Yes — in most cases a clinical trial in Brazil needs a locally admitted policy issued in Brazil, coordinated with your global master policy. That is what Brazil’s ethics system (CEP/CONEP) generally expects as evidence of the participant guarantee, even for sponsors with robust global cover. This guide explains why, and how to set it up without delaying your ethics submission.
The short answer: a local, admitted policy is usually expected
Brazil generally expects the participant’s guarantee to be evidenced by a locally admitted policy — one issued by an insurer authorised to operate in Brazil — even when the sponsor already holds a global master policy abroad. The reasoning is practical: the research-ethics system (CEP/CONEP) and Brazilian regulation operate under local law, in the local currency, and expect documentation that fits the local framework.
This does not make your global program irrelevant. Instead, the local and global policies are coordinated: limits, wordings and triggers are aligned so that participants are protected consistently and there is no gap — or unintended duplication — between the two layers.
Why the local policy matters for ethics approval
Under the framework reinforced by Brazil’s Law 14.874/2024, the sponsor must guarantee assistance and indemnification to participants for study-related harm. When a Research Ethics Committee reviews a protocol, it generally expects to see how that guarantee is secured. A locally admitted policy is the usual, most robust way to document it — which is why arranging it before submission, not after, keeps your timeline on track.
How to set it up
- Start early. Share the protocol summary, phase, number of participants and sites, the investigational product and the required limits with your local broker before submission.
- Define the insured parties. Decide who is policyholder, who is insured (sponsor, CRO, site, investigator) and who benefits — this avoids gaps later.
- Coordinate with the global program. Align the local wording and limits with the master policy so the layers work together.
- Review conditions and exclusions. Check how the policy responds to study-related harm and what the wording excludes.
For the full picture of what this cover includes, see our pillar guide on clinical trial insurance in Brazil. When you are ready, NeuCorr can arrange the local policy and coordinate it with your global program — talk to our team.
This content is informational and does not replace specific legal, regulatory or insurance advice for your study.