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

Presentation Outline

Defining and explaining a Central IRBIRBMED ceding oversight

Focus on commercial IRBsIRBMED accepting oversight

Brief informationBrief FAQs

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

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

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 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

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

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.

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

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)

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

Who May Request to Cede Oversight?

SponsorCROExternal Institution / IndividualGrant/awardU-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”) application.

The Ceding application is routed to/reviewed by the ancillary committees

The Ceding application is reviewed and acknowledged by IRBMED

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

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 eResearchComplete any additional documentation requested by

IRBMED 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 agreementExternal institution signsAgreement is uploaded into eResearch

IRBMED as a Central IRB?

IRBMED as a Central IRB for multi-site research is under consideration

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.

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.

Resources

NIAID Research ToolkitOHRP WebsiteIRBMED Website for Central IRBs

Questions?

Thank you!