- 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 under-
tanding 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 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