The current situation and problems of participant rights protection in clinical trials for drugs were analyzed based on the discussion of administrative licensing for clinical trial, construction of ethics committee and responsibilities of researchers. The problems existed in clinical trials including: unserviceable institutions are still carrying out the clinical trials, there are some problems in the independence and ability construction of ethics committee, informed consent cannot be executed and some researchers'behavior are not proper in the process. To solve these problems, some suggestions were put forward: perfecting adverse reaction treatment mechanism ami subject compensation mechanism, strengthening the ability construction of the ethics committee, strengthening the ethics training of GCP, regulating the qualification and review management of the clinical trial institutions, establishing and perfecting the administrative supervision mechanism.%从我国临床试验行政许可、伦理委员会建设和研究者应承担的责任等角度出发,分析临床试验中受试者保护措施现状及在受试者权益保护方面存在的主要问题:不胜任的机构仍在开展临床试验,伦理审查委员会的独立性和能力建设存在问题,知情同意流于形式或在知情同意过程中研究者行为失范 针对这些问题提出了一些建议和改善措施:完善不良反应处理机制和受试者补偿机制,加强伦理审查委员会的能力建设,加强GCP的伦理培训,规范临床试验机构资格认定与复核管理,建立健全行政监督机制.
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