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  • 14 May 2024

New rules for research with human subjects

Aft­er almost 10 years of deliberation, on April 23, 2024, the Federal Senate approved Bill 6.007/2023, which addresses research with human subjects in Brazil. The text, which awaits presidential approval, will usher in significant advancements in this field.

According to the Bill’s authors, the objective is to accelerate the release of clinical research in Brazil. As a result, the bill should generate more incentives for the sector and the carrying out of research that today, due to flaws in the legislation, cannot be carried out in the country.

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

Check out these and other topics covered in the Bill 6.007/2023 on 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 Bill 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

Bill 6.007/2023 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.

If there is a need to provide the drug after a clinical study, a post-supply program must be designed to ensure continuous monitoring of the participant and access to the experimental treatment. For more details on cases of interruption of free post-study supply, see the material here.

Protection of research participants

Bill 6.007/2023 regulates the protection and anonymity of personal data of research participants. The project prohibits remunerating the participant or granting any type of advantage for their participation, except if the research involves phase I or bioequivalence clinical trials. Furthermore, participants can withdraw from the research at any time, without penalty or loss.

To check these and other highlights of the Bill that creates rules for research with human beings, 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.

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