知情同意文件的可读性及其对拒绝同意率的影响
Yash V Kamath1, Yashashri C Shetty1, Ishita C Lanjewar1
1Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Perspectives in clinical research
|January 27, 2025
概括
研究中的知情同意文件 (ICD) 在六年内在质量和可读性方面得到了改进. 药物研究表明,对指导方针的遵守更好,尽管仍然需要更简单的语言.
科学领域:
- 医学研究伦理学医学研究伦理学
- 临床试验文档临床试验文档
背景情况:
- 知情同意文件 (ICD) 对于参与者在研究中的理解至关重要.
- 评估ICD的质量和可读性对于伦理研究实践至关重要.
研究的目的:
- 在六年内分析知情同意文件 (ICD) 的质量和可读性.
- 评估遵守印度医学研究理事会 (ICMR) 准则,并将文档质量与拒绝同意率相关联.
主要方法:
- 来自机构伦理委员会提交的300个ICD的回顾性横截面分析.
- 使用了基于ICMR指南的Flesch-Kincaid阅读易度得分 (FRES),估计的阅读时间 (ERT) 和ICD质量得分 (IQS).
- 与同意拒绝率 (CRR) 相关联的文档参数.
主要成果:
- 平均IQS在六年内从11.95显著改善到12.60 (P < 0.001).
- 平均FRES为48.3分钟,平均ERT为4.5分钟.
- 较低的FRES和较长的参与持续时间显示出与CRR的弱负和正相关性,分别.
结论:
- ICD已经证明了可读性和符合ICMR指南的改进.
- 药物研究通常在ICD质量方面表现更好.
- 需要继续努力,以提高参与者对研究同意流程的理解.
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