人类遗传资源研究和利用中知情同意模式的伦理选择  

Ethical Selection of Informed Consent Models in the Study and Utilization of Human Genetic Resources

作　　者：高旭东 焦艳玲[1] GAO Xudong;JIAO Yanling(College of Medical Humanities,Tianjin Medical University,Tianjin 300070,China)

机构地区：[1]天津医科大学医学人文学院,天津300070

出　　处：《中国医学伦理学》2021年第4期408-413,432,共7页Chinese Medical Ethics

摘　　要：大数据时代背景下,知情同意的模式选择成为人类遗传资源研究与利用中一系列问题的解困之路。围绕人类遗传资源信息采集过程中社会效益与个人权利的论辩,存在“概括知情同意”与“具体知情同意”的模式之争。尽管两种知情同意模式都有充分的伦理基础,但是在大数据时代单独适用任何一种模式都有缺陷。为避免概括知情同意滑向“数据主义”的深沟,也使具体知情同意更能适应大数据时代的要求,采行概括知情同意与具体知情同意融合的模式才是最佳的选择。在具体路径上,可以借鉴美国采取“场景风险评估的同意分层”制度,在法律与伦理层面落实“概括知情同意+具体知情同意”模式选择的最佳途径与方法,达到数据利用与个人信息保护的平衡。In the era of big data,the mode selection of informed consent has become the solution to a series of problems in the research and utilization of human genetic resources.There is a dispute between“generalized informed consent”and“specific informed consent”in the debate on social benefits and individual rights in the process of information collection of human genetic resources.Although both models of informed consent have sufficient ethical basis,the application of either model in the era of big data is flawed.In order to avoid generalized informed consent sliding into the deep ditch of“data”and make specific informed consent more adaptable to the requirements of the era of big data,the best choice is to adopt the mode of integration of generalized informed consent and specific informed consent.In terms of the specific path,researchers can learn from the“consent stratification of scenario risk assessment”system adopted by the United States,and implement the best way and method of“generalized informed consent+specific informed consent”mode selection at the legal and ethical levels,to achieve the balance between data utilization and personal information protection.

关 键 词：人类遗传资源 数据利用 知情同意 伦理争议 

分 类 号：R-052[医药卫生]