On October 7, 2025, Decree No. 12.651/2025 was published, regulating provisions of Law No. 14.874/2024, also known as the “Brazilian Clinical Trials Law“. The Decree aims to operationalize provisions of the Law, especially with regard to the structuring and functioning of the National System of Ethics in Research with Human Beings.
Law 14.874/2024 lays down principles, guidelines and standards for research involving human beings, providing for the creation of a national ethics governance system.
The Decree complements and regulates the Law by defining organizational outlines, competencies and procedures for the functioning of the National Body and the publication of its resolutions.
As for the Research Ethics Committees (“CEPs” – collegiate bodies responsible for the analysis, review and ethical approval of research protocols), , the Decree formalized their official recognition procedure (for low and moderate risk analysis) and accreditation procedure (for low, moderate and high-risk analysis) and provided greater detail about their functioning, with better precision of their competencies, including provisions regarding the conduct of ethical analysis of the research submitted to them and monitoring and execution of the approved research. In addition, the Decree:
- disciplines the composition, attributions and formalities of the National Research Ethics Body (INAEP) and the CEPs;
- establishes rules for the use of biological materials and data obtained in research, limiting their use to the purpose set out in the project, unless expressly authorized in the consent form.
- establishes an electronic platform under the management and supervision of the Ministry of Health for registering, submitting, evaluating and monitoring research projects (single system).
- establishes a 30-day deadline for the formation of a temporary working group to draw up complementary rules and operational procedures for implementing the national system.
- determines that previous normative acts of the National Health Council that do not conflict with the Law or the Decree will remain applicable until new regulations are issued.
In view of this new rule, institutions that carry out research with human beings should review their internal procedures, terms of consent, protocol submission flow and policies for the use of biological material and personal data, to ensure compliance with the new regulatory framework.
We are fully available to support you in interpreting, adapting and implementing the requirements arising from Decree No. 12.651/2025, as well as monitoring any complementary regulations that may be issued.
To access the full decree, in Portuguese, click here.