Which statement is NOT an essential element of informed consent?

• A. Voluntary, informed authorization by a competent patient or surrogate
• B. Explanation of purpose, risks/benefits, and alternatives
• C. Assessment of understanding and voluntary agreement
• D. Written consent is the only acceptable form

Answer: (D)

Informed consent means the patient or a legally authorized surrogate makes a voluntary, knowledgeable decision about care. The essential pieces are that authorization is voluntary and given by someone who is competent; there is clear explanation of the procedure’s purpose, risks, benefits, and alternatives; and there is an assessment that the patient understands what was explained and agrees to proceed.

Written documentation is a common and practical way to record consent, but it is not always required. Consent can be given verbally and still be valid if the patient is competent, adequately informed, and there is a record of understanding. Therefore, saying that written consent is the only acceptable form is not an essential element of informed consent.