BRITISH MEDICAL JOURNAL No 7070 Volume 313: Page 1448,
7 December 1996.
Introduction
The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to
which physicians must conform when carrying out experiments on human subjects in
a new code that is now accepted worldwide.
This judgment established a new standard of ethical medical behaviour for the post
World War II human rights era. Amongst other requirements, this document
enunciates the requirement of voluntary informed consent of the human subject. The
principle of voluntary informed consent protects the right of the individual to control
his own body.
This code also recognizes that the risk must be weighed against the expected
benefit, and that unnecessary pain and suffering must be avoided.
This code recognizes that doctors should avoid actions that injure human patients.
The principles established by this code for medical practice now have been extended
into general codes of medical ethics.
The Nuremberg Code (1947)
Permissible 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:
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, 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