人體試驗委員會之相關規定對研究用組織庫運作之影響

Related Rules for IRB and Research Tissue Bank

在重視聲學倫理和醫學人文的今天，不斷地強調病志的權益，所以任何 閥混、人類甚至是動物的研究都必須經過人體試驗委員會和動物委員會的核 可，要確認係符合倫理的規範，相關聲學雜誌才可能會接受其發表刊登。本 文擬介紹人體試驗委員會之相關規定和其對於研究用組織庫的影響，並對照 美國相關的法規和作法，希望借鏡於他山之石，能夠使我國研究組織庫繼續 順利地運作，相信對於相關哥學研究將會有所助益。

According to the World Medical Association, reports of experimentation not complying with the principles of Declaration of Helsinki should not be accepted for publication. Therefore, it is necessary to point an Institutional Review Board (IRB) to approve the experimental protocol involving human subjects. However, the related regulations for IRB seem to be misunderstood. Following, the strict rules are applied on the tissue bank for research, which may result in the difficulty to run the tissue bank. The article reviewed the related US Federal Regulated and the practical application in the US research Institutions. Hopefully, these evidences can soften the IRB requirements on tissue bank for research.