1946 年 11 月 21 日,盟軍第一軍事法庭案件 「醫生之審判」(the Doctor’s Trial)在德國紐倫堡開庭審理, 被告為納粹德國醫生,在未經告知的狀況下,被俘虜的猶太人成了活生生的實驗對象,被迫接受慘無人道的臨床醫學試驗。 起訴罪名為在二戰期間進行不道德的人體試驗,在審判期間,被告曾極力為其犯行辯護,根據德國醫師的辯護詞, 納粹政府在當時的確頒佈了人體實驗的最高指導原則:「只要能夠幫助國家贏得戰爭,不論何種實驗都可以進行。」 當時全世界的學術界對人體實驗的看法莫衷一是、沒有一定的標準, 因此德國政府的規定是最適用當時的特殊情況。既然沒有正確的適用標準,就沒有不適用的問題, 既然國際公法沒有對人體試驗進行規範,那麼這樣作就不算違法。 他們辯稱科學研究在戰時確有必要、以犯人為研究對象是普遍可接受的,德國醫師的辯詞看起來似乎是無懈可擊 但是紐倫堡審判法庭則根據「自然法則適用權(natural propriety)」 的理由、 充分駁斥德國戰犯的狡辯:「所有人類均同意,人類生活的世界存在著重要的基本法則,以期滿足人類的道德觀、倫理觀、法治觀。」 同時於 1947 年 8 月20 日終審判決,總計 23 名被告中有 16 名獲判有罪。 因此紐倫堡審判法庭特別針對人體實驗的適用性,列出了包括「使實驗對象完全了解實驗內容」、「實驗對象必須出於自願」、「 所有處置須符合人道原則」、「不可使實驗對象遭受不必要的痛苦」等特點的十項原則,也就是現在通稱的「紐倫堡規範(Nuremberg Code)」。 是第一件有關人體試驗的國際倫理規範,同時也是一份簡略但影響深遠的重要文獻。 因為過於簡略,有些學者批評,在人體試驗的倫理規範的發展過程中,紐倫堡守則事實上是一種退化現象, 不論在內容或範圍方面,它都遠不及普魯士政府在 1900 年發佈的行政命令或德國政府在 1931 年制訂的準則周延詳盡。 這一說法雖是事實卻不盡公平,因為紐倫堡守則並非專為約束實際研究行為而制訂的法規,而只是為法庭審判的目的而訂立的判決依據, 換言之,紐倫堡守則的性質極為特殊,極難與一般的法規準則相提並論。 The Nuremberg Code From "Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10", Vol. 2, Nuremberg, October 1946 - April 1949. (Washington, DC: US Government Printing Office, 1949). pp 181-182. The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts. 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe in the exercise of the good faith, superior skill and careful judgement required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. Nuremberg Code (Morgana's Observatory)
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