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 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 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.]
TEXT PROVIDED BY University of
Michigan Medical IRB
