C entral IRBs An IRB Infoshort - PowerPoint Presentation

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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

Limited to NCI clinical

trials

Western IRB (WIRB)

Includes all Yale/Pfizer

Bioimaging

Alliance Studies

Other

studies as identified and agreed to

Quorum Review IRB

Limited to studies that are part of the Novartis P

2

P 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

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.