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The clinical research decree inaugurates a detailed governance and operational structure for the national system of ethics in research involving human subjects (in portuguese, “sinep”), under the coordination of the ministry of health. This work was based on a documentary research, descriptive and retrospective. The article examines the vital considerations and functions of ethics committees in brazil, specifically their oversight of clinical research involving human subjects.
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Additionally, per lawno14.874 and resno945, research involving human beings must be subject to prior ethical analysis by research ethics committees (ecs) (comitês de ética em pesquisa (ceps)). 12,651/2025 vests the ministry of health with the competence to structure and organize the national system of ethics in research involving human subjects, aimed at protecting research subjects and promoting good scientific practices in brazil. 12,651/2025 (“decree”), published on october 7, 2025, regulates law no
14,874/2024 and inaugurates a new era for clinical research with human subjects in brazil
More than a regulatory advance, it brings guidelines that strengthens ethics, transparency, and participant protection. In brazil, the highest ethical authority for research involving human subjects is the national research ethics committee (conep) Established in 1996, it is a central regulatory committee which coordinates a communication network of 836 institutional recs [11, 12, 13]. On october 8, 2025, the brazilian government published decree no
12,651/2025 to establish general guidelines on the structure and functions of a national ethics body for clinical trials involving human subjects, as well as risk classification guidelines for research. Brazil has enacted law no 14,874/2024, which is the first law regulating human subjects research in the country. Decree #12,651/2025 establishes the national system of ethics in research involving human subjects.
