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Noncompliance is a failure to follow the federal regulations (45 CFR 46; 21 CFR 50) with respect to protection of human subjects in research or failure to follow the determinations of the IRB with respect to conduct of the research as approved by the IRB.
Investigators who are self-reporting noncompliance with federal regulations or the requirements or determinations of the IRB to IRB-01, IRB-02, and IRB-03 use the Reportable Event Form (REF). This form includes a description of the noncompliance and description of impact on the rights, safety, or welfare of subjects or others. Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or within 10 working days of the PI becoming aware of the event.
Others may report noncompliance as described in Chapter 10 of this Guide. All reports of noncompliance, regardless of the source are reviewed by the IRB Chair and/or UI IRB according to the procedures described in Chapter 10 of this Guide.