When documenting informed consent, which elements should be included?

• A. The patient’s signature only.
• B. A generic note that consent is given.
• C. Documentation of the explanation of risks and alternatives, patient understanding, voluntariness, and the patient’s decision.
• D. The physician's feelings about the patient.

Answer: (C)

The essential point is that documenting informed consent must show that the patient was informed about what will be done, the risks, and reasonable alternatives, that the patient understood this information, that the decision was voluntary, and what the patient decided. A record that simply states a signature was obtained or that consent was given does not prove what was explained or that the patient truly understood and chose freely. Likewise, noting the physician’s feelings about the patient has no relevance to the patient’s ability to consent and should not appear in the record.

In practice, the note should reflect that the risks and available alternatives were explained, that the patient had an opportunity to ask questions and seemed to understand, that the decision was voluntary, and the patient’s explicit decision to proceed or decline. Include who obtained consent, the date and time, and the specific procedure. If language barriers exist, document the use of an interpreter and that comprehension was confirmed.