Compliance Training

Financial Conflict of Interest (FCOI)

UGA Policy on Conflicts of Interest in Sponsored Programs complies with U.S. Department of Health and Human Services (DHHS) regulations for all Public Health Services (PHS) units, including the NIH, CDC, FDA, Indian Health Service (IHS), Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ).

UGA applies the PHS requirements ONLY to those Investigators submitting to PHS units. However, all UGA investigators must use the DHHS/PHS Disclosure of Significant Financial Interests form when required to do so. As a reminder, all University employees must comply with UGA’s Policy on Conflicts of Interest in Sponsored Programs and must disclose any activity that might constitute a financial conflict of interest.

 

PHS Investigator Disclosures

  • All PHS Investigators (defined 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 PHS-funded projects, either funded or proposed”) are covered.
  • Investigators must file an annual Disclosure of Significant Financial Interests (SFIs) that is retrospective rather than prospective, covering the 12-month period prior to a proposal’s submission. A disclosure update is required within 30 days of discovering the presence of an unreported SFI or acquiring a new SFI.
  • The Disclosure must cover all financial interests that have an annual monetary value of $5,000 or more, whether or not the value is readily ascertainable.
  • The Disclosure must have been filed by the time of proposal submission for any proposal submitted on or after August 25, 2012.
  • PHS regulations apply to competing continuation awards. Your out year awards will be held up if you have not filed a disclosure in the previous 12 months or if you have not completed the FCOI training. Pending awards will be allowed to proceed for a subaward for any period prior to you having met the required disclosure and training requirements.

UGA employees disclose in the eResearch Portal.

Non-UGA employees must complete the Annual Disclosure of Financial Interests for Non-University of Georgia Investigators.

Training

Conflict of Interest training/education is required for all Investigators on PHS grant and cooperative agreement proposals. Training for UGA Investigators will be provided via the CITI online system that UGA uses for Responsible Conduct in Research and Human Subjects training.

Training must be completed prior to an expense being recorded in UGA’s official records (i.e., training is not required at proposal time but must have been completed by award time). Refresher courses are required every four (4) years.

FCOI FAQs

  • UGA (not the employee) must decide whether Significant Financial Interests (SFIs) are sufficiently related to a particular proposed or funded PHS project such that they could directly and significantly affect the project’s design, conduct, or reporting.
  • If UGA determines that a disclosed SFI is sufficiently related to the proposed or funded project, then a Financial Conflict of Interest (FCOI) exists and it must be managed, mitigated, or eliminated. UGA is required to report each FCOI to the PHS funding entity.
  • To manage or mitigate a FCOI, UGA and the project personnel must implement a documented Management Plan to safeguard objectivity of the research project.

UGA is required to review Disclosures and determine the relatedness of the disclosed Significant Financial Interests (SFIs) to proposed/funded NIH projects. Relatedness is defined as “a reasonable determination by UGA’s designated official(s) that a SFI could be affected by the PHS-funded research or the SFI is in an entity whose financial interest could be affected by the research.” Disclosures will be reviewed by UGA’s Institutional Integrity Officer, who will make the necessary determinations.

FCOIs are defined as Significant Financial Interests (SFIs) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. They arise when a secondary objective could affect the performance of a person’s primary mission. Conflicts of interest are not inherently wrong; they are a normal part of our existence. They must be managed so that objectivity in research is maintained.

The Institutional Integrity Officer will determine whether an Investigator’s disclosed Significant Financial Interests (SFIs) are related to the proposed or on-going research. Determining “relatedness” likely involves communication between the Investigator and the Integrity Officer, as the Officer will need the Investigator’s help in understanding the proposed project in order to determine “relatedness.” If the SFI is deemed to be related to the proposed project, the Integrity Officer may refer the matter to the University’s Conflict of Interest Committee (COIC). The COIC comprises senior faculty members selected from the broader University community and appointed by the Vice President for Research. In referral cases, the COIC will make a final determination of relatedness and whether a real or apparent financial conflict of interest (FCOI) exists. The COIC may help develop a Management Plan for any identified FCOI that cannot be eliminated. UGA must report details of any COI Management Plan to the awarding PHS unit.

No one, not even a member of the wider community (such as a local physician who is helping with a clinical study), can be allowed to perform project activities if he/she meets the definition of Investigator and has not disclosed SFIs. Solutions include eliminating that Investigator before the proposal is submitted or altering the individual’s role so that he/she no longer meets the Investigator definition.

There is only one clearance required for an Investigator before submitting a PHS proposal. Sponsored Projects grants administrators will check to see that the required Annual Disclosure of Significant Financial Interests has been submitted and is up to date. PHS proposals cannot be submitted until every individual who meets the PHS definition of an Investigator has submitted his/her Disclosure.

Two behind-the-scenes clearance steps are required before a sponsored account is established and before an Investigator can spend PHS award funds.

  1. Your Sponsored Projects Administration (SPA) team will check the electronic proposal/award record to verify that any Investigator with identified FCOIs related to the proposed project has had the required electronic FCOI report submitted to the appropriate PHS funding unit. FCOI reports must be filed before a sponsored account can be established.
  2. Your SPA team will check online CITI records to ensure that mandated COI training has been completed and is up to date for each Investigator on a PHS project.

Each Investigator seeking external PHS funding must complete a short financial conflicts of interest educational program every four years. Training for all Investigators on a given project should be completed no later than 30 days past award start date or Sponsored Projects Administration will freeze the account, preventing further spending until training is complete for all investigators. Course content for Investigators will be delivered via the CITI program and will focus on the August 2011 DHHS/PHS requirements unique to PHS applicants. This entire FCOI training program is designed to be completed comfortably within approximately 90 minutes.

Researchers with any questions should contact UGA’s Institutional Integrity Officer to discuss the matter. There are situations in which a financial interest may not relate to one’s institutional responsibilities and may not need to be disclosed. The Integrity Officer will work with researchers to determine whether a particular item should be included in the Disclosure of Significant Financial Interests or to answer any other questions an individual might have about FCOIs or the required training.