What is the required documentation for informed consent?

• A. Written, signed, and dated informed consent form
• B. Verbal consent only
• C. An unsigned note
• D. A video recording only

Answer: (A)

Informed consent must be captured in a written, signed, and dated form. This creates a verifiable record that the participant was informed about the study, understood the information, and voluntarily agreed to participate. The participant (or a legally authorized representative) signs the document, the date is recorded, and the participant should receive a copy of the signed form. The form should cover the study purpose, procedures, risks, benefits, alternatives, confidentiality, compensation, and the right to withdraw.

Verbal consent alone does not leave a tangible record for audits or oversight. An unsigned note does not document that consent was properly obtained, and a video recording by itself does not meet the standard documentation requirement.