The Ten Principles of the Nuremberg Code
On August 19, 1947, the judges of the
American military tribunal, before rendering verdict in the Doctors' Trial
USA vs. Karl Brandt et al., presented ten basic principles for human
experimentation 'in order to satisfy moral, ethical and legal concepts' under
a section entitled Permissible Medical Experiments. They became
known as the Nuremberg 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.
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.
Arrowsmith, by Sinclair Lewis
Claude Bernard's experimental method, or the search for scientific truth