Decree regulates law on research involving human subjects and establishes the National System of Ethics in Research

On October 7, 2025, Decree No. 12,651 was published, regulating Law No. 14,874/2024. The decree provides for research involving human subjects in Brazil and establishes the National System of Ethics in Research Involving Human Subjects.

Below is a summary of the key aspects of the new regulation:

National System of Ethics in Research Involving Human Subjects

Decree No. 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. The system comprises the National Ethics in Research Authority and the Ethics Review Authority, which are represented by Research Ethics Committees (CEPs).

Key highlights include:

• Detailed responsibilities and a multi-sectoral composition of the National Ethics in Research Body, including representatives from the Ministry of Health, National Health Council (CNS), Ministry of Science, Technology and Innovation (MCTI), Ministry of Education, Brazilian Health Regulatory Agency (ANVISA), National Council of State Research Foundations (CONFAP), and experts selected through a public tender.
• Guidelines for CEP accreditation and registration based on research risk classification, ensuring proportional procedures and distinct timelines.
• Ethical review rules, including single-CEP review for multicenter studies with a unified protocol, and the possibility of conducting an integrated ethical and regulatory review with ANVISA.
• Prioritization criteria for studies of strategic interest to the Brazilian Unified Health System (SUS), with shortened review deadlines.
• Creation of a single electronic platform for research registration, submission, monitoring, and transparency, under the governance of the Ministry of Health.

Protection of research subjects

Decree No. 12,651/2025 tasks the National Ethics in Research Authority with regulating the monitoring and assistance plans for subjects in discontinued clinical trials, and with establishing guidelines for drafting, submitting, and conducting the ethical review of post-trial supply plans and programs.

Decree No. 12,651/2025 also specifies post-trial supply scenarios, requiring sponsors to provide the investigational product free of charge – which, under Law No. 14,874/2024, includes investigational medicines, placebos, and comparator medicines – if the principal investigator deems it the best therapeutic option based on scientific evidence and a favorable risk-benefit assessment.

Additionally, Decree No. 12,651/2025 identifies special groups that require special treatment throughout all study phases due to vulnerability or unique lifestyles, including:

• Children and adolescents
• Pregnant and lactating women
• Indigenous peoples
• Quilombola communities and other traditional peoples
• People deprived of liberty
• People with disabilities that affect decision-making

Use of data and human biological material

Under Decree No. 12,651/2025, biobanks and biorepositories will be regulated by the National Ethics in Research Authority and other competent authorities. The use of such materials is limited to the purpose stated in the original clinical protocol, unless explicitly authorized otherwise in the informed consent form for future research, and in compliance with applicable law.

Research in human and social sciences

The National Ethics in Research Authority must issue specific regulations for research in human and social sciences, addressing methodological, epistemological, and sociocultural particularities, as well as individual and collective vulnerabilities. For studies classified as low risk, notification to CEPs or simplified review may be allowed, without prejudice to full compliance with ethical guidelines and the possibility of comprehensive review at any time.

Final and transitional provisions

Decree No. 12,651/2025 clarifies that:

• Existing CNS regulations remain valid, provided that they do not conflict with Law No. 14,874/2024 and Decree No. 12,651/2025, until the National Ethics in Research Authority issues new regulations.
• The National Research Ethics Commission (CONEP) will act as an appellate body until the new National Ethics in Research Authority is fully formed.
• Accredited and registered CEPs remain authorized to conduct ethical reviews until the National Ethics in Research Authority reassesses this matter.
• The Ministry of Health will establish, within 30 days, a three-month temporary working group, extendable for an equal period, to support guidelines and supplementary regulations for implementing the system.
• Funding agencies and support foundations covered by Law No. 10,973/2004 will not be considered sponsors for regulatory purposes.

Demarest’s Life Sciences & Healthcare team is available to provide any additional clarifications you may need.