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 rest 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 preparation 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 and 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 judgment required of
him, that a continuation of the experiment is likely to result in injury,
disability, or death to the experimental subject.
