北京市医学伦理审查互认现场督导检查评分标准的制订与初步应用

doi:10.3969/j.issn.1006-7795.2022.04.024

首都医科大学学报 ›› 2022, Vol. 43 ›› Issue (4): 664-668.doi: 10.3969/j.issn.1006-7795.2022.04.024

北京市医学伦理审查互认现场督导检查评分标准的制订与初步应用

岳小林¹, 李晓玲¹, 王美霞², 白桦³, 张卓然¹, 王香平^1*

1.首都医科大学宣武医院伦理委员会,北京 100053;
2.北京积水潭医院临床试验机构管理办公室,北京 100035;
3.中国医学科学院北京协和医院临床药理研究中心,北京 100730

收稿日期:2022-04-08 出版日期:2022-08-21 发布日期:2022-10-28
基金资助:
北京市医学伦理管理和审查质量提高项目,北京市医学伦理审查互认现状调研(京伦2021-2)。

Formulation and preliminary application of on-site supervision and inspection scoring standards for mutual recognition of medical ethics review in Beijing

Yue Xiaolin¹, Li Xiaoling¹, Wang Meixia ²,Bai Hua³, Zhang Zhuoran¹, Wang Xiangping^1*

1. Ethics Committee, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
2 Clinical Trial Institution Management Office, Beijing Jishuitan Hospital, Beijing 100035, China;
3 Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China

Received:2022-04-08 Online:2022-08-21 Published:2022-10-28
Contact: *E-mail:wangxp@xwhosp.org
Supported by:
This study was supported by Beijing Municipal Medical Ethics Management and Review Quality Improvement Project, Investigation on the Status Quo of Mutual Recognition of Medical Ethics Review in Beijing (Jinglun 2021-2).

摘要/Abstract

摘要： 目的为检验伦理审查互认的实施效果,北京市卫生健康委员会决定对联盟中25家具备主审资质的医疗机构进行现场督导检查,为此联盟制定了伦理审查互认现场督导检查的评分标准,以保证检查的客观性和一致性。方法评分标准主要参考《北京市医学伦理审查互认联盟工作规则》及25家医疗机构前期基本调研情况制订。结果评分标准由3个一级指标、10个二级指标和13个三级指标构成。3个一级指标分别为制度建设(30分)、互认情况(25分)和审查效率(45分)。结论评分标准为北京市医学伦理审查互认推进的重要工具,尽管个别指标在现阶段有使用上的局限性,但总体能较全面地考察伦理审查互认的实施情况及效果,且有一定可操作性。

关键词: 伦理审查互认, 多中心临床研究, 评分标准, 研究型病房

Abstract: Objective In order to test the implementation effect of the mutual recognition of ethics, the Beijing Municipal Health Commission decided to conduct on-site supervision and inspection of the 25 medical institutions in the alliance that have the qualifications for the main review. To this end, the alliance has formulated the scoring standards for the on-site supervision and inspection of mutual recognition of ethical review to ensure the objectivity and consistency of the inspection. Methods The scoring standard is mainly formulated with reference to the Working Rules of Beijing Medical Ethics Review Mutual Recognition Alliance and the preliminary basic research of 25 medical institutions. Results The scoring standard consists of 3 first-level indicators, 10 second-level indicators and 13 third-level indicators. The three first-level indicators are system construction (30 points), implementation of mutual recognition (25 points) and review efficiency (45 points). Conclusion The scoring standard is an important tool for promoting mutual recognition of medical ethics review in Beijing. Although individual indicators have limitations in their use at the current stage, in general, they can be used to comprehensively examine the implementation and effect of mutual recognition of ethical review, and have certain operability.

Key words: mutual recognition of ethical review, multi-center clinical research, scoring criteria, research ward

中图分类号:

R052

岳小林, 李晓玲, 王美霞, 白桦, 张卓然, 王香平. 北京市医学伦理审查互认现场督导检查评分标准的制订与初步应用[J]. 首都医科大学学报, 2022, 43(4): 664-668.

Yue Xiaolin, Li Xiaoling, Wang Meixia,Bai Hua, Zhang Zhuoran, Wang Xiangping. Formulation and preliminary application of on-site supervision and inspection scoring standards for mutual recognition of medical ethics review in Beijing[J]. Journal of Capital Medical University, 2022, 43(4): 664-668.

北京市医学伦理审查互认现场督导检查评分标准的制订与初步应用

Formulation and preliminary application of on-site supervision and inspection scoring standards for mutual recognition of medical ethics review in Beijing

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