The UCAIHS agrees to allow the use of an oral consent process for semi- or illiterate subjects, but explains to the investigator that this does not mean that written documentation of consent is not required. The investigator must have a witness who is literate but unassociated with the study observe the oral consent process and sign the consent form, which must include the name of the subject, as evidence that all the required information for informed consent was provided to the potential subject prior to their agreement to participate.