For each study enrolling children, the CIRB determines assent requirements, including age ranges when the child’s assent is required. The assent requirements are documented in the “outcome letter” that the CIRB issues when approving a study.
KEY POINTS
- Institutions participating in a study reviewed by the NCI CIRB must comply with the assent requirements documented in the outcome letter.
- The Institution’s assent process must occur with the child, and the child must indicate assent to participate prior to enrollment.
- The CIRB does not require a specific method for documenting assent. Local policy and Coordinating Group guidelines should be followed to ensure an acceptable method of documentation is used.
- If a child in the age range determined by the CIRB cannot provide assent, a Waiver of Assent must be obtained from the CIRB prior to the child’s enrollment in the study.