我國臨床試驗倫理審查效率精進機制

This is a review of process and practices in institutional ethics review of clinical trials in Taiwan, with a focus on items related to improving efficiency of the review process, especially for multi-center trials. Barriers to improving ethics review efficiency are identified and potential solution...

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Bibliographic Details
Published in台灣醫學 Vol. 26; no. 2; pp. 228 - 236
Main Authors 吳倚晴(Yi Ching Wu), 戴君芳(Chun-Fang Tai), 蔡甫昌(Daniel Fu-Chang Tsai), 陳建煒(K. Arnold Chan)
Format Journal Article
LanguageChinese
Published 台灣 臺灣醫學會 25.03.2022
Subjects
ethics review of clinical trials
TSCI
臨床試驗倫理審查
臨床試驗倫理審查
ethics review of clinical trials
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ISSN1028-1916
DOI10.6320/FJM.202203_26(2).0012

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Summary:This is a review of process and practices in institutional ethics review of clinical trials in Taiwan, with a focus on items related to improving efficiency of the review process, especially for multi-center trials. Barriers to improving ethics review efficiency are identified and potential solutions are discussed. Better efficiency in ethics review of clinical trials will result in better protection of research subjects and higher overall quality of clinical trials.
本文針對我國過去及現今採取用以提升臨床試驗倫理審查效率之方式、程序及相關制度加以彙整，同時對實務現況所遇之困難進行分析，並進一步提出建議，以期藉由提升臨床試驗倫理審查程序之效率，落實受試者權益之保障，並提升臨床試驗之品質
ISSN:1028-1916
DOI:10.6320/FJM.202203_26(2).0012