For global sponsors, CROs & research sites
Clinical trial insurance in Brazil
If you sponsor or run a clinical study in Brazil, the participant guarantee normally has to be backed by a local, admitted insurance 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 ethics committee 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 ethics committees and sites as local proof 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 / CONEP
Research with human subjects is reviewed and overseen by the ethics system — local Research Ethics Committees (CEP) and the national commission (CONEP).
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. Alongside the CEP/CONEP ethics system and ANVISA's regulation of medicines and health products, this law consolidated the duty to guarantee assistance and indemnification for participants who suffer harm related to their participation in a study.
Insurance is the usual instrument used to back that guarantee. In practice, sponsors and ethics committees typically expect proof that the guarantee is in place before a study begins — and a dedicated clinical trial policy, issued locally, is the standard way to demonstrate 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, and extends protection to the investigator and the research site. Sites and institutions can also appear on the policy.
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 satisfies the participant guarantee and fits your global programme. We work in English.
FAQ
Clinical trial insurance in Brazil — common questions
Is clinical trial insurance mandatory in Brazil?
In Brazil, clinical research with human subjects is overseen by the CEP/CONEP ethics system and, when it involves medicines or health products, regulated by ANVISA. Law No. 14,874/2024 established the legal framework for clinical research with human subjects and consolidated the duty to guarantee assistance and indemnification for participants harmed in connection with the study. Insurance is the usual instrument used to back that guarantee, and sponsors and ethics committees typically require proof of it before a study can start. In practice, rather than a single rule simply saying 'buy insurance', the requirement is that the guarantee of assistance and indemnification be in place — and a dedicated policy is the standard way to demonstrate it.
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, and extends protection to the investigator and the research site. Sites and institutions can also appear on the policy. 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?
Broadly, the policy responds to harm to the health of research participants arising from their participation in the study, together with the civil liability of the sponsor and the investigator, including medical expenses and indemnities set out in the protocol. 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.