帮助临床研究的伦理审查的资源:探索性范围审查,确定差距和机会
Merle-Marie Pittelkow1, Daniel Strech2
1QUEST Center for Responsible Research, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Anna-Louisa-Karsch Straße 2, Berlin, 10178, Germany. merle-marie.pittelkow@bih-charite.de.
Trials
|March 3, 2025
概括
临床研究伦理学可获得资源,但对研究设计和分析的支持需要改进. 需要对研究人员和研究伦理委员会 (RECs) 提供更全面的指导方针,以确保在方法上健全的研究.
科学领域:
- 临床研究伦理学
- 研究方法研究方法研究方法学
- 监管合规性 监管合规性
背景情况:
- 研究伦理委员会 (REC) 对于审查临床研究中的伦理,法律和方法标准至关重要.
- 导航研究人员和REC成员的复杂要求提出了重大挑战.
- 人们认识到,需要有可访问的资源来指导研究中的伦理和法律合规性.
研究的目的:
- 识别和绘制用于伦理临床研究的可用资源.
- 评估这些资源在关键的伦理和方法检查点上的覆盖范围.
- 确定研究人员和REC成员缺乏支持的领域.
主要方法:
- 探索性搜索来自12个国家和3个国际组织的网站,以及16个国家REC.
- 233个提取的资源 (模板,指南,检查清单等) 的定性映射. 针对35个伦理研究检查点.
- 用专题分析来描述所识别的资源的内容和适用性.
主要成果:
- 总共有233个资源被确定,主要是模板 (58.5%) 和指南 (26.6%).
- 大多数资源 (87.6%) 属于特定的检查站,其中101个是德语的,132个是英语的.
- 资源分布不均,对参与者信息和知情同意的支持充足,但对研究设计和分析的支持较少.
结论:
- 对于伦理研究的某些方面,特别是知情同意,存在很大的支持.
- 在研究设计,数据分析和生物识别等领域,急需加强资源.
- 建议对现有资源进行进一步的质量分析,以确定和解决剩余的支持缺口.
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