The Nuremberg Code (1947)
Permis sible 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:
- 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 problem under study that
the anticipated results 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.
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.