Policy Contacts Matthew Fox, J.D. Senior Research Compliance Officer, OVPR Paul Liebman, J.D. Senior Research Compliance Officer, OVPR
On May 26, 2010, the President and Fellows of Harvard College approved a University-wide policy on Individual Financial Conflicts of Interest (pdf). This policy, revised in May, 2012, provides guidance for school deans, faculty and other individuals holding teaching appointments, in identifying, evaluating, and managing conflicts of interest. The policy is confined to issues arising from a financial conflict of interest, defined 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 University will be inappropriately influenced by a secondary financial interest.”
The University has a primary interest in preserving and furthering institutional integrity, ethical conduct, and public confidence and trust in all academic and research pursuits, an interest it shares with every faculty member. Faculty members inevitably hold legitimate secondary interests as well, ranging from career advancement to obtaining or renewing sponsored research funding. Although these secondary interests often align with the core mission and values of the University, they may at times occasion a departure from the University’s and faculty member’s shared primary interests.
The university-wide policy provides a framework for implementation that allows for some flexibility among the various Schools in recognition of their wide variance in culture, mission, and the nature of acceptable faculty interactions with external entities. Each School’s approach to implementation of the policy is described in a School Implementation Plan.
The University Policy is supplemented by procedures specific to the implementation of the August 25, 2011 Public Health Service Rule (pdf).
Faculty at the Medical School should refer to the website of the Office for Academic & Research Integrity for HMS-specific policies and procedures. In addition to complying with the Medical School’s conflict of interest policy, Medical School faculty are also expected to comply with their hospital’s conflict of interest rules.
On September 14, 2020, the President and Fellows adopted an additional policy on Institutional Conflicts of Interest (PDF). That policy governs how possible conflicts between the institution’s own financial interests and its primary interests as defined above.
Outside Activities and Interests Reporting (OAIR)
The Outside Activities and Interests Reporting (OAIR) system is the University’s shared platform for the confidential internal disclosure of outside financial interests, in accordance with the FCOI Policy and the Statement on Outside Activities by Holders of Academic Appointments. This system takes the place of the former FCOI reporting system and the Outside Activity Reporting (OAR) system at Harvard Medical School. It also incorporates some information on outside professional activities that has previously been collected by Faculty Affairs offices, in an effort to streamline the overall reporting process and reduce duplication and confusion between the two systems. For more detailed information pertaining to each school’s implementation of the OAIR system, please see the table below:
|Facutly of Arts & Sciences / School of Engineering and Applied Sciences||OutsideActivities@fas.harvard.edu|
|Graduate School of Design||Anne Mathew|
|Graduate School of Education||Tiffany Blackman|
|Harvard Divinity School||Karin Grundler-Whitacre|
|Harvard Kennedy School||Carrie Kachoria|
|Harvard Medical School||Cindi-Ann Hirst|
|Harvard TH Chan School of Public Health||Angela Brazeau||Chan OAIR FAQ|
|Wyss Institute||Katrin Duevel|
The Research Administration and Compliance Systems OAIR Systems page offers job aids (like a submission guide, and a system fact sheet, among others), information-session scheduling, and the latest system status updates.
Related Documents and Trainings
- Harvard University FCOI Policy, supplemented by the Procedures specific to the implementation of the August 25, 2011 Public Health Service Rule
- fCOI definitions
- fCOI Training
- Disclosure Form for non-Harvard PHS Investigators
- Disclosure Form for Harvard Investigators (with no Harvard ID)
- SBIR and STTR Collaborations: Guidance on Conflict Management Considerations
- fCOI Privacy Statement
- Policy on Institutional Conflicts of Interest
- OAIR Definition and Guidance
- OAIR What to Include
- OAIR Training & Education
- OAIR Frequently Asked Questions
Related Committees and Groups
- FOCI Council:
The Conflict of Interest Council is comprised of the school administrators who collect the financial disclosure statements of faculty members, and manage the review of those statements and actions to be taken based upon the results of the disclosure statement reviews. These administrators, Designated Institutional Officials (DIOs) meet to coordinate their review processes and share suggestions about procedures and conflict of interest management, working with Council members who manage the online reporting and grants management systems.
- fCOI Standing Committee
The Standing Committee on Financial Conflicts of Interest is the university-wide committee charged with overseeing the implementation of the University Financial Conflict of Interest Policy by each School. The committee is concerned with maintaining the appropriate balance between policy consistency and school-to-school variations that reflect the norms of different professional and academic disciplines.
Implementation Plans by School
Guidance for Harvard Administrators
- Administrator Training – Policy and Systems Overview (PDF)
- COI Enhancements to the Grants Management Application Suite (GMAS) (including GMAS FAQs)
- How to submit a disclosure through oair.harvard.edu
The Harvard University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty or Teaching Appointments (PDF) was approved in May, 2010. It was revised in May, 2012 and later supplemented by Procedures for the Implementation of the U.S. Public Health Service Final Rule on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought (PDF).
Under both the University Policy and the PHS regulations, individuals with faculty and teaching appointments and PHS “investigators” must file with their School an annual disclosure of significant financial interests in related outside entities. This disclosure must be on file before an individual may submit a proposal for sponsored funding and must be updated within 30 days of the discovery or acquisition of a new significant financial interest.
To facilitate compliance with the PHS regulations and the University policy, a working group of representatives from the Office of the Vice Provost for Research (OVPR), the Office for Sponsored Programs (OSP), Harvard University Information Technology (HUIT), and the schools has implemented a new system for the reporting of outside professional activities and interests under the University policy (“the OAIR”), integrated with GMAS. As part of these upgrades, all individuals covered by the University policy in schools using the OAIR system, as well as PHS investigators in those schools, after January 25, 2021, will disclose outside professional activities and interests related to their University activities using the OAIR system.
As an administrator, you should be familiar with the PHS regulations, the University policy, and your School’s “implementation plan” (describing the COI process at the School). To facilitate the transition to the new business process and systems, the Office of the Vice Provost for Research will provide policies, guidance and other information on this site as they become available. For any questions that you are not able to answer by reference to materials on this site, please contact your School’s Conflict of Interest Officer (pdf), or Matt Fox in the Office of the Vice Provost for Research.
CONFLICT OF INTEREST & COMMITMENT TRAINING
Request Information About Identified PHS COIs
Requesting Information Regarding Financial Conflicts of Interest Related to Public Health Service-Funded Research
Harvard University is committed to overseeing the conduct of research in a manner that ensures the integrity of the research process and maintains the public trust and that of the sponsors in the integrity and the credibility of its faculty, its staff, and its research programs. Harvard’s policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments (pdf) described the University’s commitment and procedures related to the identification and management of conflicts of interest. Additional information can be found on the website of the Vice Provost for Research.
Please note that the Harvard Medical School is responsible for the oversight of its own conflict of interest program. Request for information about identified conflicts of interest of Medical School faculty must be directed to the Medical School and not to the Office of the Vice Provost for Research. Information about the program and how to make a request for information is available at http://ari.hms.harvard.edu/.
Harvard ensures public accessibility of certain information regarding identified conflicts of interest with funding received from agencies of the US Public Health Service (PHS) including the National Institutes of Health (NIH). Information is publicly available, via a written response within 5 business days upon receipt of a request as detailed below, of information concerning a Significant Financial Interest (SFI) disclosed to the University that meets the following criteria:
- The individual for whom information is sought, is identified by the University in the grant application, progress report, or any other required report submitted to the PHS as senior/key personnel on an active PHS grant or cooperative agreement for which a notice of award was issued on or after August 24, 2012;
- The SFI is still held by the senior/key personnel individual for the PHS-funded research project;
- A determination has been made that the SFI is related to the PHS-funded research; and
- A determination has been made that the SFI is a Financial Conflict of Interest (fCOI)
Instructions for Requesting Information Regarding fCOIs Related to PHS-Funded Research at Harvard Schools except the Harvard Medical School:
- Complete form for each SFI for which you are seeking information. Incomplete forms will not be considered and will not be responded to.
- Print, sign, and attach a scanned copy of the form, to an email. The title of the email should be “Public Request for Information”. Send the email with attachment to email@example.com
- Alternatively, you can print the completed form, sign, and send it by regular mail to:
Office of the Vice Provost for Research
Attention: Conflict of Interest Coordinator
Richard A. and Susan F. Smith Campus Center
1350 Massachusetts Avenue, Suite 836
Cambridge, MA 02138
The Office of the Vice Provost for Research will respond via email to the email address provided in the form. If a paper copy is required, please enclose a self-addressed postage paid envelope. Mailed responses will be postmarked no later than five (5) business days after receiving a valid request (as detailed above) at the email address or mailing address provided above.
CONFLICT OF INTEREST & COMMITMENT TRAINING