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

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.

The result analysis of initial clinical research ethics review in a hospital / 中华医学科研管理杂志

Objective In this paper,we analyzed the initial review projects of clinical research during past five years in a hospital,which aims to summarize the experience and analysis existent problems,in order to provide a reference for the future hospital ethics review.Methods Summarizing and analyzing the meeting records during past five years,which were also in the field of the initial review projects of clinical research.Results Clinical trials of drug and divice,and clinical research projects exist in varying degrees of problems,which express in these two aspects:research design and ethical rational.Conclusions Ethics Committee should stengthen review the following two parts,the scientific of research project and the informed consent form.Improve their own system constantly,and ensure the efficient operation of the Ethics Committee.

Common Issues in the Initial Review of the Clinical Trial Ethics Committee / 中国医学伦理学

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.