Brazil ethical AI research guidance (2026)
AI-generated text. This page was generated using artificial intelligence.
Brazil’s National Instance of Research Ethics (INAEP), within the Ministry of Health, published version 1.0 of its Guia de Uso Ético de Inteligência Artificial em Pesquisa com Seres Humanos on September 25, 2026. The guide addresses researchers, institutions and research ethics committees reviewing studies involving people in which AI is a subject, research tool, analytic method or decision component.[1][2]
Guidance and legal status
The guide offers operational recommendations for ethical assessment of research protocols. It calls for evaluation based on the AI system’s actual use and the risks to participants and affected groups; it describes questions about data provenance, bias, validation, explainability, effective human oversight and changes in a system’s performance during a study. It is guidance for applying Brazil’s existing research-ethics framework, with decisions remaining with human ethics committees.[2]
Researchers are advised to disclose material AI use in protocols, identify the system’s role and the person responsible for checking its output, and address consent, data governance and potential sensitive inferences. For AI that may affect diagnosis or treatment, the guide distinguishes ethics-committee review from health-regulator assessment and calls for context-specific validation and oversight.[2]
Related coverage
- September 26, 2026 daily digest — Publication of the September 25 guide.
- Brazil AI Law — Brazilian legislation and policy directory.
- Governance — Applied AI-risk and organizational guidance.