Amendment to the national law on ethical issues in research involving human subjects

Decree 158/019 of June 13, 2019

Abstract

Decree 158/19 introduced numerous modifications to the national regulations on research ethics involving human beings. As these changes are contained within a decree that retains a large part of the text of decree 379/08, it is easy for at least some of them to go unnoticed by readers not directly involved in research with human beings. Your knowledge is important because it includes not only modifications
in the operation of institutional research ethics committees and the National Research Ethics Commission, but also important conceptual claims on points regarding the timeliness of the use of placebo, informed consent in epidemiological studies, and requirements for research conducted from the outside.