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Developed by:
U-MIC
1
CENTRAL IRBs
Developed by:
U-MIC
University of Michigan IRB Collaborative
Central IRBs
Central IRB
single IRB that provides review for multiple sites
• independent (sometimes called commercial)
o
o
o
o
o
•
Chesapeake IRB
Western IRB
Schulman Associates IRB
Quorum Review
NCI CIRB
institutional
o
o
university IRBs
hospital IRBs
Developed by:
U-MIC
3
Central IRBs
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
o
IRB Authorization Agreement (institutional IRBs with FWAs)
Master Services Agreement (independent IRBs)
Developed by:
U-MIC
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Central IRBs
Fees
•
Independent IRBs charge fee.
o
o
•
usually paid by sponsor
Billing process varies based on Master Services Agreement.
Institutional IRBs usually charge fee only for industry-sponsored
research.
Developed by:
U-MIC
5
Central IRBs
Requesting use of central IRB
•
eResearch Proposal Management (eRPM)
o
•
PAF application
o
•
Create Clinical Trial Routing Form (CTRF).
Specify central IRB.
eResearch Regulatory Management (eRRM)
o
Complete “Requesting Review by a Non-UM IRB” application
(ceding application).


Developed by:
U-MIC
reviewed by ancillary committees
reviewed/acknowledged by UM IRB
6
Central IRBs
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
o
o
o
related, serious AE at UM
UaP (UPIRSO) at UM
serious and/or continuing noncompliance determination regarding UM site
project placed on hold or suspended
• termination
Developed by:
U-MIC
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Central IRBs
Central IRBs
Developed by:
U-MIC
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THANK YOU.
Brian Seabolt
IRBMED
Developed by:
U-MIC
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