藥物臨床試驗保險之研究－－受試者保護觀點

A Study on Medicine Clinical Trials Insurance: from a Trial Subjects' Protection Point of View

本研究探討現行藥物臨床試驗相關法令或行政命令，對於受試者保護是否足夠，同時分析受試者是否透過保險制度獲得充分保障。本研究發現：主管機關之管理機制不夠確實，我國法令對受試者權益規範仍嫌不足，而且國內藥物臨床試驗保險投保率暨責任限額仍屬偏低。本研究認為，宜強化審查與監督機構之管理機制，主管機關應將試驗業者違反告知義務賦予法律責任並納入受試者同意書標準規範內，另應推動藥物臨床試驗業者強制投保及修正對受試者之賠償制度等。

The purposes of this study are to investigate whether the trial subjects' protection from current related ordinances about the medicine clinical trial is enough and whether the trial subjects are guaranteed to acquire sufficient protection through the liability insurance system. This study found that the protection for the trial subjects is inadequate from either point of view of the authority or the domestic medicine clinical trial insurance. We conclude that the authority should strengthen the monitoring mechanism, including the representation within the scope of the trial subjects' consent standards and promote the compulsory insurance compensation system for the trial subjects' protection.