United States v. Brandt (The Medical Case), 2 Trials of War Criminals
Before the Nuremburg Military Tribunals Under Control Council Law No. 10,
at 181-82 (1949) (Nuremburg Code).
The great weight of the evidence before us is to the 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.
- 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.
- 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
problems 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 seems 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.
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