| DIRECTIVES FOR HUMAN EXPERIMENTATION The Nuremberg Military Tribunal's decision in the case of the United States v Karl Brandt et al. includes what is now called the Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects. According to this statement, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that "satisfy moral, ethical, and legal concepts." To some extent the Nuremberg Code has been superseded by the Declaration of Helsinki as a guide for human experimentation.

--"Permissible Medical Experiments." Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg October 1946 - April 1949, Washington. U.S. Government Printing Office (n.d.), vol. 2., pp. 181-182.

- 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 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 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.

- 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 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. 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 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.

- 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 judgement required by him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

ACHES - MC