The Ethical Crisis of Clinical Research in Brazil: Law 14.874/2024 and the Flexibilization of Brazilian Regulations for Participant Protection

Abstract

Clinical research is an essential field for the advancement of medical science and the development of new treatments. However, the globalization of clinical trials has caused controversy, especially regarding the integrity of the data collected and possible violations of participants' rights [1][2][3] . Lobbying in Brazil by the international biopharmaceutical industry ("Big Pharma") is strong and has led to the relaxation of regulations protecting participants, raising serious ethical concerns. With the recent enactment of Law 14.874/2024 4 it is imperative to discuss how these regulatory changes affect research ethics and the need for policies that prioritize the protection of participants and national sovereignty.