HSPH Policy on Conflicts of Interest and Commitment

 

 

INTRODUCTION

NOTE REGARDING NONFACULTY ACADEMIC APPOINTEES

GUIDELINES

EXAMPLES

APPENDIX A - IMPLEMENTATION

APPENDIX B - GUIDELINES FOR RESEARCH PROJECTS UNDERTAKEN IN COOPERATION WITH INDUSTRY

 

 

 

INTRODUCTION

With the acceptance of a full-time appointment to the faculty of the School of Public Health, an individual makes a commitment to the School that is understood to be full-time. Every member is expected to accord the School his or her primary professional loyalty, and to arrange outside obligations, financial interests and activities so as not to conflict or interfere with this overriding commitment to the School.

At the same time, no one benefits from undue interference with the legitimate external activities of faculty members who fulfill their primary duties -- teaching at the University, conducting research under its sponsorship, and meeting the other obligations to students and colleagues that faculty must share. The Faculty of Public Health recognizes that the involvement of faculty members in outside professional activities, both public and private, often serves not only the individuals but also the School of Public Health. Instead of detailed rules or elaborate codes of ethics, the Faculty of Public Health therefore provides its members with guidelines on outside professional activities and commitments that leave as much discretion as possible to the individual. It is assumed that all faculty members will be alert to the possible effects of outside activities on the objectivity of their decisions, their obligations to the School of Public Health, and the School's responsibility to others.

The areas of potential conflict may be divided into two broad categories. The first relates to conflicts of commitment -- situations in which members' external activities, often valuable in themselves, interfere or appear to interfere with their paramount obligations to students, colleagues and the School. Faculty members are given great freedom in scheduling their activities with the understanding that their external activities will enhance the quality of their direct contributions to the School. The second is concerned with conflicts of interest -- situations in which members may have the opportunity to influence the School's research, teaching, service or business decisions in ways that could lead to personal gain or give improper advantage to their associates.

A Standing Committee on Professional Conduct, with broad representation from the various departments of the School, will be appointed by the Dean to advise him and individual faculty members on problems involving conflicts of interest and commitment. The responsibility for decisions and implementation of this Policy will belong to the Dean or his representatives.

Conflicts of Commitment

The Faculty of Public Health recognizes that its members may engage in outside professional work, and to the extent these activities serve the Faculty's interests, as well as those of the participant, the Faculty of Public Health approves of such involvement. However, excepting work performed in lieu of summer salary, faculty members should ordinarily, spend no more than 52 days per year (one day per week) in outside professional activities. Some outside work such as service on NIH Study Sections, committees of the NAS/NRC or IOM, or other public service activities may, to varying degrees, be considered part of a faculty member's responsibilities. On the other hand even public service efforts can become excessive. Therefore all outside activities must be disclosed on the attached form and discussed with the Dean if that seems appropriate.

Conflicts of Interest

A faculty member is considered to have a conflict of interest when he or she, or any of his or her family or any associated legal instrument such as a trust, possesses a significant financial interest in an activity which involves his or her responsibilities as a member of the Faculty of Public Health.

 

 

NOTE REGARDING NONFACULTY ACADEMIC APPOINTEES

With the acceptance of a nonfaculty academic appointment at the School of Public Health—as research scientist, research associate, research fellow, postdoctoral fellow, or visiting scientist—individuals are expected to adhere to this policy with the following exceptions:

1. Nonfaculty academic appointees are ineligible to engage in outside professional commitments without explicit permission from the appointee’s faculty supervisor, research unit head, center director, or department chair, and only when the activity is consistent with the appointee’s role and responsibilities.  While faculty members are entitled to 52 days per year of outside professional commitments, this allowance does not apply to nonfaculty academic appointees.  (See Conflicts of Commitment.)
2. Nonfaculty academic appointees who are making contributions to a grant as members of the research project staff or who are on a Harvard payroll, with the exception of those stipendee postdocs who are engaged in research for their own benefit or that of a third party (e.g., Takemi Fellows, Fogarty Fellows, Occupational Health Residency Program), must submit annual disclosure reports before reappointment or promotion paperwork will be processed. (See Compliance Responsibility.)

January 7, 2008

 

 

GUIDELINES

In the absence of specific rules (beyond the requirement of consultation), and in light of the difficulty of applying general statements of principle to specific cases, there follows a sampling of activities and situations that may present conflicts of interest or commitment. They are divided into three categories:

Category I. Activities that are ordinarily allowable because they are (a) accepted practices and (b) generally minimal in their personal financial impact.

Category II. Activities which will ordinarily be permissible following disclosure and, where necessary, the implementation of oversight procedures designed to ensure academic standards, intellectual values, and institutional integrity.

Category III. Activities that appear to present such serious problems that the burden of demonstrating their compatibility with policies of the School of Public Health rests with the faculty member, and which may be allowable with appropriate oversight only after disclosure, review and approval by the Dean on the advice of the Standing Committee on Professional Conduct.

Obviously, these classifications are somewhat arbitrary. They are not intended to serve as a rigid or comprehensive code of conduct or to define absolute 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 the Harvard School of Public Health in education, research, and service. Activities that might appear to be technically permissible but which tend to distort the pursuit and dissemination of knowledge or to undermine public confidence in faculty activities will not be allowed. Conversely, in those cases where an inflexible application of a rule would produce an excessive result, it is expected that the rule will be tempered with appropriate discretion. Hence, an integral part of the adaptation to the guidelines will be a process of interpretation and application by the Committee on Professional Conduct of the Faculty. By this process it is expected that a common institutional experience in the application of these guidelines will gradually evolve. Finally, the complexity of the subject matter is such that these guidelines and their ensuing interpretations should be formally reviewed annually.

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 Public Health. Therefore, students and trainees should not ordinarily participate in research that involves confidential or proprietary information or other information which would constrain their right to publish or communicate freely. In addition, 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 Public Health 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 included are the various Deans, Chairs of Departments, and Directors of Programs and Centers. While the guidelines are applicable to all faculty members, these individuals with great influence must take particular care not to become involved in research relationships that would lead to personal financial gain or that would adversely affect the professional or academic advancement of junior faculty members.

 

EXAMPLES

Examples of the categories may help clarify these general statements, although the list cannot include all potential problems and the separation into categories is somewhat arbitrary.

Category I. Activities That Are Clearly Permissible and May Be Pursued Without Consultation.

1.  
   1. Receiving royalties for published scholarly work and other writings.
   2. Accepting honoraria for commissioned papers and occasional lectures.
   3. Receiving royalties under institutional royalty sharing policies.
   4. Services as a consultant to outside organizations, provided that the time and energy devoted to the tasks are not excessive and the arrangements in no way inhibit publication of research results obtained within the University.
   5. Service on boards and committees of organizations, public or private, that does not distract unduly from School obligations.

Category II. Activities That Are Ordinarily Allowable Following Disclosure to the Dean or the Chair of the Standing Committee and, Where Necessary, the Implementation of Oversight Procedures.

1.  
   1. A faculty member assigning students, post doctoral fellows or other trainees into a research area from which the member hopes to realize financial gain, e.g. projects sponsored by a for-profit business in which the faculty member, a member of his or her family or an associated legal instrument such as a trust, has a significant financial interest, unless the activity falls under Category III.
   2. 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 or her family receives research support or with which the School has a substantial contractual relationship, unless the activity falls under Category III.

Category III. Activities That Seem Likely to Present an Unacceptable Conflict of Interest or Commitment But Which May be Allowable with Oversight After Disclosure, Review, and Approval by The Standing Committee on Professional Conduct and the Dean.

1. A faculty member participating in research on a technology owned by a business in which the faculty member has a consulting relationship, holds a stock or similar ownership interest, or has any other financial interest, other than receipt of University supervised research support or royalties under institutional royalty-sharing policies. This relationship applies to a faculty member's family or an associate legal instrument such as a trust.
2. A faculty member receiving sponsored research support from a business in which he or she, a member of his or her family, or an associated legal instrument such as a trust, holds a stock or similar ownership interest.
3. Circumstances in which a substantial body of research that could and ordinarily would be carried on within the University is conducted elsewhere to the disadvantage of the University and its legitimate interests.
4. Situations in which a faculty member serves as an officer or assumes managerial responsibility in an outside organization.
5. A faculty member possessing a financial interest in a business which competes with services provided by the University.
6. Use for personal profit of discoveries emanating from University research or other confidential University sources; or assisting an outside organization by giving it exclusive access to such information; or consulting under arrangements that impose obligations that conflict with University patent policy or with the institution's obligations to a research sponsor.
7. A faculty member publishing or formally presenting research results, or providing expert commentary on a subject, without simultaneously disclosing any financial interest relating to such results or such subject.
8. A faculty member taking administrative action within the University which is beneficial to a business in which he or she has a significant financial interest.

APPENDIX A
IMPLEMENTATION

The Office of the Dean is responsible for overseeing the implementation of the policy, including the process and mechanism for disclosure. This Office will review all breaches of the disclosure process, including (a) failures to comply with such process, whether by virtue of a faculty member's refusal to respond or by his responding with incomplete or knowingly inaccurate information, (b) failures to remedy conflicts, and (c) failures to comply with a prescribed oversight plan.

Such cases will be forwarded to the Standing Committee for review. Based on its review, the Committee will make recommendations to the Dean for further action. In all cases, faculty members will be provided the explicit opportunity to respond in person and in writing to the issues raised in the course of such review. Any such written response will be appended to the Committee's report for review by the Dean.

DISCLOSURE PROCESS

The Office of the Dean has the ultimate responsibility for confirming compliance by all faculty members with the policies of the Faculty of Public Health.

Submission of Disclosure Forms

1. The Office of the Dean is responsible for the dissemination, collection and review of the disclosure forms for members of the Faculty of Public Health.

2. All members of the Faculty of Public Health, both full- and part-time, are required to complete and submit a disclosure form on an annual basis. Updated forms must be submitted throughout the year if changes arise which the faculty member believes may either: (a) give rise to a conflict of interest, or (b) eliminate a conflict previously disclosed.

3. Disclosure forms should be returned to the Office of the Dean. The disclosure forms will be considered strictly confidential and it will be the responsibility of the Office of the Dean to ensure that the information disclosed in the forms is available only to the individuals duly charged with the responsibility for review.

Establishment of Oversight Protocols

The Standing Committee is responsible for designing appropriate oversight mechanisms. It is expected to seek advice from individuals outside as well as within HSPH in preparing such mechanisms. The associated rationale and details must be presented to the Office of the Dean for review and approval.

COMPLIANCE RESPONSIBILITY

The Faculty of Public Health expects its members to comply fully and promptly with the policy, including the requirements of disclosure. Instances of deliberate breach of policy, including failure to file or knowingly filing an incomplete, erroneous, or misleading disclosure form, violations of the guidelines, or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures of the Faculty of Public Health. Possible sanctions will include the following:

1. Formal admonition;

2. The inclusion in the faculty member's file of a letter from the Office of the Dean indicating that the individual's good standing as a member of the Faculty has been called into question;

3. Ineligibility of the faculty member to apply for grants or to supervise graduate students;

4. Non-renewal of appointment;

5. Dismissal from the Faculty of Public Health.

 

APPENDIX B
GUIDELINES FOR RESEARCH PROJECTS UNDERTAKEN IN COOPERATION
WITH INDUSTRY

The Harvard University Faculty of Public Health welcomes industrially supported research agreements which stimulate its investigators, promote technological transfer, and provide the University with valuable support. At the same time, it recognizes the need to avoid arrangements that might compromise, or seem to compromise, its intellectual principles and purposes and the freedom of inquiry the members of the Faculty enjoy.

These guidelines outline some general principles -- concerning how and why research is conducted within the School of Public Health -- with which all research agreements with for-profit external sponsors (referred to, hereafter, as industrially-supported research agreements) should conform.

I. Conduct of Research

The exchange of information and the discussion and interchange of ideas are basic elements of all University research. Agreements to perform secret research in Harvard laboratories are unacceptable.

A. The proscriptions on secrecy in industrially-sponsored research agreements must conform with those that apply to federally-sponsored research. If a research project involves confidential information that would inhibit free and open interactions among scholars, the University should not accept it.

B. It is essential that the research of students and postdoctoral-fellows-in-training contribute, and be perceived to contribute, to their scholarly development. Even as individuals, they should not ordinarily participate in agreements that involve confidential information or otherwise constrain the right to publish or communicate freely. Exceptions consistent with the principles of the Faculty of Public Health should be approved in advance in writing by the student's department chairperson or at a higher level. In addition, departments should periodically review the work of students engaged in industrially-sponsored research to see that the educational commitment of the University to its students is maintained.

C. Agreements may permit industrial sponsors to examine completed manuscripts for potential inventions or discoveries on which patent applications should be filed, but agreements may not restrict the rights of investigators to publish their findings nor to communicate their research results freely in other ways consistent with ethical and professional standards.

Although agreements may recognize the need to protect inventions from "disclosure" prior to the filing of a patent application, agreements to treat University-based research as confidential, to withhold publication or delay it significantly, or to permit sponsors to modify materials submitted for publication are unacceptable.

D. The responsibility for the design and conduct of research programs and flexibility in directing them must remain with principal investigators. Sponsors may consult on matters of mutual concern but they may not dictate how research shall proceed.

E. Proposals for research to be funded by industry must be approved by appropriate departmental authorities.

F. Faculty members should be informed of the existence of industrially-sponsored research agreements in their departments, and any special provisions in such agreements should be explained to them.

G. General information on the subject, duration, funding sources, and budget of each industrially-sponsored research agreement should be openly available, along with information on whether there are any associated exclusive or nonexclusive patent agreements or other restrictions on open communication. Publications should identify explicitly industrially-sponsored research.

H. The support of a major portion of a faculty member's research by a single corporate sponsor is generally undesirable; whenever such support is permitted, the research should be periodically reviewed and approved by the Dean.

I. It is expected that these guidelines on free and open exchange of information will be followed in all instances that involve concepts, processes, products, and other information about natural phenomena. There may, however, be situations (for example, studies involving records of individuals or identifiable industrial organizations, or university-coordinated educational programs of an apprenticeship character) where exceptions to these guidelines are consistent with the University's educational, professional, and scholarly principles. Such exceptions should be granted only after detailed review by the Dean with advice from appropriate faculty committees, and the reasons should be publicly explained.