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目的 本文目的从医学科研管理角度 ,探讨医学科研实验中使用人体作为被试的法制化、规范化管理问题。方法 依据多年科研管理工作的经验 ,对当前医学科研中人体实验管理现状和存在问题进行分析 ,提出作者的改进建议。结论 当前医学人体实验管理存在的主要问题是 :缺乏健全的法制法规 ,管理水平明显滞后。人体实验管理缺少透明度 ,责、权、利关系模糊。管理运行机制不健全 ,缺少严肃性、严密性、合法性。因此 ,对完善人体实验管理运行机制提出如下建议 :一是人体实验管理要纳入法制化轨道 ;二是建立健全完备的管理运行机制 ;三是要充分重视和尊重被试者的权力 ,做好安全保障工作 ;四是做好特殊环境下人体实验的被试者选拔、训练和保障工作。
Objective The purpose of this paper is to explore the legalization and standardization of human subjects as subjects in medical research experiments from the perspective of medical research management. Methods Based on the experience of many years of scientific research management, this paper analyzed the current status and existing problems of human experimental management in medical research, and proposed the author’s suggestions for improvement. Conclusion The main problems existing in the current experimental management of medical human body are: the lack of sound laws and regulations, the obvious lag in management level. Lack of transparency of human experimental management, responsibility, rights, interests and ambiguous relationship. Management mechanism is not perfect, the lack of seriousness, rigor and legitimacy. Therefore, to improve human experimental management mechanism proposed the following recommendations: First, the human laboratory management should be incorporated into the track of legalization; second is to establish and improve the management mechanism; third is to give full attention and respect the subjects of the power to make safety Fourth, to do a good job of human subjects under special circumstances, the selection, training and security work.