Conflict of Interest (COI) or Financial Conflict of Interest (FCOI)
Description
Effective March 23, 2026, all research team members listed on an IRB application must have a Sponsor Specific Questionnaire (SSQ) disclosure completed within 12 months prior to the date of the IRB study review with either no related significant financial interests (SFI) or a managed Financial Conflict of Interest (FCOI) before the study will be approved by the IRB.
Federal regulations and University of Illinois System policy require anyone that participates in human subject research to disclose significant financial interests related to their university responsibilities. If a FCOI is related to an IRB study, the researcher must work with their department, COI administrators, and the IRB to determine if the conflict can be managed.
Submitting an SSQ Disclosure
Go to START myDisclosures → Select “Start new Sponsor Specific Questionnaire” and complete the disclosure.
Information on what SFIs must be disclosed can be found here: https://coci.research.illinois.edu/fcoi/what-to-disclose
More information about the FCOI review process can be found here:
FCOI Disclosure Compliance in IRBOnline
In the IRBOnline application once research team members have been added in #2.1, the “Team” tab can be selected above and while viewing the team members there will be a section for training compliance and FCOI disclosure compliance.
Status of FCOI Compliance in IRBOnline
Flag | Status, meaning of the indicator | IRB approval |
Green | The individual has submitted an SSQ within the past 12 months and review determined there is no FCOI related to the study. | No hold or delay |
Blue | The individual has submitted an SSQ within the past 12 months and the COI review determined there is a FCOI related to the study and the FCOI has been managed. | No hold or delay |
Yellow | The individual has submitted an SSQ within the past 12 months and a potential SFI has been identified. A COI administrator must review the SFI to determine if there is a FCOI related to the study. If FCOI exists, it must be managed or eliminated. | IRB review may be conducted but IRB will hold approval until FCOI is managed. |
Red | The individual has not submitted an SSQ within the past 12 months. A new SSQ is required. IRBOnline will send an email notification to the team member the requires disclosures, PI copied. | IRB Review may be conducted but IRB will hold approval. |
Required for Study Approval
New IRB submissions will not be approved unless every research team member is confirmed to have no potential conflict or their conflict has been managed (i.e., must have a green or blue flag).
In addition, during Continuing Review applications and Progress Updates, OPRS must confirm all research team members have no potential conflict or their conflict has been managed (i.e., must have a green or blue flag).
When an Amendment is submitted to add a new research team member, that new research team member must be both current on their training as well as having no potential conflict or their conflict has been managed (i.e., must have a green or blue flag).
Yellow flags (potential conflicts) require COI administrator review before IRB approval, as this has always been the standard procedure.