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, with potential extension to 180 days if deficiencies are identified or amendments are requested. Initial submission to CONEP from CEP generally occurs within 30 days of local approval. 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.
Protocol amendments (substantial changes to study design, population, safety endpoints) must be submitted to CEP/CONEP for approval before implementation. Complex studies include those involving novel investigational devices not yet approved in Brazil, studies using high-risk Class III/IV devices in new patient populations, and those with significant safety concerns identified during recruitment.