Short Form Consent Checklist
Short Form Consent Checklist: All conditions must be met:
(1) The consent document states that the Elements of disclosure required by regulation had been presented orally to the participant or the participant's legally authorized representative.
(2) A written summary embodies the basic and appropriate additional Elements of disclosure.
(3) There will be a witness to the oral presentation
(4) For participants who do not speak English, the witness is conversant in both English and the language of the participant.