The questions below are from the Common Protocol Cover Form that is submitted to the Committee for initial review of a protocol and will assist researchers in creating an informed consent process for a protocol.

• Who initiates the informed consent discussion & answers questions?
• Where is the consent process initiated?
• How much time is the subject given to decide?
• Is the PI present for the initial & subsequent consent discussions?
• What other method of documentation is used to record the consent process, in addition to the executed consent form?
  

Each of these questions will be addressed further on subsequent pages.