Which elements must be documented when obtaining informed consent?

• A. Only the patient’s signature on the consent form.
• B. Disclosure of risks/benefits/alternatives; assessment of capacity; voluntary decision; patient questions answered; time; and interpreter details if used.
• C. Only the physician’s opinions.
• D. Only the procedure name and date.

Answer: (B)

Documentation of informed consent should show that the patient was informed and able to decide, not just that a signature was obtained. This means recording that risks, benefits, and alternatives were disclosed; an assessment of the patient’s capacity to consent was made; the decision was voluntary and free of coercion; the patient’s questions were answered; the time the consent was given is noted; and, if an interpreter was used, details about language assistance are documented. Each of these elements supports the patient’s autonomy and provides a clear record that the patient understood what they were deciding and freely agreed to the procedure. Merely capturing a signature or listing only the procedure name and date does not demonstrate that the patient was informed, understood, or capable of making the decision, and noting only the physician’s opinions would not reflect the patient’s understanding or voluntariness.