Brazil publishes decree to regulate law on clinical trials involving human subjects

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. The decree comes a little over a year after the law on the topic – No. 14,874/2024 – took effect in the country.

In addition to defining transitional rules for the certification and accreditation of the Institutional Review Boards (Comitês de Ética em Pesquisa – CEPs), the decree also establishes fundamental principles on the protection of research participants and the efficiency of approval processes.

This development has been widely awaited ever since Law No. 14,874/2024 was published in May 2024, as the decree is set to provide greater clarity and legal certainty in regard to the law’s provisions.

Structure of the National System of Ethics in Clinical Trials with Human Subjects

In line with the provisions of Law No. 14,874/2024, the system consists of two types of bodies:

• The National Research Ethics Board (Instância Nacional de Ética em Pesquisa – INEP): responsible for drafting and publishing rules on ethics in research, accrediting, certifying and supervising CEPs, and acting as an appellate body for the decisions rendered by the committees;
• Institutional Review Boards (CEPs): these have an advisory and deliberative nature, and are made up of members from several disciplines, including medical, scientific and non-scientific areas.

CEPs act independently and autonomously, and are responsible for conducting ethical analysis of submitted research and monitoring approved trials.

Brazil’s Ministry of Health will be responsible for organizing the National System of Ethics in Clinical Trials with Human Subjects. Furthermore, it will be responsible for appointing all 33 members of the National Research Ethics Board.

CEP accreditation and certification

The CEPs are classified according to the degree of risk of the research:

• Certified Committees (credenciados): authorized to analyze low and moderate-risk research;
• Accredited Committees (acreditados): authorized to analyze low, moderate and high-risk research.

Risks are classified via multidimensional analysis that considers factors such as the degree of invasiveness, the target group involved, scientific uncertainty, direct benefits to the participant and the community, and the stage of clinical development of the product or technology.

The decree does not make it clear how the risk classification of each trial will work in practice, nor which body will be responsible for confirming the classification. In addition, there are concerns that the rules the ethics bodies establish potentially may not comply with the classification rules in the Brazilian Health Regulatory Agency’s (ANVISA) Resolution No. 945/2024.

Post-study supply

The decree establishes that the trial sponsor must guarantee participants a free supply of the product once the trial has ended, whenever the researcher responsible considers it the best therapeutic alternative. This must be based on available evidence and a favorable assessment of the risk-benefit ratio, according to Article 30 of Law No. 14,874/2024.

The post-study access program must be prepared by the sponsor, submitted to the competent Institutional Review Board for evaluation, and contain the product supply strategy after individual participation ends.

However, the decree leaves it to the National Research Ethics Board to regulate supplementary guidelines for preparing, presenting and ethically analyzing the plan and the post-study supply program.

Human Clinical Trial Platform

The Ministry of Health will run an integrated electronic platform for registering, informing and analyzing clinical trials carried out in Brazil. The platform will contain a single system for petitioning, submitting documents, evaluating and electronically monitoring processes related to trials involving human subjects.

Strategic research for the SUS to be prioritized

Ethical analysis of trials will be prioritized when they are considered strategic to Brazil’s Unified Health System (SUS). Trials are considered to be of strategic interest when they are focused on the following (among other topics):

• Responding to a public health emergency declared by a Brazilian health authority;
• The sanitary regularization of medicines or medical devices for treating, preventing or diagnosing socially determined, emerging or reemerging diseases; serious or debilitating clinical conditions with no therapeutic or prophylactic alternative available; and rare diseases;
• Pediatric care, when no therapeutic or diagnostic alternative is available;
• Research resulting from Productive Development Partnerships (Parcerias para Desenvolvimento Produtivo – PDP), the Local Development and Innovation Partnership Program (Programa de Desenvolvimento e Inovação Local – PDIL), or related initiatives within the scope of Brazil’s Health Economic-Industrial Complex;
• The use of domestically manufactured active pharmaceutical ingredients;
• Vaccines of interest to Brazil’s National Immunization Program.

The maximum period for ethical evaluation in these cases is 15 days, in line with the provisions of the law.

Aspects still requiring regulation

Some topics still depend on specific regulations from the National Research Ethics Board: 

• Post-study provisions: the supplementary guidelines for preparing, presenting and ethically analyzing the post-study provision plan and program will be established by the National Research Ethics Board via a specific rule;
• Discontinued clinical trials: the National Research Ethics Board will regulate the follow-up and care plans for participants in discontinued clinical trials, as per the provisions of Article 57, Paragraph 1 of Law No. 14,874/2024.
• CEP accreditation: the National Research Ethics Board will regulate the accreditation process, and will establish criteria, requirements and procedures for granting, renewing, reviewing, suspending and canceling accreditation.

The Ministry of Health has 30 days (from the publication of the decree) to establish a temporary working group, which is to provide input and support the creation of complementary and regulatory procedures related to the functions of the National Research Ethics Board and the implementation of the National System of Ethics in Clinical Trials with Human Subjects.

Transition process

• Accredited CEPs: until the National Research Ethics Board determines to undertake a new assessment, the status of previously accredited or certified CEPs will remain unchanged.
• National Health Council Regulation: until the National Research Ethics Board publishes regulations on ethical research, the rules of the National Health Council (Conselho Nacional de Saúde – CNS) remain valid – provided they do not contradict the provisions of Law No. 14,874/2024, and Decree No. 12,651/2025.
• CONEP: The National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa – CONEP) will continue to operate as an appeals body until the members of the National Research Ethics Board officially take office.

Decree No. 12,651/2025 took effect on October 8, 2025, the date of its publication.

For more information on this topic, please contact Mattos Filho’s Life Sciences & Healthcare practice area.