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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Correspondence Regarding Use of Central IRB in Multi-Site Research

May 10, 2010 at 6:22am

OHRP has posted on its website OHRP's April 30, 2010 response to a medical center regarding the use of a central IRB, as well as the incoming letter to OHRP. We have chosen to make these letters available since they address an issue that may be of interest to others (see: http://www.hhs.gov/ohrp/policy/protocol/cirb20100430.html).

The 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 multi-center 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.