“All areas of knowledge”: the legal regulation of scientific research in Brazil and the (non) place of Human and Social Sciences

Abstract

This study aims to discuss the controversies surrounding Senate Bill 200/2015 and Bills 7.082/2017 and 6.007/2023, which provide a new system of ethical review for scientific research. The bills were later promulgated as the Law da Lei 14.874 of 2024. At the beginning of its processing in the Senate, under the name PLS 200/2015, the bill proposed the regulation of clinical research as its object, in conjunction with sectors associated with pharmaceutical laboratories and national and international research centers. However, in 2019, during its passage by the Brazilian Chamber of Deputies, the text incorporated the Human and Social Sciences (HSS) into its scope by extending the project to “all areas of knowledge.” Building on an ethnography of documents, this study highlights two dimensions of this process: the setbacks relating to the loss of rights of clinical research participants and the inadequacy of the attempt to update biomedical references to regulate human and social sciences research. This study aims to contribute to understanding the contemporary panorama of the ethical regulation of human and social sciences research in Brazil based on an ethnography of the relations and tensions that constitute the shaping of a bill.