Experimentation With Human Beings In Brazil From Law N°14.874/2024

Abstract

This paper analyzes the approaches taken in Brazil regarding experimentation with human beings. The question that guides the study can be demonstrated as follows: Considering experimentation with human beings and the new contours of Law n° 14.874/2024, what are the main repercussions regarding the rights of research participants? The study adopts the hypothetical-deductive approach method through bibliographic review. It starts from the historical rescue of experiments in Nazi concentration camps concluding that the subjects were objectified with disregard for their identity and autonomy. Subsequently, it refers to the Nuremberg trial as a milestone for the punishment of professionals who implemented such practices, as well as a milestone for the emergence of the Nuremberg Code with guidelines for research with human beings. Then, the structuring of bioethical principles emerges and, in Brazil, the gradual structuring of the Cep/Conep system, responsible for ensuring the rights of research participants. This year, President Lula signed Law n°14.874/2024, and a preliminary analysis shows the erosion of the CEP/CONEP System, the weakening of social control over proposed research, and the submission of the system to the interests of the pharmaceutical and hospital equipment industries. Thus, the rights of research participants suffer significant losses, as the law authorizes the export of their biological material abroad, as well as their data, which allows exploitation by unknown third parties; access to post-study medications, which previously were guaranteed for life and free of charge, is made difficult. This is a legislative setback for Brazil.