FDA 483 - HealthPartners Institute IRB - March 14, 2022

An FDA inspection of HealthPartners Institute IRB in Bloomington, MN, revealed that the Institutional Review Board failed to follow its own written procedures for the initial and continuing review of research. The deficiencies included inadequate documentation for studies involving vulnerable populations, failure to properly assess investigational device use with MRI, and not completing required reviewer forms or providing written non-significant risk determinations to investigators. These issues indicate a lack of adherence to established internal protocols for IRB oversight.