Application of PDCA cycle method in the initial ethical review of clinical research / 中华医学科研管理杂志

ABSTRACT

Objective:To explore the application and feasibility of PDCA cycle mode during the initial review of medical ethics committee in the hospital, to further promote the sustainable capacity building of ethics committee.Methods:To improve the quality of initial review management in the hospital ethics committee, PDCA method was used in this study from four aspects that including planning, implementation, inspection and action.Results:Measures adopted including clarifying the scope of ethical review, strengthening the practicability and operability of the review system, standardizing the ethical review procedures, strengthening the substantive review, reinforcing the cooperation among departments, and strengthening the training of medical ethics. Along with the implementation of these measures, ethics committee members were empowered their capacity of conducting initial review, at the same time, investigators also had better understandings and be more serious of the initial review. Furthermore, a PDCA improvement plan was proposed, which including the establishment of independent consultant expert database, the initiative of ethical review data management system, adopting clinical decision analysis methods in ethical review, as well as the improvement of post-approval management and operating procedures.Conclusions:The ethical review management work is continuingly improved under the guidance of PDCA cycle theory. The method of PDCA cycle theory is an ideal model for the long-term development of ethical management.