The The New Legal Framework for Research with Human Beings in Brazil

a Critical Analysis of Law No. 14.874/2024 and its Implications for Scientific Research Involving Children and Adolescents

Abstract

This article focuses on scientific research involving human beings within the Brazilian legal system, with emphasis on situations in which the research subjects are children and adolescents. The aim is to understand the impact of the transition from a system composed of legal, constitutional, and infraconstitutional norms—as well as regulations issued by the Executive Branch (National Health Council)—to a legal framework established by Law No. 14,874/2024, which inaugurated a microsystem for research involving human beings. This study offers a critical analysis of the new legal framework, highlighting its implications for children and adolescents. Given that the topic involves both bioethical and biolegal dimensions, the relevant principles of each are presented as a foundation for the ensuing dogmatic-legal analysis, conducted in two stages: the first centers on identifying norms that already protected human beings prior to the enactment of the new legal framework; the second addresses the study of the new microsystem in its fundamental aspects, with an emphasis on the specific requirements for involving age-related vulnerable individuals as research subjects. Upon completion of these stages, the article aims to reveal the advances, setbacks, and challenges to the effectiveness of the rights of children and adolescents. This is a qualitative and exploratory approach.