INAEP Public Consultation on Administrative Appeals Seeks to Bring Predictability to the New Research Ethics System
The National Research Ethics Authority (INAEP) has submitted for Public Consultation No. 2/2026 a proposed resolution governing the procedures for filing, admissibility, processing, review, and adjudication of administrative appeals within the National System for Ethics in Research Involving Human Participants (Sinep). Although the subject may appear primarily procedural, the documents underpinning the proposal reveal the development of a dedicated appeals framework for the new system established by Law No. 14,874/2024.
In practice, the public consultation seeks to address a question that remained open following the creation of Sinep: how should decisions issued by Research Ethics Committees and by INAEP itself be reviewed, and what should be the limits of such administrative review?
What the Draft Regulation Proposes
The proposal establishes a uniform procedure for administrative appeals related to research ethics involving human participants. Key features include:
- the definition of two distinct appeal pathways: one applicable to decisions issued by Research Ethics Committees and another applicable to original decisions issued by INAEP itself;
- confirmation of INAEP as the second and final administrative instance for appeals against Research Ethics Committee decisions;
- the creation of specific criteria regarding admissibility, standing, and appeal proceedings;
- the delimitation of the scope of administrative review, preventing a complete reassessment of research protocols when the dispute is limited to specific issues;
- the introduction of mechanisms such as conditional granting of an appeal, remand of the protocol to the Research Ethics Committee for a new review on defined issues, and partial reopening of the technical review process;
- the preservation of valid administrative acts whenever possible, avoiding the need to restart proceedings in their entirety; and
- the possibility of consolidating INAEP’s interpretations through the issuance of precedent decisions (“arestos”), aimed at promoting consistency and predictability in future decisions.
The draft regulation also establishes a deadline of 30 business days for filing appeals and provides that appellate decisions must be issued within 30 business days, as already established by Law No. 14,874/2024.
More Than Regulating Appeals: Building Sinep’s Governance Framework
Perhaps the most interesting aspect of the public consultation is not the detailed regulation of appeal procedures, but rather the regulatory problem that INAEP itself states it is attempting to solve. According to the preparatory documents, Sinep still lacks a dedicated, integrated, and systematized framework governing administrative appeals. In the absence of specific rules, Research Ethics Committees, researchers, sponsors, and research participants have relied on the subsidiary application of Law No. 9,784/1999, which was not designed to address the particularities of research ethics involving human participants.
According to the regulatory authority, this has resulted in recurring uncertainty regarding who may file appeals, which decisions are appealable, what documents may be submitted, which bodies have jurisdiction, and what effects arise from the filing of an appeal.
The Proposal Seeks to Limit the “Infinite Reassessment” of Protocols
One of the most relevant aspects of the draft regulation is its explicit concern with the limits of appellate review. The text makes clear that an appeal should not serve as a mechanism for a complete reassessment of a research protocol. Instead, review should focus on the issues effectively challenged by the appellant, while preserving analyses that are not affected by the dispute.
The proposal also prevents the use of appeals as a mechanism for routinely reopening the evidentiary phase, restricts the submission of new documents to specific circumstances, and seeks to avoid situations in which the appellate phase is used to substantially reformulate requests originally submitted to Research Ethics Committees.
This principle appears repeatedly throughout the supporting documentation and reflects an effort to balance two potentially competing objectives: safeguarding the right to review administrative decisions while preserving the system’s administrative efficiency.
Legal Certainty and Consistency as Central Objectives
Another noteworthy aspect is that INAEP expressly identifies legal uncertainty as one of the main regulatory challenges of the current model, particularly given the existence of divergent approaches to similar situations, procedural inefficiencies, and delays in resolving disputes affecting scientific research and its participants.
In this context, special attention should be paid to the proposal allowing the issuance of precedent decisions (“arestos”) to consolidate INAEP’s interpretations. The intention is to create interpretative references capable of guiding Research Ethics Committees, researchers, sponsors, and other stakeholders, thereby reducing inconsistencies and increasing predictability in administrative decision-making.
From a regulatory perspective, this represents one of the proposal’s most significant innovations, as it introduces a mechanism similar to the harmonization tools adopted in other administrative and regulatory frameworks.
A Regulation Designed for Gradual Implementation
INAEP has acknowledged that practical implementation of the model will require ongoing monitoring. For this reason, a Regulatory Outcome Assessment (ARR) is planned after the future resolution has been in force for 24 months. Among the aspects to be monitored are the number of appeals filed, processing times, rates of inadmissibility decisions, the outcomes of appeal judgments, the use of conditional remedies, and recurring questions identified during implementation of the regulation.
An Opportunity for Stakeholders to Participate
The public consultation will remain open until December 13, 2026, and is expected to be of interest not only to Research Ethics Committees, but also to researchers, sponsors, research institutions, organizations representing research participants, and other stakeholders involved in clinical research and research involving human participants.
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.