INAEP Public Consultation Signals a Paradigm Shift in the Risk Classification of Research Involving Human Participants
The launch of Public Consultation No. 3/2026 by the National Research Ethics Authority (INAEP) may, at first glance, appear to be just another regulatory initiative aimed at defining criteria for the classification of risk in research involving human participants. A closer review of the documents supporting the proposal, however, reveals a broader discussion: the development of the mechanisms required to operationalize the new National System for Ethics in Research Involving Human Participants (Sinep), established by Law No. 14,874/2024.
More than defining technical concepts, the draft regulation seeks to establish the practical foundations for the operation of an ethics review system structured around risk-based criteria, gradually replacing models historically influenced by the thematic area of the research. In this context, the public consultation represents an important opportunity for researchers, sponsors, research institutions, and Research Ethics Committees to participate in the development of one of the regulatory pillars of Brazil’s new legal framework for clinical research.
What the Draft Regulation Proposes
The proposal submitted for public consultation establishes the rules that will govern the risk classification of research involving human participants within Sinep. Key measures include:
- the creation of three research risk categories: low, moderate, and high;
- the adoption of a multidimensional assessment based on the actual risks of the study rather than solely on its thematic area or methodology;
- the definition of the responsibilities of accredited and certified Research Ethics Committees according to the risk category assigned to the protocol;
- the implementation of simplified procedures for low-risk studies and for certain amendments deemed non-substantial;
- the establishment of criteria for risk reclassification during the conduct of the study;
- the creation of ethical oversight mechanisms proportionate to the level of risk involved in the study; and
- the regulation of the distinction between substantial and non-substantial amendments, with implications for the ethics review process.
Although operational in nature, these measures represent one of the first attempts to translate into concrete procedures the risk-based ethics review framework introduced by Law No. 14,874/2024.
More Than a Risk Classification Framework
The preparatory documents suggest that the proposal’s primary objective is not merely to create three risk categories, but rather to make risk classification the organizing principle of the new ethics review system.
The public consultation document acknowledges that uniform national criteria are still lacking to guide both the classification of protocols and the allocation of studies among the different types of Research Ethics Committees provided for under the new model. The proposed regulation is intended precisely to fill this gap and enable the proper operationalization of Sinep.
From this perspective, risk classification ceases to be merely a conceptual exercise and begins to directly influence responsibilities, review pathways, oversight procedures, and amendment processing.
From a Thematic-Area Approach to a Risk-Based Approach
Perhaps one of the most significant changes introduced by the proposal is the effort to move away from automatic classifications based on the subject matter of the research. The current system still relies on transitional mechanisms inherited from the CEP/Conep model, under which certain research areas or study characteristics may influence the regulatory pathway assigned to a study. The new proposal seeks to replace this approach with an assessment centered on the actual risks arising from participation in the research.
The draft regulation is particularly careful in stating that factors such as the multicenter or international nature of a study, the use of artificial intelligence, the processing of sensitive personal data, or the participation of vulnerable populations should not, in isolation, lead to a higher risk classification. Instead, the focus shifts to an integrated assessment of the risks effectively presented by the protocol and the measures adopted to prevent or mitigate them.
In practical terms, the proposal seeks to distinguish three concepts that are often conflated in regulatory practice: research risk, research complexity, and review priority. That said, not every complex study will necessarily be considered high risk, just as the strategic relevance of a study does not, by itself, alter its risk classification.
Regulatory Efficiency Is Also at the Center of the Discussion
Another aspect that stands out in the preparatory documents is the explicit concern with regulatory efficiency, particularly as a means to increase the predictability of classifications, reduce interpretive discrepancies among Research Ethics Committees, avoid unnecessary protocol reallocations, and ensure that ethics review efforts are directed toward studies that genuinely require a more in-depth analysis.
This rationale is also reflected in the treatment of protocol amendments. By establishing criteria to distinguish substantial from non-substantial modifications, the proposal seeks to enable more proportionate review pathways, ensuring that administrative changes or modifications with limited ethical impact do not require the same level of review as changes capable of altering the study’s risk-benefit balance.
For sponsors, research centers, and investigators, this initiative directly addresses longstanding concerns within the sector regarding regulatory predictability, procedural efficiency, and review timelines.
Influence of International Trends
In preparing the draft regulation, consideration was given to references such as CIOMS, the World Health Organization (WHO), UNESCO, the ICH E6(R3) and ICH E8(R1) guidelines, as well as regulatory models adopted in the United Kingdom and the European Union.
This influence is reflected in several concepts incorporated into the proposal, including inherent risk and residual risk, risk-proportionate ethics review, risk-based monitoring, reclassification during study conduct, and the distinction between substantial and non-substantial amendments. Accordingly, rather than simply replicating foreign experiences, the initiative signals an effort to align the Brazilian system with the most recent international discussions on risk management and proportionate ethics review.
A Regulation Designed to Evolve
INAEP has indicated that a Regulatory Outcome Assessment (ARR) will be conducted after the future resolution has been in force for a number of years. The assessment will monitor aspects such as consistency in risk classifications, review timelines, protocol reclassifications, and reallocations among Research Ethics Committees.
This provision suggests that the regulation is viewed as part of a broader institutional development process, in which practical experience gained through implementation of the system will inform future regulatory improvements.
An Opportunity for the Sector to Contribute to the New System
The public consultation will remain open until December 29, 2026, and represents an important opportunity for researchers, sponsors, research institutions, CROs, and Research Ethics Committees to contribute to the refinement of a regulation that may shape the operation of Sinep for years to come.
Although the discussion involves technical aspects of risk classification, the documents released by INAEP indicate that the broader issue under debate is how the ethics review, protocol processing, and oversight mechanisms established under Brazil’s new legal framework for clinical research will function in practice.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to answer any questions regarding these matters via email at lifesciences@soutocorrea.com.br.