Public Consultation No. 2/2026 and Public Consultation No. 3/2026, issued by the Collegiate Body of the National Research Ethics Authority (INAEP), were published in the Federal Official Gazette (DOU) on October 26, 2026.
The consultations invite comments and suggestions from the general public on two draft resolutions, which address matters provided for in the new legal framework for research involving human subjects (Law No. 14.874/2024 and Decree No. 12.651/2025):
- administrative appeal procedures within the scope of the National System of Ethics in Research with Human Beings (SINEP) and INAEP; and
- the risk classification of research involving human subjects, including the respective procedures for processing protocols and amendments.
Public Consultation No. 2/2026: Administrative Appeals within SINEP
The proposed resolution sets forth the procedures for filing, admissibility, investigation, analysis, and adjudication of administrative appeals filed within the scope of SINEP and INAEP.
The text covers appeals against (i) opinions of Research Ethics Committees (CEPs) that result in the approval, disapproval, or suspension of previously approved research; (ii) original decisions by INAEP regarding the accreditation, renewal of accreditation, and certification of CEPs; (iii) decisions resulting from the monitoring, supervision, and inspection activities of the CEPs; and (iv) other administrative acts with concrete legal effects carried out within the scope of INAEP’s authority.
According to the draft under discussion, appeals against CEP decisions may be filed in the first instance with the CEP itself, and if the decision is upheld, in whole or in part, in the second and final instance with INAEP. Appeals against decisions issued by INAEP will be adjudicated by the Collegiate Body itself, with a rapporteur other than the one who handled the matter under appeal.
Those entitled to file an appeal include, among others, the researcher, the sponsor, and the proposing or executing institutions directly affected; the research participant and their legal representative; as well as representative organizations and associations, provided they demonstrate thematic relevance.
The review of the appeal shall not entail a new comprehensive analysis of the protocol, and the appeal phase is not intended for conducting inquiries with the appellant or for substantially reformulating the original request, except for the possibility that INAEP may, on its own initiative, examine a specific issue that violates applicable rules or affects the rights and safety of participants.
In addition to dismissal, denial, and full or partial approval, the proposal provides for approval conditional on the adoption of corrective measures, the annulment of the appealed decision, the return of the protocol to the CEP for further review of a specific issue, and the reopening of the technical review.
Regarding the effects, the absence of a favorable ethics opinion prevents the initiation or continuation of the research while an appeal is pending against a decision that does not approve or suspends it. An appeal against a decision that approves the research, however, does not automatically suspend it.
The proposed deadlines are 30 business days to file an appeal, counted from the date of the appealed decision, and up to 30 business days both for the decision, counted from the date of receipt of the appeal, and for its publication, counted from the date of submission of the appeal.
The proposal also provides that INAEP may issue rulings to consolidate interpretations arising from repeated appellate decisions or those of particular significance.
Public Consultation No. 3/2026: Risk Classification and Processing of Protocols and Amendments
The proposed resolution addresses the risk classification of research involving human subjects and establishes procedures for the processing of research protocols and amendments within SINEP.
According to the text, research studies will be classified as low, moderate, or high risk based on a multidimensional analysis that comprehensively considers criteria such as the nature of the intervention, the degree of invasiveness, the population involved, the use of emerging technologies, sensitive personal data, or artificial intelligence in healthcare, scientific uncertainty, and the product’s stage of clinical development—none of which, taken in isolation, is determinative for classification.
The regulation under discussion defines, among others, the following classification parameters:
- Low risk: research with a low probability and low magnitude of harm, without significant potential for serious, permanent, or irreversible harm, such as observational and retrospective studies, those involving questionnaires or interviews, and those using medical records or databases, provided the specified conditions are met;
- Moderate risk: research with foreseeable risks greater than those of low-risk studies, without significant potential for serious, permanent, or irreversible harm, such as studies involving invasive procedures with known and controllable risks, and bioequivalence or bioavailability studies with products having a known safety profile;
- High risk: scenarios such as the first administration of an investigational product in humans, dose escalation, interventional clinical trials for regulatory purposes involving investigational drugs, advanced therapy products, or medical devices not regulated in Brazil, and research involving gene therapy, cell therapy, tissue engineering, or genome editing.
Jurisdiction for ethical review will follow the risk classification: accredited or certified CEPs will review low- and moderate-risk research, and the review of high-risk research will be the exclusive responsibility of certified CEPs. The review process will also be proportional to the risk, such that low-risk research may be subject to a simplified procedure, without prejudice to the CEP’s decision, while moderate- or high-risk research will follow the ordinary collegial procedure.
The proposal also regulates amendments, classified as substantial and non-substantial, both of which are subject to prior approval by the CEP:
- Substantial amendments, which may significantly alter relevant elements of the ethical review, follow the ordinary review procedure;
- Non-substantial amendments will be reviewed under a simplified procedure, with a decision issued within 15 business days from receipt of the complete documentation; the rapporteur may propose that such amendments be transferred to the ordinary procedure.
In any case, early implementation is permitted only to protect the participant from an immediate risk to their safety.
Ethical oversight will be proportional to the degree of risk, and the protocol may be reclassified in the event of an inappropriate previous classification, an amendment, or new facts, with reassignment to the competent CEP when there is a change in jurisdiction.
The specific requirements for research in the humanities and social sciences shall comply with the specific regulation of INAEP.
Participation in Public Consultations
The proposed resolutions and the documents that informed their drafting are available on the Brasil Participativo website. Contributions may be submitted by December 13, 2026, for Public Consultation No. 2/2026, and by December 29, 2026, for Public Consultation No. 3/2026.
The Life Sciences and Health practice can provide further information on this topic.
