人體試驗倫理

The Ethics of Human Experiment

醫師照顧病患時的各種行爲，是法律上所特許的工作。由於是爲了病患醫療上的需要，即使執行時侵犯到病人的身體或隱私，並不會被認定爲是侵犯病人的權益。但是當醫師在病患身上所做的，並不是爲了病人醫療上的需要，而是爲了醫師自己的研究工作時，病人的權益是否有被侵犯，就是値得討論的問題。國內醫療單位常常未善盡告知醫療研究的目的與結果，即進行抽血等試驗，有侵犯人權之嫌。人體試驗並非如有些人所誤會，是將病人當成實驗動物的行爲，而可以是非常嚴謹，尊重人權，小心仔細的科學研究。

The origin of human subject protection in Taiwan begun in 1986 when the Medical Care Act was enacted which requires the informed consent for all medical treatments and researches. The Enforcement Rules of Medical Care Act in 1987 stipulate the mandatory items for research protocols and requirements for Institutional review board (IRB) review. Protocols reviewed by IRB must compliance with Declaration of Helsinki and other international ethics codes. Good clinical practice (GCP) guidelines were originally announced in November 1996 and a proposed revision of the GCP guidelines to harmonize with ICH-GCP was published in September 2002. An official GCP inspection has begun since 2000. IRB Operational Guidelines were announced by DOH in November 2003. The IRB review system in Taiwan provides an important mechanism for human subject protection.