You did not know it, but the last time they went to the doctor or
went to the hospital, your wife or your husband or your daughter or your son became the
subject of a medical experiment that they were not even told about."
You just think about your own family, your own son, your own daughter, or
grandchildren who might be, the next time they go to a doctor, the subject of some medical
experiment that they are not even told about. I do not think there can be many things more
un-American than that."
Sen. John Glenn, Jan 22, 1997
BRITISH MEDICAL JOURNAL No 7070 Volume 313: Page 1448,
7 December 1996.
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 behavior 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
The principles established by this code for medical practice now have been
extened 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:
- 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 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 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 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.
For more information see Nuremberg Doctor's Trial, BMJ
- The Nuremberg Code (1947) In: Mitscherlich A, Mielke F. Doctors of infamy: the
story of the Nazi medical crimes. New York: Schuman, 1949: xxiii-xxv.
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