戴明环循环法在医学伦理跟踪审查工作中的应用

Utility of PDCA Tool in Medical Ethical Follow-Up Review

伦理跟踪审查工作是保护人体受试者权益的核心环节。本研究运用戴明环(又称PDCA)循环法,根据现状,分析原因,制定和实施干预措施,进行效果检查和事后处理分析。使伦理跟踪审查工作的规范化取得了良好的效果:增强了伦理跟踪审查制度实用性和可操作性,提高了伦理委员会委员跟踪审查能力、研究人员对伦理跟踪审查的认知和重视程度、跟踪审查报告规范化。各项跟踪审查报告填写的规范率、资料的完整率、持续审查按时递交率都较前有显著提升(P<0.001),不断完善了伦理项目数据库信息。伦理委员被动审查与主动审查相结合,完善了伦理委员和研究者的考评体系。

Ethical follow-up review is essential for the protection of human subjects. Based on the status quo,PDCA cycle of analyzing the causes,developing and implementing interventions,checking results and post-treatment analysis was conducted. Thus,ethical follow-up review work has achieved good results in the process of standardization： the practicality and operability of the ethics follow-up review system has been enhanced,the ethics committee members have improved their ability of follow-up examination while researchers have improved cognizance and emphasis on ethical follow-up,the overall quality of ethical follow-up has been improved. The standard rate of filing various follow-up reports,the completeness of submitting data and the on-going filing rate of continuous review have been promated significantly（ P〈0.001）. The ethical project database has been continuously improved. The passive review and active review by ethics committee members has been combined as well as the evaluation system of ethics committee and researchers has been improved.