Patient Consent: Legal Obligations and Best Practices

Consent to care is not a signature at the bottom of a form. It is the outcome of an information process that the healthcare professional must be able to demonstrate they carried out. This burden of proof, which rests on the practitioner and not on the patient, turns a professional-ethics obligation into a concrete legal risk: the procedure may have been performed flawlessly and liability may nonetheless be engaged.

The principle: no procedure without free and informed consent

No medical procedure or treatment may be carried out without the free and informed consent of the person concerned. Three adjectives, three distinct requirements.

Free means free from constraint and pressure. Consent obtained under organisational time pressure, just before entering the operating theatre, is particularly open to criticism on this point.

Informed requires that the information has been provided beforehand and understood. This is the link that most often fails.

Revocable lastly: consent may be withdrawn at any time, even after having been given, and the patient may refuse treatment. The professional must then do everything possible to persuade them, inform them of the consequences of their refusal, and respect their decision.

The content of the information

The information covers the investigations, treatments and preventive actions proposed, their usefulness, any urgency, their consequences, as well as the frequent or serious risks that are normally foreseeable. It includes the possible alternatives and the foreseeable consequences of a refusal.

Two points deserve attention. A serious risk must be disclosed even if it is rare: rarity does not exempt the practitioner from providing information once the seriousness of the risk is established. And the duty to inform continues even where new risks are identified after the procedure, which means the patient must be able to be contacted again.

It is provided during an individual consultation, in accessible language. Handing over a document does not replace this consultation, it complements it — and in practice it is the combination of the two that makes for the strongest file.

The burden of proof, the heart of the matter

Since a 1997 court ruling, now enshrined in law, it is up to the healthcare professional to prove that they provided the information, not up to the patient to prove that they did not receive it.

This reversal has a direct consequence: failure to inform constitutes an independent ground for liability. It requires no technical fault whatsoever. A practitioner whose procedure was performed impeccably can still be held liable for failing to show that they informed the patient of a risk that materialised. The harm compensated is then the loss of the chance to avoid the risk by declining the procedure, or the harm of being unprepared for it.

Proof may be established by any means. In practice, three elements complement one another:

• The traceability in the medical record: a dated note of the consultation, the points discussed, and the questions asked.
• The information document provided, for which it can be shown that it was indeed handed over and on what date.
• The reflection period left between the information and the procedure, which on its own demonstrates that consent was not obtained under duress.

This is precisely what an electronically signed consent form delivers: a dated document, attributable to an identified person, whose integrity can be demonstrated years later. The issue ties in with professional civil liability, for which failure to inform is one of the most frequent and most avoidable grounds for claims.

Cases where a written record is required

Consent is in principle oral. The law nonetheless requires a written record in several situations, sometimes with a mandatory reflection period:

• Research involving human subjects.
• The donation and use of elements and products of the human body.
• Medically assisted reproduction.
• Cosmetic surgery, accompanied by a reflection period after the quote is provided.
• Sterilisation for contraceptive purposes, with a longer reflection period.

In these situations, the absence of a written record is not merely a weakness of proof: it is an irregularity in itself.

Minors, protected adults and emergencies

For a minor, consent is obtained from the holders of parental authority, but the minor must be informed and their opinion taken into account according to their degree of maturity. Under certain conditions, they may object to their parents being consulted.

For a protected adult, the principle is personal consent, with the assistance or representation provided for under the protection measure.

When the person is unable to express their wishes, the professional consults the trusted support person, family or relatives, and takes advance directives into account. This consultation is subject to limits on what may be shared, an issue covered in our article on medical confidentiality: informing a relative in order to obtain their opinion does not authorise disclosing the entire record to them. In the event of a life-threatening emergency where it is impossible to obtain consent, the essential procedure may be carried out — but this exception is to be interpreted strictly and requires that the emergency and the impossibility be documented.

Usage scenarios

Scheduled procedure. The information is provided during a consultation, a document is handed over, and a period of time separates this consultation from the procedure. This period is not a mere formality: it is the most convincing element of the file.

Procedures carried out in series. A standard consent process for all patients makes proof easier, provided that an individual record exists. A process without a record for each named patient proves nothing.

Patient refusing treatment. The refusal must be recorded in the same way as consent, noting the information given about the consequences. The file must establish that the practitioner attempted to persuade the patient.

Frequently asked questions

Is a signed form enough? No. It constitutes an item of evidence, not proof in itself. What is required is a demonstration that the information provided was appropriate and understood; a signed form with no record of a consultation remains open to challenge.

Who must prove that the information was given? The healthcare professional. This reversal of the burden of proof, established in 1997 and subsequently enshrined in law, is what makes failure to inform so frequently sanctioned.

Must an exceptional risk be disclosed? Yes, if it is serious. Rarity does not exempt the practitioner from the duty to inform once the seriousness of the risk is established.

Can the patient go back on their consent? At any time, even after having given it. The professional must inform them of the consequences of their refusal and respect their decision.

What happens in a life-threatening emergency? The essential procedure may be carried out where consent cannot be obtained. The emergency and the impossibility must be documented, as the exception is to be interpreted strictly.

What compensation applies in the event of a failure to inform? The harm compensated is the loss of the chance to have refused the procedure, or the harm of being unprepared for the risk that occurred. These are independent heads of damage, unrelated to any technical fault.

Key takeaways

Consent is a process, not a document. What is required of the professional is not to obtain a signature but to demonstrate that they informed the patient — about the usefulness, alternatives, consequences and serious risks, however rare.

Three elements together make for a solid file: a dated record of the consultation in the medical record, an information document whose delivery is established, and a period of time between the information and the procedure. The latter is the simplest to put in place and the hardest to challenge.