アクセス数 : ?
ダウンロード数 : ?
ID 109592
著者
カタシマ, ルミ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital KAKEN研究者をさがす
サトウ, チホ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
木下, 成三 Tokushima Medical Association
川島, 周 Tokushima Medical Association
楊河, 宏章 Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital 徳島大学 教育研究者総覧 KAKEN研究者をさがす
キーワード
ethics committee
research ethics
clinical research
regional area
資料タイプ
学術雑誌論文
抄録
Clinical research is important to improve medical quality, and ethics review is essential to conduct clinical research. Since the establishment of the first Japanese ethics committee at the University of Tokushima in 1982, Japanese ethics committees have increased. In this study, we surveyed the status of clinical studies and ethics committees in one Japanese region. The survey was conducted in collaboration with the Tokushima Medical Association. A questionnaire was established and mailed to all medical institutions (n=737) registered to the Tokushima Medical Association in 2012. Among 737, 223 (30.3%) questionnaires were returned and 221 were completed and are included in this analysis (respondents). Among respondents, 51 (23.1%) had performed clinical research, and of these, 17 had established ethics committees (though one was omitted from the following analysis due to an unsatisfactory response). Among 16 ethics committees, review of protocol amendments, review of serious adverse events, annual follow-up of approved protocols, and education for committee members were active in 10 (62.5%), 9 (56.3%), 6 (37.5%) and 4 (25.0%), respectively. Research ethics education was active in 4 (25.0%). Based on the results, we attempt to establish an appropriate system for ethical conduct of health-related research in Tokushima Prefecture.
掲載誌名
The journal of medical investigation : JMI
ISSN
13431420
cat書誌ID
AA11166929
61
3-4
開始ページ
399
終了ページ
403
並び順
399
発行日
2014-08
EDB ID
フルテキストファイル
言語
eng
著者版フラグ
出版社版
部局
病院