臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
原著
国内における研究倫理コンサルテーションのニーズ:予備的質問紙調査
會澤 久仁子中田 はる佳土井 香大北 全俊松井 健志
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2015 年 46 巻 3 号 p. 115-125

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Background: The research ethics consultation service (RECS) is an advisory service in which bioethicists evaluate research and development projects and assist in making sure that ethical principles are upheld within the projects. It has been implemented in several clinical research institutions and programs in Japan. However, the specific demand for this service has not yet been investigated.
Objective: To identify the needs for RECS and its related factors among parties involved in clinical research.
Design: An anonymous self-administered questionnaire survey delivered on site or by post.
Participants: The questionnaire was administered to 144 ethics committee members and clinical research coordinators (CRC) from 78 institutions who participated in four research ethics seminars that we held in Kyoto,Tokyo and Osaka from December 2012 to January 2014.
Survey period: December 2013 to February 2014.
Measurements: Questionnaire with 11 multiple-choice questions.
Results: 119 of 144 participants responded (return rate 82.6%). Of the respondents, 64.7% were research ethics committee members and officials, and 26.9% were CRCs. 54.6% were affiliated with universities and colleges. Irrespective of their roles and institutions, more than 90% answered that they themselves would like to use the RECS. While 37.0% preferred an institution-based service, 22.7% favored either a district-based service or service specialized for specific type or area of research.
Limitations: The results obtained in this study may not be generalizable to the needs of all clinical research communities.
Conclusions: We propose that public RECSs should be developed at 15 or more core research institutes in Japan to provide consultations in ethics to both ethics committees and CRCs across the country.

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© 2015 日本臨床薬理学会
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