The Nuremberg Code
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.
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 will 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
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
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 seemed 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 judgement required of him, that a continuation
of the experiment is likely to result in injury, disability,
or death to the experimental subject.
"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.]
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Updated November 7, 2005