OHRP has posted its April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. This OHRP letter clarifies that OHRP fully agrees with the Food and Drug Administration’s position on the benefits of relying on a single central IRB for multicenter research.
In addition, OHRP’s letter clarifies that the advance notice of proposed rulemaking on IRB accountability that OHRP issued on March 5, 2009, was proposed to address this issue. Even in the absence of new regulation, the OHRP response also notes that OHRP is taking steps to address institutions’ concerns about relying on an IRB external to the institution.
The links below provide the full text of OHRP's April 30, 2010 letter and the incoming letter to OHRP. OHRP welcomes comments on the content of its response letter. Comments on this or other topics may be submitted to OHRP by email at email@example.com. Please include the phrase “April 30, 2010 letter regarding central IRB review” in the subject field. Alternatively, comments may be submitted to:
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Comments received, including any personal information provided, will be made available to the public upon request.