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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。
The United States is the forerunner of the legislation on the protection of subjects’ rights and interests and also has a relatively mature system of experience. However, the legal experience in that country was also obtained on the basis of serious reflection on its historical lessons. On the basis of the scientific scandals such as the Tuskegee incident, it issued a series of legal construction measures including the universal rules and established the system of guaranteeing the rights and interests of the participants, including informed consent and ethical review. In recent years, the federal government’s latest amendment to the common rules has also shown that it is necessary to strengthen the protection of subjects’ rights and enhance the efficiency of ethics review. The historical process of legislative protection of rights and interests of the United States testifies to the positive and negative aspects of China’s legal construction.