Do you have to undergo a medical examination? Learn what medical liability and informed consent are.

All those who, for one reason or another, have had to undergo certain types of medical examinations or medical-surgical procedures, have already been confronted with the expression — whether orally or in some type of form — of “informed consent.”

However, it is often unclear what this consent actually means; what it is for, and what the consequences of its violation are.

These are the questions that will be answered here in a topical manner.

1. What is informed consent?

Informed consent consists of the patient’s expression of will in deciding about their own health. It is, therefore, an essential requirement for the performance of any medical act.

For informed consent to be valid, three requirements must be met in summary:

• The patient must have the capacity to consent;
• The doctor must fulfill the duty of information incumbent upon them, namely to provide the patient with the necessary and sufficient information to allow them to decide;
• Consent must be voluntary and free.

2. How should the information be provided?

Information is the essential element of consent.

The obligation to provide information may, depending on the circumstances, fall upon the doctor or the medical team.

It is difficult to envisage the possibility of delegating this duty to other non-medical professionals (e.g., assistants, among others). Even though they may collaborate in providing clarifications, this does not remove the doctor’s duty.

The patient has the right to be informed in terms they can understand. The information must be explained clearly and objectively, with technical terms translated into language that the patient can comprehend. Thus, it should be stressed that it is not enough for the doctor to merely provide information: there is also a duty to ensure that the patient has understood it.

3. What type of information should be provided?

The content is relatively flexible and must be assessed according to the specific case, starting with the type of procedure and, for example, its diagnostic or therapeutic purpose.

In general, all information regarding diagnosis, treatment, methods, prognosis, effects, risks, alternative treatments, benefits, urgency of the treatment, among others, should be provided.

It should be noted that this scope of content does not mean that the doctor must detail every single aspect. However, it is required that they ensure the provision of all information necessary for the patient to understand what is at stake and, in particular, the associated risks.

From the outset, the doctor must disclose possible side effects, whether possible or probable, as well as the risks and benefits of the medical intervention.

Finally, it should be noted that the duty to provide information exists even if informed consent is not formally obtained.

4. Is the duty to inform absolute?

No. There may be exceptions, namely in cases of manifest urgency or when the patient has waived the right to be informed (also referred to as the right not to know).

5. When and how must informed consent be given?

Consent, as a rule, must be given before the performance of any medical act and with reasonable notice, so that the patient has time to reflect on the decision to be made.

Consent must be given expressly, either orally or in writing, and may be revoked — up until the medical act is carried out.

There are, however, situations in which the law requires that consent/information be given in writing.

6. What happens if informed consent is violated?

The doctor may be held civilly, disciplinarily, and even criminally liable if they perform a medical act without having obtained consent.

In particular, as regards civil liability:

The right to informed consent exists in any doctor–patient relationship, whether public or private in nature, and its violation gives rise to civil liability.

As for damages, it is necessary to make a distinction:

1. If an intervention is performed without informed consent — or where consent was defective — but without bodily harm, the patient’s right to freedom of decision is considered violated, giving rise to non-pecuniary damages.
2. On the other hand, if a medical act is carried out without consent — or where consent is defective — and as a result of such act the patient’s state of health worsens or any adverse consequences occur, the damages will cover both non-pecuniary damages and physical damages.

It should be noted, however, that it will always be necessary to demonstrate that such a situation is an adequate cause of the damage in question.