811: Elements of Quality Review of the RIO and the IRB

Reviews may include, but are not limited to the following activities:

  • Interviews of the principal investigator, co-investigators and/or research staff


  • Review of administrative files to:
    •  Determine whether IRB review was timely
    •  Determine if continuing reviews were completed within one year (or more often if appropriate)
    •  Determine whether IRB (RIO) and VA R&D administrative file(s) contain all modifications and adverse events submitted by the investigator
    •  Determine whether IRB activities were appropriately documented


  • Review of IRB meeting minutes to determine if they include the elements required by federal regulations and applicable laws and policies.