OVERVIEW
This Quickguide outlines the steps for requesting an assent waiver from the CIRB for an individual child.
BEFORE YOU BEGIN
- Review the Determining Assent Requirements Quickguide to determine if assent is required by the CIRB.
- If assent is required, but the child is unable to provide assent, then request an assent waiver prior to enrolling the child in the study.
STEPS
PI CONFIRMS CHILD MUST PROVIDE ASSENT
When assent is required by CIRB, the Principal Investigator (PI) reviews Determining Assent Requirements to confirm an assent waiver is required.
PI SUBMITS LETTER TO CIRB HELPDESK
The PI or enrolling investigator emails a letter to the CIRB Helpdesk. The letter should include:
- A study ID or unique anonymous identifier for the specific child
- An explanation of why the child cannot provide assent
- The signature of the PI or the enrolling investigator
The request is emailed to the CIRB Helpdesk. Indicate in the subject line of the email that this is an urgent request for an assent waiver.
CIRB OPERATIONS OFFICE CONDUCTS REVIEW
The CIRB Operations Office receives and forwards the request to a Local Context Subcommittee member for review. Within one business day, the CIRB Local Context Subcommittee member determines whether the assent waiver is granted. If granted, the CIRB emails the PI and institution contacts an Approval Letter of the assent waiver for the individual child.
PI PROCEEDS WITH ENROLLMENT PROCESS
Once the assent waiver determination letter is received, the PI can continue the enrollment process at the Institution.