HSPH Implementation Plan for the Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments
This Plan implements, on behalf of the Harvard School of Public Health (the “School”), the Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments (the “University Policy”), as voted and approved by the President and Fellows of Harvard College on May 26, 2010. Holders of faculty and teaching appointments at the School are responsible for maintaining familiarity with the University Policy and this Plan and complying with both.
The following Governing Principles, as articulated in the University Policy, should guide the conduct of School faculty and inform the application of this Plan:
- Society grants special privileges to universities and their faculty in return for their contributions, especially in fulfilling their role as independent arbiters of knowledge. With these privileges come special responsibilities and standards of conduct.
- Societal trust in the University depends upon the independence, integrity, and transparency of the University’s endeavors, and the University must, accordingly, practice responsible and vigilant self-governance to ensure that it remains trustworthy.
- The University’s missions as well as the public interest are served by responsible interactions between faculty members and others (including government, business, and other organizations and individuals), with a view towards stimulating and nurturing research and education, the development and beneficial application of policies and technologies, and the pursuit of other scholarly and educational activities.
- Independent inquiry and the publication of scholarly findings are vital to the integrity and objectivity of research.
II. DEFINITION OF INDIVIDUAL FINANCIAL CONFLICT OF INTEREST
We define an individual financial conflict of interest as:
A set of circumstances that reasonable observers would believe creates an undue risk that an individual’s judgment or actions regarding a primary interest of the School will be inappropriately influenced by a secondary financial interest.
It is important to understand that a financial conflict of interest is a matter of objective circumstance. It does not depend on the character or actions of the individual. It exists (or does not exist) regardless of whether it is operative; that is, whether it is in fact influencing an individual’s judgment or actions. To recognize the existence of a financial conflict of interest is not to pass judgment on the character or actions of an individual and does not per se imply wrongdoing.
III. STANDARDS OF CONDUCT
A. Avoidance of Financially Conflicting Interests. The educational and research activities of the School should be motivated primarily by a concern for the advancement of knowledge and the pursuit of truth. Accordingly, faculty members should not permit outside activities and financial interests to compromise their primary commitment to the missions of the School and to the highest intellectual and ethical standards in discharging their academic responsibilities. They should refrain from actions that could reasonably bring discredit upon Harvard and their own academic and scholarly integrity, and they should avoid circumstances that reasonable observers would believe create an undue risk that the prospect of direct or indirect personal financial gain could inappropriately influence faculty members’ judgment or actions in fulfilling their School duties.
B. Compliance with Laws. Faculty members must comply with all state and federal requirements applicable to financial interests in research or other academic activities, including but not limited to licensure and professional conduct standards, financial disclosure requirements, laws concerning “finder’s fees” for research subjects, prohibitions against insider trading, and statutes and regulations concerning conflicts of interest.
1. Federal agencies have promulgated regulations that address conflicting financial interests in research and contracting, including the U.S. Public Health Service (42 C.F.R. §§ 50.601, et seq., and 45 C.F.R. §§ 94.1 et seq.) and the Food and Drug Administration (21 C.F.R. §§ 502 et seq.). In addition, the National Science Foundation has essentially adopted the PHS rules in NSF Award and Administration Guide, Chapter IV.A (NSF 10-1), published at 60 Fed. Reg. 35820 and here.
C. Free Inquiry and Intellectual Exchange. The free and open exchange of ideas and the results of scholarly activities is the essence of academic freedom and is fundamental to the integrity of the University as a community of scholars. Faculty members must foster an atmosphere of academic freedom by promoting the free, open, and timely exchange of results of scholarly activities. Financial conflicts of interest cannot be permitted to undermine independent inquiry or uncensored publication of ideas and findings.
1. Agreements with commercial enterprises that sponsor academic work must comply with the University’s “Principles Governing Commercial Activities of Harvard University, with application to Partnerships between the University and Outside Organizations.” “Commercial enterprises,” for this purpose, are for-profit and not-for-profit entities whose activities involve a substantial commercial element.
2. Faculty members must not be induced by financial interests to (1) give outside sponsors or other organizations or individuals authority to direct their studies or to restrict or unreasonably delay the release or publication of research results, or (2) participate under the aegis of the University in scholarly activities whose existence, methods, purpose, or results are held confidential. Although this second prohibition does not apply to projects undertaken as part of a faculty member’s permissible outside activities, faculty should avoid entangling outside projects with their academic duties in ways that could subject members of the University community to improper constraints (for example, by assigning students or trainees to work for academic credit on outside projects that require their ideas or scholarly products to be held in confidence).
3. The obligation of faculty to promote the free, open, and timely exchange of the results of scholarly activities should not be construed to be inconsistent either with protections of individual or group privacy and confidentiality required by regulation, ethical standards, or professional codes of conduct, or with legal protections accorded intellectual property and confidential or proprietary information.
4. To respect privacy interests, it is often necessary to provide the source of non-publicly available information the right of prior review, or even approval, of the final work product. Similarly, the University may agree to provide sponsors with copies (or drafts) of publications up to thirty (30) days in advance of submission for publication or up to thirty (30) days in advance of the anticipated publication date. When necessary, and extension of thirty (30) days is permitted, per the University’s Policy on Publications: http://vpr.harvard.edu/sites/vpr.harvard.edu/files/news/Publication%20Policy%20FINAL%201%2022%2011mb.pdf However, if there is a financial relationship between the faculty scholar and the source of the information or materials, a financial conflict of interest exists and must be disclosed, reviewed, and adjudicated under the Plan.
D. Instruction and Advising of Students. “The student-faculty relationship lies at the heart of the academic enterprise.”  A faculty member’s outside financial interests should not adversely influence his or her instruction, guidance, or supervision of students, trainees, or post-doctoral fellows. Academic assignments to students, trainees, and post-doctoral fellows should principally serve their interests in learning, self-development, and satisfaction of requirements for academic advancement. Faculty should not assign students, trainees, or post-doctoral fellows to participate in research projects or other scholarly projects that constrain or could constrain their ability freely to discuss, defend, and publish their research. Without the prior approval of the Dean, no faculty member may assign any student, trainee, or post-doctoral fellow to any research project or other scholarly project in which the faculty member or a member of his or her family has a financial interest directly or through an outside entity. Further, a faculty member must ensure that the work of students, trainees, and post-doctoral fellows is not exploited in service of the faculty member’s outside activities.
1. When the subject matter of a faculty member’s instruction of and assignments to students, trainees, and post-doctoral fellows overlaps with the subject matter of the faculty member’s outside activities, the faculty member must exercise special care to avoid exploiting student work or subordinating the prerogatives and interests of his or her students to such activities. To this end, faculty members must disclose to their students their activities with and obligations to outside entities that could benefit from the students’ work or ideas and should allow the students ready access to information about the faculty members’ sources of funds that support the students’ research or scholarly work.
2. The restriction on assigning students to research projects in which a faculty member has a financial interest does not include research projects in which the faculty member’s “financial interest” is entirely aspirational or speculative. At some point in the commercial development of a licensed technology, however, the inventor may realize a sufficient financial interest to trigger the requirement of decanal approval prior to assigning students to follow-on research. If uncertain about the application of this restriction, faculty members should seek advice and/or approval from the Dean.
3. Faculty members should not, directly or through an outside entity under their substantial control (or under the substantial control of a family member), employ or enter into commercial relationships with students who are concurrently enrolled in their classes or for whom they serve as assigned faculty advisors. This restriction does not apply to the practice of hiring students to assist with a faculty member’s academic duties, for example, as research or teaching assistants; nor does it prohibit a faculty member from hiring students to assist in the preparation or editing of a scholarly text. (Note, however, that a faculty member may not assign students to work on such tasks without prior approval by the Dean.)
4. Faculty members should not be employed by or enter into a commercial relationship with a current student or an entity substantially controlled by the student. A commercial relationship for these purposes includes, but is not limited to, the ownership of stock, stock options, or other equity.
E. Supervisory Responsibility. Faculty members in positions of academic seniority or administrative authority must maintain the highest level of ethical integrity in carrying out their supervisory responsibilities. A faculty member’s outside financial interests should not influence his or her supervision, mentoring, evaluation, or direction of other faculty or staff. Faculty must not exploit junior faculty or staff in service of the faculty members’ outside activities or otherwise to realize personal financial gain.
F. Disclosure. To promote the transparency essential to societal trust in the School and its faculty, faculty members receiving financial support for their academic work, or having financial interests in or related to the subject matter of the work, are expected to disclose such interests and sources of support in all publications, public reports, communications to the media, and formal presentations, written or oral, concerning that work and to comply with the disclosure requirements of their professional journals and societies. Disclosure of support and financial interests is also expected when faculty members are sought as experts to inform the public on matters of concern and to help shape public policy. None of the above provisions is intended to compromise professional duties of confidentiality or violate confidentiality protections dictated by law or professional codes of conduct.
1. Faculty members are often sought as experts to inform the public about matters of concern, to help shape public policy, and, more generally, to legitimate knowledge. When addressing the public, faculty members usually act in their individual capacity and, in many instances, are engaged in the “private” sphere of their permissible consulting activities. While faculty members will not be acting on behalf of the School in any of these roles, the public ordinarily will not appreciate this distinction. Accordingly, actions in that sphere that bring discredit upon the faculty member have the potential to injure the School’s reputation as well. Public expectation of transparency is justifiably high when Harvard faculty serve as expert advisers to governmental entities. Faculty in such roles should be mindful of this Standard of Conduct and disclose financial interests and sources of financial support that could be seen as biasing.
2. Disclosure may also be advisable when the content of lectures intended for student audiences includes subject matter in which the lecturer holds a financial interest.
3. Faculty members are expected to comply with the School’s disclosure requirements irrespective of, and in addition to, the disclosure requirements of their professional journals and societies.
G. Use of School Resources. Faculty members may not use School resources, including confidential information or – other than in a purely incidental way – facilities, personnel, or equipment to support their outside consulting activities or for any other purposes that are unrelated to the education, research, scholarship, and public service missions of the School. Use of the Harvard name by faculty members must comply with regulations set forth in existing University policies. Use for personal profit of unpublished information emanating from School research or other confidential School sources, or assisting an outside organization by giving it exclusive access to such information, is prohibited.
1. Resources shared with other members of the Harvard community (e.g., library materials, studios, support staff) must be available for uses related to School activities ahead of uses related to a faculty member’s outside activities.
2. Inappropriate use of School resources includes the following:
- More than incidental use of School staff on a faculty member’s outside consulting or business activities without prior approval by the Dean.
- Granting outside entities access to Harvard resources or services for purposes unrelated to sanctioned School activities.
- Unilaterally appropriating patentable inventions or protectable software rather than disclosing such products to the Office for Technology Development for its determination of ownership in accordance with the University’s “Statement of Policy in Regard to Intellectual Property.”
- Using for personal gain, or granting others unauthorized access to, confidential information acquired through conduct of School business or research activity, including, for example: medical, personnel, or security records of individuals; proprietary knowledge about the corporate affairs or business dealings of the School; and information from public agencies concerning contract awards or regulatory decisions in advance of their public release date.
- Providing preferential access to research results, materials, or products generated from School teaching or research activities to an outside entity for personal financial gain. (This would not preclude appropriate licensing arrangements for inventions, or consulting on the basis of sponsored project results where there is significant additional work or expertise involved.)
IV. IMPLEMENTATION DETAILS
- Academic Activity means research, scholarship, teaching, School service, or public service in which a Covered Individual engages in conjunction with his or her School duties.
- Conduct Research means participate in the direction, design, implementation, analysis, or reporting of research, and, when human research participants are involved, in the enrollment of subjects and determination of their initial and continuing eligibility to participate.
- Covered Individual means an individual holding a full- or part-time faculty or teaching appointment at the School, as well as any individual, regardless of title or position, who is responsible for the design, conduct, or reporting of research. In the circumstances specified in paragraph 6 of Section D below, Covered Individual shall include an individual holding a visiting faculty or teaching appointment at the School.
- Designated Institutional Official (“DIO”) means the Senior Associate Dean for Academic Affairs. The DIO and the Committee on Professional Conduct (“CPC”) will oversee and be accountable for the general implementation and enforcement of the Implementation Plan.
- Disclosure means a release of information about Significant Financial Interests to parties responsible for the School’s and University’s Financial Conflict of Interest review and management processes.
- Equity means stock, stock options, warrants or other ownership interests.
- Family Member means spouse or spouse equivalent and dependent children.
- Fiduciary or management role means service as an officer, director or service on an advisory board (including scientific advisory boards). Per D.5. below, individuals may need prior approval from the Dean before assuming such responsibilities. Fiduciary or management role does not mean service on an editorial board.
- A Financial Conflict of Interest is a set of circumstances that reasonable observers would believe creates an undue risk that an individual’s judgment or actions regarding a primary interest of the School will be inappropriately influenced by a secondary financial interest.
- Financially Conflicted Individual means a Covered Individual who has been determined by the DIO to have a Financial Conflict of Interest.
- Human Subjects Research includes all research meeting the definition of “research” performed with “human subjects” as these terms are defined in the federal Common Rule (45 C.F.R. Part 46 [Public Health Service] and 21 C.F.R. Part 56 [Food and Drug Administration]), regardless of the source of research funding or whether the research is otherwise subject to federal regulation.
- Internal Confidential Disclosure means the provision of information about Significant Financial Interests by a Covered Individual to the DIO or the transmission of such information within institutional channels.
- Related Academic Activity refers to an Academic Activity whose performance could be affected by a Covered Individual’s outside financial interests.
- Related Outside Entity means an entity that may, or may reasonably appear to an outside observer, to influence the discharge of teaching, research, or other University-related responsibilities. In determining relatedness, investigators should employ a standard of common sense, and when in doubt, disclose. Examples of entities that might, or might appear to, exercise influence include those:
(1) whose products, services or activities are related to the areas of an investigator’s teaching or research;
(2) that fund research in an investigator’s area of academic interest;
(3) that own or have rights to develop intellectual property that is the subject of research in which an investigator participates;
(4) that compete commercially with such an entity as described in (3);
(5) that make or propose to make a gift to the University that would support an investigator’s teaching or research activities;
(6) that furnish products or services to the University through a contractual process in which an investigator participates in any way;
(7) that propose to enter a licensing agreement with the University with respect to technology invented by the investigator;
(8) that act as a legal or de facto agent for any outside entity engaged in any of the above activities.
- Significant Financial Interests are financial interests that must be included in a Covered Individual’s disclosure of financial interests. “Financial Interest” includes, but is not limited to, (1) financial compensation, including travel, from consulting, employment, managerial, and fiduciary relationships above $5,000; (2) equity and other financial interests above $5,000; (3) equity interests of any amount, or entitlement to the same, in a non-publicly traded, for-profit, entity; and (4) intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests. Financial Interests are to be disclosed if they relate in any way to the Covered Individual’s School or University responsibilities.
Exceptions. Significant Financial Interests do not include the following:
o Interests of any amount in diversified financial holdings (e.g., mutual funds or pension funds) that are not controlled, influenced, or managed by the Covered Individual.
o Payments to the School, or via the School to the Covered Individual, that are directly related to reasonable costs incurred in the conduct of the Covered Individual’s Academic Activity (as may be specified in an agreement between the sponsor and the School).
o Salary or other remuneration from the School.
o Income from seminars, lectures, or teaching engagements sponsored by public and 501(c)(3) entities.”
o Income from service on advisory committees or review panels for public and 501(c)(3) entities.”
o Royalties or other income received from an independent publishing company for authoring, editing, or reviewing publications (print or electronic).
B. Designated Institutional Official.
1. Appointment. Federal rules require PHS- and NSF-funded institutions to appoint an institutional official to review financial interests in agency-sponsored research. To meet this requirement, the Dean shall appoint a Designated Institutional Official (“DIO”) who shall also be responsible and accountable for the implementation of this Plan. The DIO may be assisted by other School officials and by a standing faculty Committee on Professional Conduct.
2. Responsibilities. The DIO shall be responsible for performing the following functions:
- Review disclosures of financial interests submitted by Covered Individuals in accordance with the principles and procedures set forth in Section E below.
- Formulate recommendations for disposition of financial conflicts of interest, including management and oversight plans in accordance with the principles and procedures set forth in Section F below.
- Review requests from Covered Individuals to reconsider DIO decisions concerning disclosed financial interests.
- Prepare a summary report, in any instance in which a Covered Individual is determined to have a Financial Conflict of Interest, that documents the DIO’s findings (including findings upon reconsideration), the bases for the findings, and the disposition of the conflict of interest, including plans for management and oversight.
- Provide copies of the summary report to institutional officials and bodies with a need to know (e,g., Institutional Review Board, Institutional Animal Care and Use Committee, Office of Technology Development).
- Oversee and be accountable for the implementation and enforcement of this Plan, and recommend modifications of the Plan to enhance its effectiveness.
C. Conflict of Interest Committee.
1. Composition. The DIO shall appoint a Committee on Professional Conduct (“CPC”) composed of Faculty members and of School officials experienced in the oversight of research, scholarship, and training and familiar with applicable laws, regulations, and institutional policies. Members shall be appointed to staggered renewable three-year terms.
2. Responsibilities. As directed by the DIO, the CPC shall review faculty members’ annual and ad hoc financial interest disclosures and shall advise the DIO as to their disposition.
D. Internal Confidential Disclosure of Financial Interests and Related Outside Professional Activities.
1. Annual disclosure and certification. Upon initial appointment and, thereafter, on or before February 15of each year, Covered Individuals shall disclose electronically their Significant Financial Interests and related outside professional activities, using the prescribed disclosure document. (Covered Individuals who are “Senior Officials” within the meaning of the “Harvard University Policy on Conflicts of Interest and Commitment for Senior Officers and Administrators” are exempt from disclosure obligations under this Plan but must annually file with the Office of the General Counsel the reports required by the cited policy and file a copy of such report(s) to the DIO.) The School reserves the right to request additional information and supporting documentation as needed. Covered Individuals who have no Significant Financial Interests shall certify to that fact in their disclosures. Covered Individuals shall also affirm in their disclosures that they have reviewed, and are in compliance with, the requirements of the “Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments” and with this Plan.
2. Updates of annual disclosures. Covered Individuals shall update their annual disclosures of financial interests and related outside professional activities promptly upon becoming aware of circumstances, existing or reasonably anticipated, that would cause their original disclosures to be materially incomplete or inaccurate. Whenever possible, Covered Individuals should submit updates in advance of material changes in order to permit timely review by the DIO.
3. Ad hoc transactional disclosures. Covered Individuals who have a Significant Financial Interest in, or outside professional activities on behalf of, a related outside entity, regardless of whether the interest or activity is already identified in a submitted annual disclosure, shall call the attention of the DIO to the interest or activity on an ad hoc basis upon becoming aware that the School or University (including a University subsidiary or University-affiliated hospital) is considering entering into any of the following transactions with the outside entity or with a third party acting as the legal or de facto agent of the outside entity:
- A gift from the related outside entity in support of the Covered Individual’s teaching or research responsibilities.
- A sponsored research agreement to fund research in which the Covered Individual participates or proposes to participate or involving investigation of a technology (a device, product, compound, method, etc.) owned by or contractually obligated to the related outside entity. (Covered Individuals may also have certification obligations to the School’s Sponsored Research Administration office. No sponsored project application may be submitted by the School or University (including a University subsidiary or University-affiliated hospital) unless each Covered Individual who would Conduct Research under the proposal has on file an up-to-date and complete annual financial interest disclosure. Similarly, no awarded project funds may be received by the School or University (including a University subsidiary or University-affiliated hospital) unless the annual financial disclosure on file for each Covered Individual who would Conduct Research under the proposal is, at that time, up-to-date and complete.
o Note that if an outside entity proposes to sponsor research on a technology, and a Covered Individual who proposes to participate in the research has a Significant Financial Interest with respect to the technology under investigation, the Covered Individual must bring this financial interest to the attention of the DIO.
- A contract for products or services from the outside entity, if the Covered Individual participates or anticipates participating in the selection and contracting process in any way.
- A licensing agreement for the development or exploitation of a technology invented by the Covered Individual. (Covered Individuals may also have disclosure obligations to the Office of Technology Development under the University’s “Policy Statement Regarding Application of Harvard University’s Conflict of Interest Policies to the Granting of Licenses.”)
Covered Individuals proposing to serve as principal investigator or co-investigator under a sponsored research agreement shall indicate on the institutional routing sheet whenever they have a Significant Financial Interest in the sponsoring entity or, in the case of research involving a product or technology, in either (1) the entity that owns or has contractual rights to the product or technology, or (2) a commercial competitor of the entity that owns or has contractual rights to the product or technology.
With respect to any transaction discussed above, approval by the DIO will be required before the transaction may commence or continue. The DIO’s approval may be withheld or conditioned on measures to reduce, manage, or eliminate any financial conflict of interest.
4. Disclosure obligations. Covered Individuals are expected to be diligent in compiling and disclosing their financial interests in a timely manner (reviewing their financial records, making inquiry of family, verifying data with outside entities as necessary, and so forth). If uncertain about any aspect of their disclosure obligations, Covered Individuals should seek guidance from the DIO. Failure to make good faith efforts to file timely, accurate, and complete disclosures and certifications (annual or ad hoc) is unacceptable and constitutes grounds for sanctions.
5. Managerial and fiduciary relationships. Because related outside professional activities that involve managerial or fiduciary responsibilities may give rise to irremediable financial conflicts of interest, and because unwinding these relationships can be awkward and difficult, faculty members shall obtain prior approval from the Dean before assuming such responsibilities.
6. Visiting faculty. Holders of visiting faculty or teaching appointments whose appointments require them to participate in academic duties within the School for six months or longer shall (1) disclose in accordance with Part III.F above any financial interests that are directly related to their Harvard responsibilities and (2) disclose in accordance with procedures established by the DIO any Significant Financial Interests or related outside professional activities that are directly related to their Harvard responsibilities. Regardless of the length of time of their participation in duties at Harvard, visiting faculty are required to comply with the requirements of paragraph 3 above in the case of any Significant Financial Interests or related outside professional activities that pertain to transactions that arise during their Harvard service.
E. Review and Handling of Annual and Ad Hoc Disclosures.
1. Review. The DIO, assisted by the CPC, shall review all reports of financial interests (ad hoc and annual, including updates) submitted by Covered Individuals and, based upon the submitted information and whatever supplemental information the DIO requires, identify any disclosed interests that give rise to Financial Conflicts of Interest. If the DIO or any CPC member has a conflict of interest in reviewing disclosed information, he or she shall immediately recuse himself or herself, inform his or her superior, and request that the review be performed by a disinterested alternate.
2. Confidentiality. Disclosures of financial interests shall be collected and maintained in a secure format, held in confidence, and released only to the DIO, the CPC, and School and University officials and entities with a need to know, or as otherwise authorized by this Plan.
3. Principles for evaluating financial interests. Whether a financial interest gives rise to a financial conflict depends upon the objective circumstances and not upon the state of mind of the Covered Individual. The test is whether reasonable observers would believe the presented circumstances create an undue risk that the financial interest will inappropriately influence the Covered Individual’s judgment and actions concerning the University’s primary interests in independent and objective scholarship, furtherance of students’ educational interests, protection of human research participants and animal research subjects, and the like.
Disposition of financial conflicts of interest. If the process of review leads to the finding that a Financial Conflict of Interest exists, the DIO shall decide whether to (1) eliminate the conflict, for example, by requiring that the Financially Conflicted Individual either divest the financial interest or refrain from engaging in the Related Academic Activity, (2) reduce the interest below the level that the DIO deems of concern for the Related Academic Activity at issue, for example, by requiring that the Financially Conflicted Individual forego receipt of a portion of outside income, or (3) permit the Financially Conflicted Individual to proceed with the Related Academic Activity under terms or conditions designed effectively to manage and minimize the associated risks. In determining the appropriate response, the DIO must consider the extent to which the financial interest is amenable to elimination, reduction, or credible oversight and management. Among the circumstances that the DIO should evaluate are: the nature of the Related Academic Activity; the magnitude of the financial interest and the degree to which it is related to the Related Academic Activity; the extent to which the financial interest could be directly and substantially affected by the Related Academic Activity; the degree of risk inherent in the related Academic Activity to involved individuals, to the School, or to public safety and well-being, including risks to reputation and to the School’s core missions and values; any risks to the rights of and obligations to students, fellows, and trainees; the benefit to the School community or general public of permitting the individual to participate in the Related Academic Activity; whether the individual has unique expertise or brings other unique resources to the Related Academic Activity; and the harm or loss that would result from prohibiting the Financially Conflicted Individual from participating in the Related Academic Activity.
Rebuttable presumption of irreconcilable conflict. There are certain instances in which a Financially Conflicted Individual ordinarily should not be permitted to conduct or participate in a Related Academic Activity in the absence of compelling circumstances. Such instances include:
- Human subjects research that an IRB determines is of greater than minimal risk;
- When the Financially Conflicted Individual has an equity interest in a non-publicly-traded corporation and proposes to Conduct Research sponsored by the corporation that could enhance the value of the equity interest; and
- When the Financially Conflicted Individual serves in a fiduciary role in an entity and proposes to Conduct Research sponsored by the entity.
In each instance, the DIO may conclude that compelling circumstances justify permitting a Financially Conflicted Individual to conduct or participate in the Related Academic Activity. Typically, such permission will be conditioned on measures that minimize the risks arising from the conflict of interest, such as reducing the conflicting financial interest, implementing a credible management plan, and requiring appropriate disclosures. To maintain the credibility of the University Policy and of the School’s Implementation Plan, the bar for overcoming the rebuttable presumption should be set high.
4. Notification, reconsideration, and appeal. The DIO shall promptly notify Financially Conflicted Individuals of findings and decisions concerning Financial Conflicts of Interest, the disposition of the conflict, and the terms and conditions of any management plan. A Covered Individual may request the DIO to reconsider any of the foregoing and may appeal the DIO’s final decision to the Dean. If the Dean overturns the DIO’s final decision, the Dean shall retain documentation of the basis of his or her decision and shall furnish a copy to the Provost or Designee.
5. Documentation. With respect to every disclosed financial interest determined to constitute a Financial Conflict of Interest, the DIO shall prepare a written report summarizing the nature and amount of the financial interest, the DIO’s findings (including findings upon reconsideration), the bases for the findings, the disposition of the conflict, the terms of any plan for management or reduction of the financial interest, and any other actions taken. In addition, the DIO shall annually prepare a report for submission to the Provost or designee describing all conflicts of interest identified during the year, how they were resolved (including terms of management plans), and any sanctions imposed or other actions taken.
6. Communication with other institutional entities. In any instance in which the DIO makes a final determination that a Financial Conflict of Interest exists, the DIO shall provide copies of the summary report to the Financially Conflicted Individual and to the chair or director of the Individual’s administrative unit. If the Related Academic Activity involves non-exempt human subjects research, the DIO shall promptly provide a copy of the summary report to the responsible Institutional Review Board, and if animal research, to the responsible Institutional Animal Care and Use Committee. (An IRB or IACUC may impose more, but not less, stringent requirements upon the conflicted investigator than those imposed by the DIO.) If the Related Academic Activity involves a proposal to conduct sponsored research, the DIO shall provide a copy of the summary report to the Sponsored Research Administration office. If the Related Academic Activity involves a disclosed invention, the DIO shall provide a copy of the summary report to the Office of Technology Development.
7. Consultation with the Office of the Provost. When dealing with a financial conflict of interest of unusual significance due to its complexity, magnitude, notoriety, or precedential impact, the DIO will consult with the Provost or Designee in advance of making a final determination concerning the disposition of the conflict of interest or other remedial actions.
F. Management and Oversight of Conflicts.
1. Acknowledgement of management plan. Each management plan shall be agreed to and signed by the Financially Conflicted Individual before he/she is permitted to proceed with the Related Academic Activity. The DIO shall retain a copy of the signed management plan.
2. Objectives of management plans. Plans for ongoing oversight or monitoring of Related Academic Activity following the identification of a Financial Conflict of Interest should be designed to protect the integrity of the academic activity; the integrity of the educational experience for students; the welfare of human research participants and research animals; and the reputations of involved faculty, the School, and the University. Among other things to be considered in the development of management and oversight plans are the following:
- What risks are to be mitigated (e.g., biased scholarship, exploitation of students or junior faculty, inappropriate use of School resources, unnecessary exposure of human or animal research subjects to harm)?
- How can the interests of students and junior faculty best be protected?
- Can the conflicting financial interest be reduced or placed under the control of a disinterested trustee?
- To whom should the conflicting financial interest be disclosed in order to ensure transparency and protect the interests of third parties and the public?
- To what extent can the Financially Conflicted Individual be excluded from sensitive aspects of the Related Academic Activity (e.g., enrollment of human research participants, design of survey instruments, evaluation of student performance)? Can these aspects be handled by individuals not subject to the control or influence of the Financially Conflicted Individual?
- Is effective oversight or monitoring of the Related Academic Activity feasible by individuals within the School or external to the School or University?
3. Oversight of management plans. The DIO must ensure that the management plan is being followed and should periodically audit the Related Academic Activity to ensure that the plan is practical and effective. If the management plan involves monitoring the activity of the Financially Conflicted Individual, the monitor(s) should report to the DIO at regular intervals concerning the Individual’s compliance with the elements of the management plan.
4. Outside Disclosure. As a precondition to participating in Related Academic Activity in which a faculty member has a conflicting interest, a management plan should require a faculty member to disclose his or her conflicting interest: (a) to all participants in the Related Academic Activity, including students and trainees; (b) to prospective students, trainees, and new faculty before such individuals make a decision to participate in the Related Academic Activity, (c) to funders and sponsors of the Related Academic Activity; (d) to human research participants, as determined by an Institutional Review Board; (e) to state and federal officials, as required by statute or regulation; or (f) to other parties as deemed appropriate in the circumstances (e.g., advisees, students, general public). If the Related Academic Activity involves a multi-institutional collaboration, the existence of the Financial Conflict of Interest should be made known to the collaborating investigators, the sponsor, and appropriate officials of the other institutions participating in the Related Academic activity.
G. Education and Training.
The DIO, in consultation with the CPC and the Provost or Designee, shall develop and disseminate materials to educate faculty about financial conflict of interest concerns in general and the requirements of the University Policy and the School’s Implementation Plan in particular. All such materials, along with self-testing tools, shall be available on a School website.
1. Covered Individuals are expected to comply with the University Policy, the Standards of Conduct and Implementation Details set forth in this document, and management plans imposed by the DIO in connection with any Financial Conflict of Interest.
2. The DIO shall recommend to the Dean appropriate sanctions to be imposed on a Covered Individual for failure to comply with any of the above. Sanctions may include, but are not limited to, the following:
a. Formal admonition;
b. Inclusion in the Covered Individual’s personnel file of a letter of censure from the Office of the Dean;
c. Ineligibility of the Covered Individual to (1) submit an application for funding to the Sponsored Research Administration office; (2) submit a protocol to the IRB or IACUC; (3) utilize students, staff, equipment, or other School resources in connection with outside activities; or (4) supervise graduate students or trainees;
d. Reduction of compensation;
e. Non-renewal of appointment; and
f. Dismissal from the Faculty of Public Health.
 Holders of visiting faculty and teaching appointments at the School are responsible for complying with the requirements specified in Part IV, Section D, paragraph 6.
 “Principles Governing Commercial Activities of Harvard University”, as approved by the Corporation on September 17, 2001.
 As used in this section and the discussion in paragraph 3 below, a “family member” means spouse or spouse equivalent and dependent children.
 See, in particular, the University’s “Statement on Outside Activities of Holders of Academic Appointments” and “Policy on the Use of Harvard Names and Insignias.”
 42 C.F.R. § 50.604(b) and NSF Grant Policy Manual (NSF 05-131 July 2005) Sec. 510(d).
 Extensive discussion and examples of management techniques can be found in “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research (February 2008), 23-32.