Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.
Research ethics committees in Japan: A perspective from thirty years of experience at Tokushima University.
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日本的研究伦理委员会：德岛大学三十年经验的视角。
DOI：
10.2152/jmi.62.114
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
N. Takeda
中科院分区：
文献类型：
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作者：
H. Yanagawa;R. Katashima;N. Takeda
1982年，日本第一个涉及人体的生物医学研究伦理委员会在德岛大学成立。尽管该委员会不是为了响应国家指令而成立的，但政府最终制定了伦理准则，例如2003年制定的临床研究伦理准则。这类指导方针的实际影响是，寻求道德操守委员会批准的议定书数量迅速增加，从而增加了道德操守委员会的工作量。本审查描述了德岛大学伦理委员会在过去30年中的活动，并讨论了最能支持该委员会活动的基础设施。此外，我们还解决了道德委员会目前面临的问题，并讨论了未来的方向。J.Med.投资。2015年8月，62：114-118。
The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.