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随机抽取上海市8所公立医院145份涉及人体的医学科研项目知情同意书,对其内容、语言和签字状况进行了审核。研究显示,知情同意书总体符合研究伦理要求,但仍存在不足。为此,建议规范知情同意书的的内容。
145 informed consent forms of medical research projects involving human body in 145 public hospitals in Shanghai were randomly selected and their contents, languages and signatures were reviewed. Research shows that informed consent generally meets the research ethical requirements, but there are still some shortcomings. To this end, it is recommended to regulate the content of informed consent.