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 ...

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).

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 ...

The plan for obtaining consent must be included in the Human Subjects Protocol. Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, ...