Ceding IRB Oversight

Central IRBs:
Ceding IRB Oversight
Presentation Outline
 Defining and explaining a Central IRB
 IRBMED ceding oversight
 Focus on commercial IRBs
 IRBMED accepting oversight
 Brief information
 Brief FAQs
What is a Central IRB?
 A single IRB
 Provides regulatory and ethical oversight for research
conducted by one or more institutions not otherwise
affiliated with it
 Per specific agreement, it becomes the IRB of Record for
oversight of the research at all sites
Establishing the Relationship
 Federal regulations allow FWA-holding IRBs to enter into
joint review agreements to reduce regulatory burden
 Central IRBs may be
Independent (commercial)
 Agreements may also be called
 Reliance Agreements
 Cooperative Agreement
 IRB of Record Agreements
 Master Service Agreements
 IRB Authorization Agreements (IAA) – OHRP terminology
Common Scenarios for Use of Central IRBs
 Multi-site studies
 Industry-sponsored
 Federally-sponsored
 Time-sensitive studies
 Public health emergency such as flu
 Specialized IRB expertise is necessary
 Special populations
 Specialized reviewers
Potential Benefits
 Eliminates full, duplicative review across sites
 Reduces variability of the study parameters across sites
 Decreases cumulative review time
 Decreases burdens on local IRBs
 Costs are reduced locally and perhaps for the study as a
Perceived Challenges
 Quality and thoroughness of review
 How well do you know the central IRB?
 Consideration of local context
 How well does the central IRB know you?
 Apportionment of institutional liability
 How will problems be managed?
 Managing ‘shared’ control and accountability
 Who will perform certain functions?
 Agreeing to different standardized procedures
 New workflows may be necessary
 Ceding oversight lets PIs avoid IRBMED, ORSP, CRAO, COI,
and other ancillary committees
WRONG! Only IRBMED oversight is ceded.
 The regulatory oversight will be different with another
WRONG! All IRBs follow the same regulatory authority.
 All Central IRBs have the same process
 WRONG! Each IRB has their own process for applying.
Ceding to a Central IRB
 Collaborating institutions complete the agreement
Roles and responsibilities are apportioned
 FWAs are amended, if necessary (OHRP)
 Assure all internal institutional documents are in
alignment with the arrangements
 Informed consent template language is finalized
 Does not require OHRP or FDA signature or approval
IRBMED Ceding Parameters for Central
(Commercial) IRBs
All requests are evaluated on a case-by-case basis.
 Multi-site
 Industry-sponsored
 Federally-sponsored (rare)
 Phase II, III, and IV
 U-M must not be a coordinating center
 NCI-CIRB clinical trials (all phases)
Finalized IRBMED Agreements - Ceding
 Ceding oversight
 Single academic institutions
 Independent (central/commercial IRBs)
Schulman Associates IRB
 Western IRB (WIRB)/Copernicus IRB
 Chesapeake IRB
 Quorum Review IRB
 Generally, an IRB must be accredited or well-known
to U-M before IRBMED will cede IRB oversight
Who May Request to Cede Oversight?
 Sponsor
 External Institution / Individual
 Grant/award
 U-M PI
Application Process
 Study teams create a Clinical Trial Routing Form (CTRF) in
eResearch Proposal Management (eRPM)
Select the Central IRB (check with IRBMED if the IRB is not listed)
 In eResearch Regulatory Management (eRRM), complete
the “Requesting Review by a Non-UM IRB” (“Ceding”)
 The Ceding application is routed to/reviewed by the
ancillary committees
 The Ceding application is reviewed and acknowledged by
Ongoing PI/Study Team Obligations at U-M
 Amendments must be submitted for any
 Changes to the U-M study team membership
 Changes to the research impacting ancillary committee
 Investigational Pharmacy
 Changes to research may impact IRBMED’s decision to cede
the project to the central IRB
 Noncompliance of the Central IRB
Ongoing PI/Study Team Obligations at U-M
 AE/ORIO reports must be submitted if:
 Related, serious adverse events occur in U-M subjects
 Unanticipated problems occur in U-M subjects
 Serious and/or continuing non-compliance determinations are made
regarding U-M participation
 The study is placed on hold or suspended
Ongoing PI/Study Team Obligations at U-M
 Continuing reviews or termination reports
 The research study continues to be approved at the Central IRB
 The research study is terminated at the Central IRB
IRBMED Agreements-Accepting
 Accepting oversight
 Single academic institutions
 Single non-academic sites (e.g., private medical practice)
 Single individuals (e.g., a consultant on a study)
 Generally, the studies/roles of the individual at the
external institution are of lower risk
IRBMED is Accepting Oversight
*PI/Study Team Actions
 Contact IRBMED
 Application to Request IRBMED Oversight
Provides details about the roles/responsibilities and the relationship
 Identify the collaborators in eResearch
 Complete any additional documentation requested by
 Work with IRBMED to obtain/provide any additional
documentation to/from the external site/individual
IRBMED is Accepting Oversight
*IRBMED Actions
 Collect documentation from PI/Study team
 Review ‘Application Requesting IRBMED Oversight’
 Consult with IRBMED Directors and UMOR (formerly OVPR)
 Pre-screening to resolve outstanding questions
 Seek approval from IRBMED co-Chairs and other
designated officials
 UMOR reviews the request and signs the agreement
 External institution signs
 Agreement is uploaded into eResearch
IRBMED as a Central IRB?
 IRBMED as a Central IRB for multi-site research is under
FAQs for Ceding to a Central IRB
Q: How long does the application review process take at
A: If all agreements are in place, review of the ceding
application received by IRBMED should take approximately
2 business days.
Q: Do I use the IRBMED consent or the sponsor’s consent?
A: Generally, you will use the sponsor’s consent that
includes U-M required language.
FAQs for Ceding to a Central IRB
Q: Who pays for the cost of a Central (commercial) IRB?
A: Usually, the sponsor does.
Q: I am a U-M sponsor-investigator of a research study –
may I use a Central (commercial) IRB?
A: No, not at this time.
 NIAID Research Toolkit
 OHRP Website
 IRBMED Website for Central IRBs
Thank you!

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