For global sponsors, CROs & research sites
Clinical trial insurance in Brazil
No Brazilian rule makes clinical trial insurance mandatory — but the sponsor owes participants care and indemnity for study-related harm, some ethics committees (CEP / CONEP) ask for a policy before approving the study, and sites and contracts usually expect that duty to be insured. When it is, the cover normally has to be a local, admitted policy — issued in Brazil, in Portuguese and in reais. Here is how it works, who regulates it and who is usually the insured.
NeuCorr is a Brazilian insurance broker (SUSEP-registered) specialised in clinical research cover. We speak English and structure local policies that sit under your global programme.
Why a local, admitted policy matters
Under Brazilian insurance regulation, risks located in Brazil must, as a rule, be insured by an insurer authorized to operate in the country — the admitted market, supervised by SUSEP, the federal insurance regulator. Cover placed directly with a foreign, non-admitted insurer is restricted and generally allowed only in narrow, specific situations.
For a global sponsor or CRO, this usually means a local policy is issued in Brazil for the Brazilian study, even when a global master programme already exists abroad. A local broker coordinates the Brazilian placement so it aligns with the global programme, the protocol and the expectations of the contracts and sites. We cover the question in detail in do you need a local insurance policy for a clinical trial in Brazil, including how a local placement sits alongside a global master programme.
Policy issued in Brazil
- Issued in Brazil by a SUSEP-authorized insurer
- Written in Portuguese, in Brazilian reais (BRL)
- Recognised by sites and contract counterparties as local evidence of the guarantee
- Claims and indemnities handled domestically, under Brazilian rules
Placed outside Brazil
- Placed with a foreign insurer not authorized in Brazil
- Only permitted in narrow, specific situations under Brazilian rules
- May not be accepted locally as proof of the participant guarantee
- Usually needs a local admitted layer to sit under a global master programme
Simplified comparison for orientation only — not legal or regulatory advice. Whether and how a non-admitted placement is possible depends on the specific circumstances and on current Brazilian rules.
Who regulates it
Ethics, health and insurance oversight
A clinical trial in Brazil sits at the intersection of three regulatory worlds. The insurance policy is the piece that backs the guarantee owed to participants.
CEP / INAEP
Research with human subjects is reviewed by accredited Research Ethics Committees (CEP) under the National Research Ethics Body (INAEP) created by Law 14,874/2024; CONEP no longer reviews protocols and acts only as an appeal body during the transition.
ANVISA
When a study involves medicines or health products, the national health surveillance agency (ANVISA) regulates the clinical investigation.
SUSEP
The Superintendência de Seguros Privados is the federal regulator of the private insurance market — it authorizes and supervises the insurers that issue local policies.
Law No. 14,874/2024 — the legal framework
In 2024, Brazil enacted Law No. 14,874/2024, which established the legal framework for clinical research with human subjects in the country. Regulated by Decree No. 12,651/2025, it moved ethics review to accredited Research Ethics Committees under a new National Research Ethics Body (INAEP), alongside ANVISA's regulation of medicines and health products, and places on the sponsor the duty to provide indemnification and health assistance to participants who suffer harm related to their participation in a study.
Neither the law nor the decree requires insurance, and no rule of the ethics review system makes it a formal requirement — but the committee will ask how participants will be cared for and compensated, and some committees (CEP / CONEP) ask for a policy before approving the study. Insurance is the usual instrument used to fund the sponsor's duty, and in practice it is commonly required by contract — by the global sponsor, the sites and the clinical trial agreement — before a study begins; a dedicated policy, issued locally, is the standard way to meet it.
For a fuller account of what changed and what it means for sponsors, see our guide to Brazil's clinical research law (14.874/2024).
This page is informational and does not replace review of the specific protocol or advice from a qualified specialist. We deliberately avoid citing specific article or resolution numbers here — the applicable requirements should be confirmed for each study.
Who is the insured — sponsor, CRO or site?
In most studies, the sponsor (typically the pharmaceutical company) contracts the study's cover, often through the CRO that represents it. The investigator, the research site and the CRO are not covered automatically: they can be included, but that depends on the policy wording, so naming them expressly is recommended.
The exact structure depends on the study's contracts, so it is worth confirming who is named as insured — and how the local Brazilian policy interacts with any global master programme — before the study starts.
Practical questions we help answer
- Should the policy be issued in Brazil, in Portuguese and in BRL?
- How does the local layer sit under our global programme?
- What sum insured fits this phase and number of participants?
- Who must be named as insured — sponsor, CRO, investigator, site?
Running a trial in Brazil? Let's structure the local cover.
Tell us about your study — phase, participants and sites — and we'll structure a Brazil-admitted policy that backs your duty to participants and fits your global programme. We work in English.
FAQ
Clinical trial insurance in Brazil — common questions
Is clinical trial insurance mandatory in Brazil?
No Brazilian rule requires insurance as such. Law No. 14,874/2024 places on the sponsor the duty to indemnify participants and to provide the health assistance they need for harm arising from their participation in the study — but neither the law nor its regulating decree mentions insurance, and ANVISA's clinical trial rules do not require it either. Insurance is not a requirement of the ethics review system (CONEP's guidance says it does not require proof of insurance), but the committee assesses how participants will be cared for and compensated if an adverse event occurs and may ask for clarification — and the policy is usually how sponsors show it; the consent form cannot limit indemnification or assistance to the policy or its sum insured. In practice, insurance is the usual instrument used to fund the sponsor's duty, and it is commonly required by contract — by the global sponsor, the sites and the clinical trial agreement.
What is the difference between admitted and non-admitted insurance in Brazil?
Under Brazilian insurance regulation, risks located in Brazil must, as a rule, be insured by an insurer authorized to operate in the country — the 'admitted' market — supervised by SUSEP, the federal insurance regulator. Buying cover for a Brazilian risk directly from a foreign (non-admitted) insurer is restricted and generally only permitted in narrow, specific situations. For a global sponsor or CRO, this usually means a local admitted policy is issued in Brazil, even when a global master programme exists abroad. A local broker helps structure the Brazilian placement so it aligns with that global programme.
Who buys the policy — the sponsor, the CRO or the site?
In practice, the sponsor (typically the pharmaceutical company) usually contracts the study's cover, often through the CRO that represents it. The investigator, the research site and the CRO are not covered automatically: they can be included, but that depends on the policy wording — naming them expressly is recommended. The exact structure depends on the study's contracts — it is worth confirming who is named as insured before the study begins.
What does clinical trial insurance cover in Brazil?
In Brazil it is a civil liability policy written on a claims-made basis (there is no Brazilian no-fault product). Broadly, it responds to harm to the health of research participants arising from their participation in the study, covering the civil liability of the sponsor and of any other named insureds (such as the investigator or the site), including medical expenses and indemnities. Because it is claims-made, the retroactive date and the extended reporting period matter: cover should run until the study closes, plus the extended reporting period. Coverages, limits and exclusions vary by policy and by insurer.
Does the policy have to be issued in Brazil, in Portuguese and in reais?
Because a Brazilian risk is generally insured in the admitted market, the local policy is issued in Brazil by a SUSEP-authorized insurer, typically in Portuguese and in Brazilian reais (BRL). It can be coordinated with a global master programme, but the terms that apply to the Brazilian study are the ones in the local policy. Confirm the language, the currency and how the local and global layers interact when structuring the cover.