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未报告的协议偏差 - - 这是研究山峰的顶端
Uma Kulkarni1, Ravi Vaswani2, Mohammed Guthigar3
1Professor, Ophthalmology, Yenepoya Medical College, Additional Faculty Centre for Ethics, Mangalore, Karnataka, India.
Perspectives in clinical research
|June 16, 2023
概括
内部审计发现研究生研究中的协议偏差,突出了对参与者和机构信誉的风险. 解决这些偏差对于伦理研究行为和对伦理委员会保持信任至关重要.
科学领域:
- 医学伦理 医学伦理
- 临床研究治理治理 临床研究治理
背景情况:
- 协议偏差和违规 (PD/PVs) 发生在批准后,并且可以错过.
- 伦理委员会 (EC) 负责检测和减轻与PD/PVs相关的风险.
研究的目的:
- 评估PD/PVs在研究生论文中的发生情况.
- 评估PD/PVs对研究完整性和参与者安全的影响.
主要方法:
- 叶内波亚伦理委员会-1进行了内部审计.
- 54名研究生接受了自我报告的检查清单,随后对协议文件进行了物理验证.
主要成果:
- 在80篇研究生论文中,在54篇论文中观察到协议偏差.
- 偏差包括不符合EC有效性,方法,知情同意和数据存储.
- 没有发现违反协议 (严重违反) 的情况.
结论:
- 协议偏差对科学有效性和参与者伤害构成风险.
- 解决PD/PV问题对于欧洲共同体的有效运作和机构信誉至关重要.
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