From: Castillejo,Marta-Ines [MCastillejo@sjha.org]
Sent: Tuesday, March 26, 2002 11:36 AM
To: 'fdadockets@oc.fda.gov'
Cc: Gerety, Sister Jane; Gallagher, John A
Subject: Whether To Require Sponsors/Investigators to Inform (IRBs) of
Any Prior IRB Reviews.

FDA Seeks Comment on Whether to Require Sponsors and Investigators to Inform
Institutional Review Boards (IRBs) of Any Prior IRB Reviews.

It is the policy of our institution's IRB to require notification by the
sponsor/investigator of another IRB's review of their research; this
provides us information about that other IRB's determination and assurance
that the research design, risks, etc have been reviewed and addressed.  

  
Marta-Inés Castillejo, M.A., CIM
IRB Administrator
Saint Joseph's Hospital of Atlanta
404-851-5703