HMS Faculty Policy on Conflicts of Interest and Commitment

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Note: An Interim Policy Statement incorporates the 2010 recommendations of the Faculty Committee on Conflicts of Interest and Commitment, which was charged with reviewing the existing policy. The Interim Policy Statement supplements and, in the case of inconsistency, supersedes the below Policy on Conflicts of Interest and Commitment and shall be enforced until the final policy is issued.

Introduction

An important goal of the Harvard Faculty of Medicine is to make scientific discoveries that will benefit the sick and suffering. For many years the Faculty has worked hard to achieve this goal. In 1980, the United States Congress explicitly sanctioned and facilitated this process with the passage of legislation designed to stimulate the commercialization of faculty inventions by permitting academic institutions and scientists to benefit financially if their federally-sponsored research led to commercial products. Moreover, during the past decade the rate of growth of biomedical research has outpaced federal funding, compelling universities and hospitals to develop alternative sources of revenue to support the expenses associated with their educational, research and clinical missions.

In response to these influences, biomedical research institutions have cultivated a growing variety of relationships with industry which promise to benefit the public as well as the institutions themselves, their faculty and staff, and their industrial partners. Over the last several years, these relationships have grown substantially, bringing new resources to the support of science and facilitating the translation of knowledge from the laboratory to the bedside. The Harvard Faculty of Medicine remains strongly committed to continued growth in these innovative and mutually beneficial relationships.

Together with these benefits, the growing partnership between for-profit enterprises and the University has created new possibilities for conflicts of interest. These conflicts arise from a faculty member's opportunities to benefit financially either from the outcome of his/her research or from the legitimate activities conducted in the course of his/her responsibilities as a faculty member. In light of these possibilities, there is emerging public concern regarding the appropriateness of some relationships between academic medicine and industry.

Public trust in the enterprise of academic medicine and the legitimacy of its powerful role in society require a constant amenability to public scrutiny. Consequently, it is necessary at this time to ensure the continued confidence of the public in the judgment of researchers and clinicians and in the dedication of academic research institutions to the integrity of the scientific enterprise. The strength of this assurance is based on two assumptions underlying the explicit rules and implicit norms governing faculty behavior at the Harvard Medical School:

  • that the vast majority of scientists are honest and conduct their research with the highest standards and integrity, and,
  • that, for the vast majority of cases, self-regulating structures and processes in science are effective.

Based on these assumptions, the Faculty of Medicine believes that with clear guidelines and principles, in conjunction with appropriate mechanisms for supervision and monitoring, cooperation between industry and academic medicine is consistent with the highest traditions of the medical profession and can energize scientific creativity.

This policy is intended to serve as a guide for faculty members in structuring their relationships with industry and other outside ventures in view of their academic responsibilities for teaching, research and patient care. Faculty members are expected to make reasonable inquiry as to whether their relationships and activities fall within the provisions of the policy. It is not the intent of this policy to regulate or eliminate all situations of conflict of interest, but rather to enable faculty members to recognize situations that may be subject to question and ensure that such situations are properly reviewed and, if necessary, resolved as applicable. Thus, an integral part of the policy is a disclosure mechanism whereby faculty members regularly review their activities. The guidelines are intended to maintain the professional autonomy of scientists and physicians inherent in the self-regulation of science. These guidelines should be viewed as complementing and elaborating upon the Faculty of Medicine's Statement on Research Sponsored by Industry.(1)

The policy fulfills two other purposes as well. First, it provides faculty members with meaningful guidance for the continued development and future structuring of productive relationships with industry. Second, by virtue of its explicit nature and provision for full disclosure, the policy will provide assurance to the faculty, the University, and most importantly the public, that such relationships have been examined and will be conducted in a manner consistent with institutional and public values. It is expected that these relationships will allow the University and its affiliated Hospitals to pursue energetically new knowledge in the biomedical sciences and to insure that the transfer of such knowledge to the care of patients is rapid and cost-effective.

Types of Conflicts

Conflicts of Commitment

With the acceptance of a full-time appointment in the Faculty of Medicine, an individual makes a commitment to the University (and Hospital, if part of a hospital-based department or other health-care institution) coipolicy(2) that is understood to be full-time in the most inclusive sense. Full-time members of the Faculty of Medicine are expected to devote their primary professional loyalty, time, and energy to their teaching, research, administrative responsibilities and, where applicable, patient care at the School and its affiliated Hospitals. Accordingly, they should arrange outside activities and financial interests so as not to interfere with the primacy of these commitments. The Faculty of Medicine 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 Medicine approves of such involvement. However, no more than twenty percent (20%) of a full-time faculty member's total professional effort may be directed to outside work, not to exceed the equivalent of one working day per week. Potential conflicts of commitment must be disclosed and resolved as described in the section on implementation in Appendix B.

Members of the Faculty whose appointments are less than full-time are expected to devote professional loyalty, time, and energy to their teaching, research, patient care, and administrative activities, in accordance with their agreed-upon time commitments.

Conflicts of Interest

A Faculty Member(3)is considered to have a conflict of interest when he/she, any of his/her Family, or any Associated Entity possesses a Financial Interest in an activity which involves his/her responsibilities as a member of the Faculty of Medicine. Included in these responsibilities are all activities in which the Faculty Member is engaged in the areas of teaching, research, patient care and administration.

Guidelines for Conflicts of Interest

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), I(b), I(c), and I(d) consist of relationships that are generally not allowable, with certain de minimis exceptions. Categories II(a) - (g) 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. Another classification (Category III) 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 IV) 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), (b), (c), and (d) 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

I(a) A Faculty Member Participating in Clinical Research on a Technology owned by or contractually obligated(4) to a Business(5)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 post-market royalties under institutional royalty-sharing policies.(6)

I(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. Sponsored Research (and the prohibition of equity ownership) is considered to have ended when the term of the Sponsored Research agreement has ended and publications reporting on the research are completed (or the decision made not to publish). It is the Faculty Member's responsibility to determine when that time has been reached.

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 $30,000 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. 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 II(e) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.

(b) A Faculty Member may consult for a Business in a situation which would otherwise create an impermissible Category I (a) conflict only if all of the following conditions are met:

  1. The amount of money received by the Faculty Member for consulting relationships, fees or honoraria from a given Business should not exceed $20,000 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 II(e) which imposes an obligation to disclose a Financial Interest in the research in any publication or presentation.

External Activities

I(c) A full-time Faculty Member is not permitted to take an Executive Position (responsible for a material part of the operations of a Business such as Chief Executive Officer, Chief Operations Officer, Scientific Director or Medical Director) in a for-profit Business engaged in commercial or research activities of a biomedical nature.

I(d) A Faculty Member who serves on the Board of Directors of a Business is not permitted to Participate in Clinical Research on a Technology owned by or obligated to the Business regardless of whether he/she has a Financial Interest in the Business and is not permitted to receive Sponsored Research from that Business regardless of whether he/she has an equity interest in the Business. This provision does not apply to a Faculty Member who is a member of a Scientific Advisory Board and who does not either hold an Executive Position or serve on the Board of Directors.

Category II

(a) - (g) Activities that May be Allowable Only after Disclosure, Review, and Approval by University or Affiliated Hospital with Advice from the Standing Committee When Requested:

Research Activities

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

Committee Participation

II(b) 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

II(c) 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.

II(d) 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

II(e) 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

II(f) 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 Research Funding

II(g) Under federal regulations(7)a Faculty Member who is an applicant for Public Health Service and/or National Science Foundation funding 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.

"Significant Financial Interest" for Category II(g) Conflict

For the purposes of a Category II(g) 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 II(g) 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 II(g) Conflict

A Category II(g) 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 II(g) 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 II(g) conflict.

Category III

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

Research Activities

III(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.

III(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. (See section on Mentor's Obligation to Students and Trainees below)

Board Memberships

III(c) A Faculty Member serving on the 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. See Category I(d) above.

External Activities

III(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 IV

Activities that are Routinely Allowable:

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

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

Mentors' Obligations to Students and Trainees

(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 appear 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) the source of funding of the research project, including any corporate support of the research to be undertaken, 2) any personal Financial Interest the mentor has in a Business, that sponsors the research, or has or is seeking licensing rights in the research or in the Technology being studied, 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 licensing rights, and in which the mentor has any Financial Interest.

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 desiginated Faculty member or committee) for the graduate program and by the mentor's department chairperson.

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 Dean for Academic and Clinical Programs. For research in the Hospital, permission must be given by the appropriate Faculty Dean.

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 Dean for Academic and Clinical Programs, the Hospital's Faculty Dean, and or the School's or Hospital's Ombudsperson.

(e) A Faculty Member must also disclose his or her Financial Interests in a Business that sponsors the research or which has or is seeking licensing rights in the research or in the Technology being studied, to members of the research laboratory and/or research team. This includes disclosure to prospective students, trainees, and new faculty before those individuals make a decision to join the laboratory or research team.

Appendix A—Operating Definitions

(a) An "Associated Entity" of a Faculty Member means any trust, organization or enterprise other than the University or any affiliated Hospital over which the Faculty Member, alone or together with his/her Family, exercises a controlling interest.

(b) "Business" means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes, but excluding the University, any affiliated Hospital, any Private Medical Practice, or any other entity controlled by, controlling, or under common control with the University or an affiliated Hospital.

(c) "Clinical Research" means any research or procedure involving human subjects in vivo or the use of human samples for the development and evaluation of patient therapies such as diagnostic tests, drug therapies, or medical devices. It includes early clinical studies, evaluative research, epidemiological studies and clinical trials. It excludes research using commercially obtained de-identified human cell lines as well as commercially obtained de-identified human tissue. It also excludes research that uses human tissue obtained from institutional tissue banks where the individual identifiers are unknown to the researcher. In general, the term includes all research required to be reviewed by an institution's Institutional Review Board.(8)

(d) "Executive Position" refers to any position which includes fiduciary and other responsibilities for a material segment of the operation or management of a Business. It specifically includes the titles of "Scientific Director" and "Medical Director".

(e) "Faculty Member" means any person possessing either a full- or part-time academic or fellowship appointment in the Faculty of Medicine. Full-time Faculty Members on sabbatical or other paid leave are considered full-time for the purposes of the Policy. Full-time Faculty Members on approved unpaid leave are not considered full-time for these purposes.

(f) The "Family" of a Faculty Member includes his/her spouse, minor/dependent children, and other persons living in the same household.

(g) A "Financial Interest" is an interest in a Business consisting of: (1) any stock, stock option or similar ownership interest in such Business, but excluding any interest arising solely by reason of investment in such Business by a mutual, pension, or other institutional investment fund over which the Faculty Member does not exercise control; or (2) receipt of, or the right or expectation to receive, any income from such Business (or from an agent or other representative of such Business), whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of Technology, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof.

(h) "Hospital" means a Harvard Medical School affiliated institution, including hospitals and health and research institutions.

(i) "To Participate" means to be part of the described activity in any capacity, including but not limited to serving as the principal investigator, co-investigator, study designer, research collaborator, provider of direct patient care, or author on a publication of the research study. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis), unless they are in a position to influence the study's results or have privileged information as to the outcome. This definition applies to a Faculty Member receiving sponsored research or participating in non-clinical research in the same way that it applies to a Faculty Member participating in clinical research, including such activities as collaboration, study design, and authorship.

(j) "Private Medical Practice" means the professional services rendered by a physician, including departmental practice plans, and the procedures integral to those services.

(k) "Sponsored Research"(9)means research, training and instructional projects involving funds, materials, or other compensation from outside sources under agreements which contain any of the following:

  1. The agreement binds the University or Hospital to a line of scholarly or scientific inquiry specified to a substantial level of detail. Such specificity may be indicated by a plan, by the stipulation of requirements for orderly testing or validation of particular approaches, or by the designation of performance targets.
  2. A line-item budget is involved. A line-item budget details expenses by activity, function or project period. The designation of overhead (or indirect costs) qualifies a budget as "line item."
  3. Financial reports are required.
  4. The award is subject to external audit.
  5. Unexpended funds must be returned to the sponsor at the conclusion of the project.
  6. The agreement provides for the disposition of either tangible or intangible properties which may result from the activity. Tangible properties include equipment, records, technical reports, theses or dissertations. Intangible properties include rights in data, copyrights or inventions.

(l) "Technology" means any compound, drug, device, diagnostic, medical or surgical procedure intended for use in health care or health care delivery.

Appendix B—Implementation

Standing Committee on Conflicts of Interest and Commitment

The Dean of the Faculty of Medicine will appoint a standing committee. This Standing Committee on Conflicts of Interest and Commitment will be comprised of representatives from both the clinical and preclinical faculty and will be responsible for reviewing cases which are brought to its attention by the Office of the Dean. It will review such cases and will make recommendations for conflict resolution to the Dean. The Committee will develop procedures for implementing the disclosure and approval process, the establishment of oversight protocols, and the handling of cases involving non-compliance and breach, and the designing of appropriate subsequent disciplinary actions.

The Standing Committee is responsible for reviewing the implementation of the policy on a regular basis and providing oversight to assure that the policy is applied consistently to the Faculty including both those based in the Quadrangle and those based in the affiliated Hospitals. The Standing Committee is responsible for reviewing cases which may be referred to it where the application of the policy to an individual is unclear. Finally, the Standing Committee will continue to review both the policies of other institutions and any government requirements in this area and to recommend changes to the policy when appropriate.

The Office of the Dean is responsible for overseeing the implementation of the policy by all affiliated institutions, including the process and mechanism for disclosure and resolution. 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/her 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 and, in the case of Hospital-based Faculty Members, the Hospital CEO. The Committee will also be available to advise affiliated Hospitals on the application of the guidelines to specific cases as disclosed by their Faculty.

Disclosure Process and Implementation

The Office of the Dean has the ultimate responsibility for confirming compliance by all Faculty Members with the policies of the Faculty of Medicine. Such responsibility extends not only to Quadrangle-based Faculty but also to Faculty based in the affiliated Hospitals.

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 Medicine. Each Hospital will designate a responsible office or individual to serve as a liaison representative to the Office of the Dean.
     
  2. All members of the Faculty of Medicine, both full- and part-time, are required to complete and submit a disclosure form on a regular 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. Individuals holding fellowship positions are not required to complete and submit a disclosure form unless they believe that they are involved in or may be involved in a situation which gives rise to a conflict of interest. The Office of the Dean is responsible for sending individuals who hold fellowship positions appropriate notification of their obligations under the policy.
     
  4. Disclosure forms should be returned to the Office of the Dean for initial review. The Office of the Dean will be responsible for providing the forms to the designated Hospital liaison representative for Hospital review.
     
  5. In consultation with the Office of the Dean, each Hospital will establish its own mechanism for review of the forms to ensure compliance with the disclosure process. This mechanism will include written reminders for Faculty Members to return disclosure forms, as well as statements encouraging Faculty Members to seek assistance in the event of questions or special circumstances. Offices providing such assistance will be designated in each of the Hospitals as well as in the Quadrangle. Regardless of the mechanism selected, disclosure forms which implicate any conflict category should be reviewed regularly by the department head.
     
  6. The disclosure forms will be considered strictly confidential, and it will be the responsibility of the designated offices in the Quadrangle and Hospitals to ensure that the information disclosed in the forms is available only to the individuals duly charged with the responsibility for review. Similarly, offices of department heads, the Dean and the President will be required to establish means for the preservation of confidentiality.
     
  7. In the case of Faculty Members who hold the positions of CEO (or equivalent title) of an affiliated hospital, Dean or Executive Dean of the Faculty of Medicine, or heads of departments, the regular, as well as interim, disclosure and review processes will proceed as follows:
    a) chairs of the preclinical departments will report directly to the Dean of the Faculty of Medicine;
    b) chairs of the clinical departments will report directly to the Hospital CEO, with copies to the Dean;
    c) the Dean and Executive Deans of the Faculty of Medicine will report to the University President;
    d) hospital CEOs (or individuals with equivalent title) will report to the Executive Committee of the Board of Trustees of the hospital, with copies to the Dean.

Review of Disclosure Forms

Following disclosure and upon receipt of disclosure forms from the Office of the Dean, each institution will review the forms for its Faculty and the Office of the Dean will review forms for Quadrangle-based faculty. Each institution will notify the Office for Research Issues in the Office of the Dean of the resolution of identified Category 1(a), 1(b), I(c), and I(d) conflicts as well as those instances that may require review and approval by the Standing Committee.

The CEOs and the department heads are expected to notify the Office of the Dean immediately of any cases that require review by the Standing Committee, no matter when the cases occur.

Establishment of Oversight Protocols

The hospital CEO (in the case of hospital-based Faculty) and the Standing Committee (in the case of Quadrangle-based Faculty) are responsible for designing and proposing appropriate oversight mechanisms. They are expected to seek advice from individuals outside as well as within their institutions in preparing such mechanisms. The associated rationale and details must be presented to the Office of the Dean for review and approval.

Implementation Process under Public Health Service and National Science Foundation Regulations

  1. Disclosure required by the Public Health Service and National Science Foundation regulations should be made on appropriate forms at the time of grant application submission to the appropriate offices in the Quadrangle and affiliated institutions.
     
  2. Resolution of impermissible Category I(a) and I(b) conflicts identified in the federal application disclosure process should be made by the appropriate Quadrangle or affiliated Hospital officials. Notice of such resolution should be forwarded to the Office for Research Issues in the Office of the Dean. The Standing Committee will review these and other resolutions as appropriate.
     
  3. Decisions as to the appropriate resolutions of Category II(g) conflicts identified in the federal application process should be made by the appropriate Quadrangle or affiliated Hospital officials. Notice of such resolutions should be forwarded to the Office for Research Issues of the Office of the Dean. The Standing Committee will not as a matter of course review such resolution decisions, but reserves the right to do so.
     
  4. In the case of Public Health Service funding applicants, appropriate Quadrangle and affiliated Hospital officials are responsible for notifying the Public Health Service, prior to the institution's expenditure of any funds under the award, of the existence, but not the nature, of a conflict and that the conflict will be managed, reduced or eliminated, at least on an interim basis, within 60 days after it is identified. Such officials are also responsible for informing the Public Health Service that corrective action has been or will be taken when an applicant Faculty Member does not comply with the policy.
     
  5. In the case of National Science Foundation funding applicants, appropriate Quadrangle and affiliated Hospital officials are responsible for certifying to the National Science Foundation that all identified conflicts have been satisfactorily managed, reduced or eliminated prior to the institution's expenditure of any funds under the award.

Compliance Responsibility

The Faculty of Medicine expects its members to comply fully and promptly with the policy, including the requirements of disclosure. However, it is anticipated that instances of technical non-compliance will occur. It will be the responsibility of the Standing Committee to make recommendations to the Office of the Dean for resolution of such cases.

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 Medicine and of the affiliated hospitals. 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 for grant applications, Institutional Review Board (IRB) approval, or supervision of graduate students;
  4. Non-renewal of appointment;
     
  5. Dismissal from the Faculty of Medicine.

Adopted by the Faculty Council, March 22, 1990
Amendments Adopted September 22, 1993
Amendments Adopted September 20, 1995

Adopted by the Harvard Medical Center, May 16, 1990
Amendments Adopted December 13, 1993
Amendments Adopted December 18, 1995

Amended May 25, 2000

Amended May 26, 2004

Footnotes:

1 See Statement on Research Sponsored by Industry. (back to source)

2 A similar parenthetical insert may be inferred throughout this document. (back to source)

3 A series of operating definitions of terms appearing with initial capital letters is found in Appendix A of this policy. (back to source)

4 By license or exercise of an option to license. (back to source)

5 The 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. (back to source)

6 The exemption for royalties under institutional royalty-sharing policies applies to post-market royalties through institutional royalty agreements and not to a Faculty Member's share in equity, licensing fees, milestones payments and other payments received by the institution as part of licensing or other agreements with a Business in which the investigator has a right to share, that are sometimes characterized as "royalties". A Faculty Member's share in such non post-market royalties should be considered to be personal Financial Interests and subject as such to the provisions of the Policy. (back to source)

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

8 In a time of increasing translational research, it is difficult to arrive at a definition of "clinical research" that precisely delineates research having a direct and immediate impact on human health. There may be pre-clinical studies, for example some kinds of research in animal models or certain translational research , that can have as direct an influence on human health as do clinical studies involving human subjects. While the recommended definition of "clinical research" does not include such pre-clinical research. Faculty Members and institutions should recognize the potential for conflict of interest where the Faculty Member has a related financial interest allowed under Category 1(b). (back to source)

9 Adopted from the Harvard University Principal Investigator's Handbook, 1988. (back to source)