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 ...

FDA allows waivers for the emergency use of a test article (21 CFR 50.23) and allows exception from informed consent for emergency research (21 CFR 50.24). HHS regulations allow for an exception ...

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).

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, ...

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 ...

In addition to understanding informed consent, it is important for researchers to know when to use a waiver and when to use alterations of consent. This UB CTSI Educational Modules video will outline: ...