Analysis of Legal Protection and Ethical Study in Health Research with Humans as Research Subjects Reviewed from the Republic of Indonesia Law Number 17 of 2023 Concerning Health

Abstract

Legal protection is the right of every legal subject. Ethics and morality are always linked to freedom and responsibility. Ethics imposes moral obligations on humans, which differ from obligations in legal norms; these moral obligations do not have binding force for enforcement. Moral norms are autonomous, and their enforcement cannot be compelled through external efforts (such as by authorities). Explicitly, Law number 17 of 2023 Regarding Health does not regulate legal protection for humans as research subjects. The purpose of this research is to understand legal protection and ethical considerations, examining the provisions of Law number 17 of 2023 Regarding Health concerning humans as research subjects. The method used in this research is a type of normative juridical research and a statute approach research method (legislative provisions approach). The legal materials used include primary legal materials from Law number 17 of 2023 Regarding Health and secondary legal materials such as journals, books, and other media. The research findings indicate that Law number 17 of 2023 Regarding Health does not explicitly regulate legal protection for humans as research subjects. However, in all health research involving humans as research subjects, researchers must obtain consent after providing an explanation (Informed Consent). In Law number 17 of 2023 Regarding Health, reliance is placed on three general ethical principles: respecting human dignity (respect for person) aimed at honoring autonomy and protecting individuals whose autonomy is compromised/limited, doing good (beneficence) and not causing harm (nonmaleficence), and justice. Keywords: Legal Protection, Ethics, Health Research