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分析知情同意文件,以符合ICMR生物医学和健康研究指南
Chaitali Ashish Chindhalore1, Ganesh N Dakhale1, Snehalata V Gajbhiye1
1Department of Pharmacology, All India Institute of Medical Sciences, Nagpur, Maharashtra, India.
学术研究的知情同意文件 (ICD) 正在改善,符合印度医学研究委员会 (ICMR) 的指导方针. 然而,在内容和可读性方面需要进一步的改进,以便参与者能够真正知情地做出决策.
科学领域:
- 医学伦理 医学伦理
- 研究合规性 研究合规性
- 在知情同意的情况下同意.
背景情况:
- 伦理研究依赖于自愿参与的知情同意文件 (ICD).
- 在ICD中充分披露研究信息对于道德行为至关重要.
研究的目的:
- 评估学术研究ICD是否符合印度医学研究理事会 (ICMR) 的指南.
- 通过使用Flesch-Kincaid等级水平和Flesch阅读易度 (FRE) 评分来评估ICD的可读性.
主要方法:
- 分析了2020-2022年期间提交的177个学术研究方案.
- 评估ICCD是否符合ICMR 2017年指导方针.
- 使用Flesch-Kincaid等级水平和FRE分数进行可读性评估.
主要成果:
- 流行病学和诊断研究最常见.
- 到2022年,ICD的国语翻译量显著增加.
- 2022年的参与者信息表 (PIS) 显示了关键信息 (持续时间,风险,收益,付款,联系方式) 的披露有所改善.
- 从2020年到2022年,总体合规性得分有所改善.
结论:
- 在ICMR指导方针的遵守方面,ICD显示了逐渐的改善.
- 对ICD内容和可读性进行改进是必要的,以便参与者能够做出真正知情的决定.
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