Federal regulations require that participants are provided with information about the study through a consent process. Informing a participant, by initiating a consent discussion, is the first step. The method of delivery, however, may not be appropriate for all participants. For example, if a participant is illiterate and/or unaccustomed to dealing with forms, providing then with a form to sign is not adequate for informing them about the study. Even though the information is not provided on a paper, you are still required to provide all of the necessary information to the participant before obtaining their consent. In such situations, documenting consent may be performed by recording affirmation on a consent log or in a audio/video recording. The text in the oral script template can be modified so that it represents your study.
Note that the language in the oral script should be non-technical and preferably at an 8th grade (or lower) reading level for adult participants. The oral script must be submitted for IRB review. Note, though, the oral script IS NOT an approvable IRB consent document. If the justifiable reason for a waiver of consent is appropriate, click on the below waiver link
Choose the below to submit with your IRB application:
Oral script to discuss research template
Also, be sure to review the Waivers of Informed Consent page and choose the applicable waiver request.