External Reviews of UMN IRB Signal Positive Improvements

The University of Minnesota's Institutional Review Board recently underwent two separate external reviews of its Human Research Protection Program that suggested changes made to the IRB, including expansion of the IRB, implementation of ETHOS, enhanced post-approval review, the creation of a quality assurance program, and the addition of new training and educational offerings, have made a significant difference to IRB processes and procedures that ultimately ensure compliance and ethical human research practices.

AAHRPP Application for Renewal of Accreditation

In September 2019, the HRPP provided roughly 1,400 pages of material to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as part of its "Step 1" application for re-accreditation. (The University is currently fully accredited though it must apply for a renewal every five years.). During AAHRPP’s initial review, they assess the application to determine if there are any critical gaps or areas of question or concern. We were notified in November that review of the application was complete and there were no gaps or questions identified. It is common during the application process for AAHRPP to request revisions to the application before proceeding to a site visit. It is a positive sign that no revisions were requested. The "Step 2" application has been submitted and the HRPP now anticipates a site visit in summer 2020.

FDA Inspection

In December 2019, the UMN IRB underwent a routine inspection by the FDA (12/4/19 through 12/12/19). Routine inspections typically occur every four or five years. The purpose of these inspections is to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements. Inspectors also verify if IRBs are following their own written procedures.

During an IRB inspection, FDA personnel interview responsible IRB representatives, receive a list of all protocols active at any time within the last three years, and obtain information about IRB policies and procedures. An IRB's performance is usually evaluated by tracking studies that are subject to IRB review under FDA regulations. The IRB’s membership rosters, meeting minutes, and study documents and correspondence are also reviewed to determine whether they conform to current FDA regulations.

During the exit interview, the inspection team commented on the massive changes made to the program. They congratulated IRB administrative staff for their commitment to transparency by making our SOPs and other internal processes and documents public facing. The inspection team also noted the strength and expertise of our staff, our cooperation, and dedication to the protection of research participants.

Finally, the FDA inspectors informed IRB representatives that no inspectional observations would be documented in an FDA Form 483. Receiving this feedback is a significant accomplishment.