The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulation effective August 24, 2012.
Accordingly, Clemson University has adopted a new PHS Financial Conflict of Interest (FCOI) Policy effective August 24, 2012 (policy attached). In order to fully comply with PHS’s new regulation, Clemson University has created a new PHS Financial Conflict of Interest (COI) Disclosure Form and Supplement Form. If you plan to apply for funding from a PHS (directly or flowing thru another agency) or have current PHS funding or plan to ask for no cost extension of an existing PHS award, you must comply with the new FCOI Regulations. PHS Agencies include:
Before a PI can submit a proposal to any of the PHS agencies, all investigators must have a completed Disclosure Form on file and have completed the Conflict of Interest training. Relevant links are listed at the bottom of the page.
PHS defines "Investigator" as the 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.
The FCOI regulation, effective August 24, 2012, requires that all persons applying for, receiving or being supported on PHS funds must be compliant with PHS rules on training, disclosure, and establishment of conflict of interest management plans prior to the awarding of funds. The rules apply to current interests and interests in the 12 months preceding the disclosure, rather than interests that are anticipated in the future.
The major changes to the PHS Financial Conflict of Interest Policy include:
Investigators must disclose the following as a significant financial interest if applicable to the Investigator, the Investigator’s spouse (or domestic partner), or dependent children:
Any reimbursed travel or sponsored travel related to Institutional responsibilities if paid directly on behalf of the Investigator (including purpose of trip, sponsor/organizer, destination, and duration) must be disclosed as a Significant Financial Interest.
Please note that you are not required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. For example, if travel is reimbursed or paid by Clemson University as part of a gift or sponsored project, it is not considered a significant financial interest and does not need to be disclosed.
Please note that effective August 24, 2012, each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the following circumstances:
Clemson University must make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible website or by a written response to any requestor within five business days of a request. PHS defines “senior/key personnel” as the project director or Principal Investigator and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution. At a minimum, Clemson University must provide the following information:
Things You Need to Know (informational flyer)
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