The Research Ethics System in Brazil: transformations in regulation and the need to improve protection and guarantee the rights of research participants

Abstract

Research ethics regulation in Brazil completes a historical cycle in 2025, celebrating the 29th anniversary of CNS Resolution No. 196/96. This milestone established the National Research Ethics Commission (CONEP) and spurred the creation of Research Ethics Committees (CEPs), aiming to curb abuses and protect those then referred to as "research subjects" or "volunteers". The system's evolution was marked by significant technological advances, such as the transition from the former SISNEP to Plataforma Brasil in 2012. In 2025, this tool reached the historic milestone of over 1 million registered protocols and an equal number of registered researchers. Concurrently, CNS Resolution No. 647/20 promoted an essential terminological shift, redesignating "subjects/volunteers" as research participants, thereby granting them greater agency and prominence. Currently, the country is undergoing its most significant institutional reform with the enactment of Law No. 14,874/2024 and Decree No. 12,651/2025. This new legal framework establishes the National Instance for Research Ethics (INAEP), which succeeds CONEP. Although this transition alters administrative workflows and oversight competencies, the fundamental purpose remains unchanged: to guarantee the protection and rights of participants. In this context of transformation and following the challenges of the COVID-19 pandemic, the journal Cadernos de Ética em Pesquisa resumes its activities in 2025, reaffirming its commitment to serve as an ethical information bridge for all stakeholders within this system, as well as for Brazilian society as a whole.