IRB MEMBER MINUTE
IRB Eye on COI

When investigator conflict of interest (COI) exists, the IRB or Expedited IRB reviewer does not complete the review and approval of the IRB application until it receives the final VPR-approved conflict management plan.

While you may not change the approved plan, you may impose further restrictions or conditions on the protocol to protect the rights and welfare of human subjects. Such restrictions may have resulted in different outcomes of several high-profile and tragic COI cases which occurred in the 90s and early 2000s.

In considering what actions may be necessary to protect subjects, the IRB ensures that significant financial interests are disclosed to potential subjects, typically via the informed consent process.
In addition, the IRB should determine and document whether conflicted study personnel should be limited or restricted from involvement in recruitment, enrollment, and/or informed consent.

Having another individual who does not have a potential or actual conflict of interest conduct the consent process can set an objective tone and enhance the voluntary nature of the consent process and research.
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