Pending

All IRB communications regarding the approval, disapproval or modifications required to secure IRB approval of research activities are in the form of written correspondence. The IRB communicates concerns and suggestions regarding human subject protection issues to investigators following each step of its review. This guidance outlines the possible IRB Actions, the process for IRB review, and the process of communicating results to researchers and other institutional officials. Possible IRB Actions Specific determinations will be made following Full Committee or Expedited Review, as noted below. Additionally, an IRB Chair/designee conducting a review under Expedited procedures may refer an application for Full Committee Review