临床研究信息公开的伦理原则分析

随着国内企业和研究者发起的临床研究越来越多,达到国际公认的临床研究信息公开伦理原则非常重要。临床研究信息公开包括研究开始前的注册登记以及研究结束后的结果发表及数据公开。文章基于对《赫尔辛基宣言》和《涉及人的生物医学研究国际伦理准则》的文献研究和比较分析,系统地梳理了临床研究信息公开相关伦理原则的发展沿革及最新要求,并对我国目前临床研究信息公开的现状进行分析,以期促进我国临床研究信息公开的发展完善,加强受试者保护并促进临床研究质量提升。

Analysis of Ethical Principles of Information Disclosure in Clinical Research

With more and more clinical researches initiated by domestic enterprises and investigators,it is very important to achieve internationally recognized ethical principles of clinical research on information disclosure.Information disclosure of clinical research includes registration before the start of the study and publication of results and data sharing after the end of the study.Based on the literature research and comparative analysis of the Declaration of Helsinki and International Guidelines for Biomedical Research Involving Human Subjects(CIOMS),this paper systematically reviews the evolution and the latest requirements of the ethical principles related to clinical research on information disclosure,and analyzes the current status of implementation of clinical research on information disclosure in China,with a view to promoting the development and improvement of clinical research on information disclosure in China,strengthening the protection of subjects and promoting the quality of clinical research.