BRITISH MEDICAL JOURNAL No 7070 Volume 313: Page 1448,
7 December 1996.
Introduction
The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to
which physicians must conform when carrying out experiments on human subjects in
a new code that is now accepted worldwide.
This judgment established a new standard of ethical medical behaviour for the post
World War II human rights era. Amongst other requirements, this document
enunciates the requirement of voluntary informed consent of the human subject. The
principle of voluntary informed consent protects the right of the individual to control
his own body.
This code also recognizes that the risk must be weighed against the expected
benefit, and that unnecessary pain and suffering must be avoided.
This code recognizes that doctors should avoid actions that injure human patients.
The principles established by this code for medical practice now have been extended
into general codes of medical ethics.
The Nuremberg Code (1947)
Permissible Medical Experiments
The great weight of the evidence before us to effect that certain types of medical
experiments on human beings, when kept within reasonably well-defined bounds,
conform to the ethics of the medical profession generally. The protagonists of the
practice of human experimentation justify their views on the basis that such
experiments yield results for the good of society that are unprocurable by other
methods or means of study. All agree, however, that certain basic principles must
be observed in order to satisfy moral, ethical and legal concepts:
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, overreaching,
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.
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 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.
For more information see Nuremberg Doctor’s Trial, BMJ 1996;313(7070):1445-75.
