CONFLICT OF FINANCIAL INTEREST IN ACADEMIC ACTIVITIES POLICY

GENERAL PRINCIPLES

1. New York Medical College (referred to in this document as "The College"), as an institution of higher learning, has a duty to the public to serve as an objective and independent voice of guidance and advice in matters falling within the realm of the expertise of the College and its faculty. Because of this public role, academic institutions and all their members have an obligation to behave in a manner consistent with the highest standards of professional conduct.

2. The College endorses the principle of academic freedom. Broadly understood, this means that faculty and students are free to explore ideas, conduct research, express their opinions about the concepts and theories that are encountered in this exploration and research, share information, and report their findings in accordance with recognized standards of their profession, without fear of reprisal and without pressure from within the institution or from external sources, based upon politics, creed, ideology or fiscal concerns. The search for and dissemination of knowledge, along with its service as a repository of existing knowledge, must serve as the primary guiding principles for the College, its faculty, students, administrators and trustees.

3. The application of knowledge and research results to the enhancement of the health and well being of people is a particular goal of the College as a medical university. The efficient transfer of such knowledge to the medical profession and health care system may involve interaction and cooperation with the commercial sector of our society. Towards this end, therefore, relationships between the College and Industry are to be encouraged. In a variety of ways, the College and its individual members may derive significant financial profit from such relationships with Industry. Such benefits may do much to further the mission of the College. Nonetheless, the College has an obligation to ensure that the opportunity for private or institutional financial gain does not interfere with the greater mission and obligations outlined above.

4. In order to prevent conflicts of interest between the College's academic mission and other interests, including financial interests, the College must exercise its authority to review all instances where such conflicts of interest may exist or may appear to exist. Each member of the College community who seeks or receives extramural support for research or other academic activities has the responsibility to disclose to the College all outside interests, as defined in this policy, that may represent a real or apparent conflict of interest. Based upon its review of such disclosures, the College may decide that such outside interests be severed or modified in order to remove reduce, manage or eliminate a conflict of interest as a condition of accepting external research support. Alternatively, the College may structure a mechanism so that the design, conduct and reporting of research by investigators is not likely to be biased nor be perceived to be biased by any conflicting financial interests of those investigators.

5. In keeping with the College's mission to disseminate knowledge, the College ordinarily will enter into no contract that abridges a faculty member's right to publish research results. Short delays in publication, e.g., to allow a sponsor to file patent applications, are acceptable.

6. The College's primary responsibility towards its students is to educate and train them for the professions appropriate to their degree programs. In general, students' research efforts should be devoted towards projects that will enhance their training, education and ability to pursue their own next career step. For example, participation of students in projects that, because of proprietary or other justified considerations, limit the freedom of the student to discuss the results in public forums in a timely fashion may not be in the student's best interests. The participation of students in projects and contracts supported by industrial or commercial sponsors, therefore, should be carefully evaluated as to its suitability for the students' welfare.

7. Nothing in this policy is intended to supersede or replace existing institutional policy on patent and royalty rights.


PROCEDURES

1. The President, in consultation with the Executive Committee of the Faculty Senate and the Academic Policy Committee of the Graduate School of Health Sciences, shall appoint a Committee for Review of Conflicts of Interest. The membership of this Committee shall include no fewer than three full-time, senior faculty members (associate or full professors). The appointees should include at least one individual who shall serve as a liaison to the Intellectual Property Committee, by reason of his or her concurrent membership on both of these committees. Appropriate representatives of the Administration, such as from the Offices of Research Administration and Legal Counsel, shall also be included. The Committee's membership should include sufficient breadth of expertise so as to be able to evaluate the nature of proposals that come before the Committee, i.e., the membership should include both clinicians and basic scientists. It would also be valuable towards achieving a balanced committee if some of the members have had previous professional contact with industry, e.g., as consultants or recipients of grants or contracts. Members of
this Committee shall be appointed to serve 3-year terms. Terms shall be staggered so that there is significant year-to-year continuity in membership. If a case comes before the Review Committee that involves a company or other external agency in which a member of the Committee has significant managerial or financial interests, that committee member shall excuse himself or herself from the Committee's deliberations with regard to that particular case.

2. Each application for support or conduct of research or for any other academic activity submitted by any member of the College community shall include, as part of the "College Forms," a statement disclosing all significant financial or managerial relationships, or the absence thereof, with the commercial sponsor or other third party interest that might or might appear to constitute a conflict of financial interest with respect to the proposed
academic activity. Such disclosure shall be required of all individuals who are significant participants in the project, i.e., those who will be decision makers, including the Principal Investigator and all Collaborating or Co-Investigators. In the event that the proposed research is aimed at evaluating a product in which the applicant or any of the other significant participants holds a financial interest, such interest must be disclosed, regardless of the immediate sponsorship of the research itself. Any significant financial interest of the Investigator that might reasonably be affected by the results of the proposed research must be disclosed. Statements of disclosure must be submitted at the time of each periodic request for renewal or continuation of support. If a faculty member procures a financial interest or enters into a significant outside relationship, as defined in this policy, at some time after an application has been submitted, the faculty member must inform the Committee of that new interest or relationship within 30 days. All such disclosure statements will be treated as confidential documents and their distribution will be limited to the extent defined in this policy.

3. Grant or contract proposals that include a collaborative, sub-grantee or subcontract arrangement with investigator(s) at another institution must include either (a) disclosure statements from those investigators or (b) assurances from the collaborating, sub-grantee or subcontractor institution both that it complies with the requirements of the granting agency with regard to disclosure and management of conflicts of interest and that it has reviewed this particular proposal for conflicts relevant to its investigators. Any restrictive actions resulting from this review must also be disclosed.

4. The applicant's Department Chairperson will be informed by the applicant of any possible conflicts of interest by means of the applicant's submission of the conflict of interest disclosure statement to the Chairperson. The Chairperson will indicate knowledge of the disclosure by signature on the College forms. The Chairperson may comment to the Conflict of Interest Review Committee with regard to the potential conflict situation. The
Chairperson will not, however, unilaterally approve or disapprove any application on the basis of possible conflict of interest.

5. The statements disclosing possible conflicts of interest shall be forwarded by the applicant to the designated office, along with the required number of copies of the funding or research application, at the time of submission of the proposal. The conflict-of-interest situation will be evaluated on a case-by-case basis, following the guidelines delineated in this policy as closely as possible. One of the following actions may be taken:

a) decide that no significant conflict of interest exists that could possibly interfere with the Investigator's professional judgment in conducting the research or administering the program, therefore recommending approval of the application, subject only to he Committee's own annual review.

b) resolve the conflict.


6. Resolution of the conflict may include one or more of the following mechanisms:

a) stipulation that the Investigator's relationship with the sponsoring agency or financial interest in the product be disclosed in all publications and public presentations of the results of the research.

b) recommendation that the support for the research or program be accepted only if the relationship between the Investigator and the Sponsor, or the financial interest of the investigator in the product, be modified or terminated in some specified way. The Investigator may choose to continue the relationship while withdrawing the request for financial support or approval to conduct the research.

c) stipulation that the support for the project be accepted only if the proposal is modified in some specified way Ä e.g., to allow for continuous or regular, independent, external review of the project and its results, or to clarify or modify the participation of students in the project.

d) recommendation that the sponsoring agency be notified formally that a potential conflict of interest exists. This recommendation will depend largely upon the requirements of sponsoring agencies, notably the federal and state governments, for such disclosure.

e) a request that the Investigator provide, either in writing or via a meeting, more specific information before a recommendation is made.

f) notification, in a timely fashion, to the Committee for the Protection of Human Subjects of the potential conflict of interest and of the Review Committee's recommendation. This notification is necessary only when the proposal is for the support of a clinical trial or other research involving human subjects.

g) recommendation that the College not accept external support for the project.


7. The Review Committee will make its recommendation to the appropriate Dean, i.e., the Dean of the school under whose auspices the proposed work will be conducted. The Dean will decide on the propriety of each potential conflict of interest involving external support of faculty research within the Dean's authority. It is anticipated that the Dean will follow the Committee's recommendations closely. The Dean will inform both the faculty member applicant and the Review Committee of his or her decision.

8. Faculty who disagree with the Dean's decision may appeal to the President. The Review Committee may also appeal to the President if the Dean does not follow its recommendation. In either case, the President will consider both the Committee's recommendations and the Faculty Member's argument in making a final decision. The Faculty Member is given this right of appeal in order to safeguard individual rights. The Committee is given the right of appeal to promote a uniformity of standards in this area across the different schools within the College.

9. The disclosures made to the Committee and its deliberations are to be treated as highly confidential matters. Notification of potential conflicts of interest and the Committee's recommendations and Dean's decision regarding each case shall be given only to:

a) the Dean, as a recommendation for his or her executive judgment.

b) the Committee for the Protection of Human Subjects, when the proposal is for research involving human subjects. In order to expedite the complete review of such proposals, the Committee for the Protection of Human Subjects will be informed of both the Conflict of Interest Review Committee's initial recommendation and the Dean's final ruling.

c) the Office of Research Administration.

d) funding agencies, when this is required. Ordinarily, the Office of Research Administration will be responsible for notifying external agencies of findings regarding conflicts of interest.

e) the Principal Investigator submitting the application.

f) the applicant's Department Chairperson, who will be informed of the final decision.

g) the President, in cases which are appealed according to the guidelines set forth above, and also in any case in which a significant conflict of interest is found. For the purpose of this action, a significant conflict of interest would be one in which the investigator is bound by some constraint beyond simple disclosure of a relationship with the sponsor in publications. The President need not be informed if an application is withdrawn in response to the recommendation of the Review Committee or to the Dean's ruling.

10. The College shall maintain records of all financial and managerial disclosures and all actions taken with respect to each conflict of interest for three years beyond the date of submission of the final expenditures report to the granting agency. Under special circumstances, or if required explicitly by grantors, records may be kept for a longer period. These records shall be maintained by the Office of Research Administration.

11. It is anticipated that the Committee will devise its own explicit or de facto guidelines for judgment, based upon its evolving experience. In order that the process of evaluating conflicts of interest be itself evaluated by the College community, the Chairman of the Committee shall be required to submit an annual report to the President and the Deans of the respective Schools, summarizing both the number and types of cases and decisions it considered during the year and also describing the principles it used in reaching those decisions. The Committee is encouraged to recommend changes in procedure or other aspects of the Conflict of Interest Policy as it sees fit. This annual report shall also be forwarded to the Executive Committee of the Faculty Senate. Moreover, the Chairman of the Committee shall be required to meet with the Executive Committee at least once every 2 years, to discuss conflict of interest policy and the operation of the Review Committee.

12. The Committee shall devise its own rules of operation in order to meet the needs of this policy and the requirements of external funding agencies. It is within the scope of this policy for the Committee, with the approval of the appropriate administrative officials, to delegate part of the review and action processes implemented under this policy to a designated administrative official or office. The Committee, however, shall retain its responsibility and authority to ensure a fair and uniform interpretation and implementation of this policy.

13. The Committee for the Review of Conflicts of Interest may also be used as a forum for evaluating potential conflicts-of-interest that may arise independently of some specific application for research support. For example, an outside company may wish to donate a substantial piece of equipment to the College in exchange for some consideration. Many other possibilities might also serve as examples. The Dean or other relevant official may submit the idea to the Review Committee, whose input to the overall decision-making process would be valuable. The role of the Review Committee in this case is to offer its opinion as to the propriety of the arrangement. This opinion would be viewed as valued input because of the Committee's familiarity with the ethical issues that might be involved in such an arrangement. Such out-of-the-ordinary ventures, however, should also be discussed thoroughly within the Administration, among the Faculty, as represented by the Executive Committee of the Faculty Senate, and within the Board of Trustees, as would be appropriate for the specific case.



GUIDELINES

Conflicts of interest may be seen arising from almost any human endeavor. For example, a research scientist may be motivated both by the desire to search for truth and by the desire to earn a good reputation among his or her peers, with all the honorific, career and financial benefits that derive from such a reputation. No reasonable institutional or governmental policy can legislate the exclusion of all potential conflicts of interest. In the final resort, we have to place a major level of trust in the integrity of individuals. Each member of the College is responsible for his or her own actions.

The responsibility of individuals notwithstanding, the College must recognize certain situations in which two or more goals, each of which may be honorable in its own right, present a possible conflict. This may arise for an individual faculty member or administrator, or the College itself may face a decision in which it must balance the contrasting impacts on various aspects of its mission. The purpose of this section of the policy is to lay down guidelines by which to identify situations that may present a conflict of interest to the College or its members.

The guidelines in this section are not meant to be either rigid or inclusive. Certain potential conflicts of interest, as outlined herein, may be acceptable in practice in particular cases. By the same token, one can imagine situations not explicitly covered here that would not be appropriate or acceptable. It is our intent and hope that the mechanism set up for evaluating potential conflicts of interest, as outlined in other sections of this policy, will provide both for sufficient flexibility and sufficient consistency so that conflicts that may impede the College's mission are avoided, while, at the same time, useful cooperation between the College Community and Industry is fostered.

1. Research sponsored by a company or agency in which the investigator has a financial or managerial interest presents a conflict of interest. Investigators will have a conflict between their private interests and their College interests. The Review Committee should evaluate whether the investigator's influence within the company or agency might cause the normal "peer review" of the application for support to be short-circuited, thus bypassing an important component of science's system of checks and balances. Another issue to consider is whether the investigator might be using the College and its resources (space, equipment, students, etc.) to support and further his or her external interests.

2. Although reasonable consultation fees or honoraria are normally acceptable, a potential conflict may arise when an investigator seeks research support from a company or agency from which the investigator has accepted significant amounts of gratuities or special favors. Promises of future considerations (consultancies, ownership, royalties, etc.) in connection with or contingent upon the results of the proposed research are also problematic.

3. Research evaluating a product in which the investigator holds a financial interest is particularly problematic. The severity of the problem increases with the magnitude of the financial interest. Early developmental research on a product by its inventor is undeniably justifiable, whatever the inventor's financial stake. As a general rule, however, it is inappropriate for an investigator who has a significant financial interest in a product to conduct research that evaluates the suitability of that product for public consumption, particularly in the case of new drugs or other biomedical products.

4. The principle outlined in the previous guideline may be applied as well to the College itself. There may arise cases in which the College has patent or licensing rights, or an equity interest in a product that is to be evaluated for efficacy or safety as a prelude to public availability. Careful consideration must be given to the propriety of such evaluative research being done by any individual associated with the College, even if the individual has no personal financial interest in the product.

5. Situations may arise in which a company offers to donate money, equipment or other resources to the College in exchange for access to specialized laboratories or professional expertise in the College. These arrangements may present valuable opportunities for the College and a chance for fruitful collaboration between the College and Industry. The College should be careful, however, that such arrangements do not clash with its primary academic, educational and service missions.

6. In all of the instances outlined above, reference to the financial or managerial interests in an external company or agency of any individual faculty member, administrator or other employee of the College is intended to include the financial and managerial interests of that individual's spouse, dependent children and other dependents. Major financial interests of the investigator's parents or by the parents of the investigator's spouse may also be considered in evaluating potential conflicts of interest.

7. The Review Committee shall be guided by relevant regulations established by granting agencies, particularly those of the Public Health Service, with regard to thresholds for external reporting of conflicts of interest to granting agencies. For example, in the PHS regulations governing "Objectivity in Research," effective October, 1995, "significant" equity interest is defined as that exceeding $10,000 or exceeding a 5% ownership interest. Significant salary or royalty income is defined as that exceeding or reasonably expected to exceed $10,000 per year. Other interests, such as consultancies or managerial relationships, do not have specific trigger values. Despite these external "trigger" levels, the Review Committee may require internal disclosure of all financial interests relative to the proposed research.

September 1995