OHRP: Central, External IRB OK for Multicenter Trial

A single, central institutional review board (IRB) is sufficient in a multicenter clinical trial, especially if a centralized review improves the efficiency of the IRB, according to an HHS Office for Human Research Protections (OHRP) letter. OHRP agrees with the FDA’s position on the benefits of relying on a central IRB for multisite research rather than local boards, it says in an April 30 letter to the Carolinas Medical Center. To clear up ongoing confusion about the use of external IRBs, OHRP recently posted the letter and an April 13 query from the medical center.
Clinical Trials Advisor