Fundamentos éticos e bioéticos das resoluções sobre a ética em pesquisa no Brasil

Abstract

This lecture is aimed at examining the ethical and bioethical fundamentals of the Resolutions of the National Comission of Ethics on Research (Resoluções da Comissão Nacional de Ética em Pesquisa). For this purpose, firstly, a brief description of the National System of Ethics on Research (Sistema Nacional de Ética em Pesquisa) created by the 196 Resolution of 1996 of the Health Ministry in Brazil. This system is composed of a national comission (Comissão Nacional de ética em Pesquisa -CONEP) which controls, analyzes and regulates the protection of human beings in researches as a superior and definite instance of institutional committees (448 in September/2005) that are the basis of the whole ethical evaluation system of research projects involving human beings. This system also includes the National System of Information about Ethics on Research (Sistema Nacional de Informação sobre Ética em Pesquisa) involving human beings (SISNEP). Secondly, it examines the moral principles, rules and values that head the process of the ethical evaluation activity of research projects sent to be registered and evaluated in this system. This extremely relevant system involves, nowadays, about 5000 members in Brazil. To do this study, the resolutions of the National Comission, published from 1996 to 2005 were analyzed, and the manual created by the National Comission in 2002 and dedicated to committees was also taken into account. It is also important to consider the reflection of the author on his personal experience at the Coordination of the local committee of ethics on research at the Federal University of Santa Maria (Comitê de Ética em pesquisa da Universidade Federal de Santa Maria) – Brazil.