Review highlights challenges in informed consent and legal compliance in clinical practice, involving forensic experts in the process.
Informed consent is a fundamental component of both the right to health and self-determination. Its violation, which occurs when the acquisition process is absent or flawed, can also lead to legal proceedings for isolated harm, regardless of the simultaneous existence of those related to biological and psychological harm. Across Europe, this remains a legal and ethical cornerstone, increasingly important in the context of cross-border care and culturally diverse healthcare settings. Many countries have enacted specific laws to ensure patients receive adequate information, while courts continue to refine its interpretation—often highlighting the inadequacy of informed consent in daily clinical practice. In Italy, in particular, recent rulings underscore the need for clear, comprehensive, and properly documented consent formats for health treatments. This review synthesizes rulings, regulations, and the scientific literature to offer practical guidance for improving informed consent practices in Italy, valuing the role of forensic experts in the integration in healthcare settings of the different interests at stake. The aim is to support both legal compliance and the delivery of high-quality, patient-centred care. Courts and legislation in Italy demand clear and tailored informative disclosure for health treatments, with indications of the treatment and outcomes, to be in written form. Yet, foreseeable risks, more common complications, and alternative treatment options are often poorly communicated in practice—frequently forming the basis of claims for compensation. Integrating team-based consultations and multimedia tools can significantly enhance patient understanding and secure the informed consent process. Those key points are summarized in a brief table, ideally suggesting the minimal requirements for an informed consent form. Investing in standardizing informed consent protocols, and also fostering the sharing of best practices with forensic medicine experts, are crucial steps in ensuring shared decision-making in healthcare and trying to reduce legal disputes.
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Tronconi et al. (2025) studied this question.
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