Informed Consent for High-Risk Procedures in Indonesia: Legal Formalism, Shared Decision-Making, and the Problem of Therapeutic Misunderstanding

Abstract

Introduction: Informed consent constitutes a fundamental ethical and legal requirement in modern healthcare, particularly for high-risk procedures that involve substantial risks of morbidity, disability, or mortality. Despite legal reforms that strengthen patient rights in Indonesia, informed consent is frequently implemented as a documentation-centered process, raising concerns regarding the quality of patient understanding and participation in clinical decision-making.

Methods: This study employed a normative-juridical narrative review by analyzing Indonesian health legislation, bioethical principles, medico-legal literature, and international publications related to informed consent, shared decision-making, patient autonomy, and therapeutic misunderstanding. Relevant legal and scientific sources were synthesized thematically.

Results: Indonesian regulations establish a comprehensive legal foundation for informed consent and require disclosure of information regarding diagnosis, proposed interventions, potential benefits, risks, alternatives, and prognosis. However, implementation often remains focused on obtaining signed consent forms rather than ensuring substantive patient comprehension. Contemporary evidence supports shared decision-making as a patient-centered approach that promotes meaningful involvement in healthcare decisions. Nevertheless, limited health literacy, cultural paternalism, communication barriers, emotional distress, and the complexity of medical information continue to contribute to therapeutic misunderstanding, particularly in high-risk clinical settings. These factors may undermine the validity of consent despite apparent legal compliance.

Conclusion: The validity of informed consent should extend beyond documentary authorization and encompass effective communication, patient understanding, voluntariness, and collaborative decision-making. Integrating shared decision-making principles into high-risk consent processes may reduce therapeutic misunderstanding, strengthen patient autonomy, and enhance medico-legal protection for both patients and healthcare professionals in Indonesia.