I. Introduction and Background
This plan implements the Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments (the FCOI Policy) for the Harvard T.H. Chan School of Public Health. This introduction will briefly explain the key reasons underlying the Policy and how it operates. Subsequent sections will provide detail on what exactly should be included in submissions under the Policy and explain how submissions will be reviewed.
The University has the obligation to identify potential conflicts of interest and to manage, reduce or eliminate identified conflicts. The FCOI Policy states the following:
Harvard enjoys the trust of many constituencies – students and trainees, faculty members, alumni, governments, businesses, a global community of scholars, and the general public. At root, their trust rests upon Harvard’s reputation for objective and independent scholarship. Indeed, the University’s greatest asset is its reputation for scholarly integrity, a reputation that benefits all members of the Harvard community and undergirds the institution’s merit for support in all forms – enrollments, public and private grants, donations, academic collaborations, and others.
It is therefore appropriate that the University ensure that members of its community do not engage in behaviors that risk compromising the University’s reputation and integrity. Because financial conflicts of interest especially may corrode the University’s reputation and, thereby, erode confidence in the University and diminish its trustworthiness and stature, the University must ensure that faculty are made aware of such conflicts and are dutiful in internally disclosing them, that disclosed conflicts receive scrupulous attention and management, and that all of Harvard’s units are held to standards of conduct that meet the needs of the University as a whole.
This justification is further buttressed by regulatory obligations arising out of the research support that Harvard receives from the federal government. The work of those faculty and other researchers who are supported by the Public Health Services (PHS, a group of agencies including the National Institutes of Health), is governed by a specific set of regulations that has informed the details of the way that Harvard carries out this important process.
II. Outside Activity Reporting Process
Who is required to report
Under the FCOI Policy, all faculty members and any investigator applying for or receiving funding from the United States Public Health Service (PHS) (such as the National Institutes of Health, Centers for Disease Control, and Food and Drug Administration), sponsors that follow PHS requirements, and the National Science Foundation (NSF) must disclose their outside professional activities and financial interests at least annually.
Individuals required to report outside activities at the Harvard Chan School include:
- All primary faculty
- Non-primary faculty whose FTE is 50% or greater
- Non-faculty academic appointees whose FTE is 50% or greater
- All investigators on a grant funded by, or proposed for funding by, an agency of the US Public Health Service (PHS) or a sponsor to which Harvard applies the 2011 PHS Rule (“PHS+ funded investigators”) as well as the National Science Foundation (NSF)
What to Include
Harvard University is committed to upholding its core mission and values, including the assurance of personal and institutional academic integrity in conducting of all academic duties. Among these assurances is the need to identify and appropriately manage potential financial conflicts of interest and conflicts of commitment. As such, it is important for Faculty to disclose all significant financial interests and external professional commitments, as described in the “Harvard University Policy on Individual Financial Conflicts Of Interest For Persons Holding Faculty And Teaching Appointments” (the FCOI Policy) and “Statement on Outside Activities of Holders of Academic Appointments” (the Outside Activities Statement).
Pursuant to Section E of the FCOI Policy linked above, you are required to disclose each entity relationship associated with your outside professional activities and other related interests. Outside entities are those with which you have relationships outside of Harvard or one of its affiliate institutions. Outside entities include companies, service providers, non-government organizations (NGOs), foundations, foreign governments, and any other for-profit or not-for-profit entities with which you, your partner/spouse or your dependent children (family) had a relationship in the last twelve months except as noted in the exclusions below. Please note that the Outside Activities Statement requires additional disclosures and approvals for those professional relationships closest to the core of your Harvard obligations, such as teaching or conducting research at another institution or entity. While any such relationship should be disclosed as a related outside professional activity, this requirement is distinct from your obligations under the Outside Activities Statement, including with respect to obtaining School-level approval prior to entering into any such outside teaching and research engagements.
The Harvard Chan School has additional guidance in the form of an FAQ document which we encourage you to consult prior to disclosing.
A) Related financial interests, equity holdings, ownership, and fiduciary relationships
All financial interests, equity holdings, ownership, and fiduciary relationships held by you or your family that relate to your institutional responsibilities, regardless of the associated dollar amount of the interest or whether the value can be readily determined, including:
- Equity or other ownership Interests, including any shares of stock, options, warrants, or promises of such, etc., whether the company is privately or publicly held and regardless of whether the equity currently has any value. This does not include diversified financial holdings or investments not directly controlled by you.
- Potential income related to inventorship/authorship on intellectual property that is licensed to an outside entity (including but not limited to inventions, copyrighted works, and/or trademarks) regardless of whether royalties have been received.
- Any paid or unpaid fiduciary or management role as an officer, director, or member of a governing board (e.g., board of directors or the equivalent) in a relevant outside entity.
- Any other financial interests or relevant compensated activities, held by you or your family.
Note that you do not need to report the following:
- Investments in, or income from, investment vehicles, such as mutual funds or retirement accounts, so long as you do not directly control the investment decisions made in these vehicles.
- Fiduciary or management roles in an unrelated outside entity (i.e. that does not rely on your professional expertise that serves as the basis for your Harvard appointment).
- Textbook royalties, royalties from books written in your field of professional expertise and royalties received through books published by Harvard Health Publishing. Note that if you assign your textbook to a class you are teaching, this must be disclosed.
B) Relationships that constitute outside professional activities
All outside professional activities that are related to your institutional responsibilities, including activities for which you do not receive compensation, such as:
- Professional services or employment, including any:
- Appointment, affiliation, or employment agreement with any outside entity, foreign or domestic
- Do not report unpaid affiliations and honorary appointments where there are no obligations, time commitments or payments attached.
- Private consulting or membership on a scientific or other advisory board
- Do not report Scientific Advisory Board participation for non-profit organizations if they are not funding your research.
- Teaching a program outside of Harvard
- Do not report non-recurring talks where you are a guest speaker.
- Office held in a professional organization
- Do not report unpaid roles in organizations related to your field of expertise where there are no obligations, time commitments or payments attached
- Services provided to a non-US government (including testimony)
- Paid media appearances
- Do not report unpaid media appearances where you are asked to give your expert opinion.
- Expert witness testimony
- Editorial services
- Do not report:
- Grant reviews of any kind including participation in study sections or review panels
- Review of papers or manuscripts
- Review of abstracts for meetings
- Compensation for editor services that comes in the form of a free subscription or paid conference fees
- Do not report:
- Architecture, planning, or design project services
- Participation in:
- Fellowship and artists’ residencies (other than under an award through Harvard)
- Exhibitions, design projects, professional juries (including design juries), or
- Foreign talent recruitment or development programs (Do not report paid or unpaid mentoring activities that Harvard has pre-approved)
- Appointment, affiliation, or employment agreement with any outside entity, foreign or domestic
- Conducting research or otherwise being listed on a sponsored award on behalf of a program outside of Harvard
- Do not report any sponsored awards that flow through Harvard including subcontracts
- Do not report co-authorships where the research is conducted elsewhere and you are not a named investigator on the project
- Do not report collaboration or consortium agreements where you are only contributing or receiving data (please ensure a Data Use Agreement is in place if appropriate).
- Prizes, including awards and honoraria
- Do not report unpaid prizes or awards
- Do not report prizes or awards from non-profit entities
- Speaking engagements and travel support or reimbursements, including travel paid on your behalf by a third party. Note: you need not include speaking engagements for and travel that is reimbursed or sponsored by US federal, state, or local government entities or US-based institutions of higher education and affiliated medical centers. However, speaking engagements for and travel that is reimbursed or sponsored by non-US government agencies and institutions of higher education need to be included.
- Do not report unpaid speaking engagements related to your institutional responsibilities such as the dissemination of research or talks related to potential or ongoing research projects.
You should include any companies that receive payments on your behalf. For example, if you are part of a practice or foundation, or an organized consulting group that receives payment for your work, that consulting group and the companies that paid you through the consulting group should be listed. Payments from any corporate sponsor that pass through an intermediary should be attributed to the primary sponsor. For example, if a pharmaceutical company hires a public relations firm to arrange seminars in support of the company’s product, the payments should be attributed to the pharmaceutical company, not the PR firm, regardless of which company’s name appears on the check you receive (or anticipate receiving). For the avoidance of doubt, activities in which you engage as part of your Harvard institutional responsibilities, including teaching, sponsored research, and other academic and research programs managed through Harvard, need not be included.
Because the required elements of certification include paid and unpaid activities, and to reduce the need for duplicate reporting, some schools may use the outside professional activities contained in these reports in their internal faculty review processes. Information contained in these reports will be treated on a need to know basis.
If you have any questions about what else needs to be included, keep in mind the following:
- Include any relationship that relies upon the experiences and professional expertise that serve as the basis for your faculty appointment and/or role at this institution.
- In determining relatedness to your institutional responsibilities, faculty and researchers should apply a standard of common sense — include interests that you would reasonably expect your peers to disclose and when in doubt, disclose.
- Finally, these reporting requirements are independent of whether your activities or financial interests represent a potential, perceived, or actual conflict of interest.
III. Review Process Explained
Types of disclosures and their Review
FCOI disclosures for the Harvard Chan School are now made in the Outside Activities and Interests Reporting (OAIR) system. There are three types of OAIR submissions (Annual, Update, and Research-Based), and while the submitter’s experience is nearly identical in all three it is important to understand their different purposes.
Individuals with joint or multiple appointments at Harvard will submit their disclosures to their primary school or unit. Circumstances may require that officials from other schools or units with which such individuals are affiliated may be granted access to the disclosures and may review the submissions as well. In either case, these internal confidential disclosures are held in confidence, and released only to those school officials with a need to know, as designated by each school’s Dean. Schools maintain a secure process to obtain, review, eliminate, reduce or manage any identified conflict of interest whether potential, perceived or actual.
The principal kind of submission is the Annual certification which Harvard Chan School will prompt reporters to complete at the beginning of the calendar year. All reporters must complete annual submissions regardless of whether or not any updates or research-project-based deadlines have arisen in the time since their last annual disclosure. When completing an annual submission, users will answer questions about their role at the University and their related outside financial interests and professional activities, with a reporting period covering the previous 12 months. If an individual has completed a submission before, the data from the previous submission will be displayed in the system; the submitter’s task will be to review the information, remove interests and activities that ended before the disclosing period of the past 12 months, ensure the accuracy existing activities and interests, and add any new activities or interests that have arisen since the last submission. If there are no outside interests or activities, the disclosure will be marked “No Review Required” and excluded from the ordinary review process. It may still be queried on an individual basis or considered as part of a monitoring program implemented by the school.
Officials from Harvard Chan School will review the annual submission as promptly as possible. This review focuses primarily on two basic questions: Are any of the outside interests and activities “significant,” and if so, are they “related” to the discloser’s research, teaching, or other university obligations? Depending on the answers to those questions and others the reviewer may raise, the review may result in one of several outcomes:
- after the first submission, if the submitter discloses no *new* outside activities or interests, a disclosure is marked “No Review Required” and excluded from the ordinary annual review process; it may still be reviewed as part of a monitoring process as described above;
- if the disclosure is complete, the reviewer will assess whether the interests and activities disclosed bear closely on any active research projects or other university duties of the discloser such that the outside interest or activity may influence the design, conduct, or reporting of research or the way that the discloser carries out his or her teaching or other official responsibilities. If the reviewer has no questions, and the reviewer sees no prospect of a conflict of interest or commitment, it will be marked in the OAIR system as “No Issues Found”;
- if the reviewer has questions about the details of the outside interests or their relationship with the discloser’s work, as described above, they may follow up with the discloser to obtain additional information;
- if there are financial interests that are substantially related to the discloser’s university obligations, these may present a conflict that requires management. In this event, the reviewer will work with the discloser to develop a management plan that appropriately manages, reduces, or eliminates the potential conflict;
- if the submitter is an investigator on research projects, the reviewer will evaluate the discloser’s interests in connection with all of the discloser’s active research projects to determine whether the interest related to the research and whether the interest could directly and significantly affect the design, conduct or reporting of the research. A management plan may be implemented to mitigate any potential conflicts of interest identified.
- if there is a conflict that cannot be adequately managed, FCOI Review Committee may determine that the outside interest or activity that has been reported cannot be pursued in a manner consistent with the individual’s university obligations and require termination of the outside activity or divestiture of the financial interest.
The FCOI policy provides that in addition to annual submissions, faculty members and researchers subject to the policy must update their disclosures within 30 days of the acquisition of a new related outside financial interest. The system will display previously submitted information and the discloser will only be obliged to create a new entry to report the new interest or activity. The review process is the same as described above.
Research Based Disclosures
For individuals engaged in research sponsored by a funder that follows the PHS regulations, additional obligations to report financial interests and outside activities apply at proposal and award stage.
At the time of proposal submission to a PHS+ sponsor, every individual listed as an investigator on the project must have an up-to-date outside activity and interest report (in OAIR) on file. Investigators will receive an e-mail notification to remind them to review their disclosures and to update financial interests and outside activities, if necessary. If the disclosure is accurate and complete, no further action is required at proposal stage. If there is no annual disclosure on file, the investigator will be required to submit one. Typically, the reports will be reviewed at award stage.
If the project is awarded funding, each Investigator will be prompted by the system to submit a research certification, affirming that all information in the system is current. As with the Update submissions described above, all previously-entered information will already be populated in the form and the principal task of the individual is to ensure that it is accurate and up to date. Each investigator will also be asked at this stage to describe any relationship between the newly-awarded project and any of the disclosed outside interests and activities, to aid the reviewing official in determining whether they are related and could present a potential for conflicts of interest. Submissions will be reviewed at the time of award in the same manner that Annual submissions are reviewed, as described above. Awards cannot be setup until FCOI review is complete.
IV. Faculty Affairs Review
Because the schools’ Faculty Affairs offices also review some outside professional activities as part of their annual faculty activities review, specific information gathered in OAIR may be shared with Faculty Affairs administrators as well. However, Faculty Affairs administrators will have no access to the financial details in the disclosure.
V. Oversight and Governance
Each school’s implementation of the FCOI Policy, including this Implementation Plan, is subject to review and oversight by the University Standing Committee on Financial Conflicts of Interest, a long-standing faculty committee with representation from across the University. As part of that oversight, each school submits to the Office of the Vice Provost for Research an annual report on its FCOI Compliance, which is in turn presented to the Standing Committee for its review. This report details the rate of compliance at the school, the number of management plans currently in effect, and any noteworthy challenges or issues faced by the school in the past year.
Failure to file a timely disclosure under the Policies can result in delays in submitting grant proposals or releasing funds on funded projects for those engaged in sponsored research; for faculty not engaged in sponsored research, Harvard Chan School reserves the right to implement other sanctions or penalties.