违背方案伦理审查的分析与建议

Analysis and Countermeasures for Ethical Review of Noncompliance with the Protocol in Clinical Trials

通过分析临床研究中递交伦理委员会的违背方案报告,特别是2例严重持续性违背方案的报告,对方案违背所涉及的各方(申办者、研究者与临床试验机构)在沟通与管理方面存在的问题进行了深层次探讨,针对各方存在的问题,提出申办者、研究者与临床试验机构应加强对研究项目的管理,注重沟通协作与对研究过程的监管。建议临床研究中申办者与研究者应避免对监察员的过度依赖,重视针对研究项目与研究者的定期沟通,同时重视对监察员和研究团队的培训,避免严重持续违背方案的发生。

By analyzing the noncompliance with the protocol of clinical research reported to the ethics committee, especially two cases of severe persistent noncompliance with the protocol, this paper carried out the root cause analysis against the problems of research relevant parties, including sponsors, researchers and research institutions in communication and management of persistent noncompliance with the protocol.Based on identifying the existing problems, the authors pointed out that sponsors, investigators and the research institutions should enforce the management of the research procedures and strengthen the oversight of the process of the researches.The sponsors and researchers should take their responsibilities rather than over depending on the monitors.Furthermore, more education should be provided to monitors and research teams in order to avoid the happening of severe persistent noncompliance with the protocol.