摘要
目的了解我国医学科研人员的伦理不当行为及其影响因素,为规范临床研究中的伦理不当行为提供参考。方法2021年9—11月,采用分层随机抽样方法,抽取中国临床试验注册平台的医学科研人员作为访谈对象,就临床试验中的伦理不当行为及影响因素进行半结构化访谈,运用NVivo11软件对访谈资料进行分析。结果最终纳入28位访谈对象,其中16人(57.14%)认为医学科研人员是被动接受科研伦理。医学科研人员伦理不当行为的影响因素被归纳为7个二级节点和43个三级节点,包含248个参考点。影响伦理不当行为的环境因素包括伦理监管不佳、科研压力大、受试者与研究者信息不对称以及伦理氛围不足4个二级节点,分别包含了54个、40个、38个和29个参考点;科研人员自身因素包括伦理知识欠缺、伦理意识淡薄、科研人员个体特征3个二级节点,分别包含了48个、21个和18个参考点。结论我国医学科研人员对临床研究伦理的态度和行为整体上处于被动接受到积极遵守的过渡阶段,伦理不当行为的影响因素较多。为进一步规范医学科研人员伦理行为,笔者建议相关部门应改进伦理审查和监管,建立系统化伦理培训,改善科研环境,积极开展临床试验科普。
Objective To understand the ethical misconduct of Chinese medical researchers and its influencing factors,so as to provide a reference for regulating such misconduct in clinical research.Methods From September to November 2021,a stratified random sampling method was adopted to select medical researchers from the China Clinical Trial Registration Platform as interview objects,and semi-structured interviews were made on ethical misconduct and its influencing factors in clinical trials.The interview data were analyzed using NVivo11 software.Results A total of 28 interviewees were included,57%(n=16)of whom holding that medical researchers accept research ethics passively in most cases.The influencing factors of ethical misconduct of medical researchers are summarized into 7 secondary nodes and 43 tertiary nodes,including 248 reference points.The environmental factors included poor ethical supervision,great research pressure information asymmetry between subjects and researchers,and insufficient ethical atmosphere,including 54,40,38,and 29 reference points respectively.The self-factors included lack of ethical knowledge,weak ethical awareness,and individual characteristics of researchers,including 48,21 and 18 reference points respectively.Conclusions The attitude and behavior of clinical research ethics of Chinese medical researchers are generally in the transitional stage from passive acceptance to positive compliance,and there are many factors influencing ethical misconduct.In order to further standardize the ethical behavior of medical researchers,the authors suggest relevant authorities to improve ethical review and supervision,establish systematic ethical training,improve the scientific research environment,and actively carry out clinical trials and science popularization.
作者
石书文
刘婵娟
Shi Shuwen;Liu Chanjuan(Health and Bioethics Research Center,Wenzhou Medical University,Wenzhou 325000,China)
出处
《中华医院管理杂志》
CSCD
北大核心
2022年第5期377-382,共6页
Chinese Journal of Hospital Administration
基金
国家社会科学基金重点项目(19AZX014)。
关键词
临床试验
医学科研人员
临床研究伦理
定性研究
Clinical trial
Medical researchers
Ethics of clinical research
Qualitative research
