Conflict of Interest

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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.

Proposals

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.

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.

GMAS Status Matrices

The Following tables list the "GMAS Conflict of Interest Approval" statuses and corresponding action to be taken during the proposal and award stages:

GMAS COI Proposal Submission Status Matrix

 PHS/PHS+Non-PHS
FCOI Participant with HUID

No Disclosure
No Interests
Needs review
Reviewed-no conflict
Managed

No Disclosure
Disclosure on file
Non-FCOI participant with HUIDNeeds review
No interests
Reviewed - no conflict
Managed
N/A
Non-FCOI participant without HUID

Check status
Needs review
Reviewed - no conflict
Managed
N/A

N/A
Proposal CANNOT be submitted until a disclosure is obtained
Proposal CAN be submitted AS LONG AS "Interests last updated" falls within the past year. If not, an updated discourse should be obtained PRIOR to submission.
Contact COI for further guidance


GMAS COI Award Stage Status Matrix

 PHS/PHS+Non-PHS
FCOI participant with HUIDNo Disclosure
No Interests
Needs review
Reviewed-no conflict
Managed

No disclosure
Disclosure on file

Non-FCOI participant with HUIDNeeds review
No interests
Reviewed - no conflict
Managed
N/A
Non-FCOI participant without HUIDCheck status
Needs review
Reviewed - no conflict
Managed
N/A
N/A
Award funding CANNOT be released until further action taken
Award funding can be released AS LONG AS "Interests last updated" falls within the past year. If not, an updated disclosure should be obtained PRIOR to release of funding
Contact COI for further guidance

 

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.

 

References