*Voluntary Informed Consent
*Animal Experimentation Before Human
*Physical/Mental Injury Avoided
*Benefit Outweighs Risk
*No Expectation of Death or Disability
*Participants May Withdraw at Any Time
*Researcher Must be Qualified
Reprinted from 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 Office, 1949.
- 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 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 reasonable 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
- 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 judgment required of him that a continuation
of the experiment is likely to result in injury, disability, or
death to the experimental subject.