研究用剩餘檢體之規範

The Practice of Residue Tissue Bank for Research

所謂研究用剩餘檢體庫就是收集醫療檢驗完畢後所剩餘檢體，並加以儲存以供 後續研究之利用，而這些檢體可能為腫瘤組織或血液樣本，對疾病相關研究的價值極 高，可說是現代生物技術中不可或缺的研究材料。但是，剩餘檢體因為已經離開人 體，且不會再植入人體，在人體試驗中係屬於最低危險性的研究，因此就沒有必要性 比照風險性高的標準來規範。本文試著分析國外與我國的相關規定並提出建議。

Nowadays, residue tissue bank plays an important role in biomedical research. The residue tissue specimen can be used in a board spectrum of research, such as screening cancer drug or improving disease treatment. However, the study of using residue tissue is quite different from the clinical trial. This article is to analyze the related regulations and practice among Taiwan, United States and United Kingdom.