In 2024, Law No. 14,874/2024 (“Clinical Research Law”) was enacted, establishing the baseline framework for research involving human subjects in Brazil. Since its publication, the Ministry of Health has undertaken studies to regulate the Law, focusing on institutional stability in support of clinical research. As a result of this effort, Decree No. 12,651/2025 (“Clinical Research Decree”) was issued and published on October 8, 2025.
The Clinical Research Decree inaugurates a detailed governance and operational structure for the National System of Ethics in Research Involving Human Subjects (in Portuguese, “SINEP”), under the coordination of the Ministry of Health. The governance model is organized into two layers – the National Instance and the Research Ethics Committees (CEPs) – with explicit objectives of process simplification, adherence to good practices, and strengthened oversight.
From a practical standpoint, for those who conduct, sponsor, or coordinate clinical research, the change is structural:
a) A single electronic platform is created for registration, filing, review and follow-up, with a public database and safeguards for data and trade secrets, making the law’s mandate operational.
b) Ethical review follows risk-based tracks (credentialing/accreditation of CEPs and a multidimensional risk classification), enabling simplified procedures and differentiated timelines where the study design allows.
c) Multicenter studies use a single protocol assessed by one CEP, which issues the opinion and informs the other centers.
d) A pathway opens for integrated ethical-sanitary review with Anvisa (Brazilian Health Regulatory Agency).
e) A special fast-track applies to research of strategic interest to the Unified Health System (SUS), including, for example, studies on socially determined diseases, emerging/re-emerging conditions, severe or debilitating conditions without available alternatives, and rare diseases.
For clinics and sponsors, the Platform is expected to reduce documentation asymmetries among CEPs and to provide predictability regarding submission, review, and monitoring milestones. At the regulatory level, risk becomes a procedural lever rather than merely a conceptual category. For regulatory studies, the possibility of integrated procedures with Anvisa is expected to streamline timelines in time-sensitive dossiers.
For participants, the National Instance will regulate follow-up and assistance if a study is discontinued, and sponsors must ensure post-trial access to the investigational product when it is the best therapeutic option, under a program submitted to the CEP. Use of data and biological material is restricted to the project’s purpose unless there is express consent for future research, while biobanks and biorepositories will be subject to specific regulation.
In sum, the Clinical Research Law defined the ethical foundations for research involving human subjects, and the Clinical Research Decree provided the regulatory depth for its implementation. For those in the field, it is recommended to adjust study design and documentation to the new procedures and to closely monitor the publication of complementary regulations that will further detail processes and requirements.