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纽伦堡法案

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紐倫堡法案 (Nuremberg Code)是一套人體試驗之準則﹐是成於第二次世界大戰之後的纽伦堡审判的結果。具體地說﹐其準則是頂著由於納粹於戰時對人類進行不人道的實驗而來﹐如 Dr. Josef Mengele 之類的人所進行的實驗。

於1947年8月﹐判案法官們在對對醫生的審判(Doctor's Trial)中對 Karl Brandt 和其他人等宣判了判裁決。法官們也發表了他們對醫學實驗用於人類的意見。其中幾個犯人反駮說他們的實驗與戰前的實驗分別無幾﹐以及法律上也沒有對實驗合法不合法之說。

同年4月﹐ Dr. Leo Alexander 向戰爭罪行議會(Counsel for War Crimes)呈交了六點方案為合法的醫學研究取義。在裁決中這六點被接納了﹐另外也加了四點。而這十點方案便成了紐倫堡條文。

雖然這些條文的法律效力沒被確定下來,它們也沒有被直至加進到美國或德國的法律中﹐但紐倫堡條文和其有關連的赫爾辛基宣言( Declaration of Helsinki)是作為 Code of Federal Regulations Title 45 Volume 46link 的基本﹐而其是由美國的健康與人類服務局 (Department of Health and Human Services )頒發的法則﹐是為管理在美國由聯邦政府支助的實驗。其外﹐紐倫堡條文也被加進到個別州份﹐如加州﹐和其他國家的法律中。

紐倫堡條文包括某些準則﹐如知照下的同意﹑絕無強迫性的﹑用正確方法來形成的科學實驗﹑和對實驗參與者的利益

紐倫堡條文十要點為:

  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, over-reaching, 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 reasonable 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 problem 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 judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

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