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临床研究者伦理知信行现状及其影响因素分析 被引量:3

Analysis on the Current Situation and Influencing Factors of Ethical KAP among Clinical Researchers
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摘要 目的 了解临床研究者伦理知信行现状及影响因素,为增强其伦理意识、提升临床研究质量提供参考。方法 采用自行设计问卷,通过便利抽样调查参与过临床研究的医务人员。结果 最终调查6 021例,男性占28.46%,女性占71.53%;平均年龄(37.47±11.46)岁,伦理总分及知信行各维度均分分别(70.62±12.99)分、(59.63±12.50)分、(79.55±19.62)分、(74.92±18.29)分。多元线性回归分析显示:男性、三级医院、医生、有伦理相关兼职、研究生学历、副高以上职称以及有培训经历的研究者得分较好(P<0.05)。结论 伦理态度在知识和行为之间中介效应显著,占总效应的62.72%。研究者对于伦理重要性比较认可,但对知识学习和实践运用亟须加强。 Objective:To understand the current situation and influencing factors of ethical knowledge,attitude,and practice(KAP) among clinical researchers,enhance their ethical awareness,and improve the quality of clinical researches.Methods:A self-designed questionnaire was used to conduct a convenient sampling survey of medical staff who have participated in clinical study.Results:A total of 6,021 subjects were investigated,with males accounting for 28.46% and females accounting for 71.53%.The average age of them was(37.47±11.46) years old.The total score of ethics and the mean scores of the three dimensions of knowledge,attitude and practice were(70.62±12.99),(59.63±12.50),(79.55±19.62) and(74.92±18.29),respectively.Multiple linear regression analysis showed that researchers with male,tertiary hospitals,doctors,ethics-related part-time jobs,postgraduate education,associate senior title or above,and training experience scored higher(P<0.05).Conclusion:Ethical attitudes have a significant mediating effect between knowledge and practice,accounting for 62.72% of the total effect.Researchers recognize the importance of ethics,but it is urgent to strengthen their knowledge learning and practical application.
作者 郑磊 陈宇欣 康佳玮 胡梦薇 吴建元 汪春红 黄建英 李博然 张元珍 ZHENG Lei;CHEN Yuxin;KANG Jiawei;HU Mengwei;WU Jianyuan;WANG Chunhong;HUANG Jianying;LI Boran;ZHANG Yuanzhen(Clinical Trial Center,Zhongnan Hospital of Wuhan University,Wuhan 430000,China;Medical Ethics Committee,Zhongnan Hospital of Wuhan University,Wuhan 430000,China;School of Public Health,Wuhan University,Wuhan 430000,China;Center for Evaluation,Hubei Medical Products Administration,Wuhan 430000,China)
出处 《中国医学伦理学》 2023年第12期1408-1416,共9页 Chinese Medical Ethics
基金 湖北省软科学研究计划“湖北省科技伦理治理体系建设研究”(2023EDA030)。
关键词 临床研究者 知信行 伦理意识 伦理态度 Clinical Researchers Knowledge,Attitude,and Practice Ethical Consciousness Ethical Attitude
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  • 1桑国卫,邵庆翔.多中心临床试验的设计与数据管理[J].中国临床药理学杂志,1993,9(1):47-52. 被引量:6
  • 2.药物临床试验质量管理规范[S].[S].国家食品药品监督管理局,2003..
  • 3高慧君.重视受试者安全保护,有效推进创新[R].中国药物创新论坛,2011.
  • 4Recommendations guiding physicians in biomedical re- search involving human subjects. World Medical Asso- ciation Declaration of Helsinki [ J ]. J Med Liban, 1994,42:88-89.
  • 5Uniform requirements for manuscripts submitted to bio- medical journals. International Committee of Medical Journal Editors [ J ]. BMJ, 1991,302 (6772) : 338- 341.
  • 6Yank V, Rennie D. Reportingof informed consent and ethics committee approval in clinical trials [ J ]. JA- MA, 2002,287 (21) :2835-2838.
  • 7Garattini S, Bertele V. Ethics in clinical research[ J]. J Hepatol, 2009,51 (4) :792-797.
  • 8Williams C J, Zwitter M. Informed consent in European multicentre randomised clinical trials - Are patients re- ally informed[ J] ? Eur J Cancer, 1994,30 ( 7 ) : 907- 910.
  • 9Paasche-Orlow MK, Taylor HA, Brancati FL. Reada- bility standards for informed-consent forms as com- pared with actual readability [ J ]. N Engl J Med, 2003,348 (8) :721-726.
  • 10Frye RL, Simari RD, Gersh B J, et al. Ethical issues in cardiovascular research involving humans [ J ]. Cir-culation, 2009,120 (21) : 2113-2121.

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