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

A Whole Process and Multi-Aspects Oversight Model of Human Research Ethical Review: A Study Based on Procedural Fairness Theory

摘要:

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,论文提出了人体试验全流程、多方位监督模型。该模型提出与人体试验相关的整个过程：项目申请－试验进行－结果使用,人体试验的组织、审查、进行,都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。更进一步地基于程序公平理论分析了这一模型如何影响公众程序公平感知和行为。

Abstract:

In recent years, unethical human research take place frequently, which strongly impact the procedural fairness perception on human research review institutions of subjects and public. One reason is the ineffective implementation of existing human research, review regulations, but a more deep reason lies in the absence of a complete oversight mechanism. To solve this problem, we propose a Whole Process and Multi-Aspects Oversight Model. In this model the whole processes of human research, which include project application, research proceed and results use, are all subject to oversight of multiple oversight subject. Our analysis shows that the establishment of this model may contribute to reducing the probability of unethical human research. Also,based on procedural fairness theory we provide a deep analysis of how the oversight model influences the procedural fairness perception and behavior of public.