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从塔斯基吉到通用规则:美国保护受试者立法的历史发展与启示

发布时间:2018-08-19 12:17
【摘要】:美国是保护受试者权益立法的先行者,也有着较为成熟的制度经验。但该国的法制经验,也是在认真反思其历史教训的基础上获得的。其在反思塔斯基吉事件等科学丑闻的基础上,出台了包括通用规则在内的一系列法制建设举措,确立了包括知情同意及伦理审查在内的受试者权益保障体系。近年来,联邦政府针对通用规则的最新修正案中,又表现出强化受试者权益保障及提高伦理审查效率的取向。美国受试者权益保障立法的历史进程,可为我国的有关法制建设提供正、反两方面的镜鉴与启示。
[Abstract]:The United States is the forerunner of legislation to protect the rights and interests of subjects, and has more mature system experience. But the country's legal experience is also based on careful reflection on its historical lessons. On the basis of reflecting on the scientific scandals such as the Tuskegee incident, it has introduced a series of legal construction measures, including general rules, and established a system of safeguarding the rights and interests of subjects, including informed consent and ethical review. In recent years, the federal government's latest amendment to the general rules shows the orientation of strengthening the protection of subjects' rights and interests and improving the efficiency of ethical review. The historical process of the legislation on the protection of the rights and interests of the subjects in the United States can provide both positive and negative lessons for the construction of the legal system in China.
【作者单位】: 青岛大学;国家自然科学基金委员会;
【分类号】:D971.2


本文编号:2191624

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