真实世界研究中人类遗传资源管理的伦理问题及其伦理审查  

Ethical Issues and Ethical Review of Human Genetic Resource Management in Real-world Studies

作　　者：邢荔函 黄樱硕[1] 崔焱[2] 李悦[1] 左旭 郭水龙[1] XING Lihan;HUANG Yingshuo;CUI Yan;LI Yue;ZUO Xu;GUO Shuilong(Office of Science and Technology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Office of Clinical Drug Trial Institution,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)

机构地区：[1]首都医科大学附属北京友谊医院科技处,北京100050 [2]首都医科大学附属北京友谊医院药物临床试验机构办公室,北京100050

出　　处：《中国医学伦理学》2022年第12期1341-1345,共5页Chinese Medical Ethics

基　　金：北京市科技计划课题“北京地区结肠镜诊治用语标准规范及结直肠专病数据平台建设”(Z191100006619084);2018年度消化内科学科协同发展中心协作创新项目“构建协同中心受试者保护体系,探索伦理互认机制的研究”(XXX0105)。

摘　　要：人类遗传资源是科技发展的重要战略资源,为了充分利用和有效保护真实世界研究中的人类遗传资源,通过分析真实世界研究的现状及特征,发现真实世界研究的数量逐年增多,且具有不可控因素较多、证据形成要求严格、信息易获取与泄露的特征。结合真实世界研究的特征,将真实世界研究中人类遗传资源管理的伦理问题总结为研究开展的科学性与价值性、受试者的知情同意与隐私保护、利益分享中的公平与公正三方面问题,对应提出伦理审查要点为科学合理性、充分知情、隐私和数据安全及利益相关者。除此以外,应充分发挥伦理审查的研究准入与过程监管职责,通过加强培训与过程管理引导研究者充分利用人类遗传资源,进一步推动真实世界研究规范开展。Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.

关 键 词：真实世界研究 伦理审查 人类遗传资源管理 伦理问题 

分 类 号：R-052[医药卫生]