What is Informed Consent?
Informed consent is understood as the informed authorization given by the user prior to submission to a certain medical act, any act integrated in the provision of health care, participation in research or clinical trial. This authorization presupposes an explanation and respective understanding of what is intended to be done, how to act, why and the expected result of the intervention consented to.
As a rule, any intervention in the field of health can only take place after the free and informed consent of the recipient has been given. In other words, the user must first receive adequate information regarding the objective, nature of the intervention, consequences, risks and alternatives. When in doubt about the care you will be given, do not hesitate to ask for further information.
How should the information be provided to the user for further informed consent?
The information must be provided in a simple, objective, clear, sufficient and reasonable manner with the aim of completely clarifying its recipient as to its state of health, its evolution and the risks associated with the intervention or treatment.
The person informing must ensure that the recipient of the information is properly informed, referring, where appropriate, to treatments or other alternative interventions.
The doctor, or health care professional, should check that the person concerned has understood the explanations given to him or her in order to ensure that the consent has actually been clarified.
Who should provide the information to the user for further informed consent?
The information necessary for informed consent shall, in principle, be provided by the doctor, or health professional, who carries out the treatment or intervention.
Who gets the information?
As the holder of the right to information is the user himself/herself, it is he/she who should receive it.
Can/should the user's family receive the information?
As a rule, no. The user is the holder of the right to information and has the right to confidentiality of his/her health data. Therefore, the family should only be the recipient of the information if this has been authorised by the user.
Are there exceptions to the duty to inform?
Yes. The information should not be passed on to the user where it could cause serious damage to their health. That is, when the doctor or health professional considers that the user's knowledge of the clinical situation may represent a danger to their health, they should not provide the information.
Likewise, the user has the right to be unaware. This right may be restricted, either in the interest of the user himself/herself or for the protection of others.
When should information be given so that informed consent can be given?
The information should be transmitted prior to the medical act or any act of health care, participation in research or clinical trial, sufficiently in advance to allow reflection and consideration by the user.
Who can give informed consent?
According to general law, informed consent can be given by anyone who is capable of doing so.
Thus, users who are of legal age without any definite or temporary cognitive changes are able to consent.
The consent of the incapacitated must be given by their legal representatives.
How can informed consent be expressed?
Consent may be given in writing, orally, or by any other direct means of expression of will.
The user's consent may be:
- tacit or implicit, when it results from facts which in all likelihood reveal it;
- presumed, when the user is unable to express his or her will and when the situation is urgent, in the absence of a previous expression of will, to refuse to provide health care;
- with the intervention of a third party, in particular its legal representative or judicial authority (in cases where the legal representative refuses consent but the doctor considers that there is harm to the user), in relation to incapacitated persons.
Is the user's consent revocable?
Yes. Consent may be revoked at any time, until the practice of the act consented to.
Can the user refuse treatment?
Yes. Capable users may refuse any treatment, even if that refusal could cause serious and irreversible damage to their health, or even death.
The refusal has to be informed.
Is there a mandatory model/form of informed consent?
The model written informed consent shall provide for two declarations:
- the declaration of the professional responsible for the act and treatment, including a description of the act or treatment to be performed and eventual inherent risks;
- the declaration of the person who consents.
Source: Health Regulator