我国受试者保护体系的现状与构建

Status and Construction of Subject Protection System in China

近年来,伦理失范事件不断出现,暴露了我国受试者保护环节的薄弱性。仅伦理委员会无法满足我国日益增强的受试者保护需求。当前存在缺乏相关的法律制度、行政监管缺位及伦理委员会建设和审查能力不足的问题。国家层面可考虑制定涉及伦理的法律、完善受试者权益保护的相关法律法规、加强监管和强制多渠道落实受试者补偿/赔偿角度推进受试者保护体系的建设。医院层面的受试者保护体系可在现有伦理委员会基础上,建立或协同质量控制办公室、培训中心、数据与安全监察委员会、研究合同/经费管理、学术委员会、科研诚信委员会/办公室和利益冲突委员会/办公室,加强各部门间的沟通协调,切实保护受试者权益。但作为新事物,仍需借鉴国外经验并结合国情长期探索其发展。

In recent years,many ethical news have continuously exposed the weakness of the protection of Chinese subjects.Only ethics committee is unable to meet the increasing needs of subject protection in China.At present,there are some problems,such as the lack of relevant legal system,the absence of administrative supervision,and insufficient capacity of ethics committee construction and review.At the national level,we can consider formulating ethics related laws,improving relevant laws and regulations for the protection of subject rights,strengthening supervision,and enforcing the implementation of subjects compensation/compensation in multiple channels to promote the construction of the subject protection system.On the basis of the existing ethics committee,the patient protection system at the hospital level can establish or cooperate with the quality control office,training center,data and safety supervision committee,research contract/funding management,academic committee,research integrity committee/office and interest conflict committee/office,strengthen the communication and coordination among departments,and effectively protect the rights and interests of subjects.As a new thing,it is still necessary to learn from foreign experience and explore its development in the long run in combination with national conditions.