Important Changes to FAS and SEAS Research Compliance
We are pleased to announce that the Faculty of Arts and Sciences (FAS), including the School of Engineering and Applied Sciences (SEAS), and the Office of the Vice Provost for Research have established a shared Research Compliance Program (RCP). Under this program, staff from the Office of the Vice Provost for Research (OVPR) will assume operational and administrative responsibility of certain research compliance functions, effective February 15, 2023. The research compliance functions to be transferred to OVPR include faculty/researcher outside activities and conflicts of interest, export control, and international collaborations. Read the full email announcement from Dean Scott Jordan here.
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In accordance with the FAS and SEAS Policy on Financial Conflicts of Interests Disclosures, all holders of Faculty or teaching appointments, individuals holding a ≥50% full-time-effort (FTE) non-primary faculty appointment or non-faculty academic appointment primarily in FAS, as well as any Investigator applying for or receiving funding from the Public Health Service (PHS) (including the National Institutes of Health and the Centers for Disease Control and Prevention), sponsors adopting the PHS regulations, or the National Science Foundation (NSF) must submit a financial conflict of interest (fCOI) disclosure form at least once annually. For additional guidance in determining Investigator status, please refer to the investigator matrix.
Jump To:
- Proposals
- Awards & Travel for PHS Investigators
- GMAS Status Matrices (Proposal and Award)
- Request Information About Identified PHS COIs
- References
Proposals cannot be submitted to the PHS, sponsors adopting the PHS regulations, or NSF until all listed Investigators’ financial disclosures are on file with the University. Investigators (defined as "project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research”) for each proposal must be identified by the Principal Investigator early in the proposal preparation process. At a minimum, “Investigators” must include “key persons” listed in the research proposal.
- Harvard Investigators with University IDs must submit their financial disclosure in the Outside Activities and Interests Reporting system. Harvard Investigators without University IDs may submit the Harvard University Financial Disclosure Form.
- Non-University designated Investigators must provide evidence of the subrecipient organization’s fCOI policy that is compliant with the PHS regulations. If no fCOI policy is available at the Investigator’s organization, the Investigator must submit a Non-Harvard University Financial Disclosure Form.
Awards and Travel for PHS Investigators
Spending on new PHS (including sponsors adopting the PHS regulations) cannot begin until all listed Investigators have taken fCOI training, which is part of the disclosure process, and all listed Investigators’ financial disclosures have been fully reviewed by the University.
The revised PHS fCOI regulations now include a requirement for Investigators on PHS projects to disclose the occurrence of travel paid by outside entities (where the aggregate of significant financial interests and travel reimbursements from the single entity exceeds $5,000 in the previous twelve months), which can be done using the online Financial Interest Disclosure application. Any Investigator receiving PHS funding must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid by a third party directly to or on behalf of the Investigators so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, a U.S.-based institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. In addition, this disclosure does not apply to travel that is reimbursed through the University.
The following table lists the OAIR Approval Statuses in GMAS and corresponding action to be taken during the proposal and award stages:
Request Information About Identified PHS COIs
In accordance with 42 CFR 50.605(a)(5)(i)-(iv) for managed conflicts of interest in research following PHS regulations for FCOI (at 42 CFR Part 50 Subpart F), please refer to Harvard’s instructions for requesting information regarding fCOIs related to PHS-funded research which includes the submission form.
- University Policy on Individual Financial Conflicts of Interest for Persons Holding Faculty and Teaching Appointments
- University Institution Conflicts of Interest Policy, adopted September 14, 2020
- University 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.
- COI FAQs
- Outside Activities and Interests Reporting (OAIR) FAQs
- Outside Activities and Interests Reporting (OAIR) Job Aids
- Conflict of Interest (COI) Assessments Based on Interest Type
- Conflict of Interest (COI) Determinations
