Consent is the legal foundation of every clinical intervention. Deficient consent processes are among the most frequent findings in medico-legal disputes.
Elements of Valid Consent
Valid consent requires capacity, voluntariness and adequate information. The patient must understand the nature of the proposed intervention, its material risks and benefits, reasonable alternatives, and the consequences of declining treatment.
Who Must Consent
An adult with decision-making capacity consents for themselves. Substitute consent arises only where the patient lacks capacity, in emergencies where the doctrine of necessity applies, or where statute specifically provides.
Statutory Consent Requirements
Certain statutes prescribe specific consent formalities — the MTP Act for termination of pregnancy, the Transplantation of Human Organs and Tissues Act for donation, and the ART and Surrogacy Acts for fertility procedures, among others. Compliance with the prescribed forms is mandatory.
Documentation
Consent should be documented contemporaneously, in a language the patient understands, signed and witnessed as appropriate. Procedure-specific consent forms reflecting an actual discussion carry far greater evidentiary weight than generic forms.
This article is for general informational purposes only and does not constitute legal advice.