摘要
医学伦理审查建设是加强医学科技伦理治理的基础性保障,伦理审查结果互认是加速伦理审查建设的重要方式。基于京津冀三地卫生健康委联合发布的《关于实施京津冀医学伦理审查结果互认工作的通知》在天津市三级医疗卫生机构的推进的探索,对天津市30家有临床试验资质的三级医疗卫生机构进行问卷调研。通过各单位2021—2023年临床试验情况、伦理委员会情况和伦理互认现状的调查分析,得到影响京津冀伦理审查结果互认工作推动的规律性原因,并提出合理化建议。为深化京津冀一体化发展,加速推动区域伦理互认工作提供天津地区的参考依据,推进医学伦理审查建设发展。
The construction of medical ethical review is the basic guarantee for strengthening the ethical governance of medical science and technology,and mutual recognition of ethical review results serves as a pivotal approach to accelerate the construction of ethical review.This paper conducted a questionnaire survey on 30 tertiary medical and health institutions with clinical trial qualifications in Tianjin,based on the exploration of the implementation of the Notice on the Implementation of Mutual Recognition of Medical Ethics Review Results in the Beijing-Tianjin-Hebei Region jointly issued by the Health Committees of the three regions in Tianjin’s tertiary medical and health institutions.By investigating and analyzing the situation of clinical trials,ethics committees,and mutual recognition from 2021 to 2023,the regular reasons affecting the promotion of mutual recognition of ethical review results in the Beijing-Tianjin-Hebei region were identified,and reasonable recommendations were proposed.These aimed to offer references for the Tianjin region in deepening the integration of Beijing-Tianjin-Hebei development and accelerating the promotion of regional ethical mutual recognition work,thereby advancing the construction and development of medical ethical review.
作者
宋磊
张文潇
李彬
薛琛
崔桅
SONG Lei;ZHANG Wenxiao;LI Bin;XUE Chen;CUI Wei(Medical Ethics Committee,Tianjin People’s Hospital/the First Affiliated Hospital of Nankai University,Tianjin 300121,China;Office of Drug Clinical Trial Institution,Tianjin People’s Hospital/the First Affiliated Hospital of Nankai University,Tianjin 300121,China;Office of the Dean,Tianjin People’s Hospital/the First Affiliated Hospital of Nankai University,Tianjin 300121,China;Professional Committee for Clinical Trial Ethics Review,Tianjin Pharmaceutical Association,Tianjin 300040,China)
出处
《中国医学伦理学》
北大核心
2025年第8期989-995,共7页
Chinese Medical Ethics
关键词
多中心临床试验
伦理委员会
伦理审查结果互认
审查质量和效率
multicenter clinical trial
ethical committee
mutual recognition of ethical review result
review quality and efficiency
