A pesquisa clínica no Brasil: entre a proteção e a vulnerabilidade - análise a partir da visão dos membros do sistema CEP/Conep atuantes em Minas Gerais sobre a resolução 466/12

• Ano de defesa: 2015
• Autor(a) principal: Juliana Hermont de Melo
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Federal de Minas Gerais; UFMG
• Palavras-chave em Português: Pesquisa clínica; CEP/CONEP; Vulnerabilidade; Bioética; Pesquisa biomédica
• Link de acesso: http://hdl.handle.net/1843/BUBD-ACRHBF

The science, concerned about proving theories, the range of original and effective treatments, as well as the realization of new discoveries, strives to exceed its limits. It isnt always worried or properly concerned about the ethical observation of adopted postures. Thus, competes to bioethics delimitate the limits of action of science, attest legitimacy on the involved methods and offer ethical cribble on which method the science will work to promote the widespread and fruition of the benefits of the results of research. The Nuremberg Code, the Helsinki Declaration and 466/12 Resolution of the Health Department of Brazil represents the ethical positions on the indiscriminate use of biotechnosciences occurred in the last decades of the 20th century and early 21st century. Both constitute itself as mechanisms of ethical responses of society tothe avalanche of biotechnoscientific slights brought by the postmodernity. Given above, the guiding question of this work lies on understanding the limits and possibilities of offered protection to the participant vulnerabilities of clinical research by 466/12 Resolution, in order to elucidate the progress and/or setbacks revealed by this new law. The methodology used was qualitative exploratory and descriptive research. As data collection instrument, was used the episodic interviews and datawere analyzed with argumentative analysis. Survey participants were members of CEPS research committees of the state of Minas Gerais. The results were: direct experience interference of the interviewee as a CEP member and their perception of the weakening of guarantees and protections of clinical research participants on their rights and the bureaucratic participation in CEPS of this situation and the evaluationof the obtained data by the author. Thus, was decided for the strengthening of the CEP/CONEP system and the combination between the bioethics of autonomy principles and the bioethics of protection principles.