Medical Consent: Principles, Requirements, and Documentation

Definition

Informed consent is the voluntary, informed, and competent agreement of a patient to undergo a medical intervention or participate in research.

Four Essential Elements

1. Voluntary: Free from coercion, undue influence, or manipulation. Right to refuse/withdraw without penalty.
2. Informed: Disclosure of diagnosis, nature/purpose of procedure, risks/benefits, alternatives (including no treatment), probabilities of success. Language and literacy appropriate.
3. Competent: Patient has decision-making capacity (understands, appreciates, reasons, communicates choice). If lacking: surrogate (guardian, proxy, advance directive).
4. Documented: Signed consent form (witnessed) + progress note detailing discussion. Electronic consent acceptable.

Special Situations

• Emergency: implied consent if delay threatens life/limb.
• Minors: parental permission + child assent (age-dependent).
• Research: additional IRB oversight, right to withdraw.

Ethical/Legal Foundation

Rooted in autonomy (Belmont Report), battery law, and professional codes (AMA, GMC). Failure → malpractice, battery claims, loss of license.