人体试验伦理审查全流程、多方位监督模型——基于程序公平理论的研究

摘要

In recent years,unethical human subject researches take place frrequently,which strongly impact the procedural fairness perception of the public and subjects on human subject research review institutions.Among the reasons,one appears to be the ineffective implementation of existing ethical review institutions,but a more deep reason lies in the absence of a comprehensive supervising mechanism for the ethical review of human subject researches.To solve this problem,we propose a Whole-Process and Multi-Aspect Supervising Model.In this model the whole processes of human subject researches,which include project application,research proceeding and results using,are all subjected to various supervising of multiple subjects.Analysis indicates that the establishment of this model may contribute to reducing the probability of unethical human subject researches.We also provide a deep analysis of how this model influences the procedural fairness perception and behavior of the public.%近年来我国不道德人体试验频发,严重影响了受试者、公众对人体试验的程序公平感知.究其原因,看似是现有人体试验伦理审查制度没有得到有效执行,但更深层次的原因在于完善的监督机制的缺位.为解决这一问题,提出人体试验全流程、多方位监督模型.该模型认为,人体试验相关的整个过程包括:项目申请——试验进行——结果使用,都要受到多个监督主体多种形式的监督.分析指出这一监督机制的建立有助于降低不道德人体试验的发生几率,并进一步分析这一模型如何影响公众的程序公平感知和行为.