National Ethics Committee for Research (INAEP)

The National Ethics Committee for Research (INAEP) is a collegiate body linked to the Ministry of Health, established by Law No. 14.874 of May 28, 2024 (Ethics in Research with Human Beings Law). Its mission is to contribute to strengthening a culture of ethical responsibility in research and scientific, technological, and innovative development, reconciling the protection of research participants with the efficiency of ethical review processes. INAEP works to ensure that studies conducted in the country observe ethical standards recognized nationally and internationally.

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Regulations and Guidelines

Order No. 3, dated May 29, 2026

Establishes guidelines for the centralized ethical review of multicenter research within the scope of the National Research Ethics System (SINEP), aiming at standardizing the actions of Research Ethics Committees (CEPs) and observing the principles of equality, efficiency, transparency, and procedural standardization. It determines that multicenter studies be validated through a single ethical opinion, issued primarily by the CEP of the coordinating center, eliminating the need for repetitive reviews by participating centers.

Order No. 2, of April 27, 2026

It establishes the rules for counting and operationalizing the deadlines for ethical research analysis in Brazil, in accordance with INAEP's institutional mission to promote ethical responsibility and efficiency in these processes.

Technical Note nº 1/2026 – DECIT/SCTIE/MS

It provides guidance on: the processing of research protocols involving human subjects; the definition of competencies within the National System of Ethics in Research with Human Beings (SINEP); the ethical analysis of research with the Ministry of Health as the proposing institution; the exceptional extension of the accreditation of Research Ethics Committees; and the procedures applicable to biobanks, in the context of the implementation of INAEP.

Technical Note No. 43/2025 – DECIT/SECTICS/MS

It establishes guidelines for the processing and risk classification of research within the scope of SINEP, with the aim of ensuring legal certainty, ethical and regulatory compliance, and the continuity of public service provision.

Decree No. 12.651, of October 7, 2025

This regulates Law No. 14.874, of May 28, 2024, which deals with research involving human beings and establishes the National System of Ethics in Research with Human Beings.

Law No. 14.874, of May 28, 2024

It provides for research involving human subjects and establishes the National System of Ethics in Research with Human Subjects (SINEP).