the possible criminal consequences of certain actions. The provisions in the Guidelines that either reflect legal prohibition or have been identified as having a high potential for abuse have been boldfaced and italicized in the text below. YMG physicians should be aware, therefore, that although the Guidelines are not binding, breach of the Guidelines may have serious legal consequences in some circumstances.

The Guidelines will need to be revised in the future as the law and the expectations of the public and the medical profession evolve.

1. Provision of Compensation or Gifts from Industry to YMG Physicians

a. YMG physicians may not accept any form of personal gift from industry or its representatives. (Although the acceptance of a gift of nominal value is unlikely to violate the anti-kickback law, acceptance of most types of gifts of more than nominal value is suspect and may carry serious legal consequences. Accordingly, this provision has been highlighted, and the policy adopted that YMG physicians should not accept any form of personal gift from industry.)

b. Meals funded by industry should not be provided on the YSM campus. In addition, Yale faculty and trainees should use discretion in participating in industry-sponsored meals off campus;

c. A YMG physician may accept only fair market compensation for specific, legitimate services provided by him or her to the pharmaceutical company. Payment must be commensurate with time and effort. The terms of the arrangements, services provided, and compensation must be set forth in writing;

d. YMG physicians may not accept compensation for listening to a sales pitch (e.g., detailing) by an industry representative;

e. YMG physicians who are simply attending a CME or other instructional activity and are not speaking or otherwise actively participating or presenting at the meeting, should not accept compensation from companies either for attending or defraying costs related to attending the meeting;

f. YMG physicians must consciously and actively divorce clinical care decisions (including referrals, and diagnostic or therapeutic management) from any perceived or actual benefits accrued or expected from any company (including but not limited to personal gifts, research funding, scholarships for Continuing Medical Education attendance, consulting agreements, and the like);

g. YMG physicians who are involved in institutional decisions concerning the purchase of or approval of medications or equipment, or the negotiation of other contractual relationships with industry must not have any financial interest (e.g., equity ownership, compensated positions on advisory boards, a paid consultancy or other forms of compensated relationship) in pharmaceutical companies that might benefit from the institutional decision. This provision is not intended to preclude the indirect ownership, through mutual funds or other investment vehicles, of equities in publicly traded pharmaceutical companies by Yale faculty;

h. YMG physicians may not receive any form of compensation for changing a patient’s prescription; and

i. Pharmaceutical representatives are not allowed in patient care areas. Therefore, YMG physicians should meet with pharmaceutical representatives only in non-patient care areas.

2. Provision of Scholarships and other Funds to Yale Trainees

YMG physicians should ensure that support of Yale clinical trainees by the pharmaceutical industry through funding mechanisms such as scholarships, reimbursement of travel expenses, or other non-research funding in support of scholarship or training are free of any actual or perceived conflict of interest. Industry funding of trainees should comply with all of the following:

a. The trainee is selected by the Yale School of Medicine Department, Program, or Section;

b. The funds are providedto the Departmentrather than directly to the trainee;

c. The Department, Section or Program have determined that the conference or training has educational merit; and

d. The recipient of the funds is not subject to any implicit or explicit quid pro quo (i.e, “no strings are attached”).

This guideline is not intended to preclude industry support for YMG physicians to travel to evaluate major clinical equipment for prospective acquisition by the School.

3. Provision of Free Drug Samples to Physicians

a. YMG physicians may accept free drug samples from industry for distribution to patients;

b. Since distribution of Non-Formulary Drugs to patients may encourage use of costlier medications, YMG physicians should be cautious in distributing medications that are not on Formulary;

c. Free drug samples may never be sold; and

d. Free drug samples should notbe used by YMG physicians for themselves or family members.

4. Industry Support for Educational Events on the Yale School of Medicine Campus

YMG physicians should be aware of the Standards for Commercial Support established by the Accreditation Council for Continuing Medical Education. A complete description of the Standards of the ACCME to ensure independence in CME activities is available at http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf.

All educational events sponsored by industry on the Yale campus must be fully compliant with ACCME guidelines regardless of whether formal CME credit is awarded or not.

The standards of the ACCME concerning commercial support of CME activities were made more stringent in September of 2004 and are effective for new CME activities after May 2005 and for all CME activities by November 2006. The new elements in the ACCME guidelines now require that, if an event is to qualify for CME credit, its provider must ensure the following:

a. All decisions concerning educational needs, objectives, content, methods, evaluation and speaker are made free of a commercial interest (ACCME Standard 1.1);

b. A commercial interest is not taking the role of non-accredited partner in a joint sponsorship relationship (ACCME Standard 1.2);

c. All persons in a position to control the content of an educational activity have disclosed all relevant financial relationships to the provider of the CME. A relevant financial relationship is defined as one which an individual (or spouse or partner) has with a commercial interest that benefits the individual in any financial amount that has occurred within the past 12 months; and the opportunity to affect the content of CME about the products or services of the commercial interest. Failure to disclose these relationships will result in disqualification of the individual from participating in the CME activity or its planning or evaluation (ACCME Standards 1.1, 1.2);

d. The lecturer explicitly describes all his or her related financial relationships to the audience at the beginning of the educational activity. If an individual has no relevant financial relationship, the learners should be informed that no relevant financial relationship exists (ACCME Standard 6.1, 6.2);

e. All conflicts of interest should be identified and resolved prior to the educational activity being delivered to learners (ACCME Standard 2.3). Examples of strategies to resolve conflicts of interest include severing the financial ties with the commercial entity that gives rise to the conflict, having a third party without a conflict conduct the educational event, or having the content of the educational materials reviewed and endorsed by a peer expert who does not have a conflict of interest;

f. Written policies and procedures that govern honoraria and reimbursement of out of pocket expenses for planners, teachers, and authors are in place (ACCME Standard 3.7);

g. Product-promotion material or product-specific advertisements of any type is prohibited in or during CME activities. The juxtaposition of editorial and advertising material on the same products or subjects must be avoided. Live (staffed exhibits, presentation) or enduring (printed or electronic advertisements) promotional activities must be kept separate from CME (ACCME Standard 4.2);

h. A commercial interest is not used as the agent providing a CME activity to learners, e.g., distribution of self-study CME activities or arranging for electronic access to CME activities (ACCME Standard 4.5);

i. 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 interest (ACCME Standard 5.1)

j. Attendees in the audience are not compensated or otherwise materially rewarded for attendance (e.g., through payment of travel expenses, lodging, honoraria, or personal expenses) (ACCME Standard 3.12);

In addition to the aforementioned ACCME Standards, educational events sponsored by industry on the Yale School of Medicine campus should comply with the following provisions:

a. Gifts of any type are not distributed to attendees or participants before, during, or after the meeting or lecture;
b. Funds to pay for the specific educational activity are provided to the Department, Program, or Section and not to an individual faculty member.

5. Guidelines for Delivering Industry-Sponsored Lectures or Participating in Legitimate Conferences and Meetings of Physicians off the Yale School of Medicine Campus

Clinical meetings and scientific meetings sponsored by professional societies frequently derive a portion of their support from industry. Such sponsorship may give rise to inappropriate industry influence on the content of the conference or its attendees. Grants for meetings and conferences that originate from the company’s marketing division may be particularly problematic. Industry sponsorship generally takes one of two general forms and different standards apply in each case.

a. First, industry may partially sponsor meetings run by professional societies. YMG physicians are expected to participate in meetings of professional societies as part of their CME and professional obligations. Nonetheless, faculty should be aware of the potential influence of industry on these meetings and attentive to the guidelines set forth below in evaluating whether and how to attend or participate in these meetings.

b. A second type of meeting is fully sponsored by industry. The following guidelines apply in that case. These guidelines apply to all lectures, meetings, and related publications sponsored directly by industry or by intermediate educational companies subsidized by industry. YMG physicians should actively participate (e.g., by giving a lecture, organizing the meeting) in such meetings or lectures only if:

1. Financial support by industry is fully disclosed at the meeting by the sponsor;

2. The meeting or lecture’s content, including slides and written materials, are determined by the YMG physician;

3. The lecturer is expected to provide a balanced assessment of therapeutic optionsand should promote objective scientific and educational activities and discourse;

4. The YMG physician is not required by the company 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;

5. 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)

6 Gifts of any type are not distributed to attendees or participants before, during, or after the meeting or lecture;

7. The YMG physician receives compensation only for the services provided and the compensation is reasonable;

8. Time spent in preparing and delivering the lectures does not impair the YMG physician’s ability to fulfill Departmental responsibilities;

9. The lecturer explicitly describes all his or her related financial interests (past,existing, or planned) to the audience;

10. The lecturer makes clear to the audience that the content of the lecture reflects the views of the lecturer and not Yale Medical Group or Yale School of Medicine; and

11. YMG physicians should not facilitate the participation of Yale trainees in industry-sponsored events that fail to comply with these standards.

6. Disclosure of Relationships with Industry

a. YMG physicians must disclose all of their related financial interests, including past, existing or expected interests (e.g., grants and sponsored research, compensation from consulting, speaker’s bureaus, advisory boards; investments and ownership interests) to journal editors in manuscripts submitted for publication, and audiences at lectures or presentations;

b. YMG physicians must provide specific written information on financial interests related to their work at Yale on an annual basis to their respective Department Chair and Yale’s Conflict of Interest and Commitment Committee in compliance with Yale University regulations. This disclosure must include a description of all sponsored research, and investments held by the YMG physician that are related to industry(See Yale University Policy on Conflict of Interest and Commitment at http://www.yale.edu/provost/html/coi.html);

c. YMG physicians must disclose their actual and potential conflicts of interest related to any institutional deliberations and generally may not participate in deliberations in which he or she has an actual or potential conflict of interest; and

d. YMG physicians with supervisory responsibilities for trainees or staff must ensure that the faculty’s conflict or potential conflict of interest does not affect or appear to affect his or her supervision of the activities or responsibilities of the trainee or staff member.

The following references were utilized in the compilation of these Guidelines:

1. American Medical Association. Opinion of the Council on Ethical and Judicial Affairs, E-8.061 <http://www.ama-assn.org/ama/pub/category/4001.html)> Accessed January 20, 2005.

2. Department of Health and Human Services, Office of Inspector General. OIG Compliance Program Guidance for Pharmaceutical Manufacturers. Fed Regist 2003;68:23731-43.

3. Pharmaceutical Research and Manufacturers of America. PhRMA Code on Interactions with Healthcare Professionals. Wash D.C., PhRMA, 2002.

4. Accreditation Council for Continuing Medical Education Report on Standards for Commercial Support accessed March 12, 2005 at http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf

5. Moses, H, et.al. Collaborating with Industry-Choices for the Academic Medical Center. N Engl J Med 347:1371-5, 2002.

6. Yale University Faculty Handbook, Section X. University Policies Concerning Teaching and Research (http://www.yale.edu/provost/handbook/
handbook_x__university_policies_concerni.html)

7. Yale University Policy on Conflict of Interest and Conflict of Commitment (http://www.yale.edu/provost/html/coi.html)

8. Yale-New Haven Hospital and Yale-New Haven Health System Policies on Interactions with Pharmaceutical Representatives.