Ethical and Legal Perspectives on Informed Consent in the Context of International Human Rights Law

Abstract

This article examines the concept of informed consent from bioethical and legal perspectives, analyzing its evolution as a distinct legal institution within international medical law. The study explores informed consent's dual role as a decision-making process and administrative tool in medical practice and human subject research, emphasizing its importance in protecting patient rights and autonomy. The analysis traces the philosophical foundations of informed consent from Kantian thought to contemporary interpretations, highlighting its development in international human rights law and European Union legislation. Key legal instruments and ethical declarations are discussed, including the UN Charter, Universal Declaration of Human Rights, Oviedo Convention, and Declaration of Helsinki. The article argues that informed consent has transcended its origins in civil law to become a complex, unilateral legal act specific to the medical field. It examines the tension between contractualist perspectives on the doctor-patient relationship and the unilateral nature of informed consent, emphasizing the latter's role in protecting individual autonomy and self-determination. Challenges in implementing informed consent are addressed, including adapting information to patients' understanding and ensuring truly voluntary decisions. The study also explores medical liability, distinguishing between obligations of means and results in medical practice. Through analysis of European Court of Human Rights jurisprudence, the article demonstrates the evolving interpretation of informed consent in relation to privacy rights and patient autonomy. It concludes by affirming informed consent's transformation into a distinct legal-social practice, reflecting growing recognition of individual autonomy in medical decision-making and the need to balance professional obligations with patient rights.