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.