If a subject cannot read, what is required during the consent discussion?

• A. An impartial witness should be present during the entire informed consent discussion.
• B. No witness is required.
• C. The subject signs and the witness signs later.
• D. An impartial witness should be present during the entire informed consent discussion.

Answer: (B)

When a subject cannot read, the consent discussion must be conducted with an impartial witness present for the entire session. The witness ensures that the information is conveyed clearly in a language the subject understands, that the subject has the opportunity to ask questions, and that the consent is given voluntarily. The information should be read aloud to the subject, and after the discussion, the subject signs (or marks) the consent form and the impartial witness signs as an attestant to the process. This setup provides an extra layer of protection for the subject and creates an auditable record of understanding and voluntary participation.