Federal Decree No. 12,651/2025 was published on October 8th, regulating Federal Law No. 14,874/2024. The latter regulates the conduct of research involving human beings in Brazil and establishes the National System of Ethics in Research involving Human Beings. The decree came into effect on the date of its publication.
In summary, the decree:
• Defines the Ministry of Health’s authority to structure and organize the National System of Ethics in Research involving Human Beings, aimed at protecting research participants and promoting good scientific practices nationwide;
• Establishes that the National System of Ethics in Research involving Human Beings will be composed of the National Research Ethics Body and the Research Ethics Review Body, the latter represented by the Research Ethics Committees (CEPs);
• Assigns the National Research Ethics Board to regulate the monitoring and assistance plan for participants in discontinued clinical trials, as well as to define guidelines for the preparation, presentation, and ethical review of the post-study provision plan and program;
• Determines that biobanks and biorepositories will be regulated by the National Research Ethics Board and other competent authorities, with the use of these materials restricted to the purpose specified in the original project, unless expressly authorized in the informed consent form for use in future research, in accordance with current legislation;
• Details the hypotheses for post-trial access, defining that the sponsor must provide the investigational product free of charge—which, according to Law No. 14,874/2024, includes experimental drugs, placebos, and comparators—when, according to the principal investigator, it represents the best therapeutic alternative, based on scientific evidence and a favorable assessment of the risk-benefit ratio;
• Defines special groups that require differentiated treatment throughout all stages of the study, due to vulnerability or unique lifestyles, including: children and adolescents; pregnant and lactating women; indigenous peoples; quilombola communities and other traditional populations; people deprived of liberty; and people with disabilities whose capacity to consent is compromised;
• Establishes that research considered strategic for the Unified Health System (SUS) will be prioritized in ethical review—the maximum timeframe for ethical review in these cases is 15 days. According to the rule, research aimed at responding to public health emergencies declared by a health authority; research aimed at developing vaccines of interest to the National Immunization Program; and research using active pharmaceutical ingredients manufactured in Brazil, among others, are considered of strategic interest.
The Ministry of Health, within 30 days, must establish a temporary working group to subsidize and support the development of complementary and regulatory procedures related to the operation of the National Research Ethics Committee and the implementation of the National System of Ethics in Research involving Human Beings.
The Nascimento e Mourão Regulatory team is closely monitoring this agenda and is available for clarification.
Evelini Oliveira de Figueiredo Fonseca | evelini.fonseca@nascimentomourao.adv.br
Partner in the Environmental, Regulatory, and Biodiversity Law practice
