The enactment of Law No. 14,874/2024, which regulates research involving human participants and established the National System for Ethics in Research Involving Human Participants, marked a milestone for clinical research in Brazil. After nearly a decade of legislative debate, the statute has been widely welcomed by the Brazilian scientific community as an important step toward improving the country's regulatory framework for human research. Nevertheless, both the new law and Decree No. 12,651/2025, together with other implementing regulations issued to date, still contain provisions that require further clarification and regulatory refinement.

One of the main areas of uncertainty concerns the allocation of legal liability among research sponsors, Contract Research Organizations (CROs), research institutions, and investigators. Although the legislation recognizes that all these stakeholders bear responsibilities within the research process, it does not clearly define the circumstances under which each may be held liable for injuries sustained by research participants during the trial. This uncertainty becomes even more significant in the context of post-trial access to investigational products, where the respective obligations of sponsors, investigators, and institutions remain subject to interpretation.

While these issues have become more visible under the new statutory framework, the legal responsibility of sponsors, research institutions, and investigators for research-related injuries has existed throughout the evolution of Brazilian clinical research regulation, regardless of the level of statutory detail.

The following sections provide a brief historical overview of the development of civil liability in Brazilian clinical research regulation before examining the issue that has generated the greatest concern among investigators: liability arising from the statutory obligation to ensure continued access to investigational treatments for participants who continue to benefit from them after the conclusion of the clinical trial. Investigators play a central role in determining whether the investigational product remains the participant's best therapeutic option and participate directly in developing the post-trial access plan. Consequently, their decisions—and potential omissions—may have significant implications for civil liability.

Historical Background

Clinical research involving human participants has been specifically regulated in Brazil since 1988, when the National Health Council (Conselho Nacional de Saúde – CNS) issued Resolution No. 01/1988. The Resolution was largely inspired by the Declaration of Helsinki, the Nuremberg Code, and ethical guidelines developed by international organizations, including the World Health Organization. Even at that early stage, Brazilian regulation recognized the need to ensure legal and ethical protection for research participants.

1. CNS Resolution No. 01/1988

Under CNS Resolution No. 01/1988, compensation for research-related injuries was governed primarily by the general principles of the Brazilian Civil Code. Accordingly, liability was predominantly fault-based, requiring the injured participant to establish: (i) the occurrence of damage; (ii) a causal relationship between the research activities—and the conduct of the investigator, institution, or sponsor—and the injury; and (iii) in most cases, negligence, recklessness, or professional malpractice on the part of the responsible party.

Although the Resolution required healthcare institutions to provide medical assistance to participants who suffered injuries directly related to the research and recognized the participant's right to seek compensation, it did not establish an autonomous statutory liability regime specifically applicable to clinical research. Consequently, civil liability remained subject to the general rules of Brazilian civil law.

2. CNS Resolution No. 196/1996

In 1996, CNS Resolution No. 01/1988 was repealed and replaced by CNS Resolution No. 196/1996, which modernized Brazil's regulatory framework for human research in light of the 1988 Federal Constitution and the ethical standards adopted by the World Health Organization and other international bodies.

Compared with its predecessor, Resolution No. 196/1996 introduced a substantially more comprehensive regulatory framework. It expressly recognized participants' entitlement to compensation for research-related injuries and defined a research-related injury as any immediate or subsequent harm, whether direct or indirect, suffered by an individual or by the community as a consequence of participation in clinical trials.

Despite these advances, the Resolution did not establish a comprehensive legal regime governing civil liability. As an administrative regulation rather than a statute enacted by the National Congress, it could not determine fundamental issues such as the legal nature of liability, the allocation of responsibility among sponsors, investigators, and research institutions, or the circumstances under which joint liability would arise. Consequently, its provisions were primarily ethical and administrative in nature.

Nevertheless, once a causal link between the research and the participant's injury had been established, the obligation to compensate continued to arise under the general principles of the Brazilian Civil Code.

3. CNS Resolution No. 466/2012

Although Resolution No. 196/1996 significantly strengthened participant protection, civil liability for research-related injuries continued to be governed by a combination of ethical rules established by the National Health Council and the general provisions of Brazilian civil law.

In December 2012, Resolution No. 196/1996 was repealed and replaced by CNS Resolution No. 466/2012, which represented a major step forward in the protection of research participants. For the first time, the Resolution expressly guaranteed participants the right to compensation for injuries arising from research regardless of proof of fault, thereby signaling a clear movement toward a strict liability framework.

The Resolution also expanded the responsibilities of sponsors, research institutions, and investigators by expressly recognizing their shared obligation to provide immediate and comprehensive medical care to participants who suffered research-related injuries. In addition, it reaffirmed the participant's non-waivable right to compensation, prohibiting any provision in the informed consent form that would limit or exclude this right.

Although Resolution No. 466/2012 did not have the force of a statute, it represented a significant evolution in Brazilian research ethics by clearly identifying sponsors, research institutions, and investigators as jointly responsible for ensuring participant protection throughout the conduct of the study.

During the period in which Resolution No. 466/2012 remained in force, the prevailing legal interpretation was that all parties involved in the conduct of clinical research - including sponsors, research institutions, and investigators - could be held liable for injuries sustained by research participants. While the sponsor generally bore primary responsibility for compensation, investigators and institutions could also incur liability where their conduct contributed to the occurrence of the injury.

4. Law No. 14,874/2024

The enactment of Law No. 14,874/2024, following nearly ten years of legislative debate in the Brazilian National Congress, represents a major milestone in the regulation of clinical research involving human participants in Brazil. By establishing a comprehensive statutory framework for human research, the legislation enhances legal certainty, increases regulatory predictability, and aligns the Brazilian system more closely with internationally recognized standards.

The new statute also streamlines the ethical review process without compromising participant protection, replacing a regulatory model based predominantly on administrative rules with a comprehensive legislative framework. This modernization is expected to improve Brazil's competitiveness as a destination for international clinical research while preserving robust ethical safeguards.

From the perspective of civil liability, Law No. 14,874/2024 largely codifies principles that had already emerged under previous National Health Council resolutions. It expressly guarantees that participants who suffer research-related injuries are entitled to both compensation and any healthcare required as a consequence of those injuries.

Unlike the previous regulatory framework, however, the new law expressly identifies the sponsor as the party primarily responsible for providing medical assistance and compensating participants for research-related injuries. Accordingly, as a general rule, sponsors bear primary legal responsibility toward research participants for injuries arising from their participation in the study.

This statutory allocation of primary responsibility does not, however, preclude liability on the part of investigators or research institutions. Where an injury results from an investigator's or institution's own wrongful conduct — Including failure to comply with the research protocol, negligence, lack of professional competence, recklessness, or deficiencies in participant care —those parties may also incur civil liability under the applicable provisions of Brazilian law.

The evolution of Brazilian clinical research regulation therefore reflects a consistent movement toward strengthening participant protection. While Resolution No. 196/1996 first expressly recognized the duty to compensate research-related injuries, Resolution No. 466/2012 significantly expanded participant protections by embracing a fault-independent approach to compensation. Law No. 14,874/2024 elevates these principles from administrative regulations to statutory law, thereby providing a stronger and more stable legal foundation for participant protection.

Nevertheless, the general principles of the Brazilian Civil Code continue to play an important complementary role in defining issues not expressly addressed by the statute, particularly regarding causation, allocation of liability among multiple parties, and the right of recourse between jointly liable parties.

Some commentators have argued that the Brazilian Consumer Protection Code could also apply to research-related injuries. This interpretation, however, remains controversial. Clinical research is conducted primarily for scientific and regulatory purposes rather than for the provision of goods or services to participants. Consequently, the legal relationship established between researchers and participants does not ordinarily constitute a consumer relationship within the meaning of Brazilian consumer law.

Accordingly, Law No. 14,874/2024 preserves the longstanding principle that participants are entitled to compensation for injuries arising from the inherent risks of clinical research regardless of proof of fault. As a general rule, the sponsor remains the party primarily responsible for ensuring both comprehensive healthcare and financial compensation for research-related injuries, as expressly provided in Article 23 of the statute.

Importantly, recognizing the sponsor as the participant's primary source of compensation does not exempt investigators from liability arising from their own conduct. Investigators may still be held personally liable where injuries result from violations of the research protocol, negligent clinical practice, professional misconduct, or failures to provide appropriate medical care. Thus, while the sponsor ordinarily bears primary responsibility toward participants, investigators remain legally accountable for injuries attributable to their own acts or omissions.

  • Civil Liability and Post-Trial Access to Investigational Products

The obligation to provide continued access to investigational products after the conclusion of a clinical trial is not entirely new in Brazilian law. Even under CNS Resolution No. 196/1996, participants were entitled to benefit from the results of the research, although the Resolution did not establish either the duration or the specific conditions under which post-trial access should be provided.

CNS Resolution No. 466/2012 significantly expanded this protection by expressly requiring sponsors to provide all participants, free of charge and for an indefinite period, with access to the most effective prophylactic, diagnostic, and therapeutic interventions identified during the study. This provision aligned Brazilian regulation with the ethical principles reflected in the Declaration of Helsinki, which recognizes post-trial access as an important safeguard for research participants.

Law No. 14,874/2024 transformed this ethical obligation into a statutory duty. Rather than merely recognizing a general entitlement, the legislation establishes detailed rules governing the circumstances under which post-trial access must be provided, the criteria for maintaining such access, and the situations in which it may lawfully be discontinued. These provisions are set forth in Chapter IV of the statute and represent one of its principal innovations.

The new statutory framework also assigns investigators a more active role in decisions concerning post-trial access. Investigators are responsible for assessing whether the investigational product continues to represent the participant's best therapeutic option and participate directly in the preparation of the post-trial access plan.

This expanded role has important implications for civil liability. Because investigators participate in clinical decisions regarding continued treatment, their actions—or omissions—may become legally relevant in determining responsibility for injuries suffered during the post-trial period. If an investigator fails to comply with the applicable standard of care, disregards the statutory requirements governing post-trial access, or inadequately evaluates a participant's clinical condition, such conduct may constitute an independent basis for civil liability.

Accordingly, where an investigator's conduct materially contributes to the occurrence of a participant's injury, both the investigator and the research institution may be held jointly liable alongside the sponsor, depending on the specific facts of the case and the applicable principles governing causation and fault.

Nevertheless, even where an injury results from an investigator's act or omission, this does not diminish the sponsor's primary responsibility toward the participant. Under Law No. 14,874/2024, the sponsor remains legally responsible for selecting qualified investigators and research institutions, ensuring that adequate resources are available for the conduct of the trial, and appointing the investigator responsible for clinical decisions. These statutory responsibilities justify maintaining the sponsor as the party primarily accountable to participants for research-related injuries.

Accordingly, where a participant suffers a research-related injury, the sponsor must provide comprehensive medical care and financial compensation as required by law. If it is subsequently established that the injury resulted from the wrongful conduct of an investigator or research institution, the sponsor may seek reimbursement from the responsible party through the appropriate legal mechanisms, in accordance with the allocation of liability established under Brazilian law.

Conclusion

Law No. 14,874/2024 elevates participant protection in Brazilian clinical research from the level of administrative regulation to statutory law, consolidating the right to compensation for research-related injuries and establishing a comprehensive legal framework governing post-trial access to investigational products. In doing so, the legislation reinforces the sponsor's position as the party primarily responsible toward research participants while preserving the possibility of holding investigators and research institutions liable where injuries result from their own conduct.

The statute's principal contribution is therefore not the creation of entirely new obligations but the codification and clarification of principles that had gradually emerged through previous ethical regulations. At the same time, it provides a more coherent allocation of responsibilities among the various stakeholders involved in clinical research.

The principal challenge that remains is not whether research participants are entitled to compensation, but rather how responsibility should be allocated among sponsors, investigators, research institutions, and other entities involved in the conduct of clinical trials, particularly in disputes arising from post-trial access to investigational products. Future judicial decisions and regulatory guidance will play a critical role in defining the practical boundaries of this shared liability regime.

Life Sciences Team

Marcos Levy – Mariana Muniz – Roberto Seixas – Vinicius Santos