New rules for research with human subjects

After almost 10 years of deliberation, on May 28, 2024, Law No. 14,874/2024 was sanctioned. The legislation creates rules for research with human subjects in Brazil and brings important news that impacts everyone involved in the clinical research ecosystem. Furthermore, it also establishes the National Research Ethics System.

In exclusive material, experts from our Life Sciences and Healthcare practice bring the main points of the law, such as the attributions of the National System of Ethics in Clinical Research with Human Subjects, the rules for post-study study, deadlines for analysis and the responsibilities of the sponsor and researcher.

Check out these and other topics covered in the legislation on clinical research with human subjects in Brazil in the material here.

The National System of Ethics in Clinical Research

In addition to establishing guidelines for research with human subjects, the law mentions the National System of Ethics in Clinical Research with Human Subjects with the purpose of exercising control over good clinical practices.

Although it is awaiting regulation by the Executive Branch, the system is segmented into two instances. This is the national body for research ethics and the analysis body, represented by the Research Ethics Committees (CEPs). To better understand the functions of these instances, consult the full material.

Post-study supply

Law No. 14,874/2024 provides rules for the continuity of post-clinical study treatment and the creation of a post-study access plan. According to the text, before the start of the study, the sponsor and the researcher must submit the plan to the CEP.

A post-supply program must be developed if there is a need to provide the drug after a clinical study. In this way, the legislation ensures continuous monitoring of the participant and access to experimental treatment. For more details on cases of interruption of free post-study supply, see the material here.

Protection of research participants

Legislation regulates the protection and anonymity of personal data of research participants. Furthermore, it prohibits remunerating the participant or granting any type of advantage for their participation, except if the research involves phase I or bioequivalence clinical trials. It is worth noting that participants can withdraw from the research at any time, without penalty or loss.

To check these and other highlights of the law that creates rules for research with human subjects, such as the deadlines for analysis, the responsibilities of the sponsor and the researcher and the general rules, access the material here.

Our team specialized in Life Sciences & Healthcare closely monitors the changes and updates that impact the healthcare sector. For more information on this or other topics that are of interest to you, contact our team.