What must be demonstrated by documented informed consent?

• A. That the patient signed a consent form.
• B. That the patient was informed about risks and benefits.
• C. That the patient was provided all information.
• D. Evidence that the patient understood risks, benefits, alternatives, and that consent was voluntary.

Answer: (D)

Documented informed consent requires evidence that the patient understood the risks, benefits, and alternatives and that the decision was voluntary. It’s not enough to simply sign a form or to have information given; the record should show that the patient comprehended what would happen, what the potential risks and benefits are, what other options exist, and that no coercion influenced the choice. Documentation should reflect capacity to consent, opportunity to ask questions, and the patient’s voluntary agreement. If the record only shows a form was signed or that information was provided without confirming understanding and voluntariness, it doesn’t demonstrate truly informed consent.