新藥臨床試驗受試者同意書現況分析

The Profile of Informed Consent Forms of Investigational New Drug in Taiwan

黃政仁(Cheng-Jen Huang) ； 林志六(Chih-Liu Lin) ； 陳恆德(Herng-Der Chern) ； 王薏雯(Yi-Wen Wang) ； 廖宗志(Joh-Jih Liao)

《臺灣家庭醫學研究》 5卷2期 (2007/04) Pp. 81-88

https://doi.org/10.29475/TFMR.200704.0004

摘要

受試者同意書寫的內容及品質，與受試者的保護相關。目前受試者同意書書寫的原則，主要是依據赫爾辛基宣言及試驗執行地政府所訂定的法現。本文研究2005年1月至12月查驗中心及衛生署藥物審議委員會對新藥臨床試驗受試者同意書審查意見，分析資料包含廠商國別、試驗委託者、研究期程(phase)、受試者族群及審查意見。結果發現受試者同意書常出現不同審查意見的段落，按百分比的高低依序為：可能副作用及危險(52%)、機密性(36%)、試驗方法與相關檢驗(29%)、損害賠償與保險(29%)、全球上市簡介(12%)。
另以每一份受試者同意書不同審查意見的段落中位數來看，試驗委託者為國外廠商者較多（3比1），可能的原因應是跨國性的臨床試驗同意書，大多依英文版的受試者同意書翻譯，其部份內容或許不適合國情。受試者同意是現代臨床試驗的倫理基石，但直到最近，這項觀念才受到重視。惟有真正尊重受試者權利及自主性，經由品質良好的受試者同意書取得受試者同意，才能得到受試者的信任，如此不僅保護受試者且有助研究進行。

並列摘要

Informed consent is the ethical cornerstone of modern clinical trials. Until recently, the importance of informed consent had not been emphasized. We examined the inform consent forms in the period of January to December, 2005 which had been reviewed by the Center for Drug Evaluation and Advisory Committee, Department of Health. The data analyzed were the nationalities of sponsor, trial duration and phases, subjects inclusion and reviewer's comments. The result showed that defects in the consent forms appeared most frequently in the paragraphs of possible side effects and risks (52%), confidentiality (36%), methodologies (29%), compensation and insurance (29%), and global introduction (12%). The median value of the defect paragraphs was 1 for domestic sponsors and 3 for international sponsors which were possibly due to the poor Chinese translation and different national health regulatory requirements. It is imperative to improve the quality of informed consent forms by respecting the right, autonomy and confidentiality of the trial subjects.

並列關鍵字

investigational new drug ； informed consent form ； clinical trial