摘要
传统生物医学研究中对受试者身份的保护,常通过一系列机制措施来实现,如仅以聚合形式发布数据、将可识别变量去除后再作信息公开等,其旨在对目标对象的健康信息进行保密性处理。此类隐私保护被视为医学研究伦理最基本的原则之一,其确切执行则有利于维系研究受试者与社会公众的信任和支持。当前遗传学与基因组学研究广泛采用此类传统隐私保密模式,然而其在基因研究层面的普遍适用性不乏争议,且尚待考证。当前的隐私风险评估,亟需将整个"数据环境"纳入考虑,并不能仅孤立的局限于数据披露公开层面的质量管理。随着涉人研究数据资源的飙增,基因数据公开问题倍受关注,特别是涉及隐私保护的问题。本文围绕上述核心问题在数据环境、数据入侵者、数据主体隐私等方面展开论述,并就数据主体身份公开的控制、主体身份识别的风险及主体隐私的保护等层面进行相关性分析,以期为当前人体生物样本受试者的隐私保护及伦理审查实践提供参考。
In traditional biomedical research, a series of mechanism and measures had been taken for identity protection of data subjects, such as data disclosure in aggregated methods, information restricted in public only after identified variables removal and etc. The purpose of such process was aimed to properly keep confidentiality of health information for the target subjects in research. As the protection of subject privacy was viewed as one of the most essential principle of medical ethics in human research, the effects to fulfill and accomplish such process can help to maintain the trust and support among participants and social public. Currently, such traditional modes of privacy safeguard are widely-applied in genetics and genomics study. However, the universal applicability also causes a number of controversies, and the effectiveness remains to be proven. Nowadays, the risk assessments of data subjects’ privacy call for taking the whole“data context” into consideration, not just self-restricted in isolation and confined to quality control of data disclosure. With the soaring increasing of data resources in research involved human subjects, the issues of releasing genetic data have caused more and more public attention, especially for the sensitive domains of privacy protection. Based on the core problem and principles, this article attempted to discuss the controversial bioethical issues such as data context, data-intruder concept, privacy of data subject, identity control of releasing data, potential risk of individual identification, privacy protection of data subject, and etc. We hope these considerations can provide references to the bioethical understanding of biobanks research and decision-making of ethic review.
出处
《世界科学技术-中医药现代化》
2015年第7期1567-1576,共10页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金项目(81473698):浸润性T淋巴细胞表达IRF-7对骨性关节炎微环境的调控作用与补肾活血中药干预的研究
负责人:刘军
2014年省级优博培育项目(广中医研〔2014〕55号):循证医学在Alzheimer病防治中的应用
负责人:曾令烽
广东省财政厅项目([2014]157号):中老年退行性膝骨关节炎中医药防治管理体系
负责人:刘军
教育部博士点基金项目(20124425110004):基于P38MAPK信号通路的间充质干细胞对骨关节炎免疫调剂机制及补肾活血中药干预研究
负责人:刘军
