Etik Penelitian dan Pengembangan Kesehatan (Health Research Ethics) in Indonesia

Under Article 1 point 2 of Permenkes Number 75 of 2020, Etik Penelitian dan Pengembangan Kesehatan (Health Research. Furthermore, Development Ethics) is the set of fundamental principles that must be applied when conducting health research and development involving human subjects or animal models. Both Permenkes 75/2020 and PP Number 28 of 2024 Article 1000 anchor these rules in three core principles. Respect for human dignity (respect for persons), doing good and avoiding harm (beneficence and non-maleficence), and justice (justice).

Position in Law 17/2023, PP 28/2024, and Permenkes 75/2020

Permenkes 75/2020 establishes the National Health Research and Development Ethics Committee (KEPPKN) to foster and enforce health research ethics (Article 1 point 1. Article 2). KEPPKN accredits institutional health research ethics committees (Article 4(2)(b)), and every such ethics committee must be accredited (Article 5(1)).

Law Number 17 of 2023 Article 335(1)-(2) requires research developing health technology—tools, products. Alternatively, Methods supporting diagnosis, prevention, and handling of human health problems (Article 1 point 18). To comply with ethical norms, scientific norms, scientific methodology, and regulatory permits. PP 28/2024 Article 999 mandates prior research ethics approval whenever human subjects are involved.

Informed Consent, Cost Prohibition, and Data Protection

Clinics or hospitals conducting human-subject research for health technology development must obtain prior written informed consent from participants. Before consenting, subjects must receive clear explanations of the research purpose and use of results, guarantees of identity. Furthermore, Personal data confidentiality, methods used, and potential risks (PP 28/2024 Article 1001(1), (5), (7), and (8)). Research organizers are prohibited from charging research costs to human subjects (Article 1002) and must safeguard data protection (Article 998(3)).

Related Terms

• Ethical Approval (Persetujuan Etik): Mandatory prior approval from an accredited health research ethics committee. With KEPPKN advising the Minister on complex disputes over methods or subject risks (Permenkes 75/2020 Article 4(2)(a)(6). PP 28/2024 Article 999).
• Ethical Norms (Kaidah Etik): Research requirements governing researcher conduct and actions (Elucidation of Law 17/2023 Article 335(2)).

Legal basis: Permenkes Number 75 of 2020 Articles 1, 2, 4, and 5. Law Number 17 of 2023 Articles 1 point 18 and 335 with Elucidation. PP Number 28 of 2024 Articles 998-1002.