Author: Eva Pastor
Date: 06-04-10 15:55
Source: Research Ethics Law Blog
URL: http://researchethicslawblog.wordpress.com/
Date published: June 4th 2010
Using a Single Central IRB for Multicenter Research
June 4, 2010 ·
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.
For links to the letter of inquiry and the OHRP response, click here:
http://www.hhs.gov/ohrp/policy/correspond/CIRB20100430.html.
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