Loosening research ethical standards in Brazil? An analysis of bill 6007/2023

Abstract

Bill 6007/2023 proposes significant changes to the National System of Ethics in Clinical Research with Human Beings. The justification is that the debureaucratization of the system would contribute to scientific progress. The article analyzes the main points of the bill, to verify the adequacy between what is proposed and the expected outcomes: normative level; time of analysis; role of the central organ; consent; post-study treatment; placebo; monitoring; and measures resulting from non-compliance. Although the normative level and the proscription of placebo, except when there is no proven effective intervention, offer a protective effect. The other changes either do not contribute to increasing the protection of the participants or effectively loosen moral obligations towards them. The lack of protections and guarantees does not speed up research, as is often argued, but, on the contrary, can cause more risk to participants and lead to discredit and distrust of science.