CEP / CONEP Ethics Approval
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.
Verify all information against official ANVISA sources before making regulatory decisions.
CEP review typically takes 30–60 days; CONEP review of complex studies may require 60–120 days. Approval documentation must be submitted with the clinical investigation protocol and protocol amendments. For post-study adverse events or serious deviations, formal notifications to CEP/CONEP are required.