Informed consent in Spain: what must be explained

The paper signed before an operation does not exist to protect the hospital. It exists so that the patient can decide with the same information as the person proposing the treatment.

What it must contain

Identification of the patient and the practitioner. A description of the procedure in language the patient can follow. Its certain consequences, meaning what will happen with certainty. Its typical risks and those personalised to this patient's circumstances. The reasonable alternatives, including not intervening. And the date and signature of both parties.

The timing matters

The information must be given with enough notice to think about it, ask questions and consult others. A document handed over at the door of the operating theatre, with the patient already prepared, satisfies the form and empties the substance: there is no decision where there is no time and no way back. Receiving it days in advance, with the option of a second appointment for questions, is what makes it real.

The rights that accompany it

To withdraw consent at any time and in writing, without needing to justify it and without prejudice to subsequent care. To waive the right to be informed, a decision that must be recorded in writing and does not prevent consent being given for the procedure. And to designate the people with whom clinical information may or may not be shared.

Everything signed becomes part of the clinical record, which must be kept for at least 5 years from discharge and of which the patient may request a copy at any time.

The exceptions

Where there is an immediate serious risk to the physical or mental integrity of the patient and their authorisation cannot be obtained, treatment may proceed without consent, consulting relatives or connected persons where circumstances allow. There is also an exception on public health grounds. Outside those defined cases, the absence of informed consent is a breach of rights rather than a paperwork defect.

The figures help judge whether a document is doing its job. A useful consent form runs to 2 or 3 pages, lists between 5 and 12 specific risks with an indication of how often each occurs, and describes at least 2 alternatives. One of half a page with 3 generic lines and no frequencies does not allow a decision. In scheduled surgery, 24 to 72 hours of notice is the reasonable minimum.

Two more figures. The clinical record holding the signed consent must be kept for a minimum of 5 years from discharge, and the patient may request a copy at any time within that period, paying only the material cost of reproduction, in the order of 5 € to 25 €.