我国临床科研项目伦理审查存在的问题及建议

Discussion on the Problems and Suggestions in Ethical Review of Clinical Scientific Research Projects in China

目的规范医学伦理委员会能力建设,以提高临床科研项目伦理审查质量,更好地保护受试者权益。方法查阅国内外有关临床科研项目伦理审查规范化建设的文献并进行综合分析。结果结合伦理审查实践中所面临的关于监管制度、审查标准、教育培训、伦理意识和跟踪审查等方面的诸多难题,提出未来医院临床科研项目的伦理发展趋势和解决策略方面的思考和建议。结论规范临床科研项目伦理审查体制建设,加强教育培训,提高我国医学伦理委员会的建设能力,提升临床科研项目伦理审查的科学性和规范化。

Objective： To standardize the capacity construction of medical ethics committee,improve the quality of ethical review of clinical scientific research projects,and better protect the rights and interests of subjects.Methods： This paper reviewed the literature about standardization construction of ethical review of clinical scientific research projects and analyzed them comprehensively. Results： Based on the problems of regulatory system,review standards,education training,ethic awareness and tracking review facing in the practice of ethical review,this paper put forward some reflections and suggestions for the ethical development trend and solving strategies of clinical scientific research projects in future. Conclusion： It should standardize the construction of ethical review system of clinical scientific research projects,strengthen education and training,promote the construction capacity of medical ethics committee of our country,and promote the scientificity and standardization of the ethical review of clinical scientific research projects.