对捷克学术环境中研究伦理委员会现行实践的调查:一种混合方法的研究研究
Renata Veselska1,2, Jan Sirucek3, Josef Kure4
1Department of Experimental Biology, Faculty of Science, Masaryk University, Brno, Czechia, Czechia. veselska@mail.muni.cz.
BMC medical ethics
|December 22, 2024
概括
捷克的研究伦理委员会因缺乏国家立法而面临挑战. 实施立法框架和提供支持对于负责任的研究伦理治理至关重要.
科学领域:
- 医学伦理 医学伦理
- 研究治理研究治理
- 公共卫生政策 公共卫生政策
背景情况:
- 对检查捷克学术研究的研究伦理委员会 (RECs) 的实践进行了全面调查.
- 本研究解决了关于REC运作的数据缺口,并确定了对负责任的研究伦理治理的挑战.
- 关于实施生物医学研究附加议定书的CETS No. 195也被调查了. 195也被调查了.
研究的目的:
- 提供对捷克当前REC实践的公正评估.
- 确定阻碍RECs有效运作的特定困难和短缺.
- 评估将国际生物医学研究标准纳入国家实践的整合.
主要方法:
- 采用混合方法的方法,使用带有闭式和开放式问题的在线问卷.
- 匿名问卷是用捷克语编写的,涵盖了REC运营的18个方面,并通过Qualtrics平台进行管理.
- 达到了67%的响应率,61个目标REC中的43个提交了完整的响应.
主要成果:
- 收集了有关REC任务,组成,议程范围和评估过程 (包括投票) 的有价值数据.
- 开放式问题揭示了捷克REC面临的重大问题.
- 在常规实践中,对人类参与者的研究进行负责任的伦理评估尚未得到充分的确立.
结论:
- 在捷克,有效的研究伦理的主要障碍是缺乏国家立法.
- 强有力的立法框架对于治理研究伦理至关重要.
- 需要对REC采取支持措施,包括教育和指导,特别是在学术领域.
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