Investigation and analysis on the efficiency of ethical review and the feasibility of implementing mutual recognition of ethical review in tertiary hospitals in Tianjin / 中华医学科研管理杂志

ABSTRACT

Objective:This study aims to explore the feasibility of ethical review and mutual recognition, focusing on the operational efficiency and review processes of the Ethics Committees in Tianjin′s third-level hospitals.Methods:A thorough online survey was conducted across tertiary hospitals in Tianjin, utilizing a detailed questionnaire. The survey primarily examined the operations and reviews of Ethics Committees from 2019 to 2022, evaluating the efficiency of ethical reviews, the effectiveness of clinical research administration, and the hospitals′ perspectives on mutual recognition of ethical reviews. From 29 collected responses, 28 were deemed suitable for in-depth statistical analysis.Results:In Tianjin′s 28 surveyed tertiary hospitals, 16 routinely hold ethics review meetings monthly. Nine hospitals have established pre-ethics review processes, and three have achieved mutual recognition of their ethical review outcomes. Additionally, five hospitals have integrated electronic information systems. From 2019 to 2021, there has been an increase in clinical trials and Investigator-Initiated Trials (IITs) under initial review, with a significant presence of multi-center clinical trials (90%) and multi-center IIT studies (75%). The timeframe for clinical research review opinions ranged from 18.84 to 20.69 days between 2019 and September 2022, while the duration for clinical research review approvals varied from 22.03 to 23.68 days. During the same period, clinical trial management efficiency spanned from 48.42 to 62.65 days, and IIT study management efficiency was between 25.54 to 28.17 days. Participants identified the main factors influencing management efficiency as stemming from research institutions and sponsors.The majority of hospitals expressed support for the advancement of mutual recognition of ethical reviews and the implementation of a unified submission checklist and template.Conclusions:The Ethics Committees in Tianjin′s third-level hospitals have progressively evolved towards standardization. There is a marked improvement in the efficiency of ethical reviews and overall management of clinical research, indicating a positive development towards more streamlined and effective ethical governance in clinical studies.