The following is a representative and non-inclusive list of extramural relationships subject to this policy. These examples have been divided into three groupings.

Categories I(a) and I(b) consist of relationships that are generally not allowable, with certain de minimis exceptions. Categories I(c) - (j) consist of relations that are generally allowable only after disclosure, review, and approval with oversight by the University or affiliated Hospital with advice from a standing committee of the Harvard Faculty of Medicine when requested. A second classification (Category II) consists of instances that will ordinarily be permissible following disclosure and, where necessary, the implementation of oversight procedures designed to ensure academic standards, intellectual values, and institutional integrity. Lastly, there is a category of relationships (Category III) that are thought to be allowable because they are (a) accepted practices and (b) generally minimal in their personal financial impact.

These classifications are not intended to serve as a rigid or comprehensive code of conduct or to define "black letter" rules with respect to conflict of interest. It is expected that the guidelines will be applied in accordance with the spirit of the mission of Harvard Medical School in education, research and patient care. By this process, it is expected that a common institutional experience in the application of these guidelines will gradually evolve. The complexity of the subject matter is such that the current guidelines and their ensuing interpretations should be formally reviewed on a periodic basis.

The impact of a Faculty Member's conflict of interest on student training (including that of post-doctoral fellows and other trainees) is of special concern to the Faculty of Medicine. Many of the specific issues related to student training have already been addressed in the Faculty of Medicine's Statement on Research Sponsored by Industry. As noted in that policy, students and trainees "should not ordinarily participate in research that involves confidential information or otherwise constrains their right to publish or communicate freely." Additionally, as set forth in more detail below, the Faculty is particularly concerned about the content and quality of the training experience for students whose research is sponsored by a for-profit business and whose preceptors have a personal interest in that business.

It is essential that Faculty Members demonstrate at all times their commitment to the highest intellectual and ethical standards in all aspects of research, particularly research in which opportunities for conflict may exist. As a corollary, the training experiences of students are expected to incorporate the values of objectivity in research and the importance of public trust.

Lastly, the rigorous application of the guidelines will be particularly important in the case of persons exercising significant authority. There are those in the Faculty of Medicine who have substantial influence over others by virtue of their major role in professional appointments, promotions, tenure decisions, allocation of space and determination of salary. Typically these individuals hold positions such as Chief Executive Officer (CEO or equivalent title) of an affiliated Hospital, Dean or Executive Dean of the Faculty of Medicine, or Heads of Departments. While the guidelines are applicable to all Faculty, these individuals must take particular care not to become involved in research relationships that would lead to their personal financial gain or that would adversely affect the professional or academic advancement of junior faculty members.

CATEGORY I   (a) and (b) Activities are Generally Not Allowable. The only exceptions are conflicts that arise in extraordinary circumstances such as the recruitment of a new Faculty Member, where a conflict may be allowed to continue for a finite time period with disclosure and the approval of the Standing Committee, the Dean and the CEO.

Research Activities

(a) A Faculty Member Participating in Clinical Research on a Technology owned by or contractually obligated⁽¹⁾ to a Business⁽²⁾ in which the Faculty Member, a member of his/her Family, or an Associated Entity has a consulting relationship, holds a stock or similar ownership interest, or has any other Financial Interest, other than receipt of University- or Hospital- supervised Sponsored Research support or royalties under institutional royalty-sharing policies.

(b) A Faculty Member receiving University- or Hospital-supervised Sponsored Research support (whether in dollars or in kind) for Clinical Research or research which does not involve human subjects, from a Business in which he/she, a member of his/her Family, or an Associated Entity holds a stock or similar ownership interest.

De Minimus Exception to Category I (a) and I (b) Conflicts

(a) A Faculty Member may continue to hold stock or similar ownership interest in a Business in a situation which would otherwise create an impermissible Category I (a) or I (b) conflict only if all of the following conditions are met:

1. The stock or similar ownership interest must be in a publicly held, widely traded Business.

2. The current value of the stock or similar ownership interest may not exceed $20,000 at any time.

3. There must be no relationship between acquisition of the stock or similar ownership interest and research to be conducted. Situations that satisfy this requirement include stock or similar ownership interest acquired in arms-length transactions or by family gift sufficiently prior to the beginning of the research to assure the lack of a relationship and stock or similar ownership interest acquired by inheritance. In any such situation there must be complete independence between a purchase decision or other acquisition and the research.

4. A Faculty Member who is a successful applicant for Public Health Service and/or National Science Foundation funding in a situation which would otherwise create an impermissible Category I(a) conflict can continue to hold stock or similar ownership interest in a publicly held, widely traded Business if the value of the ownership interest, when aggregated with that of spouse and dependent children, does not exceed $10,000 and the ownership interest was acquired in a manner unrelated to the research.

5. While meeting the above criteria excepts a Faculty Member from what would otherwise be an impermissible Category I (a) or I (b) conflict, it does not except a Faculty Member from other conflict categories such as Category I (h) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.

1. The amount of money received by the Faculty Member for consulting relationships or honoraria from a given Business should not exceed $10,000 a year. Consulting relationships include contractual relationships with a Business (or from an agent or other representative of such Business), service on advisory boards and any other relationship whereby the Faculty Member receives, or has the right or expectation to receive, income from a Business in exchange for services. Honoraria include commissioned papers and occasional lectures (no more than four lectures a year) for which money is received, either directly or indirectly, from a given Business (or from an agent or other representative of such Business).

2. While meeting the de minimis criteria above excepts a Faculty Member from what would otherwise be a Category I(a) conflict, it does not exempt the Faculty Member from other possible conflict categories such as Category I(h) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.

Research Activities

(c) A Faculty Member conducting research externally that would ordinarily be conducted within the University or Hospitals.

Committee Participation

(d) A Faculty Member participating in the consideration by a committee of the FDA, other governmental agency, or private insurer of Clinical Research on a Technology which is owned by or contractually obligated to a Business in which that Faculty Member, a member of his/her Family, or an Associated Entity has a Financial Interest.

External Activities

(e) A full-time Faculty Member assuming an Executive Position in a for-profit Business engaged in commercial or research activities of a biomedical nature.

(f) A Faculty Member making clinical referrals to a Business in which such Faculty Member, a member of his/her Family, or an Associated Entity has a Financial Interest.

(g) A Faculty Member possessing a Financial Interest in a Business which competes with the services provided by the University or any Hospital with which the Faculty Member is affiliated.

Public Disclosure

(h) A Faculty Member publishing or formally presenting research results, or providing expert commentary on a subject, without simultaneously disclosing any Financial Interest in a Business which owns or has a contractual relationship to the Technology being reported or discussed or which sponsors the research being reported or discussed.

Administrative Responsibilities

(i) A Faculty Member taking administrative action within the University or any affiliated Hospital which is beneficial to a Business in which he/she has a Financial Interest.

Applicants for Public Health Service and/or National Science Foundation Non-Clinical Research Funding

(j) Under federal regulations⁽³⁾ a Faculty Member who is an applicant for Public Health Service and/or National Science Foundation funding for non-Clinical Research has a potential conflict under the federal regulations, if the Faculty member, spouse and/or dependent children have a "significant financial interest", which could directly and significantly affect the design, conduct or reporting of the federally funded research. A Faculty Member who is an applicant for Public Health Service and/or National Science Foundation funding for Clinical Research is covered by Category I(a) above.

"Significant Financial Interest" for Category I(j) Conflict

For the purposes of a Category I(j) conflict, as defined above, a "significant financial interest" consists of "anything of monetary value" from the Business, including salary, consulting fees, honoraria, equity interests and intellectual property rights, with the exception of salaries, royalties and remuneration from University or an affiliated Hospital, honoraria for presentations sponsored by public or non-profit entities or income from service on advisory or review panels for public or non-profit entities. Also excepted for the purposes of a Category I(j) conflict are salary, royalties or other payments that, when aggregated for the Faculty Member, spouse and/or dependent children, are not expected to exceed $10,000 over the subsequent twelve months and equity interests, that, when similarly aggregated, do not exceed $10,000 in value or, if the monetary value cannot be ascertained, 5% ownership interest in the business.

Resolution of Category I(j) Conflict

A Category I(j) conflict as defined above must be resolved by management, reduction or elimination, prior to the expenditure of funds from the Public Health Service and/or National Science Foundation. Possible resolution of Category I(j) conflicts may include, but is not limited to, public disclosure of the significant financial interest, monitoring of research by independent reviewers, modification of research plans, disqualification from participation in Public Health Service and/or National Science Foundation funded research, divestiture of the significant financial interest, and severance of relationships that create the Category I(j) conflict.

CATEGORY II  Activities that are Ordinarily Allowable Following Disclosure and, Where Necessary, the Implementation of Oversight Procedures:

Research Activities

(a) A Faculty Member Participating in Clinical Research on a Technology developed by that Faculty Member or a member of his/her Family, unless the activity falls under the guidelines of Category I.

(b) A Faculty Member assigning students, post-doctoral fellows or other trainees to projects sponsored by a for-profit Business in which the Faculty Member, a member of his/her Family, or an Associated Entity has a Financial Interest, unless the activity falls under the guidelines of Category I.

Board Memberships

(c) A Faculty Member serving on the Board of Directors or Scientific Advisory Board of a Business from which that Faculty Member or a member of his/her Family receives University- or Hospital-supervised Sponsored Research support or with which the University has a substantial contractual relationship known to the Faculty Member, unless the activity falls under the guidelines of Category I.

External Activities

(d) A Faculty Member assuming an Executive Position in a not-for-profit Business engaged in commercial or research activities of a biomedical nature.

CATEGORY III  Activities that are Routinely Allowable:

(a) A Faculty Member receiving royalties for published scholarly work and other writings.

(b) A Faculty Member receiving royalties under institutional royalty-sharing policies.

MENTORS' OBLIGATIONS TO STUDENTS AND TRAINEES IN INDUSTRIAL SPONSORED RESEARCH

(a) Trainees (medical students, graduate students and post doctoral fellows) must always be encouraged to conduct research in areas that optimize their training. Special care must be taken to assure that a trainee's research is not designed to (and does not apear to) enhance their mentor's Financial Interest, and is not adversely affected by that interest or by contractual aspects of the Sponsored Research agreement that inhibit scientific communication or that commit intellectual property rights to the industrial sponsor.

(b) Before embarking on a research project, a trainee must be provided by the mentor with a clear description of 1) any corporate support of the research to be undertaken, 2) any personal Financial Interest the mentor has in a sponsoring Business, and 3) any restrictions that might be imposed on the scientific communication of the data.

(c) Written approval must be obtained before a trainee can be assigned to conduct research which is sponsored by a Business or which involves a Technology to which the Business has license rights, and in which the mentor has any Financial Interest.

1. In the case of graduate students (Ph.D., M.D./Ph.D., M.P.H., and D.M.Sc. candidates), permission must be given by the chairperson (or desginated Faculty member or committee) for the graduate program and by the mentor's department chairperson.

2. In the case of medical and dental students (M.D., and D.M.D. degree candidates), permission must be given by the mentor's Medical School department chairperson. Additionally, for research in the Quadrangle departments, permission must be give by the Executive Dean for Academic Programs. For research in the Hospital, permission must be given by the appropriate Faculty Dean.

3. In the case of postdoctoral fellows, permission must be given by the mentor's Medical School department chairperson.

(d) A trainee may appeal his/her involvement in any industrially Sponsored Research or research which involves Technology to which a Business has license rights when the trainee believes that he or she is being adversely affected by any conflict of interest (real or apparent) resulting from the mentor's relations with the sponsoring Business or with any Business that may benefit from the trainee's research or from the Sponsored Research agreement. The appeal should be made as appropriate to the Executive Dean for Academic Programs, the Hospital's Faculty Dean, and or the School's or Hospital's Ombudsperson.

²The definition of 'Business' excludes the University, any affiliated hospital, any Private Medical Practice or any entity controlled by, controlling, or under common control with the University or affiliated hospital. (go back to source)

³Public Health Service Final Rule 42 CFR Part 50 and 45 CFR Part 94; National Science Foundation Rule 59 FR 3308 and 60 FR 35820. (go back to source)

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Guidelines for Conflicts of Interest

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