judy birk, jd irbmed director central irbs: ceding irb oversight
TRANSCRIPT
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J U D Y B I R K , J DI R B M E D D I R E C T O R
Central IRBs: Ceding IRB Oversight
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Presentation Outline
Defining and explaining a Central IRBIRBMED ceding oversight
Focus on commercial IRBsIRBMED accepting oversight
Brief informationBrief FAQs
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What is a Central IRB?
A single IRBProvides 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
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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) Academic
Agreements may also be called Reliance Agreements Cooperative Agreement IRB of Record Agreements Master Service Agreements IRB Authorization Agreements (IAA) – OHRP terminology
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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
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Potential Benefits
Eliminates full, duplicative review across sitesReduces variability of the study parameters across sitesDecreases cumulative review timeDecreases burdens on local IRBsCosts are reduced locally and perhaps for the study as a
whole
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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
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Misperceptions
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 IRB WRONG! All IRBs follow the same regulatory authority.
All Central IRBs have the same process WRONG! Each IRB has their own process for applying.
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Ceding to a Central IRB
Collaborating institutions complete the agreement document 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
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IRBMED Ceding Parameters for Central (Commercial) IRBs
All requests are evaluated on a case-by-case basis.
Parameters:Multi-site Industry-sponsoredFederally-sponsored (rare)Phase II, III, and IV U-M must not be a coordinating centerNCI-CIRB clinical trials (all phases)
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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
NCI CIRB
Generally, an IRB must be accredited or well-known to U-M before IRBMED will cede IRB oversight
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Who May Request to Cede Oversight?
SponsorCROExternal Institution / IndividualGrant/awardU-M PI
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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”) application.
The Ceding application is routed to/reviewed by the ancillary committees
The Ceding application is reviewed and acknowledged by IRBMED
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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
reviews COI CRAO Investigational Pharmacy RDRC/SHUR
Changes to research may impact IRBMED’s decision to cede the project to the central IRB Noncompliance of the Central IRB
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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
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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
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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
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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 eResearchComplete any additional documentation requested by
IRBMED Work with IRBMED to obtain/provide any additional
documentation to/from the external site/individual
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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 agreementExternal institution signsAgreement is uploaded into eResearch
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IRBMED as a Central IRB?
IRBMED as a Central IRB for multi-site research is under consideration
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FAQs for Ceding to a Central IRB
Q: How long does the application review process take at IRBMED? 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.
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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.
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Resources
NIAID Research ToolkitOHRP WebsiteIRBMED Website for Central IRBs
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Questions?
Thank you!