伦理视野下人体受试者权益保护体系的建设与完善--以安徽省某医院为例  

The Construction and Improvement of the Protection System for the Rights and Interests of Human Subjects in Trial Institutions from the Ethical Perspective:Taking a Hospital in Anhui Province as an Example

作　　者：张静 辛昌茂[3] ZHANG Jing;XIN Changmao(School of Public Health, Anhui Medical University,Hefei 230601, China;Department of Scientific Research, the Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China;Department of Health Service Management, Anhui Medical University,Hefei 230601, China)

机构地区：[1]安徽医科大学公共卫生学院,安徽合肥230601 [2]安徽医科大学第二附属医院科研部,安徽合肥230601 [3]安徽医科大学卫生管理学院,安徽合肥230601

出　　处：《中国医学伦理学》2022年第5期522-527,共6页Chinese Medical Ethics

摘　　要：针对当前国内人体受试者权益保护存在的问题,以安徽省某医院为例,提出了伦理视野下人体受试者权益保护的相关建议,包括:塑造国际化愿景,切实发挥伦理委员会的核心作用,加强法律法规保障机制建设,成立人体研究保护委员会以及积极推进受试者保护体系建设等。这些举措将有助于中国人体受试者权益保护体系的建设与完善。This paper took a hospital in Anhui province as an example,aimed at the problems existing in the protection of human subjects'rights and interests in China,and put forward relevant suggestions from the ethical perspective.The suggestions included shaping the international vision,playing the core role of ethics committee,strengthening the construction of legal and regulatory protection mechanism,setting up the human research protection committee and actively promoting the construction of subject protection system.These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.

关 键 词：伦理审查体系监管 临床研究受试者 权益保护 人体研究保护委员会 

分 类 号：R192[医药卫生—卫生事业管理]