Is capacity to consent to healthcare a uniformly defined concept? Insights from a document analysis of laws and national guidelines across six European countries

BACKGROUND: Capacity to consent or decision-making capacity to healthcare is a key prerequisite for a valid informed consent. A clear understanding of this concept is important to protect patients' autonomy. Without it, clinical assessments may vary, jeopardising patients' participation in decisions about their care and increasing the risk of delayed, denied or harmful treatment. Despite substantial international debate and reforms concerning norms on capacity assessment, there remains a paucity of scholarly literature comparing national approaches, which could enable countries to learn from one another. This study aimed to explore how the concept of capacity to consent to healthcare and the assessment is described in documents, guiding healthcare professionals, issued by health authorities in: Norway, England and Wales, Belgium, France, Sweden and Ireland. METHODS: Explorative qualitative document analysis of health laws, national guidelines and recommendations published by national health authorities in each country. RESULTS: There is no uniform description of the concept of capacity to consent to healthcare across all countries, although some commonalities exist, such as the functional approach and some countries are more conceptually aligned. The level of descriptive detail on the assessment varied, and in some countries the documents did not include such descriptions. DISCUSSION/CONCLUSION: To protect patients' autonomy, it is important that healthcare professionals are provided with a comprehensive guidance document to support their understanding of the concept of capacity to consent to healthcare and how to assess this capacity. The findings indicate that several countries lack such provisions. This could threaten patient safety and wellbeing and make research and clinical practice development more challenging.