Determining Assent Requirements

The CIRB makes the determination of assent requirements for any study enrolling children.  The assent requirements are documented in the Approval Letter.     

KEY POINTS

• Institutions participating in a study reviewed by the CIRB must comply with the assent requirements documented in the Approval Letter.
• The child must indicate assent to participate prior to enrollment.
• The CIRB determines the age ranges when a child’s assent is required. If a child in the age range determined by the CIRB cannot provide assent, an Assent Waiver must be obtained prior to the child’s enrollment in the study.  For more information, go to Completing the Assent Waiver Worksheet.
• The CIRB does not require a specific method for documenting assent. Follow your local policy and Network guidelines to ensure that an acceptable method of documentation is used.