In May 2024 Brazil enacted Law 14.874/2024, a new legal framework for clinical research with human subjects, regulated in October 2025 by Decree 12.651. For international sponsors and CROs, it signals two things at once: Brazil wants to attract more studies by giving research more legal certainty — and it keeps the protection of participants firmly at the centre. Here is what matters for your study and its insurance.
What the law does
Law 14.874/2024 created the National System of Ethics in Research with Human Subjects, modernising the governance of ethical review with the stated goals of legal certainty, less bureaucracy and faster analysis timelines. Protocols are now reviewed by a Research Ethics Committee (CEP) that is either credenciado or acreditado (low or moderate risk) or acreditado (high risk) before the National Research Ethics Body (INAEP); multicentre studies receive a single CEP opinion, preferably from the coordinating centre, within 30 working days of the documentation being accepted (art. 14). CONEP no longer reviews protocols and will act only as an appeal body until INAEP’s members take office (Decree, art. 40). Studies with foreign sponsorship, which used to go to CONEP, are treated as high risk during the transition and go to an accredited CEP. The broader aim, echoed by the Ministry of Health when the law was regulated, is to make Brazil a more competitive destination for clinical research and innovation.
For a study team, the practical headline is that the framework around participant protection is now set out in primary legislation rather than resting only on ethics resolutions.
Sponsor duties the law reinforces
The law keeps the sponsor responsible for protecting participants. In particular, the sponsor must:
- Indemnify participants for damage suffered as a result of taking part in the research (art. 23);
- Provide the health assistance necessary in relation to that damage (art. 23);
- Submit a post-trial access plan to the CEP before the study starts (art. 30) and, after the trial, supply the investigational medicine free of charge when it is necessary (art. 31, §4).
The law also distinguishes indemnification (for harm) from reimbursement — the latter defined as covering the participant’s material expenses, such as transport and meals.
What it means for insurance
Neither the law nor Decree 12.651/2025 mentions “insurance”, ANVISA’s RDC 945/2024 does not require it, and insurance is not a requirement of the ethics review system (though the committee may ask how participants will be cared for and compensated). But the sponsor’s duty to provide assistance and indemnification remains — and, in practice, a locally admitted insurance policy is how sponsors fund that duty, usually because the global sponsor, the sites or the clinical trial agreement require it. In Brazil these are civil liability, claims-made policies (there is no Brazilian no-fault product). If anything, a clearer legal duty makes getting the insurance structure right even more important. International sponsors should ensure a Brazil-admitted policy, coordinated with their global program, is arranged before the study starts — see do you need a local insurance policy for a clinical trial in Brazil? and our pillar guide on clinical trial insurance in Brazil.
NeuCorr is a Brazilian broker registered with SUSEP and specialised in clinical research risk. We can help you structure the participant guarantee in line with the new framework — contact our team.
This content is informational and does not replace specific legal, regulatory or insurance advice for your study.