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

The HHS’ Office for Human Research Protections (OHRP) has retired 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 issues, such as patient population and state laws. OHRP policy now 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