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首页> 外文期刊>Journal of International Medical Research >Perspectives of non-specialists on the potential to serve as ethics committee members
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Perspectives of non-specialists on the potential to serve as ethics committee members

机译:非专家对道德委员会成员潜力的看法

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Objective In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions. Methods This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees. Results For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme “knowledge and an environment that promotes non-specialist members’ participation.” One notable result was the willingness of participants to obtain details about a study should they be selected. Conclusions The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies.
机译:目的在日本,根据与研究人员启动的临床试验有关的新《临床试验法》(于2018年4月1日生效),审查委员会应在考虑专家意见的同时审查拟议的临床试验。另外,非专家的参与是强制性的,并且正在关注他们的有效贡献。进行这项研究是为了确定可以促进这些贡献的代表性关键问题。方法该定性研究于2018年进行,使用了六名非专家进行的焦点小组访谈,内容涉及对临床研究本身和研究伦理委员会的看法。结果从临床研究本身的角度出发,建立了33个规范,并将其分为2类和6个亚类,它们与临床研究的模棱两可有关。为了研究伦理委员会的观点,建立了54项法规,并将其与“知识和促进非专业成员参与的环境”主题分为3类和10个子类。一个显着的结果是,如果参与者被选中,他们愿意获得有关研究的详细信息。结论结果表明,对一项特定研究的详细解释将鼓励非专家成员参加临床研究审查委员会。因此,在未来的研究中应考虑针对非专业人士的教育。

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