How does the IRB decide whether to approve Human Research?
You can find the criteria for IRB approval in the “WORKSHEET: Exemption Determination (HRP-312)” for exempt Human Research and the “WORKSHEET: Criteria for Approval (HRP-314)” for non-exempt Human Research. The latter worksheet references other checklists that might be relevant.
These checklists are used for initial review, continuing review, and review of modifications to previously approved Human Research.
You are encouraged to use the checklists as guidance to write your Investigator Protocol in a way that addresses the criteria for approval.