Conflict of Interest Requirements

The term “Conflict of Interest” refers to situations where financial or other personal considerations may directly and significantly affect, or have the appearance of directly and significantly affecting, a researcher’s professional judgment in research conduct. Unaddressed conflicts of interest impact research integrity of the investigator and the university.

Click on the applicable IRB review to read about COI requirements in IRB submissions.

VCU IRB Submissions
External IRB Submissions (WIRB, CIRB)

VCU IRB COI Requirements

Initial Reviews

Prior to issuing approval for any initial submission to the IRB, a conflict of interest (COI) review must be completed. The COI review may occur concurrently with IRB review, but IRB approval cannot occur until it is determined that no conflicts exist or any conflicts have been acceptably managed.

Investigators should ensure all of the following are completed to help ensure the COI review does not delay IRB approval.

  1. Designate in the Personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI Investigator.

    *COI Investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct, or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee, or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of "COI Investigator".

    See the COI page for more information about designating COI investigators.

  2. All personnel designated as COI investigators must complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS). Click here to access AIRS.

Continuing Reviews

At the time of Continuing Review, the IRB will check to ensure that all COI Investigators have updated their Financial Interest Report (FIR) within the past 12 months. Approval for continuing review will be held until all FIRs are current.

Personnel Amendments

When adding personnel who are designated as COI Investigators, a COI review will be completed for each prior issuing the IRB approval for the personnel addition. All new COI Investigators should complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS) prior to submitting the amendment to the IRB.


External IRB COI Requirements

Initial Reviews

Even though an external IRB will review the study, VCU will still conduct a conflict of interest review (COI) for each initial submission. The COI review must be complete and a final disposition provided before ORSP will authorize submission of the study to the external IRB. Any conflicts that are found will be managed jointly between VCU and the external IRB.

Investigators should ensure all of the following are completed to help ensure the COI review does not delay IRB review.

  1. Designate in the Personnel section in RAMS-IRB any research personnel who fulfill the definition of a COI Investigator.

    *COI Investigator – Any individual, regardless of title, role or position, who is responsible for the design, conduct, or reporting of research. Individuals with such research responsibilities may be, but are not limited to, senior/key personnel, sub/co-investigator or subrecipient investigator, medical investigator, collaborator, consultant, student, trainee, or research coordinator. Exceptions include students or other personnel whose research activities are directly supervised. By considering an individual’s degree of independence relative to the research, the PI on the protocol designates those who meet the definition of "COI Investigator".

    See the COI page for more information about who is a COI investigator.

  2. All personnel designated as COI investigators must complete a Financial Interest Report (FIR) in the Activity and Interest Reporting System (AIRS). Click here to access AIRS. The submission will not be forwarded to the external IRB until all FIRs are complete.

Continuing Reviews

VCU will not conduct ongoing COI reviews for studies sent to external IRBs. However, investigators are responsible for ensuring all COI investigators update FIRs as required by COI policies.