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ID 115521
Author
Kane, Chikako Tokushima University
Chuma, Masayuki Tokushima University
Takagai, Tomoko Tokushima University
Keywords
Ethics committee
non-specialists
members
perspectives
Japan
clinical research
Content Type
Journal Article
Description
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.
Journal Title
Journal of International Medical Research
ISSN
03000605
14732300
NCID
AA00700686
Publisher
SAGE Publications
Volume
47
Issue
5
Start Page
1868
End Page
1876
Published Date
2019-01-24
Rights
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
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DOI (Published Version)
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language
eng
TextVersion
Publisher
departments
University Hospital