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ID 114780
Author
Sato, Chiho Tokushima University
Kane, Chikako Tokushima University
Chuma, Masayuki Tokushima University
Aoe, Yuki Tokushima University
Keywords
Research ethics consultation
Research ethics
Clinical research
Japan
Regulation compatibility
Content Type
Journal Article
Description
Objective: 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.
Results: 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.
Journal Title
BMC Research Notes
ISSN
17560500
Publisher
BioMed Central|Springer Nature
Volume
11
Start Page
665
Published Date
2018-09-12
Rights
© The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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language
eng
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departments
University Hospital