临研人必读：纽伦堡法典

临床试验GCP培训都会提到一个临床试验历史上经具有划时代意义的事件，“纽伦堡法典”的颁布。今天小编和大家一起复习一下纽伦堡法典的全文和背景。

第二次世界大战时，德国纳粹分子借用科学实验和优生之名，用人体实验杀死了600万犹太人、战俘及其他无辜者，这些人被纳粹统称为"没有价值的生命"。主持这次惨无人道实验的，除纳粹党官员外，还有许多医学教授和高级专家。

德国战败后，这些为首分子被作为战犯交纽伦堡国际军事法庭审判，其中有23名医学方面的战犯。同时，纽伦堡法庭还制定了人体实验的基本原则，作为国际上进行人体实验的行为规范，即《纽伦堡法典》，并于1946年公布于世。 《纽伦堡法典》一共有10条。

纽伦堡法典THE NUREMBERG CODE

1.受试者的自愿同意绝对必要。这意味着接受试验的人有同意的合法权力；应该处于有选择自由的地位，不受任何势力的干涉、欺瞒、蒙蔽、挟持，哄骗或者其他某种隐蔽形式的压制或强迫；对于试验的项目有充分的知识和理解，足以作出肯定决定之前，必须让他知道试验的性质、期限和目的;试验方法及采取的手段；可以预料得到的不便和危险，对其健康或可能参与实验的人的影响。确保同意的质量的义务和责任，落在每个发起、指导和从事这个实验的个人身上。这只是一种个人的义务和责任，并不是代表别人，自己却可以逍遥法外。 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 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．实验应该收到对社会有利的富有成效的结果，用其他研究方法或手段是无法达到的，在性质上不是轻率和不必要的。 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．实验应该立足于动物实验取得结果，对疾病的自然历史和，别的问题有所了解的基础上，经过研究，参加实验的结果将证实原来的实验是正确的。 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．实验进行必须力求避免在肉体上和精神上的痛苦和创伤。 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5.事先就有理由相信会发生死亡或残废的实验一律不得进行，除了实验的医生自己也成为受试者的实验不在此限。 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．实验的危险性，不能超过实验所解决问题的人道主义的重要性。 T he 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．必须作好充分准备和有足够能力保护受拭者排除那怕是微之又微的创伤、残废和死亡的可能性。 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8.实验只能由科学上合格的人进行。进行实验的人员，在实验的每一阶段都需要有极高的技术和管理。 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.当受试者在实验过程中，已经到达这样的肉体与精神状态，即继续进行已经不可能的时候，完全有停止实验的自由。 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 seemed to him to be impossible.

10．在实验过程中，主持实验的科学工作者，如果他有充分理由相信即使操作是诚心诚意的，技术也是高超的，判断是审慎的，但是实验继续进行，受试者照样还要出现创伤、残废和死亡的时候，必须随时中断实验。 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.