The Gerencia Regional de Salud of Castile and León issued the revised version of the Guía de Consentimiento Informado . The Junta de Castilla y León cites the adaptation to amended legal provisions, the greater use of digital procedures and the aim of more clearly embedding patient autonomy in day-to-day care as reasons for the update. The guidance was drawn up by the Comisión de Bioética de Castilla y León; it applies to all facilities run by the regional health administration.
The main changes concern a more precise assessment of decision-making capacity (evaluación de la capacidad), revisions to the documento de instrucciones previas — an instrument for planning consent and refusals in advance — and updated documentation requirements and information standards for specific groups, including minors, people with mental illnesses and people with impaired judgement. The guidance retains a question-and-answer format to make it easier to use in everyday clinical practice.
The Junta stresses that the consentimiento informado process should be understood as an ongoing dialogue: healthcare professionals must explain the purpose, benefits, risks and alternatives of a measure in clear language tailored to each person’s information needs, so that they can decide freely and in accordance with their values. For difficult decisions, the Guía refers to the role of the Comités de Ética Asistencial.
The legal section of the Guía de Consentimiento Informado follows relevant state and regional legislation, as well as international rules protecting patients’ rights. Specific formal changes concern the information that must be included in written consent, the handling of exceptional circumstances — such as an immediate threat to life — and internal quality assurance procedures. The aim is to provide greater legal certainty for healthcare professionals and strengthen the protective role of informed consent for patients.
Implementation in healthcare facilities will now be key to the impact of the changes. This includes staff training, the widespread availability of updated forms — including the registro de instrucciones previas — and close coordination with the medical ethics committees. The publication of 12 September 2026 provides a binding reference for health centres in Castile and León. Any implications across Spain will depend on possible further discussions with the Ministerio de Sanidad .
Editor: Mira Cadena (Article created with AI assistance).