Yale University Policy on Conflict of Interest and Conflict of Commitment
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.
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.