临床试验伦理委员会初始审查中的主要问题

Common Issues in the Initial Review of the Clinical Trial Ethics Committee

目的了解伦理审查的质量关系到受试者的权益是否得到有效保护。方法通过《药物临床试验伦理审查工作指导原则》出台后两年该伦理委员会的审查工作的分析,总结了目前伦理委员会审查中的方案和知情同意书的常见问题。结果该伦理委员会通过召开伦理例会的形式审查了94个新立项的药物/器械临床试验项目,其中29个项目的初始审查结论为同意,会议审查一次性通过率仅有31%。其中,方案中出现最频繁的问题包括:试验背景和立题依据、试验设计、试验风险与受益三方面;知情同意书的主要问题集中于知情同意书的内容、语言和签署页的设计。结论受试者的保护仍需研究者、申办者、药物临床试验机构及伦理委员会能力的共同提高。

Objective：To analyze that if the quality of ethics review is closely related to the protection of human subjects＇ right and interest. Methods：This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since ＂guideline of ethical review of drug clinical trials＂ was published, summed up the most common problems occurred in protocols and informed consents. Results：Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include： the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions：The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.