Potential subjects or the parents of children who are subjects are presented (either verbally or in writing) with the same information required in a written consent document ... subject to the FDA ...

or a waiver to alter or omit the entire consent process. In either case a detailed justification is needed. Waivers of documentation allow for verbal consent procedures. The IRB will typically expect ...

A waiver of documentation is permissible when: Per HHS regulations 45 CFR part 46, the investigator must obtain informed consent from the participant or their legally-authorized representative (LAR).