Informed Consent and the Doctor–Patient Relationship

Legal Brief by Carlos Vasconcelos

Informed consent is, increasingly, an essential element of the doctor–patient relationship and a fundamental legal and ethical requirement of clinical practice. It constitutes a condition for the lawfulness of medical intervention, and its omission or deficient collection may give rise to autonomous medical civil liability, even when the clinical act is technically correct and complies with the leges artis.

In truth, it represents an expression of the patient’s autonomy — a free, informed, voluntary, specific, and timely decision, made by someone with the legal capacity to do so, after being properly informed about the diagnosis, therapeutic proposal, expected benefits, typical and materially relevant risks, reasonable alternatives, and the consequences of refusal, except in exceptional urgent situations, in accordance with the principle of necessity.

It is, therefore, much more than a “written consent”.

Beyond all the above, it is a right inherent to any patient; a personality right. Its violation may give rise to compensation for non-pecuniary damages, due to the infringement of legally protected interests such as freedom of decision and the right to self-determination, even when the technical performance is impeccable and the outcome of the intervention is completely successful.

In times when citizens are, fortunately, increasingly informed, aware, and protective of their rights, it is advisable that healthcare professionals and organisations adopt best practices to mitigate risks. Among others, improving institutional protocols and consent templates by type of procedure; ensuring regular training of teams in clinical communication and documentation; guaranteeing adequate decision-making time, with prior delivery of informational materials; implementing dynamic consent models with open fields and room for procedure-specific risks; periodically reviewing the risk matrix for each specialty and incorporating new information and knowledge.

In short, adopting a structured approach focused on dialogue, personalised information, and robust documentation.