After the informed consent form is read and explained, what should happen?

• A. The investigator should sign the form alone.
• B. The participant or their representative should orally consent and sign the form, with a witness signing as well.
• C. Consent is optional if the participant agrees verbally.
• D. The form should be archived without consent.

Answer: (B)

After the consent discussion, consent must be documented by the person agreeing to participate. The participant or their legally authorized representative should orally agree and sign the consent form, and a witness should sign as well to attest that the process occurred and that the participant was informed and free to decide. This combination ensures voluntary participation, understanding, and proper documentation in the study records. Signing by only the investigator or archiving without consent would not meet GCP requirements, and consent cannot be omitted even if there’s verbal agreement.