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评估科学不当行为中的机构责任:埃诺西蒙研究的案例研究 由 Joachim Boldt
1Institute of General Practice and Public Health, Claudiana-College of Health Professions, Bolzano, Italy.
Clinical trials (London, England)
|December 19, 2024
概括
博尔特和亨佩尔曼早期对恩西蒙 (一种固酶III抑制剂) 的研究显示了数据操纵的证据. 五份出版物需要撤回,以维护科学完整性,并突出系统监督问题.
科学领域:
- 心脏病学 心脏病学
- 医学伦理 医学伦理
- 研究诚信研究诚信
背景情况:
- 埃诺西蒙是一种固酶III抑制剂,于1989年在德国批准用于心力衰竭和外科手术期间的条件.
- 约阿希姆·博尔特 (Joachim Boldt) 和冈特·赫佩尔曼 (Gunter Hempelmann) 对系统的科学不当行为的调查导致了众多的撤回.
- 本综述重点介绍了博尔特和海佩尔曼在1988年至1991年间对埃诺西蒙的早期研究.
研究的目的:
- 分析博尔特和赫佩尔曼早期的埃诺西蒙研究,寻找科学不当行为的证据.
- 评估有关这些出版物的科学记录的完整性.
- 评估机构监督和指导,以应对发现的不当行为.
主要方法:
- 对PubMed上市的出版物和论文的分析关于伊诺西蒙来自吉森的Justus-Liebig-大学.
- 对研究设计,参与者人口统计,方法和结果进行复制和不一致的选.
- 检查与发现的不当行为相关的共同作者和撤回历史.
主要成果:
- 在分析的7篇随机对照试验文章中,有5篇显示患者人口统计,结果和心脏指数值重叠不一致,这表明数据重复和操纵.
- 分析显示,在撤回的研究中,存在不当行为和合著的证据,这表明导师的指导不足.
- 该大学对支持撤销的缓慢反应表明有系统的监督问题.
结论:
- 五个分析的出版物仍然活跃,但为了保持科学记录的完整性,需要撤回.
- 改善机构监督,全面的伦理培训和定期审计是必不可少的.
- 目前的出版道德委员会撤回指南对于大规模的科学不当行为是不够的.
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