- The voluntary consent of the human subject is
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 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.
- 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.
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 Office, 1949.]