Informed consent (consentimiento informado) when you do not understand

Key rules

• Written consent: Surgery, invasive procedures and treatments with notable risks need your written consent.
• Revoking: You can withdraw consent at any time in writing, but only for what has not yet been done.
• Translation: You have no guaranteed right to an interpreter or translated report, so ask early and expect to pay.
• Complaints: Start with the patient service, which must answer in writing, then go to the regional health authority or ombudsman.

When consent is needed

Before treatment, the doctor must give you information and you must agree. Written consent is required for surgery, for invasive tests or treatments, and for any procedure with notable risks. For simpler care, a spoken explanation and your agreement are normally enough.

The information must be understandable

Spain's patient law gives you the right to information in a way you can understand, adapted to your needs, so you can decide. The doctor should normally explain in advance and out loud. At a minimum, you should hear:

• what the procedure is and what it is for
• its risks and consequences
• risks linked to your own circumstances or job
• the risks that normally arise
• contraindications, meaning reasons it may not suit you

Be aware that the law does not expressly give you a free interpreter or a translated report. Some regions run interpreting or intercultural mediation programmes, so ask the hospital whether one exists. Translation is generally at your own expense. Private insurers may supply reports in English.

Reports are issued in Spanish. In regions with a co-official language (Catalonia, Basque Country, Galicia, Valencia and the Balearics), you may ask for the report in that language.

What a consentimiento informado contains

Layouts vary by hospital and region, but a consentimiento informado usually has:

• your details
• the name of the procedure, with its description and aim
• expected benefits
• common and rare risks
• risks specific to you
• alternatives
• a declaration that you were informed and could ask questions
• how to revoke consent
• the signatures of you (or your representative) and the doctor, with the date

Do not sign until you have read it and the doctor has answered your questions. The checklist below gives questions to ask.

If you signed without understanding

Signing does not bind you. You can revoke consent at any time, freely and in writing.

• Revoking only stops the part of the procedure not yet carried out. Once it is done, it cannot be undone. Act before the procedure.
• Ask for a further explanation and a copy of the form you signed.
• If you think you were not properly informed, complain to the hospital or health centre's patient service (Servicio de Atención al Paciente or Usuario). It must reply in writing.
• You can escalate to the regional health authority or the regional ombudsman.
• If lack of proper information caused you harm, you may claim damages. Against the public health service this goes through an administrative claim. Against a private provider it is a civil action. Time limits are short (generally one year for public-service claims), so get legal advice quickly.

Documents you need

• The signed consent form (consentimiento informado), with patient details, procedure, risks, alternatives, your statement that you were informed, the revocation section, and signatures and date. Ask the clinic for a copy.

• Your medical report, issued in Spanish or, where it applies, in the regional co-official language if you request it. Ask the hospital or health centre that treated you.

• A translation of the consent form or report into a language you understand, if you need one. You normally pay for it yourself.

Questions to ask before agreeing to treatment

• Ask for your diagnosis: "¿Cuál es mi diagnóstico?"

• Ask what treatment is proposed and what it is for: "¿Qué tratamiento me propone y para qué sirve?"

• Ask about the expected benefits: "¿Cuáles son los beneficios esperados?"

• Ask about risks and side effects, including any linked to your own health, job or circumstances: "¿Qué riesgos y efectos secundarios tiene?"

• Ask about alternatives, including not treating: "¿Existen alternativas, incluida no tratarme?"

• Ask what happens if you do not have the treatment: "¿Qué pasa si no me trato?"

• Ask how long treatment and recovery will take, and whether tests are needed first: "¿Cuánto durará el tratamiento y la recuperación? ¿Hay que hacer pruebas antes?"

• Ask how to take any medication and whether it interacts with what you already take: "¿Cómo debo tomar la medicación y qué interacciones tiene con la que ya tomo?"

• Ask about follow-up: when your next check-up is and who to contact if there are problems: "¿Cuándo es la próxima revisión? ¿Con quién contacto si tengo problemas?"

• Ask whether you can have a second opinion: "¿Puedo tener una segunda opinión?"

• Ask what it costs and whether your insurance covers it: "¿Cuánto cuesta y lo cubre mi seguro?"

• Check that the consent form names the procedure, its risks and the alternatives, and says you can withdraw your consent (revocación del consentimiento), before you sign.

• Ask for time and an interpreter or translation if you do not understand something, and do not sign until your questions are answered.

What to watch out for

• Signing a form you do not understand: A signature on a form in Spanish you cannot read can leave you agreeing to risks you were never told about. Consent is only valid after you get adequate information, normally spoken to you in advance. Do not sign until you understand the procedure, its purpose, risks, alternatives and what applies to your own health or job.

• Written consent is required for serious procedures: Surgery, invasive tests or treatments, and procedures with notable risks need written consent, so you will be handed a form to sign. Ask for the form ahead of time so you can have it translated or explained before the day.

• Revoking is too late once the procedure is done: You can revoke consent in writing at any time, but only the part not yet carried out is stopped. If you have doubts, revoke in writing before the procedure starts.

Frequently asked questions

Can I get my medical report in English?

Not as a legal right, because Spanish law does not give you a translated report or a professional interpreter. Reports are issued in Spanish, or in the regional co-official language if you ask for it where that applies. Translation is usually at your expense, though a private insurer may supply an English report.

Can I cancel my consent after signing a form I did not understand?

Yes, you can revoke consent freely and in writing at any time, and signing without understanding does not bind you.

Where do I complain if I was not properly informed?

Start with the patient service of the hospital or health centre (SAP or SAC), which must reply in writing. If that does not help, you can go to the regional health authority or the regional ombudsman. If poor information caused you harm, you can also claim damages, so get legal advice first.