Conflict of Interest (COI) or Financial Conflict of Interest (FCOI)
Description
After March 23, 2026, all research team members listed on an IRB application must have a current (within one year) FCOI disclosure (SSQ) on file with either no potential FCOI or a managed FCOI before a study will be approved.
Federal regulations and University of Illinois System policy require researchers (defined as anyone conducting human subject research) to disclose any potential financial conflicts they might have with a research project. If a conflict exists, the researcher must work with their department, the COI Office, and the IRB to determine if the conflict can be managed.
OPRS and the IRB will utilize the SSQ (Sponsor Specific Questionnaire) that is already used by researchers conducting sponsored research. The SSQ asks basic questions about financial disclosures for the individual related to receiving remuneration, honorariums, and travel reimbursement from external sources. Intellectual Property ownership must also be disclosed. Information on what must be disclosed can be found here: https://coci.research.illinois.edu/fcoi/what-to-disclose/
This disclosure will only take a few minutes, especially if the individual has nothing to disclose.
FCOI 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.
FCOI Disclosure flag in IRBOnline
Red: The individual has not submitted an SSQ within the past one year. A new SSQ is required. (A red flag will hold up approval starting March 23, 2026.)
Green: The individual has submitted an SSQ within the past year and there are no potential significant financial interests. (A green flag does not hold up approval at any time.)
Yellow: The individual has submitted an SSQ within the past year and has a potential significant financial interest that must be reviewed by the COI Office. An automatic notification will be sent to the COI Office. (A yellow flag will hold up approval at any time, since it means there may be a financial conflict of interest.)
Blue: The individual has submitted an SSQ within the past year and has a significant financial interest, but a conflict of interest management plan is in place and has been accepted by the COI Office. (A blue flag does not hold up approval at any time.)
The IRBOnline system will send an email to anyone who needs to submit a disclosure (i.e. a red flag in the system). The PI will be copied on emails sent to research team members.
Submitting an SSQ Disclosure
http://mydisclosures.uillinois.edu/
Select – Start new Sponsor Specific Questionnaire and complete the disclosure.
Required for Study Approval
After March 23, 2026, 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).
After that date, in addition to new study applications, during the Continuing Review application 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).
Prior to March 23, 2026, individuals who do not have a current (within the past year) SSQ on file will receive notification to submit a disclosure. However, the final approval will not be held up if the disclosure has not been completed. This “grace period” allows individuals time to submit the SSQ without delaying the start of the study but all individuals are encouraged to submit an SSQ as soon as possible to avoid future delays.
Prior to March 23, 2026, if an individual does have a potential conflict of interest (i.e. yellow flag) which means they have already completed a disclosure and a potential conflict has been identified and must be reviewed by the COI Office, that review must be completed before the IRB can approve the project as this has always been the standard procedure based upon reported conflicts because all potential conflicts have always been required to be reported for any human subject research.
More information about the FCOI review process can be found here:
https://coci.research.illinois.edu/fcoi/