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Message-ID: <4988BA4A.1020206@columbia.edu>
Date: Tue, 03 Feb 2009 16:42:34 -0500
From: Alan Teller <at2059@columbia.edu>
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To: cuhs-irb@cumc.columbia.edu
Subject: Procedural Change: Review of Oncology Protocols
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Dear Colleagues,
 
The Columbia IRB Office is pleased to announce that a fourth IRB on the 
Columbia University Medical Center campus has been formed, and is 
scheduled to hold its first business meeting on Wednesday, February 4, 
2009. 
 
The decision to constitute CUMC IRB #4, which will focus on the review 
of cancer-related research, was based on volume of submissions, unique 
review processes mandated by NCI, and requirement for specific expertise 
of IRB members.  We are confident that the review of all protocols 
submitted to the CUMC IRBs will be more efficient as a result of the 
advent of this new Board.
 
Effective immediately, all new protocols that are cancer-related and 
would previously have been reviewed by an existing CUMC IRB will be 
assigned to IRB #4 for review.  Investigators do not need to alter the 
manner in which they submit protocols, but should be aware of the 
special focus of IRB #4.
 
New protocols that are cancer-related and otherwise meet the 
institutional criteria to undergo review by the Western Institutional 
Review Board (WIRB) will also be reviewed by CUMC IRB #4, beginning with 
those that are submitted on or after February 18, 2009.  The decision to 
review all oncology protocols locally was based on multiple analyses of 
regulatory review time and financial considerations. 
 
Approved protocols that are cancer-related will be reassigned to IRB #4 
at the time of continuing review, according to the following transition 
plan:
-- effective immediately for protocols that were previously reviewed by 
a CUMC IRB; and
-- for protocols that were previously reviewed by the WIRB, beginning 
with protocols for which the WIRB approval expires on or after March 15, 
2009.
 
New protocols for which we rely on the NCI CIRB for review, and renewals 
of protocols that were previously approved under this process, will be 
assigned or reassigned, as applicable, to IRB #4 effective immediately.
 
Lauren Privitera (lp2183) will be managing IRB #4 during its 
implementation phase, after which a permanent manager will assume 
responsibility for its administration.
 
Your patience during the transition process will be appreciated.  We 
have made every effort to ensure a smooth implementation and transfer of 
protocols, and are confident that occasional glitches which may arise 
can be promptly resolved. 
 
Please do not hesitate to contact Lauren or myself should you have any 
questions.
 
Sincerely,
 
George Gasparis
Executive Director, IRB