If oral consent is necessary (e.g. due to limited literacy) the subject or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. The IRB might require that a witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The subject or his/her legal representative must receive a copy of both signed documents.