Autonomia e vulnerabilidade dos sujeitos nas pesquisas com seres humanos na normativa brasileira

considerações sobre as evoluções bioéticas nas Resoluções do Conselho Nacional de Saúde e as controvérsias do Projeto de Lei nº 7082/2017

Abstract

The paper intends to discuss human subjects research from the bioethical point of view. The new laws on the subject tend to remove rights already guaranteed by the Brazilian resolutions. The study will be divided into three topics. First, it will be mentioned, even if briefly, how the resolutions seek to treat vulnerables as research subjects In the second tropic, the ethical aspect with human beings will be explained, especially in the approach to the concepts of autonomy and vulnerability. The third tropic will discuss the controversies in relation to the Bill No. 7082/2017, which is being processed in the Chamber of Deputies and provides for clinical research with human subjects and institutes a national system of human subjects research's ethics. The methodology was based on the bibliographic and documentary analysis of bioethic's scientific papers, in addition to legislation and opinions of organizations related to the theme. The results of this paper conclude that it is essential to reconcile the need to encourage scientific progress to protect human dignity and defend collective and individual rights.