Department of Medical Research and Clinical Promotion Office, Nagoya University Hospital, Nagoya, Japan.
Clinical Research Innovation and Education Center, Tohoku University Hospital, Sendai, Japan.
Nagoya J Med Sci. 2021 May;83(2):299-309. doi: 10.18999/nagjms.83.2.299.
In 2018, we conducted a study on 121 ethics review committee offices in Japan to examine the state of "central review" in non-interventional studies and discern any challenges regarding its introduction. Of the 452 offices that were invited to participate, 121 responded (26.8% response rate), and 35 (28.9%) had records of furnishing contracting agreements with ethical reviews by other research institutions. The merits of central reviewing include easing the burden on ethics review committees, improving the quality level and consistency of ethical reviews, and enhancing the efficiency in conducting them. The demerits include increased administrative overheads and work for researchers, such as preparing application forms and checking institutional requirements, and a lack of clarity regarding who is responsible for conducting the research, which makes it is less desirable for institutions to have their own ethics review committees. This study revealed that the comprehensive introduction of central review in non-interventional studies continues to encounter many hurdles, and promoting central review requires overcoming these challenges one at a time. The Ethical Guidelines for Medical and Health Research Involving Human Subjects will be revised in 2021 to require central review as a part of ethical reviews for non-interventional studies. In the future, central reviews of non-interventional studies will need to be of high quality and conducted efficiently, and this will require research institutions to utilize relevant central review guidelines and checklists.
2018 年，我们对日本 121 家伦理审查委员会办公室进行了一项研究，旨在调查非干预性研究中“中心审查”的现状，并发现引入中心审查所面临的挑战。在受邀参与的 452 家办公室中，有 121 家（26.8%的回复率）提供了与其他研究机构进行伦理审查的合同协议记录。中心审查的优点包括减轻伦理审查委员会的负担、提高伦理审查的质量水平和一致性，并提高审查效率。其缺点包括增加了研究人员的行政负担和工作，例如准备申请表和检查机构要求，以及对于谁负责进行研究的责任不明确，这使得机构不太愿意设立自己的伦理审查委员会。本研究表明，非干预性研究中全面引入中心审查仍面临许多障碍，推广中心审查需要逐个克服这些挑战。《涉及人体医疗保健研究伦理审查指南（修订版）》将于 2021 年修订，要求将中心审查作为非干预性研究伦理审查的一部分。未来，非干预性研究的中心审查需要高质量且高效地进行，这要求研究机构利用相关的中心审查指南和清单。
