Items Asked at Recent AAHRPP Site Visits

  • DOD and other funding agencies — know that checklists are available for DOD funded studies and all non HHS funding sources have additional rules.
  • Rosters — Know that IRB must include an unaffiliated member, a non-scientific member, and a scientific member.
  • Changes to Research that May Increase the Risk Level — Know that changes to research that may increase risk level must be reviewed by the full board IRB
  • Component Analysis — Know what it is and provide an example (e.g., FDA on Subpart D suggests IRB review as a component analysis of each arm of placebo-controlled studies, as opposed to a single evaluation of the possible benefits and risk for the entire study