建立规范的临床试验伦理审查机制的思考

The Thought about Establishment of Standardized Ethical Review Mechanism for Clinical Trials

建立规范的临床试验伦理审查机制是搞好临床试验的伦理审查、保障各种临床试验安全顺利的客观要求。依据多年从事临床试验伦理审查的实践,提出从六个方面着手,即建立科学合理的伦理委员会;设立专门的伦理办公室;建立科学合理的伦理审查规范;把握伦理审查的重点;重视跟踪审查;严格遵守伦理审查的原则,进而建立规范的临床试验伦理审查机制。

The establishment of standardized ethical review mechanism for clinical trials is an objective requirement for improving the ethical review of clinical trials and ensuring the safety and smoothness of various clinical trials. According to the practice of years engaged in the ethical review of clinical trials,this paper proposed to start from six aspects,that is,to establish a scientific and reasonable ethics committee; establish a special ethics office; establish a scientific and reasonable ethical review standard; grasp the emphasis of the ethical review; attach importance to the continuing review; strictly observe the principles of ethical review,and then establish a standardized ethical review mechanism for clinical trials.