中国医学伦理学2018，Vol.31Issue(6)：729-731,3.DOI:10.12026/j.issn.1001-8565.2018.06.11
规范伦理跟踪审查提高临床研究伦理监管力度
Standardization of Ethical Continuing Review for the Improvement of Ethical Supervision of Clinical Researches
摘要
Abstract
This paper introduced from the aspects of the importance of ethical continuing review, the type and characteristics of the review, the recommendations for strengthening the ethical continuing review, and continuing review as an important means of ethical supervision and so on. It is recommended that it should effectively improve the efficiency of six ethical continuing reviews including the revised plan, annual or regular tracking, serious adverse events, non-compliance/violation program, suspension/early termination and conclusion through the construction of an ethical informationization platform, the reinforcement of researcher training and education,the communication with researchers and their teams, and carry out efficient ethical supervision of various stages of research projects during and after their completion. Only doing continuing review can put the subject protection into practice.关键词
医学伦理/跟踪审查/伦理监管/临床研究Key words
Medical Ethics/Continuing Review/Ethical Supervision/Clinical Research分类
医药卫生引用本文复制引用
王晶..规范伦理跟踪审查提高临床研究伦理监管力度[J].中国医学伦理学,2018,31(6):729-731,3.基金项目
2016年度首都医科大学附属北京中医医院级课题暨两院合作课题项目:中医药临床研究伦理审查平台建设及审查质量提升(课题编号:YJ-201710) （课题编号:YJ-201710）
