我國臨床試驗倫理審查效率精進機制

Optimization of Ethics Review of Clinical Trials in Taiwan

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。

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.