CITTADINANZATTIVA ANSWERS

"They made me sign the informed consent before the operation without reading it. Is that correct?"

The association for citizen participation and protection answers questions about rights and access to health services

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4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

After a herniated disc in my back that was causing me severe and persistent nerve compression, I underwent an operation to surgically remove the herniated disc fragment. The operation, which had been planned for some time, took place in a famous hospital in Rome and was performed by a team of surgeons experienced in this type of operation. The removal of the hernia was successful but, unfortunately, as a consequence of the operation I suffered damage to a nerve in my leg and a strong alteration in sensitivity. Today, several months after surgery, I am still undergoing a specific rehabilitation plan to regain function. The doctors tell me that this is something that can happen and that I was properly informed before the operation, in fact I saw the consent form I signed and there was this kind of information. I point out that I signed the form just before going into the operating theatre and nobody explained anything to me, they just told me to sign. Is it correct that the patient is not given detailed information before undergoing such an operation?

Informed consent is a fundamental principle in modern healthcare practice, representing the cornerstone of the relationship between patient and doctor. It is defined as the person's free and informed acceptance of a medical treatment or diagnostic test after having received complete and up-to-date information on the modalities, benefits and foreseeable risks.

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In Italy, Law No 219 of 22 December 2017, which came into force on 31 January 2018, regulates informed consent from a regulatory point of view. In fact, it establishes that a person must give his or her free and informed consent to any health treatment that concerns him or her, to be informed, not to be informed if he or she prefers so, to indicate a trusted person, to change his or her mind, and to refuse the proposed treatment or assessments. In addition, the law for the first time in our country has provided for DAT - Declares of Anticipated Treatment, to express one's wishes on one's treatment for when one is no longer able to decide autonomously.

The legal requirements for informed consent

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From a legal point of view, the law defines certain aspects that informed consent must possess.

- Detailed information: patients have the right to complete and up-to-date information on their health condition, possible treatment options and foreseeable risks.

- Freedom of choice: the patient may refuse or revoke previously given consent at any time.

- Designation of a trustee: the patient may designate a trustee to represent him/her in healthcare decisions.

- Respect for the patient's will: the doctor must respect the patient's will, except in exceptional cases provided for by law.

Informed consent is of central legal and medico-legal importance, since it is the instrument through which the patient's will is formalised. The doctor or health professional is not obliged to perform treatment contrary to ethics or good clinical practice, even if requested by the patient.

Not just a formality. When consent is excluded

In this context, however, it is necessary to go beyond the pure formalism of consent; it is not enough for the patient to sign the consent form, but it must be explained to him in an appropriate manner and in good language what the procedure is, the possible side effects, the rehabilitation process, etc. Informed consent must be acquired in the manner and by the means most suited to the patient's condition, and it must be documented in writing or by means of video recordings. The declaration of consent must then be included in the medical record or in the electronic health record. Every person capable of acting has the right to refuse, in whole or in part, and by the same means by which consent must be given, any diagnostic assessment or health treatment, and also to withdraw the consent given. The need for consent is excluded in two hypotheses: the first concerns TSOs (compulsory health treatment) that pursue public health purposes; the second relates to the state of necessity under Article 54 of the Criminal Code, which provides for the non-punishability of a person who has committed the act out of the need to save himself or others from the current danger of serious harm to the person, a danger that he did not voluntarily cause, nor otherwise avoidable, provided that the act is proportionate to the danger.

In conclusion, informed consent, as a condition for the lawfulness of any healthcare treatment, is based on self-determination, in the choices concerning one's own health, understood as the freedom to dispose of one's own body, which are fundamental personal rights enshrined in Articles 2, 13 and 32 of the Constitution and Articles 1, 2 and 3 of the Charter of Fundamental Rights of the European Union. The patient's consent must be free and informed, preceded by complete, up-to-date and comprehensible information on the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated, possible alternatives and the consequences of any refusal of the health treatment and diagnostic tests or of their renunciation.

For more in-depth information, please consult the Cittadinanzattiva website in the specialdeepening.

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