The Informed Consent as the cornerstone of the physician–patient relationship in medical treatments and procedures: the Theory of Singular Consent as a doctrinal proposal

Abstract

The physician–patient relationship is among the most significant of human relationships, as it involves the patient entrusting the physician with what is most fundamental: life, health, and the continuity of existence itself. In this context, informed consent is not merely a legal requirement but a foundational ethical principle that should underpin all clinical practice. This conceptual legal analysis proposes the Theory of Singular Consent, according to which informed consent in the physician–patient relationship constitutes a legal process for the formation of the patient’s autonomous will rather than an isolated documentary act. In the international context, informed consent is understood not merely as a safeguard against unauthorized interventions but as a mechanism that promotes patient self-determination. Based on this central thesis, the paper identifies a structural misalignment between medical ethics, law, and clinical practice and proposes an operational model termed the Living Consent Pathway, consisting of ten stages that document the entire process of shared decision-making between physician and patient. The international literature on shared decision-making and patient decision aids demonstrates that clinically valid decisions depend on understandable information, active patient participation, and alignment with the patient’s values and preferences. This analysis draws upon the bioethical principles advanced by Beauchamp and Childress, applicable Brazilian legislation, and recent data from the National Council of Justice regarding the increase in medical malpractice litigation in Brazil. The enactment of the Patient Rights Statute (Law No. 15,378/2026) further reinforces the procedural, relational, and revocable nature of consent, in full accordance with the proposal advanced herein. The analysis concludes that the Informed Consent Form does not constitute consent itself but rather serves as documentary evidence of a singular process: one constructed for a particular patient, within a specific therapeutic relationship, at a given moment. Any other form is merely a signature.