预授权制度在医疗机构的伦理审查和知情同意实施——基于涉及人的健康信息和生物样本研究

Ethical Review and Informed Consent Implementation of Pre-Authorization System in Medical Institutions:Based on Human Health Information and Biometric Studies

通过分析涉及人的健康信息和生物样本研究的授权合法性和研究资质以及伦理审查效力的法律风险,讨论其开发利用与维护人的尊严存在矛盾、价值与风险并存、医疗机构管理权与生物样本所有者授权的利益冲突、不同行为主体之间的法律责任与义务、目的正当性与程序合法性、公平与效率的平衡等伦理问题。然后,结合知情同意的内涵和方式,进一步探讨豁免个人知情同意与广泛告知、未来研究的潜在可能性预授权、融合研究授权到诊疗工作流程、生物样本信息被用于不同的研究等做法;同时,医疗机构应完善知情同意、伦理审查、隐私保密、伦理监督等制度体系支持,加强人员培训,以争取更佳发展机会。

Through the analysis the legal risks of authorization legitimacy,research qualification and effectiveness of ethical review of human health information and biological samples,this paper discussed the contradiction between the development,utilization and maintenance of human dignity,the coexistence of valuable and risk,the conflict of interests between the management power of medical institutions and authorization of biological sample owners,the legal responsibilities and obligations between different actors,purpose and procedure legitimacy,the balance between fairness and efficiency and other ethical issues.Then,combined with the connotation and methods of informed consent,this paper further explored the exemption from individual informed consent and extensive notification,the pre authorization of potential future research,fusion research authorization to the process of diagnosis and treatment,biological sample information is used in the study of different practices.Meanwhile,the medical institutions should improve the informed consent,ethical review,data privacy,ethical oversight and other system support,strengthen personnel training to gain a better development opportunity.