中国临床试验受试者隐私权保护的相关问题及解决策略

Problems and solutions related to the protection of privacy of clinical trial subjects in China

受试者的权益是临床试验首要考虑的问题,其中受试者隐私权的保护贯穿临床试验的整个过程。本文通过对中国受试者隐私保护相关的法规研究及大数据背景下受试者隐私权保护相关内容的检索和汇总发现,中国受试者隐私保护存在缺少具有指导意义的法规、研究者对于受试者隐私保护意识不强、伦理委员会对数据审查能力不足以及大数据背景下受试者健康数据和遗传数据存在泄露风险的问题。因此,在国家层面,应根据国情制订适用于临床试验受试者隐私保护的相关法规;在伦理委员会层面,应加强数据使用的伦理审查;在技术层面,可探索将去识别化的手段和去中心化的区块链系统应用于受试者健康数据和临床试验数据的管理,从而探索平衡医学研究和隐私保护的策略,推动中国医药研发产业的发展。

The rights and interests of subjects are the primary consideration of clinical trials,among which the protection of subjects′privacy runs through the entire process of clinical trials.By studying and reviewing the relevant laws and regulations on the protection of subject′s privacy in China,as well as relative studies on this issue in the context of big data,the research suggested that there is a lack of regulations with guiding significance for the protection of subjects′privacy in China,investigators are lack of awareness of the protection of subjects′privacy and the ethics committee has insufficient ability to review data,personal health and genetic data are at increased risk of leakage in the context of big data.Therefore,with regard to the government,regulations applicable to the privacy protection of clinical trial subjects should be formulated according to national conditions.As for the ethics committee,ethical review of data use should be strengthened.On the technical level,the application of de identification means and decentralized block-chain system to the management of subject health data and clinical trial data can be explored,so as to explore strategies to balance medical research and privacy protection,and promote the development of pharmaceutical research and industry in China.