INAEP Issues Guidance on the Use of Artificial Intelligence in Human Subjects Research
The National Research Ethics Authority (INAEP) has taken another significant step in consolidating Brazil’s new regulatory framework f by publishing a set of documents addressing the use of artificial intelligence (AI) in scientific research. These initiatives seek to promote greater legal certainty, regulatory predictability, and protection of research participants in light of the growing use of AI technologies.
These publications form part of a broader effort to modernize Brazil’s research ethics oversight system, initiated with the creation of the National Research Ethics System (SINEP) and INAEP itself. The new framework replaced the former CEP/CONEP model with a more centralized structure, featuring defined review timelines and enhanced predictability for the conduct of multicenter studies and clinical research.
What Is the Guidance on the Ethical Use of Artificial Intelligence in Human Subjects Research?
The Guidance is intended to assist researchers, institutions, and Research Ethics Committees (RECs) in identifying and assessing the ethical risks arising from the use of AI systems in research involving human participants.
Among its key principles are:
- adoption of an approach grounded in the intended use of the technology and calibrated to the level of risk involved;
- heightened scrutiny of algorithmic bias, data representativeness, and discrimination risks;
- transparency and explainability requirements for AI systems used in research;
- the need for meaningful human oversight of AI decision making;
- considerations relating to data governance, privacy, and re-identification risks;
- reinforcement of human accountability for outcomes generated by AI systems; and
- guidance on research integrity, authorship, and the use of generative AI tools in academic work.
Importantly, the Guidance clarifies that the mere use of AI does not, in itself, constitute a distinct risk category. Rather, the ethical assessment should take into account factors such as the intended purpose of the technology, the nature of the data involved, the potential impact on research participants, and the degree of autonomy exercised by the AI system.
What Is MARIAH?
MARIAH (Risk Assessment Matrix for Artificial Intelligence in Human Subjects Research) is a tool developed to support RECs in identifying, classifying, and documenting risks associated with the use of AI.
INAEP emphasizes that MARIAH:
(i) does not replace the ethical review conducted by RECs;
(ii) does not generate automatic approvals or rejections;
(iii) seeks to make ethical assessments more systematic, transparent, and traceable; and
(iv) applies criteria relating to system autonomy, participant impact, data governance, model representativeness, and human oversight.
The tool was developed based on international standards and adapted to the Brazilian regulatory landscape, taking into account Law No. 14,874/2024, the Brazilian General Data Protection Law (LGPD), and the particularities of Brazil’s Unified Health System (SUS). According to INAEP, these documents are expected to serve as national benchmarks for the ethical review of AI-related research, contributing to greater consistency in ethics committee decisions and enhanced protection of research participants.
Practical Importance
The approval of both the Guidance and MARIAH seeks to harmonize the approach of RECs to issues that have generated increasing uncertainty, particularly in connection with data protection, algorithmic bias, discrimination, human oversight, and accountability for the use of AI systems. More broadly, the initiative reflects the regulator’s commitment to keeping pace with technological developments and strengthening the governance of scientific research in Brazil.
For sponsors, research institutions, universities, technology companies, and developers of AI solutions, these documents provide an important reference framework for structuring projects involving human subjects research and offer insight into the ethical and regulatory expectations that are likely to shape the Brazilian landscape in the coming years.
Our Life Sciences & Healthcare team remains available to discuss these developments and answer any questions at lifesciences@soutocorrea.com.br.