加强临床研究中伦理审查的若干思考

Some thoughts on strengthening ethical review in clinical research

伦理审查是保证临床研究用于医学之目的、保护受试者健康与尊严的关键举措。本文回顾了我国近年来伦理审查的探索与实践,指出当前伦理审查尚存在法规体系不健全、独立性和规范性欠缺、审查模式有待完善、审查能力不足及监督制约机制薄弱等突出问题与挑战,并着重从坚持法规体系引领、强化审查独立公正、多种模式协调互补、重点提升能力效率、强化监管促进发展等方面论述加强临床研究中伦理审查工作的措施和建议,以更好地保护受试者权益,促进临床研究健康发展。

Ethical review is a key measure to ensure that clinical research is used for medical purposes and to protect the health and dignity of subjects.This paper reviews the exploration and practice of ethical review in China in recent years,points out that there are some outstanding problems and challenges in the current ethical review,such as the unsound legal system,the lack of independence and standardization,the imperfect mode of review,the insufficient ability of review and the weak mechanism of supervision,and focuses on the measures and suggestions to strengthen ethical review in clinical research by the means of adhering to the guidance of the legal system,enhancing the independence and impartiality of review,coordination and complementarity of various review models,improving capacity and efficiency,and strengthening supervision,in order to better protect the rights and interests of subjects and promote the healthy development of clinical research.