PROCEDURES FOR SUBMISSION OF RESEARCH PROPOSALS FOR IRB REVIEW
G. ALTERNATIVE TO WRITTEN INFORMED CONSENT
Under special circumstances, the IRB may approve an oral consent document that states that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. The investigator must justify in writing a request to use the "oral form" and provide the IRB with a written summary of what is said to the subject or the representative.
When the oral form of consent is used, the following three procedures must be followed: 1) The subject and an auditor- witness must sign a statement (the oral consent form) that the subject has been orally informed about the research. 2) The investigator and the auditor-witness must both sign a copy of the summary which includes a statement certifying that all information in the summary was presented orally to the subject. 3) A copy of both the oral consent form and the summary must be given to the subject. NOTE: The auditor-witness must be an independent person who is not affiliated with the investigator or part of the immediate family of someone affiliated with the investigator.
(45 CFR 46.117)