Research involving humans in Brazil: a bioethical and historical perspective

Abstract

This article analyzes the historical evolution of Brazilian ethical regulations on research involving humans,
discussing the National Health Council Resolutions 1/1988, 196/1996, 466/2012 and 510/2016, in addition
to Law 14,874/2024. It is a qualitative, document-based study with a historical-critical approach, comparing
national regulatory frameworks with key international ethical research guidelines. Although the new law
represents legal progress, significant criticisms remain, particularly regarding participant protection and
the independence of research ethics committees. The study concludes that the new regulation requires
adjustments to address gaps related to bureaucratization of processes and the autonomy of Brazilian
ethical bodies. It recommends streamlining administrative procedures, strengthening the independence
of research ethics committees and the National System of Research Ethics, and aligning Brazilian legislation
with best international practices to ensure effective and continuous protection of research participants.