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Directives for Human Experimentation
NEUREMBERG CODE
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.
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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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Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals
under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S.
Government Printing Office, 1949.