Introduction:
Working Within the Informed Consent Process .

Without a working knowledge of the IC process, the PI cannot design a reasonable procedure and the RTM cannot implement it. The IRB has put in place specific guidelines for IC design. In most institutions teaching modules on IC design and use are available for the RTM. The IRB reviews the PI's design of an IC to confirm that it adequately follows the guidelines and template. The IC process also needs to be properly deployed in the recruitment of participants. The IRB is charged with ensuring that IC procedures are designed and executed properly. Representatives from the IRB may audit your IC procedures and even sit-in during IC sessions with participants to confirm that the IC procedures are appropriate, well-understood, and applied properly by the RTM.