Financial Conflict of Interest (FCOI) in Research Procedures

All significant financial interests (SFIs) that reasonably could appear to be affected by a researcher’s USC research must be disclosed promptly, fully, and in advance, through the university’s online disclosure system, diSClose, for review.  In addition, when required by federal research sponsors such as Public Health Service (PHS) agencies or other agencies including: 

• National Institutes of Health (NIH) 

• Food and Drug Administration (FDA) 

• Centers for Disease Control (CDC) 

• Department of Energy (DoE) 

Investigators must disclose all SFIs that are related to their institutional responsibilities (e.g., research, research consultation, teaching, etc.) at USC in diSClose.

Disclosed SFIs will be reviewed by USC’s designated official(s).  A financial conflict of interest exists if the designated official(s) reasonably determines that an investigator’s SFI(s) are related to the research and could directly and significantly affect the design, conduct, or reporting of the research.  An SFI is an FCOI because: 

1.  The SFI is determined to be related to the research (i.e., the SFI could be affected by the research or the SFI is in an entity whose financial interest could be affected by the research), and  

2. The SFI could directly and significantly affect the design, conduct, or reporting of research.   

Examples of financial conflicts of interest include: 

• An SFI in a research sponsor or subrecipient. 

• An SFI in an entity that has licensed intellectual property under study in a research project at USC. 

• An SFI in an entity that has products or materials (e.g., drugs, devices, compounds, specimens, intellectual property licensed from USC) under study in a research project at USC. 

• An SFI in an entity that can reasonably be expected to economically benefit from a research project at USC. 

Identified financial conflicts of interest (FCOIs) will be reviewed by the USC CIRC. If the FCOI is found to be manageable, the university will require the implementation of a management plan designed to mitigate the conflict, as described below.  If the university determines that the conflict cannot be effectively mitigated through the implementation of a management plan, the research will not be allowed to proceed unless the investigator eliminates the outside interest or activity giving rise to the conflict. 

The CIRC will make a recommendation to the SVPRI on how to appropriately mitigate the FCOI in a way that preserves the integrity and objectivity of the research.  Faculty must keep in mind that certain significant financial interests and outside activities may create an FCOI that cannot be effectively mitigated or managed. 

Investigators and research personnel are not permitted to begin any research activity where an FCOI has been identified, until they receive a written determination from the Senior Vice President of Research and Innovation (SVPRI), or their designee, on how to manage it. 

The decision and relevant management plan, as approved by the SVPRI or their designee, will be sent to the discloser for acceptance.  For new projects, once the management plan is accepted by the discloser, and implemented, the research project may commence. 

The conflicted individual must inform the Office of Culture, Ethics and Compliance of any relevant changes in either the research project or the financial interest after the approval of the management plan.  The conflicted individual is also responsible for providing annual updates on the research project, the status of the financial interest, and compliance with the management plan. f the management plan.  The conflicted individual is also responsible for providing annual updates on the research project, the status of the financial interest, and compliance with the management plan.

PriPrior to USC’s expenditure of any funds under a PHS-funded research project, USC shall review all Investigator disclosures of significant financial interests as noted above.  

Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the Institution, OCEC shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest.  Depending on the nature of the significant financial interest, USC may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date of disclosure and the completion of the review.

USC will maintain records relating to all PHS Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable, for at least three years from the date of the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

OCEC will be responsible for providing initial and annual reports to PHS of all financial conflicts of interest identified involving PHS funding within the PHS-specified timeframes.  These reports will contain all PHS required elements per 42 CFR 50.605(b)(3).  These elements include project information, value of the financial interest reported (in ranges), a description of how the financial interest relates to the PHS-funded research, and a description of the management plan. 

Once reported, USC will submit annual reports for the duration of the PHS-funded research project or until the FCOI ceases to exist.  The annual reports will be submitted in conjunction with the annual progress report, multi-year progress report, if applicable, or at the time of extension. 

The initial and annual reports will be submitted by OCEC in the eRA Commons FCOI module.  OCEC will also submit FCOI reports for any FCOIs identified for consultants or subrecipients via the eRA Commons module as a subrecipient report. 

Prior to USC’s expenditure of any funds under a PHS-funded research project, USC shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by the Institution to be conflicting with the PHS-funded project and ensure that a management plan is in effect. 

Subsequently identified conflicts will be reported to PHS within 60 days of identification.  Any SFIs that were not disclosed in a timely manner or were not reviewed in a timely manner will be subject to a retrospective review, as described in the section below. 

If a USC Investigator fails to comply with USC’s Financial Conflict of Interest in Research policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of a PHS-funded research project, USC shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. 

Additional reporting requirements if a Retrospective Review is required are in the Retrospective Review section below.

Monitoring Requirements

USC shall monitor Investigator compliance with any management plan on an ongoing basis until the completion of the PHS-funded research project.

For PHS-sponsored research, whenever a FCOI is not identified or managed in a timely manner, including: 

• Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest; 

• Failure by the Institution to review or manage such a Financial Conflict of Interest; or 

• Failure by the Investigator to comply with a Financial Conflict of Interest management plan; 

the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. 

If bias is found, the Institution must notify NIH promptly and submit a mitigation report.  If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.”  The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).  Thereafter, the Institution will submit FCOI reports annually as prescribed by the regulation. Depending on the nature of the financial conflict of interest, USC may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator’s noncompliance is determined and the completion of the Institution’s retrospective review. 

Revised FCOI reports are only needed following the completion of a Retrospective Review when: 

• New FCOI information that results in a change to a previously submitted FCOI report (e.g., an increase in value of a previously reported significant financial interest (SFI), discovery of a new SFI, or changes to the management of the FCOI, etc.); or  

• A Mitigation Report if bias is found following completion of the Retrospective Review. e financial conflict of interest or the Investigator’s noncompliance is determined, and the completion of the Institution’s retrospective review.

USC must take reasonable steps to ensure that any subrecipient Investigator complies with PHS requirements by: 

1. Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators. 

2. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI. 

In any case in which the HHS determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by USC as required by this regulation, USC shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.