On October 8, 2025, Decree No. 12,651/25, which regulates Law No. 14,874/24 (Human Research Law) and establishes the National System of Ethics in Research with Human Beings, was published in the Federal Official Gazette (DOU).

Effective on August 26, 2024, the Human Research Law was enacted to provide legal certainty in this area and to regulate and oversee public and private institutions conducting research with human beings in Brazil (click here to check out previous materials).

Previously, Brazil maintained a structured clinical research system. However, it lacked explicit legal authorization, regulated solely by non-statutory resolutions from the National Health Council (CNS), the National Research Ethics Commission (Conep), and Institutional Review Boards (Comitês de Ética em Pesquisa – CEPs) established in hospitals, research centers, and academic institutions.

Decree No. 12,651/25 applies to research involving human subjects, whether conducted individually or collectively, and encompasses studies utilizing personal data, sensitive information, or biological material.

INEP's Role in the National Human Research Ethics System (SNEP)

Consistent with the provisions of the Human Research Law, the Decree stipulates that the National Research Ethics Instance (INEP) is a collegiate body within the Ministry of Health (MoH), serving in an advisory, deliberative, normative, supervisory, and educational capacity.

Its responsibilities encompass standardizing and evaluating the National Human Research Ethics System (SNEP), accrediting and inspecting CEPs, training members, and serving as an appellate body.

Its composition shall consist of 33 principal and alternate members:

• 6 representatives of the MoH;
• 6 representatives of the CNS;
• 2 representatives of the Ministry of Science, Technology and Innovation (MCTI);
• 1 representative of the Ministry of Education;
• 1 representative of the National Health Surveillance Agency (Anvisa);
• representatives of the National Council of State Research Support Foundations; and
• 15 specialists in human research ethics, to be appointed through a selection process, who must possess academic qualifications at the doctoral level or a minimum of 10 years of professional experience.

The quorum for INEP’s meetings and approvals shall be an absolute majority, with the coordinator casting the deciding vote in the event of a tie. Conep shall continue to serve as the appellate body until INEP members assume their positions.

The rule further provides that SNEP may establish advisory chambers to facilitate dialogue with society and various stakeholders regarding ethical regulation. Additionally, SNEP may form technical advisory groups, comprised of experts and representatives, to support the accreditation and supervision of CEPs by conducting audits, issuing reports, and assessing institutional compliance.

Integrated Electronic Platform

The MoH shall maintain an Integrated Electronic Platform (IEP) for the registration, management, data storage, and analysis of human research. This platform will facilitate the national registration of clinical research and phase I clinical study volunteers, in addition to enabling the research submission:

• for the registration, monitoring, and post-registration amendments of pharmaceuticals and medical devices;
• that do not seek immediate health regulatory approval in Brazil; and
• involving human subjects.

The platform's key objectives include:

• registration of research conducted in Brazil, and of the institutions and research centers involved;
• implementation of a unified system for application processing, document submission, evaluation, and electronic monitoring of proposals; and
• receipt, storage, and organization of data pertaining to research conducted in Brazil.

There is no deadline established for the construction or launch of the IEP by the MoH.

CEPs’ Performance

The CEPs are responsible for performing ethical reviews, deliberating on their findings, and monitoring research involving human subjects. They also serve in an advisory capacity.

Pursuant to the Human Research Law and the new Decree, CEPs are categorized into two classifications based on the complexity of their ethical analyses and the degree of risk associated with the research:

Risk classification for human research must consider the potential risks and benefits to the health, safety, dignity, and well-being of research participants, while balancing these against the legitimate interest in advancing scientific knowledge. The Decree further sets forth the following illustrative criteria:

• The nature of the intervention or procedure utilized in the research;
• The degree of invasiveness and potential for harm to the participant;
• The characteristics of the participant population, with particular attention to vulnerable groups;
• Use of emerging technologies, sensitive data, or artificial intelligence in healthcare;
• The degree of scientific uncertainty concerning the anticipated effects of the research;
• The presence of direct benefits from the research for the participant and the community;
• The complexity of the study design;
• Stage of clinical development of the product or technology evaluated; and
• The conduct of multicenter or international clinical research.

Next Steps

The decree also established a temporary working group (WG) to be coordinated by the Secretariat of Science, Technology and Innovation and the CEIS of the Ministry of Health. This WG is responsible for facilitating the development of procedures and regulations that will govern INEP's operations and enable SNEP's implementation. Its composition and term, which shall not exceed six months, will be defined by a separate act. The WG is required to submit proposals for guidelines, draft regulatory acts, and a final report.

Among the matters requiring further regulation, we highlight the following:

• INEP's internal regulations;
• Criteria, requirements and procedures for granting, renewing, reviewing, suspending and canceling accreditation by INEP;
• Guidelines for the preparation, submission, and ethical analysis of post-study supply plans and programs;
• Follow-up plan and assistance to participants in discontinued clinical trials;
• Research involving specific populations (e.g., children and adolescents, pregnant and breastfeeding women, indigenous peoples and quilombola communities, individuals deprived of liberty, and individuals with disabilities affecting their capacity to provide informed consent);
• Biobanks and biorepositories; and
• Research in the humanities and social sciences.

Notably, under the published rule, the CNS’ regulations remain valid until INEP publishes its own regulations, provided they do not conflict with the Human Research Law and the Decree.

ADI 7875

On September 16, 2025, the Brazilian Society of Bioethics filed a Direct Action for Declaration of Unconstitutionality (ADI 7875) with Brazil's Federal Supreme Court (STF), challenging the constitutionality of certain articles within the Human Research Law, including:

• Provisions regarding the establishment and responsibilities of INEP and its connection to the MoH;
• Post-study supply rules. The ADI requests that, pending a final judgment on the merits and any subsequent incorporation by CONITEC/SUS, sponsors continue to provide treatment to participants who require it. Specifically, it seeks to prevent sponsors from invoking the grounds for interrupting post-study supply;
• Interpretation of social participation in ethical analyses. The ADI demands community participation, through the CNS and CONEP, at all levels of ethical governance in research, with deliberative and comprehensive authority in the formulation, oversight, and monitoring of regulations and the conduct of clinical research involving human beings;
• The effectiveness of the article permitting the enrollment of research subjects in emergency situations without their prior consent; and
• Co-responsibility between research entities for conducting the protocol and providing comprehensive assistance to participants. The ADI seeks to prevent any interpretation that transfers financial responsibility for comprehensive care or indemnities resulting from the research to SUS or to non-sponsoring public institutions, particularly in the absence of a prior budgetary impact estimate and a clear public sponsor linkage; or, alternatively, to interpret the law to establish the sponsor's primary responsibility.

The STF’s rapporteur of ADI 7875 is Justice Cristiano Zanin.

Bill of Law

Currently, Bill No. 4,172/24 is pending before the Brazilian House of Representatives and proposes to amend the Human Research Law to permit the remuneration of participants in humanities and social sciences research that involves minimal risk and no medical interventions. The bill awaits discussion by the Health Commission.

The Life Sciences and Healthcare practice  can provide more information on the topic.