Nuremberg Code
Research ethics principles for human experimentation
In 1997, the Nuremberg Code was published on August 20, 1947, as an outcome of the
Nuremberg Trials (August 1945-October 1946), in which, along with the Nazi hierarchy,
several physicians were sentenced for serious outrages against human beings. Such text has
the merit of being the first document that explicitly posed the obligation of requesting the
Informed Consent, expression of the patient’s autonomy. The recommendations are the
following (from the US National Institutes of Health. “Nuremberg Code”):
1. 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/her 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.
2. 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.
3. The experiment should be so designed and based on the results of animal
experimentation and knowledge of the natural history of the disease or other problem under
study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
5. No experiment should be conducted where there is a prior reason to believe that death or
disabling injury will occur; except, perhaps, in those experiments where the experimental
physicians also serve as subjects.
6. 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.
7. Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
8. 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.
9. 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.