August 2010

It is the policy of the Organization that the IRBs may act on a research application to grant approval, with or without administrative changes required to the application or application documents, or table an application and defer final action until additional material is supplied to make required IRB determinations (Note: See Policy No. 109.6(a) on disapproval of an application).

• The IRB may issue approval with administrative changes.  Such action requires the PI to provide corrections in the application documents or verification of data prior to release of approval documents.  The review of such changes may occur using an expedited review process.
  
• When the convened IRB requests clarifications or modifications that are relevant to the determinations required by federal regulations, the IRB may not grant approval with administrative changes.  Such projects must be tabled and final action deferred until the PI’s response and revised materials are discussed by the IRB at a future convened meeting.