Historical Context: War Crimes to First Principles

The historical context of the EPA human experimentation scandal begins with the horrific human experiments conducted by the Nazis during World War II.These experiments included the secret administration of poisons to Buchenwald prisoners to see what would happen.

Twenty three Nazi doctors were subsequently tried by the Nuremberg war crimes tribunal in what is known as the Doctors’ Trial. Among other crimes, the defendants were charged with performing medical experiments, without the subjects’ consent.

Sixteen of the doctors were convicted of crimes against humanity. Of the convicted, seven were executed and the rest imprisoned. Among those executed was the chief doctor at Buchenwald.

As part of the verdict in the Doctor’s Trial, the Nuremberg tribunal espoused its views on human experimentation. These views became known as the Nuremberg Code and they became the first generally accepted set of principles governing human experimentation.

The 10 points of the Nuremberg Code are:

1. Voluntary and Informed Consent. 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. Beneficial and necessary. 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. Anticipated Results Justify Experimentation. 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.
4. Avoid Unnecessary Harm. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No Dangerous Experimentation. 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. Proportional Risk. 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. Adequate Preparation and Facilities. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. Qualified Scientists. 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. Subject Freedom to Terminate Experimentation. 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. Scientist Obligation to Terminate Experimentation. 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.

In 1964, the Nuremberg Code was further developed by the World Medical Association into the Declaration of Helsinki.

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