Journal of Capital Medical University ›› 2022, Vol. 43 ›› Issue (4): 664-668.doi: 10.3969/j.issn.1006-7795.2022.04.024

• Review • Previous Articles     Next Articles

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 Xiangping1*   

  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).

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

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