Ethics Committee (CEP / CEI / IRB)
The local body that reviews trial ethics, informed consent quality, and subject protection.
What it means
In LATAM, ethics review is decentralized: CEPs in Brazil, Comités de Ética en Investigación (CEI) across Spanish-speaking countries, and site-level IRBs. Each reviews the ICF and recruitment materials in the local language and can require site-specific edits before granting approval.
Why it matters for LATAM submissions
Ethics committees, not regulators, are usually the ones that read the ICF word-by-word. Translation quality at the consent level is where studies live or die on timeline.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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