From: Weiner, Craig [CWeiner@chw.edu]
Sent: Tuesday, March 26, 2002 2:27 PM
To: 'fdadockets@oc.fda.gov'
Subject: Docket 01N-322

As regards Institutional Review Boards:Regarding Sponsors and Investigators
to Inform IRB's of Any Prior IRB Reviews.
 
As an IRB Chair for 20 years, this has always been a concern that IRBs do
not communicate when problems are identified in protocols, which other IRBs
may or may not identify.  Many times we are told from Sponsors that
"Everyone else has approved this, so we don't see what your problem is."
The problem is that they frequently won't identify these other IRBs.
 
Methinks there is more shopping around for the more lax IRBs that we think.
The concern that I have is that once an investigator or sponsor identifies a
lax IRB they will continue to use this IRB, forsaking all others.
 
While I would always like to know if there has been EITHER approval or
disapproval on the part of another IRB, without funding to establish the
infrastructure to track such events, I don't think a system is workable.
Please do not send us any more unfunded or underfunded mandates.  It's hard
enough to keep up (IRB's are "understaffed and overworked" - NCQA report). 
 
Alternatively, if we had a better IRB system (again, there's that funding
problem), nonuniformity of decisions wouldn't be a problem.  Why don't we
put our energy into assuring the IRB's are doing their jobs and then we
wouldn't have to worry so much about 'shopping around.'  Increase the
frequency of audits and start considering more strident penalties
(suspension or monetary penalties).  
 
I'd be happy to provide further input as requested.
 
Thanks for listening (if you are).
 
Craig Weiner, MD 
Chair 
Mercy Healthcare Regional Institutional Review Board 

phone - (916) 537-5028 office (Mercy San Juan) 
           (916) 541-2200  cellular 

pager   (916) 762-1286 

emails    cweiner@chw.edu 
             craig@cwirb.com 

IRB Office  (916) 536-3028