‘Informed Consent’ (IC) in Health Literacy (HL): State-of-the-art of an elaborate legal-lay communication process

Informed consent (IC) is a fundamental ethical and practical part of patient care, and a critical component of clinical research: it is a mandatory legal requirement, a fundamental ethical step, and a crucial practical part both of patient care and of clinical research. A linguistic and cross-cultural approach to the study of the IC is especially complex, as it takes place at the intersection of lay (the patients or the research subjects), scientific (the physician or the researchers), and legal (the regulatory framework) discourses. From the Universal Declaration of Human Rights (1948), to the Oviedo Convention (1997-99), up to the ‘Carta di Firenze’ Document (2005), this contribution is aimed at defining the value of IC in terms of patients’ understanding, satisfaction, and anxiety. As the state-of-the-art definition stands at present, IC is an ethical concept, but more work still is needed in the area of ‘understanding’ health and illness.