Informed consent must be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the participant or the participant’s legally authorized representative. A written copy must be provided to the person signing the informed consent form.

Because the signed document is a written record of the consent discussion

• The investigator must retain the original, signed document, and
• Each participant or legally authorized representative must be given a copy of the signed document.

Investigators can request a waiver by submitting a Waiver of Informed Consent Documentation form, justifying the request for waiver or alteration of the applicable federal requirements.

Documentation of consent cannot be waived for FDA-regulated research.