Origin, evolution and challenges of regulating clinical research related to vaccines in Brazil

Abstract

This article aims to analyze how the COVID-19 pandemic has impacted clinical research. To do so, it was necessary to provide a brief analysis of the history of clinical research and research ethics, as well as to analyze the current scenario. A survey of resolutions relevant to the topic was carried out on the CNS website, as well as a survey of RDCs on the ANVISA website, carrying out a comparative study of the resolutions found with the RDCs issued during the pandemic by ANVISA, and with the bill that intends to regulate clinical research.