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CENTRAL IRBs Developed by: U-MIC University of Michigan IRB Collaborative

Central IRBs 3 Developed by: U-MIC Central IRB single IRB that provides review for multiple sites independent (sometimes called commercial) o Chesapeake IRB o Western IRB o Schulman Associates IRB o Quorum Review o NCI CIRB institutional o university IRBs o hospital IRBs

Central IRBs 4 Developed by: U-MIC Ceding via agreement that delineates responsibilities between entities transfers IRB oversight only o Other regulatory oversight and workflows remain at UM. UM IRB relinquishes certain responsibilities. Central IRB assumes certain responsibilities. o IRB Authorization Agreement (institutional IRBs with FWAs) o Master Services Agreement (independent IRBs)

Central IRBs 5 Developed by: U-MIC Fees Independent IRBs charge fee. o usually paid by sponsor o Billing process varies based on Master Services Agreement. Institutional IRBs usually charge fee only for industry-sponsored research.

Central IRBs 6 Developed by: U-MIC Requesting use of central IRB eResearch Proposal Management (eRPM) o Create Clinical Trial Routing Form (CTRF). PAF application o Specify central IRB. eResearch Regulatory Management (eRRM) o Complete “Requesting Review by a Non-UM IRB” application (ceding application). reviewed by ancillary committees reviewed/acknowledged by UM IRB

Central IRBs 7 Developed by: U-MIC Project remains active in eResearch scheduled continuing review o to record key data elements about study conduct at UM  e.g., enrollment numbers amendments o changes in UM study team o change that may impact  ancillary committee’s review  decision to cede project adverse event/ORIO o related, serious AE at UM o UaP (UPIRSO) at UM o serious and/or continuing noncompliance determination regarding UM site o project placed on hold or suspended termination

Central IRBs 8 Developed by: U-MIC Central IRBs

THANK YOU. Brian Seabolt IRBMED 9 Developed by: U-MIC