北京小汤山医院临床研究科研项目伦理审查的现状分析及思考

Analysis and consideration on the current situation of ethical review of clinical research projects in Beijing Xiaotangshan Hospital

伦理审查是受试者保护体系建设的重要环节,随着临床研究中伦理问题的日益突出,伦理审查的地位与作用越来越受到社会各界的关注。本文通过对北京小汤山医院的临床研究科研项目伦理审查现状的分析,从伦理委员会建设、临床研究科研项目的伦理审查流程、研究者对临床研究科研项目伦理审查的了解程度等方面深度分析和思考,逐步提出了加强伦理委员会监管力度、加强伦理审查队伍建设、提升临床研究者的伦理意识、加强知情同意过程的监管等相关建议和对策。通过医学伦理学理论与实践的充分融合,不断完善伦理审查体系建设,最大限度地保障受试者的权益和安全,逐步推动临床研究科研项目伦理审查工作的规范化,提高审查效率和水平,促进医学伦理学的实施与发展。

Ethical review is an important link in the construction of subject protection system.With the increasingly prominent ethical problems in clinical research,the status and function of ethical review have attracted more and more attention from all walks of life.Based on the analysis of the current situation of ethical review of clinical research projects in Beijing Xiaotangshan Hospital,this paper analyzes and thinks deeply from the aspects of ethics committee construction,ethical review process of clinical research projects,and researchers understanding of ethical review of clinical research projects.Some suggestions and countermeasures were put forward to strengthen the supervision of ethics committee,strengthen the construction of ethical review team,enhance the ethical awareness of clinical researchers,and strengthen the supervision of informed consent process.Through the full integration of medical ethics theory and practice,the construction of ethical review system should be continuously improved,the rights and safety of subjects should be protected to the greatest extent,the standardization of ethical review of clinical research projects should be gradually promoted,the efficiency and level of review should be improved,and the implementation and development of medical ethics should be promoted.