Yanagawa Hiroaki, Katashima Rumi, Sato Chiho, Takechi Kenshi, Nokihara Hiroshi, Kane Chikako, Chuma Masayuki, Aoe Yuki
Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Kuramoto-cho 2, Tokushima, 770-8503, Japan.
BMC Res Notes. 2018 Sep 12;11(1):665. doi: 10.1186/s13104-018-3772-0.
Research ethics consultation is an advisory activity that differs from ethics committees, and its role is not yet widely known in Japan. Research ethics consultations were started in 2012 by members of the Clinical Trial Center of Tokushima University Hospital, a support section for clinical trials. We analyzed the research ethics consultation records from Tokushima University Hospital during the 5-year period of 2012-2016 to examine the Japanese context of research ethics consultation.
During the study period, 125 research ethics consultations were carried out, 115 (91%) before starting studies. All but one request were from investigators at Tokushima University. The main issue was compatibility with guidance and regulations (n = 74, 67.2%), such as ethical handling of human biological specimens and information utilized in research; only 6 (4.8%) requests involved research ethics issues that investigators face in their research. Therefore, it is necessary to expand the consultation function, with a nationwide system of consultant education and data sharing. Moreover, standardization of consultation should be considered.
研究伦理咨询是一项不同于伦理委员会的咨询活动，其作用在日本尚未广为人知。2012年，德岛大学医院临床试验中心（一个临床试验支持部门）的成员启动了研究伦理咨询。我们分析了德岛大学医院2012 - 2016年5年间的研究伦理咨询记录，以考察日本研究伦理咨询的情况。
在研究期间，共进行了125次研究伦理咨询，其中115次（91%）在研究开始前进行。除一项请求外，所有请求均来自德岛大学的研究人员。主要问题是与指南和法规的兼容性（n = 74，67.2%），例如人类生物样本的伦理处理以及研究中使用的信息；只有6项（4.8%）请求涉及研究人员在研究中面临的研究伦理问题。因此，有必要通过全国性的咨询教育和数据共享系统来扩大咨询功能。此外，应考虑咨询的标准化。
