Informed consent in clinical research: Medico-legal standards, ethical challenges and forensic implications in UK and EU frameworks

BackgroundInformed consent (IC) is a legal and ethical cornerstone in clinical research involving humans. While it embodies the principle of decisional autonomy, its implementation faces significant challenges.ObjectivesThis narrative review aims to critically analyse the ethical, legal and regulatory aspects of IC in clinical research, with a specific focus on UK and European Union (EU) jurisdictions. Particular attention is given to medico-legal defensibility, the treatment of vulnerable populations and the emerging forensic implications of consent-related failures.MethodsKey international instruments (Declaration of Helsinki, Council for International Organizations of Medical Sciences Guidelines), UK statutes (Mental Capacity Act 2005, Human Tissue Act 2004) and data protection regulations (Regulation (EU) 2016/679 (EU GDPR) and its post-Brexit counterpart, the UK GDPR) were examined alongside relevant case law. Empirical findings, audit reports and forensic literature were integrated to assess procedural vulnerabilities and regulatory expectations.ResultsThe review identifies major risks associated with invalid or poorly documented consent, including therapeutic misconception, capacity fluctuation and coercion in hierarchical or cross-cultural contexts. It highlights the increasing role of forensic medicine in assessing consent adequacy and outlines innovative models such as dynamic and electronic consent, evaluating their medico-legal relevance.ConclusionsRobust, participant-centred consent frameworks are essential to uphold ethical integrity and legal compliance in clinical research. Regulatory harmonisation, institutional preparedness and forensic awareness are critical to mitigating liability, safeguarding participant rights and maintaining public trust in biomedical science.