國内對臨床試驗受試者之「知情同意」經驗，甚少實證研究。本調查以臺大醫院於2013年7到8 月間，所有被收案的臨床試驗受試者為調查對象，探討受試者經歷知情同意過程後，對參與試驗案的理 解度及對知情同意過程的滿意度。本調查收案數為67份，共回收40份有效問卷，結果發現有80.27%受 試者對試驗案的理解程度之問題填答為「大致了解」及「完全了解」；94.96%受試者對有關知情說明過 程之滿意度之問題填答「滿意」及「非常滿意」；而如一般預期，高齡與低教育程度的族群有較差的理解 度。未來進行類似的研究調查時，可考量不同科別或疾病的受試者以及計畫主持人是否為受試者原本之 治療醫師對受試者之理解度及滿意度之影響，以期產出不同研究結果供相關單位參考。

There was hardly ever empirical study on the clinical trial subjects’ informed consent experience. This survey analyzed the research subjects’ satisfaction about informed consent process and their level of understanding while participating in clinical trials during July and August, 2013 at the National Taiwan University Hospital. The number of the target sample was 67, and 40 copies of valid response were collected. The survey result revealed that 80.27% of the respondents stated that they understand or fully understand the contents of the consent form and the information provided in the consent process. Moreover, 94.96% of the respondents stated that they were satisfied or very satisfied with the informed consent process. For conducting similar research in the future, following factors need to be taken into consideration to produce a best survey result: enrolling a more statistically meaningful number of samples, designing more effective survey questions by referencing to the relevant researches in advanced countries, and the selection of survey methods.