某三甲肿瘤专科医院伦理委员会伦理审查能力影响因素分析

Factors Influencing Ability to Review Ethics by Ethics Committee in a Level A Tertiary Cancer Hospital

目的:通过对伦理委员会伦理审查效率和伦理审查质量两方面的评估,发现影响伦理审查效率和质量的主要因素,为提升伦理审查能力提出建议。方法:分析2016~2018年某三甲肿瘤专科医院医学伦理委员会审查的440项研究项目的相关环节耗时情况和不同审查方式、审查类别的项目的审查决定情况。结果:科研项目初始审查会议审查、快速审查批准耗时平均为22天、0天,跟踪审查会审、快审平均等待21天、2天;GCP项目初审平均等待16天,平均审批20天,跟踪审查会审、快审平均等待27天、2天,跟踪审查会审批准耗时平均0天。初始审查中,2016、2017、2018年审查决定为"同意"占20. 00%、36. 73%、47. 83%,此三年跟踪审查审查决定为"同意"的构成比为98. 16%。结论:建议通过提高伦理会议频率、加强伦理委员会与申办方和研究者的沟通、实行跟踪审查主审负责制、加大委员和研究者培训力度、完善伦理办公室信息化管理来提升伦理审查能力。

Objective: To find out the main influencing factors of ethics review efficiency and quality,and give some suggestions for improving the ability to review ethics. Methods: We analyzed the time consumed in reviewing 440 research projects by Ethics Committee( EC) of a level A tertiary cancer hospital from 2016 to 2018 and results of projects with different types. Results: The average time for the approval of full board review and expedited review for investigator initiated trials took 22 and 0 days,and it for the approval of full board review and expedited review in continuing review took 21 and 2 days,respectively. The average time for the initial review of clinical drug trials was 16 days,and that for approval was 20 days.The average time for full board review and expedited review in continuing review was 27 and 2 days,and that for approval of full board review in continuing review was 0 day. In the initial review,20. 00%,36. 73% and 47. 83% of reviews were approved in 2016,2017 and 2018,and 98. 16% of continuing reviews in these three years were approved. Conclusion: EC should increase the frequency of conferences,strengthen the communication with sponsors and researchers,implement the system of chief reviewer responsibility,increase training for researchers and EC members,and improve the informatization management of EC office to improve the ability to review ethics.