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OHRP: External IRBs Can Identify Local Issues as Well as Local IRBs

January 28, 2010
The HHS’ Office for Human Research Protections (OHRP) has archived two institutional review board (IRB) guidances, officially signaling a change in its policy on the capabilities of external IRBs to review local context issues. The retired guidances gave preference to local IRBs in handling local context issues, such as understanding the patient population, local requirements and state laws. But current policy views external IRBs as “equally capable of making an assessment of local issues as required under regulations,” Julie Kaneshiro, OHRP spokeswoman, said.
Clinical Trials Advisor