Pesquisa clínica com voluntários sadios: uma experiência brasileira

• Ano de defesa: 2007
• Autor(a) principal: Santos, Maria Stella Galvão
• Orientador(a): Zaterka, Luciana
• Tipo de documento: Dissertação
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Pontifícia Universidade Católica de São Paulo
• Programa de Pós-Graduação: Programa de Estudos Pós-Graduados em História da Ciência
• Departamento: História da Ciência
• País: BR
• Palavras-chave em Português: Pesquisa com seres humanos; Voluntários sadios; Universidade Estadual de Campinas > Unidade de Farmacologia Clinica; Bioetica; Medicina experimental no homem
• Palavras-chave em Inglês: Research with human being; Healthy volunteers
• Área do conhecimento CNPq: CNPQ::CIENCIAS HUMANAS::HISTORIA::HISTORIA DAS CIENCIAS
• Link de acesso: https://tede2.pucsp.br/handle/handle/13351

The first clinical research with healthy volunteers in Brazil had occurred in a tumultuated climate. In 1989 the process of institutionalization of the Unit of Clinical Pharmacology next to the Department of Pharmacology of the College of Medical Sciences on the State University of Campinas had beginning. Four years later, had started to appear public accusations on the use of healthy volunteers, called human guinea-pigs, in the clinical tests with medicines, and on the issue to remunerate them for the participation. The discussion arrived at the Justice and at the ethics councils of the area, involving the researcher and professor Gilbert De Nucci, and establishing criticizers and defenders of the initiative. In the trace of this controversy, appears the Resolution 196/96, which established the legal requirements for the accomplishment of clinical research in the country, based on the four pillars of the Bioethics: autonomy, non maleficence, beneficence and justice. The Brazilian norm incorporated what would come to become the more critical point in the discussion about the motivation of the healthy volunteers to participate of clinical research, when foresaw that they can be repaid by the financial expenses that come to have, but never remunerated. The international experience, however, openly adopts and discusses the remuneration criteria. Throughout this research and, in parallel to the demonstration of how the Bioethics has constituted itself on an important scientific field of reflection, had appeared relative questions to the link between science, language, speech, representation and power. In this context, we adopt the works of the French philosopher Michel Foucault (1926-1984) as our theoretical referential