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 related to their institutional responsibilities at USC in diSClose.
Review of SFIs
Once an SFI is submitted, it will be reviewed by a representative from the Office of Culture, Ethics and Compliance (OCEC). There may be additional questions or documentation requested of the discloser. If it is determined that the SFI could directly and significantly affect the design, conduct, or reporting of a research project at USC, or is in an entity whose financial interests could be affected by research at USC, the disclosure will be categorized as a financial conflict of interest and will require further review by a Conflict of Interest Review Committee (CIRC).
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.
Once the disclosure is complete, it will be presented for review by OCEC to the Conflict of Interest Review Committee (CIRC).
The CIRC will review the disclosure to determine whether the conflict of interest is manageable and, if so, how to manage it. The CIRC will make a recommendation to the Senior Vice President of Research and Innovation (SVPRI), or their designee, for a final decision.
The decision and relevant management plan, as approved by the SVPRI or their designee, will be sent to the discloser for acceptance. 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.
PHS-specific COI in Research Procedures
Review Requirements
Prior to USC’s expenditure of any funds under a PHS-funded research project, OCEC shall review all Investigator disclosures of significant financial interests. With review by the CIRC as described in the review of SFIs section above, USC will determine whether any significant financial interests relate to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.
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.
Record Retention
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.
Reporting Requirements
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 NIH-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.
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 Conflicts 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.
Monitoring Requirements
USC shall monitor Investigator compliance with any management plan on an ongoing basis until the completion of the PHS-funded research project.
Retrospective Reviews
For PHS-sponsored research, if USC identifies an SFI that was not disclosed in a timely way as specified in this policy, or, for whatever reason, an SFI was not reviewed by USC during an ongoing research project, USC will review the SFI; determine whether it is related to PHS-funded research; determine if a conflict of interest exists, and if so:
- Implement a management plan to manage the conflict of interest moving forward
- Conduct a documented retrospective bias review within 120 days to determine whether any PHS research, or portion thereof, conducted during the time period of noncompliance, was biased in the design, conduct, or reporting of such research. This review will include documentation of all required elements under 42 CFR 50.605(a)(3).
Based on the results of the retrospective review, if appropriate, USC shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward.
If bias is found, USC will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. 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 USC’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., 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).
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.
Subrecipient Requirements
USC must take reasonable steps to ensure that any subrecipient Investigator complies with PHS requirements by:
- 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.
- If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient’s work for the awardee Institution;
- Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;
- Alternatively, if the subrecipient’s Investigators must comply with the awardee Institution’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart.
- 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.
Unreported COIs with Clinical Research
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.