摘要
当前,我国涉及人体生物样本的知情同意退出制度实施困难,其本质原因在于立法者始终坚持传统医疗或临床试验背景下的自主、隐私等价值的绝对保护,而忽视了现代生物技术使用离体人体生物样本的场景,导致知情同意退出制度仅机械借鉴舶来规则,最终造成生物医药领域实践无法根据具体应用场景构建知情同意退出模式而处于潜在违法状态。为促进人体生物样本安全有效利用,推动生物产业发展与繁荣,需为我国人体生物样本知情同意退出制度合理化找到正确路径。本文重新回顾知情同意退出制度价值产生之初与发展之中的立法博弈,回溯其中保护自主、隐私的价值内涵,厘清本土立法出现制度设计与实践脱节的根源,并提出符合国情的知情同意退出制度本土策略。
At present, it is difficult to implement the withdrawal of informed consent system involving human biological samples in China. The essential reason is that legislators overemphasize the protection of autonomy, privacy and other values that have been fixed in the context of medical treatment or clinical trials, while ignoring the scene of modern biotechnology using isolated human biological samples. As a result, the practice in the biomedical field cannot establish a withdrawal mode according to the specific application scenarios, and it is in a potentially illegal state. In order to promote the safe and effective use of human biological samples and advance the development and prosperity of biotechnological industry, it is necessary to find a reasonable path for the informed consent withdrawal of human biological samples in biomedical research in China. This paper analyzed the origin and development of withdrawal system regarding informed consent from a historical perspective, traced the value connotation of protecting autonomy and privacy, clarified the root cause of the disconnection between system design and practice in China’s legislation, and put forward strategies optimize the informed consent withdrawal system in biotechnology research in line with the specific conditions of China.
作者
吕建伟
彭耀进
LV Jian-wei;PENG Yao-jin(Institute of Zoology,Chinese Academy of Sciences;Beijing Institute for Stem Cell and Regenerative Medicine)
出处
《科学与社会》
CSSCI
2022年第2期137-156,共20页
Science and Society
基金
中国科学院战略性先导科技专项(A类)“伦理困境下器官制造与移植的法律问题研究”(XDA16040503)
中国科学院青年创新促进会(2021080)。
关键词
知情同意
退出制度
价值
自主
生命科技
informed consent
withdrawal system
value
autonomy
life technology
