目的 概述基因信息检测的知情同意的注意事项,为临床研究中涉及基因信息检测的知情同意的伦理审查提供参考.方法 查阅国内外有关基因信息检测涉及知情同意的文献并进行综合分析.结果 基因信息检测引发个体、家庭和社会层面的隐私问题,基因信息检测的不知情权已得到广泛认可.知情同意中采用告知后同意,不仅体现对个人人格尊严和自主权的尊重,也有利于基因资源的有效利用;应在法律上构建合理的程序性制度,保障同意的自愿性和真实性,并落实于具体操作上.在确立不知情权的基础上,我国法律也应禁止用人单位和保险公司对劳动者和被保险人提出的实施基因检测或提供基因信息,也要严格禁止检测婴幼儿不可治愈疾病的基因.结论 在临床研究伦理审查中,当产生冲突时,需前瞻性设计知情同意以解决个人不知情权与自身健康利益的冲突问题,并应在立法上构建合理程序以保障告知后同意的落实.%Objective:To summarize the notice of informed consent about gene information detection,and to provide a reference for ethical review of informed consent in clinical research involved gene information detection.Methods:We researched domestic and foreign literatures about gene information detection involved informed consent and comprehensively analyzed them.Results:Gene information detection caused the individual,family,and social aspects of privacy issues,and the right not to know gene information detection had been widely recognized.Informed consent was adopted in informed consent,which not only was respect for personal dignity and autonomy,but also was conducive to the effective use of gene resources.It should construct reasonable procedural system in le gal protection,guarantee the voluntary and authenticity of consent,and put it into practice.Based on the establishment of the right not to know,the Chinese law should also prohibit the implementation of gene detection or provision of gene information put forward by employers and insurance companies.In addition,it is strictly prohibited to detect infant incurable disease genes.Conclusion:In the ethical review of clinical research,when the conflict arises,it is necessary to design informed consent to resolve the conflict between the individuals' rights not to know and their personal health benefits,and to establish reasonable procedures in legislation to ensure the implementation of informed consent.
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