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广泛知情同意是知情同意的特殊形式,国外广泛知情同意的应用和实施提升了生物样本在将来研究中的流通速度,促进了生物样本临床研究的发展,但是同时也因弱化“告知”而导致了受试者信息获取不及时、研究风险不可知和退出研究不及时等伦理问题。目前,欧美在广泛知情同意实施的条件和告知内容、框架等方面进行了颇多研究,为广泛知情同意的实践提供了强大的支持。广泛知情同意在我国的实践已经成为生物样本研究发展的方向,笔者比较国内外社会环境及理论研究认为,我国必须在社会认可、伦理审查机制完善、立法保护的基础上进行实践和实施。
Extensive informed consent is a special form of informed consent. The application and implementation of extensive informed consent in foreign countries has increased the speed of circulation of biological samples in future studies and promoted the development of clinical studies of biological samples, but also because of the weakening of “informed” It leads to the subjects’ information acquisition is not timely, the study of risk is unknown and the withdrawal of research is not timely and other ethical issues. At present, Europe and the United States have carried out quite a lot of studies on the conditions of implementation and the content and framework of informed consent, which have provided strong support for the practice of extensive informed consent. The practice of widespread informed consent in our country has become the direction of the development of biological samples. Compared with the social environment at home and abroad, the author thinks that our country must practice and implement on the basis of social recognition, improvement of ethical censorship and protection of legislation.