Informed Consent Reviewed from Indonesian Positive Law: A Legal Analysis of Informed Consent under Indonesian Positive Law
DOI:
https://doi.org/10.15575/jis.v6i4.58524Keywords:
consent to medical procedures, doctor-patient relationship, Indonesian Law, informed consentAbstract
Informed consent is defined as a statement of approval given consciously by the patient or their family after receiving complete and comprehensible information regarding the medical condition, diagnosis and the risks and benefits of the proposed medical action, serving as a form of legal protection for the patient’s rights. The principle of informed consent is grounded in ethical and legal principles that respect individual autonomy in medical decision-making, in line with the patient’s right to receive comprehensive information and to give consent voluntarily. The implementation of informed consent is regulated by various laws and regulations in Indonesia, providing a legal basis for respecting patient rights and medical practitioners’ obligations in healthcare services. This study aims to analyze the legal position and juridical implications of informed consent under Indonesian positive law, focusing on the protection of patient rights and the legal responsibilities of healthcare providers in medical practice. The research employs a normative legal method with a literature study approach, analyzing primary, secondary, and tertiary legal materials to examine the legal norms governing informed consent within the Indonesian legal system. Based on the findings, informed consent holds a strong legal position within Indonesia’s positive legal system. This position is reinforced by several laws and regulations that explicitly govern patient rights and the obligations of medical personnel. Violations of the principle of informed consent may have significant legal implications, including criminal and civil liability, as well as disciplinary and ethical sanctions against the medical practitioners involved.
References
Agestya, P., & Hariyanto, D. R. S. (2023). Pertimbangan Pertanggungjawaban Dalam Hukum Pidana Pada Penanganan Medis Seorang Dokter Tanpa Informed Consent. Jurnal Kertha Semaya, 11(6), 1320. https://doi.org/10.24843/KS.2023.v11.i06.p08
Annas, G. J., & Miller, F. H. (2024). The Empire of Death: How Culture and Economics Affect Informed Consent in the U.S., the U.K., and Japan. In Rights and Resources (pp. 25–62). Routledge. https://doi.org/10.4324/9781003576938-3
Beauchamp, T., & Childress, J. (2019). Principles of Biomedical Ethics : Marking Its Fortieth Anniversary. The American Journal of Bioethics, 19(11), 9–12. https://doi.org/10.1080/15265161.2019.1665402
Brewer-Carias, A. R. (2023). Judicial review in comparative law. Ediciones Olejnik CN - K.
Buchbinder, M., Arora, K. S., McKetchnie, S. M., & Sabbath, E. L. (2024). Sources of moral distress among obstetrician-gynecologists after Dobbs: A qualitative, multi-state study. SSM - Qualitative Research in Health, 6, 100483. https://doi.org/10.1016/j.ssmqr.2024.100483
Buelens, W., Herijgers, C., & Illegems, S. (2016). The View of the European Court of Human Rights on Competent Patients’ Right of Informed Consent. Research in the Light of Articles 3 and 8 of the European Convention on Human Rights. European Journal of Health Law, 23(5), 481–509. https://doi.org/10.1163/15718093-12341388
Burso, A. (2018). Aspek Hukum Persetujuan Tindakan Medis (Inform Consent). Law & Justice Journal, 1(1), 1–18.
Council, I. M. (2006). Indonesian Medical Council’s Manual on Medical Action Consent. Konsil Kedokteran Indonesia.
Council, O. F. E. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo: COE.
Damayanti, T., Putra, H. D., & Anggraeni, H. Y. (2024). Informed Consent Pada Kasus Kegawatdaruratan Di Rumah Sakit Berdasarkan Undang-Undang No. 17 Tahun 2023. Unes Law Review, 7(1), 246–254.
Del Villar, K., White, B., Willmott, L., Downie, J., & Stackpoole, C. (2023). Does a Refusal of Treatment need to be Informed? Towards a Resolution of the Current Confusion in English, Canadian and Australian Common Law. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.4576144
Filia, M. (2019). Aspek Hukum Persetujuan Tindakan Medis (Informed Consent) Dalam Penerapan Teknik Operasi Bedah Jantung. Esensi Hukum, 1(1), 96–108. https://doi.org/10.35586/esensihukum.v1i1.15
Fitriana, D. (2023). The Role of Informed Consent as Legal Protection for Doctors in Conducting Medical Procedures. Sinergi International Journal of Law, 1(3), 235–245. https://doi.org/10.61194/law.v1i3.101
Hughes, J. C., Crepaz-Keay, D., Emmett, C., & Fulford, K. W. M. (2018). The Montgomery ruling, individual values and shared decision-making in psychiatry. BJPsych Advances, 24(2), 93–100. https://doi.org/10.1192/bja.2017.12
Indonesia, P. R. (1999). Undang-Undang Republik Indonesia Nomor 8 Tahun 1999 Tentang Perlindungan Konsumen. Peraturan Pemerintah Republik Indonesia, 2003(1), 1–46.
Indonesia, P. R. (2004). UU No. 29 Tahun 2004 Tentang Praktik Kedokteran. Aturan Praktik Kedokteran, 157–180.
Indonesia, P. R. (2023). Undang-Undang Republik Indonesia Nomor 17 Tahun 2023 Tentang Kesehatan. Undang-Undang, 1–300.
Isriawaty, F. S. (2015). Tanggung Jawab Negara Dalam Pemenuhan Hak Atas Kesehatan Masyarakat Berdasarkan UUD 1945. Jurnal Ilmu Hukum Legal Opinion, 2(3), 1–10.
Japar, M., Semendawai, A. H., & Fahruddin, M. (2024). Hukum Kesehatan Ditinjau dari Perlindungan Hak Asasi Manusia. Jurnal Interpretasi Hukum, 5(1), 952–961.
Jeganathan, J. R., Jegasothy, R., & Sia, W. T. (2025). Minimally invasive surgery: a historical and legal perspective on technological transformation. Journal of Robotic Surgery, 19(1), 408. https://doi.org/10.1007/s11701-025-02589-7
Julesz, M. (2023). The Legal History of Informed Consent. Journal on European History of Law, 14(1), 161–171.
Kumalasari, E. P. (2022). Informed Consent Dalam Penanganan Pasien Gawat Darurat Di Puskesmas Kota Kediri Wilayah Selatan. SINAR Jurnal Kebidanan, 4(1), 1–8.
Kurihara, C., Greco, D., & Dhai, A. (Eds.). (2025). The 2024 Declaration of Helsinki. Springer Nature Singapore. https://doi.org/10.1007/978-981-96-9294-1
Kurniawan, I. G. A., & Chandra, A. (2024). The Civil Law Aspects of Informed Consent to Medical Procedures. Sasi, 30(3), 326. https://doi.org/10.47268/sasi.v30i3.2277
Kurniawati, S. N. A. (2021). Perlindungan Hukum Bagi Pasien Pada Tindakan Operasi Dalam Persetujuan Tindakan Medis (Informed Consent). Jurnal Hukum Dan Pembangunan Ekonomi, 8(2), 170. https://doi.org/10.20961/hpe.v8i2.49766
Laurenzi, C. A., Toska, E., Tallarico, R., Sherr, L., Steventon Roberts, K. J., Hansen, M., Tolmay, J., Jochim, J., Ameyan, W., & Yates, R. (2023). Key normative, legal, and policy considerations for supporting pregnant and postpartum adolescents in high HIV-burden settings: a critical analysis. Sexual and Reproductive Health Matters, 31(1). https://doi.org/10.1080/26410397.2023.2249696
Lewis, J. (2021). Safeguarding Vulnerable Autonomy? Situational Vulnerability, the Inherent Jurisdiction, and Insights from Feminist Philosophy. Medical Law Review, 29(2), 306–336. https://doi.org/10.1093/medlaw/fwab010
Meisel, A. (1996). Legal and Ethical Myths About Informed Consent. Archives of Internal Medicine, 156(22), 2521. https://doi.org/10.1001/archinte.1996.00440210023002
Octaria, H., & Trisna, W. V. (2016). Pelaksanaan Pemberian Informasi Dan Kelengkapan Informed Consent Di RSUD Bangkinang. Jurnal Kesehatan Komunitas, 3(2), 59–64. https://doi.org/10.25311/keskom.vol3.iss2.103
Osman, H. (2001). History and Development of the Doctrine of Informed Consent. The International Electronic Journal of Health Education, 4, 41–47.
Pebrina, A. R., Najwan, J., & Alissa, E. (2022). Fungsi Penerapan Informed Consent Sebagai Persetujuan Pada Perjanjian Terapeutik. Zaaken: Journal of Civil and Business Law, 3(3), 468–486. https://doi.org/10.22437/zaaken.v3i3.18966
Pemerintah Republik Indonesia. (2023). Undang-Undang Nomor 17 Tahun 2023 tentang Kesehatan.
Penyusun, T. (2008). Permenkes Nomor 290 Tahun 2008 Tentang Persetujuan Tindakan Kedokteran.
Prawira E. P, P. A., Putri K, I. G. A., & Kuswardhani, T. (2024). The Role of Informed Consent in Medical Disputes at State University Hospitals. Unram Law Review (ULREV), 8(2), 288–295.
Rahman, E., Michon, A., Rao, P., Garcia, P. E., Abu-Farsakh, H. N., Jannat, M., Hussain, S. N., Yu, N., Tam, E., Ioannidis, S., Rahman, Z., Goodman, G. J., Wu, W. T. L., Webb, W. R., & Carruthers, J. D. A. (2025). ‘Your Face, Their Stage’: A Global, AI-Enhanced, Mixed-Methods Survey on Public Perceptions of Live Educational Cosmetic Procedures. Aesthetic Plastic Surgery. https://doi.org/10.1007/s00266-025-05297-7
Ramadhan, M. S., & Nugraha, A. (2021). Tindakan Medis Dokter Terhadap Pasien Tanpa Informed Consent Dalam Perspektif Hukum Progresif. Simbur Cahaya, 1–14. https://doi.org/10.28946/sc.v28i2.1199
Rizka, A., Khairunnisa, C., Annabila, Z. I., & Windiani, S. (2023). Pelaksanaan Informed Consent Dalam Pelayanan Medik. Malahayati Nursing Journal, 5(4), 1284–1294. https://doi.org/10.33024/mnj.v5i4.8033
Shaha, K. K., Patra, A. P., & Das, S. (2013). The Importance of Informed Consent in Medicine. Scholars Journal of Applied Medical Sciences, 1(5), 455–463. https://doi.org/10.36347/sjams.2013.v01i05.0025
Sidabutar, S., Kusno, K., & Siregar, A. A. (2023). Implementation of Articles 359 and 360 of the Criminal Code Concerning Negligence Resulting in 132 Casualties in the Arema Vs Persebaya Match. Journal of Social Research, 2(4), 1402–1408. https://doi.org/10.55324/josr.v2i4.812
Simarmata, D. C. B., Kennedy, M. S., & Sinaga, L. V. (2022). Analisis Hukum Tentang Perjanjian Terapeutik Antara Dokter Dengan Pasien Dalam Pelayanan Kesehatan. Jurnal Rectum: Tinjauan Yuridis Penanganan Tindak Pidana, 4(1). https://doi.org/10.46930/jurnalrectum.v4i1.1458
Sitepu, F., Isnaini, I., & Akmal, M. R. H. (2025). Implementation of Informed Consent at Bandung Hospital, Medan City. Journal of Public Representative and Society Provision, 5(2), 259–270. https://doi.org/10.55885/jprsp.v5i2.526
SP, B., & Wisnu, A. K. (2023). Presumed Consent Atas Tindakan Medis Berisiko Tinggi Pada Kegawatdaruratan: Perspektif UU Nomor 17 Tahun 2023. Jurnal Hukum Dan Etika Kesehatan, 3, 67–81. https://doi.org/10.30649/jhek.v3i2.131
Syafruddin, Rohman, A., & Ilyas, A. (2020). Informed consent: Criminal impact in negligence of medical action. Enfermería Clínica, 30, 258–263. https://doi.org/10.1016/j.enfcli.2020.06.059
Venia, PH, A., Nasser, M., & Bungin, S. S. (2024). Analisis Yuridis Informed Consent Dalam Pelayanan Kesehatan. Jurnal Cahaya Mandalika, 5(2), 778–788. https://doi.org/10.36312/jcm.v5i2.3763
Weisleder, P. (2022). Leo Alexander’s Blueprint of the Nuremberg Code. Pediatric Neurology, 126, 120–124. https://doi.org/10.1016/j.pediatrneurol.2021.10.015
Widjaja, G., & Firmansyah, Y. (2021). Informed Consent. Cross-Border, 4(1), 539–552.
Wirabrata, I. G. M., & Darma, I. M. W. (2018). Tinjauan Yuridis Informed Consent Dalam Perlindungan Hukum Bagi Pasien Dan Dokter. Jurnal Analisis Hukum, 1(2), 278–299.
Xu, Q., Lyu, Y., Zhang, X., & Liu, J. (2025). Analysis of the causes of improper medical decision-making in medical damage liability disputes in China: a text mining approach. BMC Health Services Research, 25(1), 1112. https://doi.org/10.1186/s12913-025-13177-8
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Maijoni Hendra
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).