Developing a Responsive Legal Policy Model Based on Health Law Education to Protect Patient Autonomy in Informed Consent
DOI:
https://doi.org/10.58258/tz8d5y71Abstract
The protection of patient autonomy in informed consent remains a legal policy challenge because formal compliance with consent documentation does not necessarily ensure patients’ understanding, voluntariness, and freedom in medical decision-making. This study aims to develop a responsive legal policy model based on health law education to strengthen substantive protection of patient autonomy in healthcare services. The research employs normative legal research with a prescriptive design, using a literature review of secondary legal materials, including primary, secondary, and tertiary sources. Statutory and conceptual approaches are applied, with qualitative analysis through legal interpretation and argumentation. The analysis draws on Responsive Law Theory and principles of responsive policy design to formulate an integrated policy framework. The findings demonstrate that Indonesia has established a normative foundation for protecting patient autonomy through constitutional guarantees, Law No. 17 of 2023 on Health, and Government Regulation No. 28 of 2024. However, effective implementation requires stronger integration of legal certainty, health law literacy, participatory clinical communication, voluntary decision-making, and institutional accountability. Accordingly, this study proposes the Responsive Autonomy Protection (ROP) Model, comprising five interconnected dimensions to transform informed consent from an administrative formality into a substantive, rights-based process. The model requires further expert validation and empirical testing to assess its feasibility and effectiveness across healthcare settings.References
Asa, A. I., Munir, M., & Ningsih, R. S. M. (2021). Nonet and Selznick’s responsive law concept in a historical philosophy perspective. CREPIDO, 3(2), 96–109. https://doi.org/10.14710/crepido.3.2.96-109
Avci, E. (2026). Ethics education for patients to ensure consent is informed. International Journal of Ethics Education. https://doi.org/10.1007/s40889-026-00253-8
Baldwin, R., & Black, J. (2008). Really responsive regulation. The Modern Law Review, 71(1), 59–94. https://doi.org/10.1111/j.1468-2230.2008.00681.x
Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed.). Oxford University Press.
Chen, J., & Ye, L. (2026). Practical dilemmas and communication reconstruction of patients' right to informed consent under the Civil Code. Frontiers in Public Health, 14, Article 1831405. https://doi.org/10.3389/fpubh.2026.1831405
Entwistle, V. A., Carter, S. M., Cribb, A., & McCaffery, K. (2010). Supporting patient autonomy: The importance of clinician-patient relationships. Journal of General Internal Medicine, 25(7), 741–745. https://doi.org/10.1007/s11606-010-1292-2
Evripidou, M., et al. (2024). Ethics in patients' health literacy: A scoping review and a critical discussion. Health Promotion International, 39(4). https://doi.org/10.1093/heapro/daae100
Glaser, J., Nouri, S., Fernandez, A., Sudore, R. L., Schillinger, D., Klein-Fedyshin, M., & Schenker, Y. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: An updated systematic review. Medical Decision Making, 40(2), 119–143. https://doi.org/10.1177/0272989X19896348
Hattu, H. (2011). Tahapan undang-undang responsif. Mimbar Hukum, 23(2), 406–419. https://doi.org/10.22146/jmh.16186
ITV News. (2025, April 8). 'Multiple failings' towards woman who had hysterectomy without giving informed consent. https://www.itv.com/news/wales/2025-04-08/profound-injustice-for-woman-who-had-hysterectomy-without-giving-informed-consent
Negara, T. A. S. (2023). Normative legal research in Indonesia: Its originis and approaches. Audito Comparative Law Journal, 4(1). https://doi.org/10.22219/aclj.v4i1.24855
Ng, I. K. S. (2024). Informed consent in clinical practice: Old problems, new challenges. Journal of the Royal College of Physicians of Edinburgh, 54(2). https://doi.org/10.1177/14782715241247087
Nonet, P., & Selznick, P. (2001). Law and society in transition: Toward responsive law. Transaction Publishers.
Pietrzykowski, T., & Smilowska, K. (2021). The reality of informed consent: Empirical studies on patient comprehension. Systematic review. Trials, 22, Article 57. https://doi.org/10.1186/s13063-020-04969-w
Pleasant, A., et al. (2016). Considerations for a new definition of health literacy. National Academy of Medicine. https://doi.org/10.31478/201610a
Richter, R., Jansen, J., Bongaerts, I., Damman, O., Rademakers, J., & van der Weijden, T. (2023). Communication of benefits and harms in shared decision making with patients with limited health literacy: A systematic review of risk communication strategies. Patient Education and Counseling, 116, Article 107944. https://doi.org/10.1016/j.pec.2023.107944
Sahay, R. (2026, August 1). Kerala woman says hospital did colonoscopy without her consent, gets Rs 1.03 lakh payout. The Indian Express. https://indianexpress.com/article/legal-news/kerala-woman-colonoscopy-without-consent-rs-1-03-lakh-payout-10812120/
Saputra, W., & Yen, L. D. (2024). Dilema etik bagi tenaga kesehatan dalam menentukan pilihan tindakan medis berdasarkan prinsip berbuat baik (beneficence) atau prinsip otonomi (autonomy). Jurnal MedScientiae, 3(3), 386–392. https://doi.org/10.36452/JMedScientiae.v3i3.3212
Watkins, D., & Burton, M. (Eds.). (2026). Research methods in law (3rd ed.). Routledge. https://www.routledge.com/Research-Methods-in-Law/Watkins-Burton/p/book/9781032710372
Zhang, D., Hu, Z., Wu, Z., Huang, T., Huang, T., Liu, J., Sun, H., & Ba-Thein, W. (2024). Compromised informed consent due to functional health literacy challenges in Chinese hospitals. BMC Medical Ethics, 25, Article 91. https://doi.org/10.1186/s12910-024-01089-x
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