What an informed consent form must include

What must an informed consent form include? Under Law 41/2002 (Spain), the written document refers to a specific procedure and carries sufficient information about the procedure and its risks. Before asking for a signature, the doctor gives the patient the basic information: relevant consequences, personal risks, probable risks and contraindications.

What the law requires

More than a form, the law sets what the patient must know and what the paper they sign must carry. Three articles of Law 41/2002, the basic law regulating patient autonomy in Spain, divide it up:

Where	What it says
Article 4, paragraph 1	The information comprises, as a minimum, the purpose and nature of each intervention, its risks and its consequences. As a general rule it is given verbally, with a record kept in the medical record.
Article 8, paragraph 1	Any action in the field of a patient's health requires their free and voluntary consent, once, having received that information, they have weighed up the options appropriate to the case.
Article 8, paragraph 3	Written consent is necessary for each of the procedures that require it, with the possibility of attaching annexes and other general information, and it must contain sufficient information about the procedure to be applied and its risks.
Article 10, paragraph 1	Before obtaining written consent, the doctor provides the basic information: relevant consequences, personal or professional risks, probable risks and contraindications.

The same article 10 adds a rule of judgement: the doctor in charge must weigh in each case that the more doubtful the outcome of an intervention, the more necessary the patient's prior written consent becomes.

Which procedures need written consent and how to sign it without paper is covered in signing consent forms on a tablet. Here we look at what goes inside.

The basic information, point by point

The basic information in article 10 has four parts, and each answers a different question from the patient:

• The relevant or important consequences that the intervention will certainly cause. What will happen in any case, not what might happen.
• The risks related to the patient's personal or professional circumstances. Those that depend on that particular person. That is why a generic document, with nothing about the patient, falls short.
• The probable risks under normal conditions, according to experience and the state of science or directly related to the type of intervention.
• The contraindications.

Which specific risks each treatment carries is established by the professional who prescribes it; the document puts in writing what is explained to the patient. That text is provided by the clinic, not by a generic template downloaded from the internet.

Form matters too. The law says that clinical information will be truthful, will be communicated to the patient in a way that is understandable and suited to their needs, and will help them make decisions in accordance with their own free will. A technical three-page text in small print serves that purpose poorly, even if it is complete.

And it is not only the doctor who informs. The doctor responsible for the patient guarantees them the fulfilment of their right to information, and the professionals who attend them during the care process or apply a specific technique or procedure to them are also responsible for informing them. In a clinic with several specialties, it helps if the document says who gave the information.

One document for each procedure

Written consent is requested for each procedure, not once for everything. The law says that the patient's written consent will be necessary for each of the procedures that require it, while leaving open the possibility of attaching annexes and other general information. In practice:

• A single paper signed on arrival “for any treatment” does not refer to any specific procedure.
• What applies to several treatments, such as the clinic's details or explanations of a general nature, can go in an annex.
• If what is going to be done changes, a new document is needed, not a crossing-out on the previous one.

In a treatment with several sessions, whether one document is enough for the whole course or another is needed at some session depends on what is done in each one: it is a clinical and legal decision for the clinic, best taken with its adviser and applied equally to all patients.

What else should be recorded

Besides the information, a good document makes clear who, what and when, so that nobody has to reconstruct it afterwards. This is a practical checklist; where an item comes from the law, we say so:

Item	Why
The patient and, if someone else signs, who signs and in what capacity	To know who consented. Article 9 of Law 41/2002 regulates the cases in which consent is given by representation.
The specific procedure	Written consent is requested for each procedure.
Who gives the information	The doctor in charge and those who apply a specific technique or procedure are also responsible for informing.
The date and the signature	To place the consent before the procedure.
That the patient has been able to weigh up the options and ask questions	The law requires consent once, having received the information, the patient has weighed up the options appropriate to the case.
That they can revoke it	The patient may freely revoke their consent in writing at any time.
Teaching or research use, if any	The patient has the right to be warned about the possibility of using the procedures applied to them in a teaching or research project, which may in no case involve additional risk to their health.

There are two more situations that are also put in writing. If the patient expressly states that they do not want to be informed, their wish is respected by documenting their waiver, without prejudice to obtaining their prior consent for the intervention; the law limits that waiver in the interest of the patient's own health, that of third parties or the community, and by the therapeutic requirements of the case. And if the patient refuses treatment, their refusal will be recorded in writing.

Law 41/2002 is a basic law, and the State and the autonomous communities adopt, within their competences, the measures necessary for it to be effective. Your autonomous community may have its own rules on consent: ask your adviser to confirm which ones apply to your clinic.

What should not go on the same paper

Informed consent authorises a healthcare procedure; it is not the place for data protection information or for advertising. They are papers with different functions, as we explain in informed consent and data protection.

If the same document also asks for consent to process data, the GDPR says that the request shall be presented in a manner clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. Something similar happens with photos: clinical use and marketing use are different purposes, and marketing needs its own authorisation, as we explain in before-and-after patient photos.

Three mistakes to avoid when preparing the document:

1. Copying someone else's template without adapting it. The risks and contraindications are those of your treatment and your patient, not those of another clinic.
2. Putting everything on one paper. It is better to sign the treatment, the data and the advertising separately.
3. Correcting what has already been signed. If something was wrong, prepare a new version and keep the signed one as it was.

How Mi Clínica stores it

Mi Clínica does not write the content of your consent form or decide which treatments need it in writing: the professional and the clinic decide that. What the software does is make sure the document is signed and cannot be changed afterwards:

• Each paper in its own document. Consent forms are of four types: treatment, data protection, photography authorisation and marketing authorisation.
• Linked to the treatment. The consent form for a treatment can be linked to that treatment.
• Signing on the tablet. The patient signs on the tablet, and nothing is recorded as signed without the file of their signature.
• Signed documents stay untouched. The signed file cannot be modified, and the exact signed version is kept.
• Versions. If something has to change in a signed consent form, a new version is made and the previous one is kept intact, with its signature.

The software does not certify compliance with any regulation: it helps what the clinic decides to be properly stored and easy to find. A summary of how it works with documents is on the Mi Clínica page (in Spanish).

Sources consulted

Checked on 11 October 2026. We link to the original source so that you can consult the current text.

• Ley 41/2002, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica (texto consolidado). BOE.
• Reglamento (UE) 2016/679, Reglamento general de protección de datos. BOE (DOUE).