Pursuant to Italian Law No. 219/2017 and Lazio Region Determination G00642 of 25 January 2022

Law No. 219 of 2017 governs informed consent and Advance Healthcare Directives (DAT – Disposizioni Anticipate di Trattamento). This Law establishes that "no medical treatment may be initiated or continued without the free and informed consent of the individual, except in cases expressly provided for by law". Therefore, all medical treatments must be preceded by adequate information and by a freely-expressed consent.

Exceptions are emergency and urgent situations, in which physicians and healthcare providers must ensure necessary care while respecting the patient's will, where his or her clinical conditions and the circumstances allow for it.

Throughout your care pathway, you will be granted time to talk to your physician and to your healthcare providers in order to receive all the necessary information to decide whether or not to consent to the proposed diagnostic and therapeutic procedures. Medical school students and trainees may be involved in your care as part of their educational training at this facility.

Legally competent adults may designate a trusted person, such as a family member or another person of their choice, to receive information about their health and provide consent on their behalf.

You have the right to know your health status, but you may also choose not to receive all or part of the information. Once you, or your designated trusted person, have received the relevant information, a General Informed Consent form must be signed to begin basic medical treatments.

As your care pathway progresses, for any diagnostic and/or therapeutic treatments that may become necessary you will be presented with one or more Specific Informed Consents for the proposed procedures.

As your care pathway progresses, for any diagnostic and/or therapeutic treatments that may become necessary, you will be presented with one or more Specific Informed Consents for the proposed healthcare procedures. Before signing any specific consent form, you will be informed of any existing and viable alternatives, based on your state of health, and of the possible consequences of refusing treatment.

You may revoke your consent at any time, either in full or in part, by refusing the proposed treatment/s and/or diagnostic test/s. Both your consent and your refusal, full or partial, will be documented in your medical record and signed by you or by your designated trusted person.

The law allows any legally competent adult to issue an Advance Healthcare Directive (DAT) drafting a written statement in accordance with current legislation. The DAT expresses your preferences regarding future medical treatments in situations where you may no longer be able to provide informed consent. Advance Healthcare Directives (DAT), along with any updates or revocations, must be submitted personally by the individual to the civil registry office of their municipality of residence, following the procedures established by law.

In emergency or urgent situations, the DAT may be revoked verbally or through a video-recorded statement, made in the presence of a physician and two witnesses.

For more information, please consult the relevant law and refer to the frequently asked questions below.

What is an informed consent?

An informed consent is the foundation of the relationship of care and trust between you and your physician. This relationship is supported by the healthcare providers in the team, each contributing according to their specific roles and expertise and, if you wish, by your family members or trusted individuals.

Consent is not merely the acceptance or refusal of a medical treatment, it is an integral part of your care process.

Do not hesitate to ask for any information or clarification you may need to give your informed consent.

Is an informed consent mandatory for medical treatment?

Yes, except in specific cases established by law, such as Compulsory Medical Treatment (TSO - Trattamento Sanitario Obbligatorio).

How is an informed consent obtained in emergencies or urgent situations?

In emergency or urgent situations, physicians and care team are required to provide necessary care in accordance with current legislation, while respecting the will of the patient when his or her clinical conditions and the circumstances allow it.

Will I need to provide additional consent during my hospital stay or care pathway?

Depending on the specifics of your plan of care and health conditions, you may be asked to sign one or more Specific Informed Consent forms for diagnostic tests, medical or surgical treatments. These forms will also outline any specific risks related to the proposed procedures based on your individual health status.

What does "specific risk" mean?

Every diagnostic test or therapeutic procedure (medical or surgical) involves the risk of adverse events or complications, which are not always preventable, even when clinical guidelines and best practices are followed. Certain health conditions or vulnerabilities (e.g., age, comorbidities) can affect the incidence, frequency, or severity of such complications.

You will receive clear and comprehensive explanations of these potential risks as they relate to your specific case before any consent is requested.

Legally competent adults can provide informed consent.

For minors, consent is provided by a parent or legal guardian, taking into account the minor’s age and level of maturity.

In the case of a legally incapacitated person, consent is provided by the legal guardian, after consulting the person whenever possible. At the time of signing, the legal guardian must provide a valid ID along with the relevant court appointment decree.

In the case of a partially incapacitated person, consent must be given jointly by the individual and by his or her legal guardian with limited powers [curatore] who must also provide a valid ID and the relevant court appointment decree.

Who can provide consent for medical information and treatment?

For a person legally incapable of acting, if subject to a support administration order with exclusive authority to act in healthcare decisions, consent is provided by a court-appointed support administrator [amministratore di sostegno].

However, the person receiving care must still be consulted whenever possible. If the court-appointed support administrator holds only advisory powers and not exclusive authority in healthcare matters, the informed consent must be obtained from the latter and also by the person receiving care.

What information will I receive when accessing the hospital's services, such as for a scheduled hospital admission?

In the case of a scheduled admission or other plan of care (e.g., DH, outpatient visits), you will be provided a General Informed Consent that includes information on the tests and treatments that will be performed for diagnostic and therapeutic purposes during your care, for which specific informed consent is not required (e.g., swabs, collecting urine or blood samples, measuring vital signs like blood pressure or blood gas analysis, physical examination, suture application/removal, tetanus prophylaxis). You will receive a verbal explanation from the healthcare provider or care team, which may be supplemented with written information sheets summarizing the key points discussed. At the end of this phase, once the diagnosis, prognosis, benefits and risks of the proposed diagnostic or therapeutic procedure have been clearly explained to you, along with any existing alternative options and the possible consequences of refusing treatment in relation to your specific health condition, you will be asked to sign a Specific Informed Consent for the proposed diagnostic/therapeutic procedure.

What information will I receive during my care pathway?

The information provided at the time of admission (e.g., in the ER, hospital unit, outpatient clinic, or DH) will be updated throughout your care based on changes in your health condition.

Can I refuse to receive information about my health status?

You have the exclusive right to know your health status, but you may also choose not to receive all or part of that information. Additionally, you have the right to seek further opinions from healthcare professionals you trust.

If I choose not to receive information about my health, will I still receive care?

Expressing the wish not to receive information about your health status does not affect your diagnostic or therapeutic care pathway.

Who else can receive information about my health? Can I authorize someone else?

Under informed consent regulations, legally competent adults may delegate a family member or a trusted person to receive information about their state of health. It is important to note that this authorization only applies to receiving information. An informed consent for treatment may only be provided by a legally competent adult. The full details of the authorized person will be recorded in your medical record.

Minors and individuals with natural incapacity, in accordance with their level of understanding and decision-making ability, and in compliance with current legislation, have the right to receive information in a manner that enables them to be actively involved in their own diagnostic and therapeutic care pathway.

What happens if I refuse or withdraw from medical treatment?

A legally competent adult has the right to accept or refuse, in whole or in part, the medical treatments proposed. Any refusal, withdrawal, or revocation of previously given consent must always be documented in the medical record, including any associated risks.

The physician must respect the will of the patient, or of the person legally authorized to act on the patient's behalf, to refuse or withdraw from medical treatment.

In the case of a person who lacks legal capacity or a minor, if the legal representative or the person exercising parental responsibility intends to refuse or withdraw from a medical treatment that the physician deems appropriate and necessary, the decision must be referred to the tutelary judge.