Veselska Renata, Sirucek Jan, Kure Josef
Department of Experimental Biology, Faculty of Science, Masaryk University, Brno, Czechia, Czechia.
Bioethics Consulting, Brno, Czechia, Czechia.
BMC Med Ethics. 2024 Dec 23;25(1):153. doi: 10.1186/s12910-024-01157-2.
The primary objective of this study was to conduct a comprehensive questionnaire survey on the practices of research ethics committees reviewing academic research projects in Czechia. The study aims to provide an unbiased and objective assessment of the current practices of research ethics committees, namely to obtain the missing data on their functioning in the context of academic research, to identify difficulties and shortages that threaten the responsible functioning of research ethics committees in the country and to investigate the implementation of Additional Protocol on Biomedical Research CETS No. 195 in their practice. Such research has never been conducted in Czechia.
This was a mixed-methods study, in which the online survey with closed and open-ended questions was chosen to explore the situation regarding ethics assessment of research involving human participants. We developed a questionnaire containing 18 questions concerning several aspects of the functioning of research ethics committees. The questionnaire was in Czech language and was administered through the Qualtrics platform anonymously. The target group of 61 research ethics committees at research institutions was approached by emails and we received 43 completely filled questionnaires, i.e., response rate of 67%.
We obtained valuable data on the functioning of research ethics committees in Czechia in three main domains: the mandate and composition of the committee; the scope of its agenda; the process of evaluation including the voting procedure. In addition, the final set of open-ended questions provided an in-depth look at the problems faced by research ethics committees in Czechia. From the results is evident that the responsible assessment of the ethics of research involving human subjects is still not satisfactorily addressed and established for routine practice in the country.
The outcomes of our study revealed that the main problem of research ethics in Czechia is the lack of national legislation on research ethics governance. To address this problem, the country requires a legislative framework accompanied by supportive measures aimed at educating, guiding and advising research ethics committees, especially in the Czech academic environment.
Not applicable.
本研究的主要目的是针对捷克研究伦理委员会审查学术研究项目的实践开展全面的问卷调查。该研究旨在对研究伦理委员会的当前实践进行公正客观的评估，即获取其在学术研究背景下运作的缺失数据，识别威胁该国研究伦理委员会负责运作的困难和不足，并调查《生物医学研究附加议定书》（CETS第195号）在其实践中的实施情况。捷克从未进行过此类研究。
这是一项混合方法研究，选择了包含封闭式和开放式问题的在线调查来探究涉及人类受试者研究的伦理评估情况。我们编制了一份包含18个问题的问卷，涉及研究伦理委员会运作的多个方面。问卷为捷克语，通过Qualtrics平台进行匿名发放。通过电子邮件联系了研究机构的61个研究伦理委员会这一目标群体，共收到43份完整填写的问卷，即回复率为67%。
我们在捷克研究伦理委员会运作的三个主要领域获得了有价值的数据：委员会的职责和组成；议程范围；评估过程，包括投票程序。此外，最后一组开放式问题深入探讨了捷克研究伦理委员会面临的问题。从结果可以明显看出，该国对涉及人类受试者研究的伦理进行负责任的评估在常规实践中仍未得到令人满意的解决和确立。
我们的研究结果表明，捷克研究伦理的主要问题是缺乏关于研究伦理治理的国家立法。为解决这一问题，该国需要一个立法框架，并辅以旨在教育、指导和为研究伦理委员会提供建议的支持措施，特别是在捷克学术环境中。
不适用。
