醫療器材臨床試驗之倫理審查實務

Ethics Review of Medical Device Clinical Trials

近年我國推動醫療器材的研發，也執行了越來越多的醫療器材臨床試臉，更於2021年施行新法來管理醫療器材。本文為首篇探討國內執行醫材試驗的現況與相關倫理審查的研究，透過回顧某醫學中心所執行的82個醫材試驗案，發現國內研究者具有相當的研發能力，但於送審試驗案時，常有計畫書內容不完整或送審資料不完備的情形，影響試驗的嚴謹度與研究倫理的審查。再者，新的醫療器材管理法導入美國規範，要求人體研究倫理審查委員會判斷試驗案的風險程度，如果有顯著風險，試驗案才須送衛生福利部審查，否則由試驗機構自行管理。為了提升醫材試驗案的審查品質，本文也研擬醫療器材臨床試驗審查檢核表，供各醫院的研究倫理審查委員會參考。

In recent years, Taiwan has promoted the research and development of medical devices, and has also conducted more and more clinical trials of medical devices. In 2021, a new law has been implemented to regulate medical devices. This article is the first study to examine the current situation of device trials in Taiwan and the ethical review of these trials. By reviewing 82 cases of medical device trials conducted by a medical center, it is found that domestic researchers have considerable research and development capabilities, but the protocol documents submitted for review are often incomplete, which affects the rigor of the study and the protection of the research subjects. Furthermore, the new medical device management law has adopted the American regulation, requiring the ethics review committee to assess the risk level of the trial. If there is a significant risk, the trial needs to be approved by the Ministry of Health and Welfare, otherwise it will be managed by the trial site itself. In order to improve the review quality of medical device trials, this article also develops a checklist for the ethics review committees of hospitals.