《纽伦堡法典》 The Nuremberg Code (1947)
发布时间:2025-08-23 阅读数:316 发布:AgilePub
纽伦堡国际军事法庭的判决规定了医生在进行人体试验时必须遵守的10项标准。
允许进行的医学试验
摆在我们面前的大量证据表明,对人进行某些类型的医学试验,如果保持在合理规定的范围内,一般符合医学职业的伦理。人体试验活动的支持者在解释其观点时,指出这类试验产生的结果是为了社会利益,而且无法通过其他研究方法或手段所获得。大家都对此认同,然而为了满足道德、伦理和法律观念的要求,必须遵守某些基本原则:
1.受试者的自愿同意绝对必要。这意味着有关人员应具有给予同意的法律行为能力;其所处地位应使其能够行使自由选择权,免受任何武力、欺诈、欺骗、强迫、哄骗或其他隐蔽形式的限制或胁迫因素的干预;并应对试验内容相关要素有足够的知识和了解,使其能够作出明白而理智的决定。后一个要素要求,在试验对象作出同意的决策之前,应使其了解试验的性质、持续时间和目的;进行试验的方法和手段;合理预期的所有不便和危险,以及参与试验可能给其健康或人身造成的影响。每位发起、指导或参与实验的人负有确保这一同意之质量的义务与责任。这是个人的义务和责任,不能委托给他人而不受惩罚。
2.试验应当收到利用其他研究方法或手段是无法达到的对社会有利的富有成效的结果,且不具有随机和非必要的性质。
3.试验的设计,应以动物实验的结果和对疾病的自然史或其他待研究问题的了解为基础,使预期的结果证明进行试验的正当性。
4.在试验进行时应避免一切肉体上和精神上不必要的痛苦和创伤。
5.如果事先有理由相信会造成死亡或残废,则不得进行试验,但做试验的医生自己也作为受试者的试验也许不受此限制。
6.试验所冒风险的程度,不得超过试验所要解决问题人道主义重要性的程度。
7.必须作好恰当准备和提供适当设施以保护受试者免除哪怕是极少的创伤、残疾和死亡的可能性。
8.试验只能由在科学上具有资质的人员进行。应要求进行或参与试验的人员在试验的所有阶段都保持最好的技艺和细心。
9.在试验过程中,如果受试者达到的肉体或精神状态使得对他来说继续进行试验已不可能时,他应当有令试验停止的自由。
10.在试验过程中,如果主持试验的科学家通过运用其应具有的良好初衷、高超技艺和细心判断,有很大理由相信继续进行试验可能给受试者造成创伤、残疾或死亡时,必须随时准备在任何阶段终止试验。
The Nuremberg Code (1947)
The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects.
Permissible Medical Experiments
The great weight of the evidence before us to 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:
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.
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.
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 justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
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.
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.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
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.
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.
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.
转载自:《纽伦堡法典》 The Nuremberg Code (1947) - International Research Collaboration Information P
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