摘要
“研究参与者”是传统受试者以及研究样本、研究数据的提供者的统称。研究参与者的同意撤回权一方面包含针对身体介入活动(手术等)的同意撤回权,另一方面包含针对个人信息收集和处理等活动的同意撤回权。本质上讲,同意为意思表示,同意撤回权性质上属形成权,其与传统意思表示规则相异之处具备充足的正当性基础,为人格权法上所作的例外安排。研究参与者同意撤回权的行使具有“随时”与“无条件”的“锋利”特点,特殊情况下可采取缓和路径,然而其始终不可被放弃。为确保其同意撤回权得到法治实现,应构建合理的规范赋权体系,并充分发挥伦理委员会的作用,全程保障研究参与者的知情权。
Theterm"research participant"is a general term for traditional subjects and providers of research samples and data.The right to withdraw consent for research participants includes the right to withdraw consent for physical interventions(surgery,etc.)on the one hand,and the right to withdraw consent for activities such as the collection and processing of personal information on the other.In essence,consent is an expression of intent,and the right to withdraw consent is a right of formation in nature.The differences between the right to withdraw consent and the traditional rules for expression of intent have a sufficient basis for justification,which is the exception in Personality Right Law.The exercise of the right to withdraw consent is"sharp"in the sense that it is"ready"and"unconditional",and can be moderated under special circumstances,but it cannot be waived.In order to ensure that the right to withdraw consent is realized under rule of law,a reasonable regulatory empowerment system should be established,and the role of the ethics committee should be fully utilized to guarantee the right to information of research participants throughout the process.
出处
《中国政法大学学报》
CSSCI
2023年第3期156-168,共13页
Journal Of CUPL
关键词
研究参与者
同意
撤回权
research participants
consent
right to withdraw
