Transcript Central IRBs

Central IRBs
An IRB Infoshort
June 2014
Working Definition
A
central IRB is one that serves as IRB of
record for all of the sites engaged in a
research study
 All institutions involved in the study have
developed an agreement ceding IRB
review responsibility to the central IRB
 The agreement may be for a single study
or multiple studies.
Current Yale Agreements with
Central IRBs

National Cancer Institute Central IRB


Western IRB (WIRB)
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Includes all Yale/Pfizer Bioimaging Alliance Studies
Other studies as identified and agreed to
Quorum Review IRB


Limited to NCI clinical trials
Limited to studies that are part of the Novartis P2P program
NeuroNEXT IRB

Limited to studies of the National Institute of Neurological
Disorders and Stroke NeuroNEXT Network
Background
 Prior
to issuance of the ANPRM, there was
no pressure to defer to another IRB
 The ANPRM encouraged the use of
central IRBs
 Some NIH grants now require use of a
central IRB (NeuroNEXT)
 Industry increasingly requires use of a
central IRB as part of the contract
(Quorum for Novartis)
Responsibilities
 When



deferring to another IRB
The reviewing IRB is responsible for review of
the protocol and approval of related study
documents
The Institution is responsible for conducting
a local context review
The Institution retains full responsibility for the
conduct of the study
Responsibility (2)

The Principal Investigator



Is responsible to the reviewing IRB for
compliance with their policies and procedures
Is responsible to the Yale IRB for maintaining a
current and accurate protocol file (local
context information, copies of all reviewing IRB
correspondence)
Is responsible for reporting adverse
events/UPIRSOs to both entities in accordance
with their reporting requirements.
Establishing an Agreement
with a Central IRB
Agreements are processed through the HRPP
Education and Community Outreach
Manager
 The PI submits a formal request to the
Manager
 The Manager works with the central IRB to
develop an agreement
 Agreements with commercial IRBs require
review by the Office of the General Counsel
 When approved, the agreement is signed by
the Institutional Official (Andrew Rudczynski)

Timeframes
 From
request to execution varies,
depending on the requirements of the IRB
of record. Each IRB has unique and
distinct requirements that must be
negotiated and for which internal Yale
processes must be in place.
 Generally investigators should expect the
process to require at least 8-12 weeks.
Advantages

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For the PI and the IRB staff the primary
advantage comes in the review of
amendments: there is no need for each site
to individually submit, review and approve
amendment requests
For the sponsor the advantage is


rapid single review of the protocol
elimination of multiple site-specific revisions,
which might ultimately affect the study design
or feasibility of conducting the study in multiple
sites
Disadvantages
 Ceding
to another IRB is not an automatic
process
 Each IRB has unique requirements which
must be learned and met
 The Institution retains responsibility for the
research. The PI has reporting
responsibilities to both the reviewing IRB
and the Yale IRB
Projections
 Requests
for central IRB review are
expected to increase
 In the absence of a standard model,
multiple systems will need to be in place
for investigators, research staff and IRB
staff.