Hossne William Saad, Vieira Sonia, De Freitas Corina Bontempo Duca
Botucatu Medical School, UNESP- São Paulo State University.
J Int Bioethique. 2008 Mar-Jun;19(1-2):131-41, 200.
In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.
自1996年10月起，巴西就出台了涉及人类受试者研究的指导方针。现在，人类受试者知道他们的治疗何时属于研究范畴。欺骗行为不再被容忍。但仅仅说我们在潜在受试者面对知情同意书之前向其提供解释并给予选择是不够的。如同在所有专业活动中一样，科学研究需要社会监督。在巴西，调查的最终责任在于研究者，但在开展研究的每个机构都设有研究伦理委员会。所有委员会都隶属于国家研究伦理委员会，该委员会隶属于巴西卫生研究院。2005年期间，全国475个委员会对约17000项涉及70万名人类受试者的研究方案进行了审查。目前约有7000人在这些委员会工作。
