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紐倫堡宣言( Nuremberg code) Directives for Human Experimentation
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 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.
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