CEP / CONEP Ethics Approval

BR-unique

Brazil has a two-tier research ethics system: CEP (Comitê de Ética em Pesquisa) — local ethics committee at each site, and CONEP (Comissão Nacional de Ética em Pesquisa) — national body for complex or multicentric studies.

All ethics submissions are made through Plataforma Brasil. CONEP review is required for multicentric studies, studies involving novel high-risk devices, and studies involving vulnerable populations.

• Plataforma Brasil
• CONEP

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.