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The Nuremberg Code
Established in 1947, the Nuremberg Code was a series of 10 principles in medical research ethics created by Allied scientists during the Nuremberg trials of Nazi scientists following the end of World War 2.

The Nuremberg Trials
The first seeds of the Nuremberg trial (And the subsequent creation of the Nuremberg Code) were planted in October of 1943 with the Moscow Declaration. This brief declaration served as a warning to the Germans committing atrocities that they would be "brought back to the scene of their crimes and judged on the spot by the peoples whom they have outraged." They initially wanted to round up the leaders of the Nazi party and have them shot without any trial. However, calmer heads prevailed, and in 1945, the London Agreement was promulgated, containing the means of establishing an international tribunal for "the trial of war criminals ... whether they be accused individually or in their capacity as members of organizations or groups or in both capacities." The tribunal was formed, the defendants were named, and the trial was held. The trial marked the first time that individuals were held accountable on an international level for their actions in war. (Hopkins)

Following the end of World War 2, 22 Nazi leaders were put on trial in Nuremberg, Germany. These men had been involved in multiple human experiments over the course of the war, ranging from tests involving hypothermia, malaria, high pressure, mustard gas, and others. Determined to put the doctors on trial on an ethical basis, the prosecution had two American physicians-- Leo Alexander and Andrew Ivy-- create a document entitled the Nuremberg Code. They were charged with a series of four counts- War Crimes, Crimes against Humanity, Crimes against Peace, and conspiring to commit the other crimes. ("The Nuremberg Trials and Their Legacy." United States Holocaust Memorial Museum. United States Holocaust Memorial Council, n.d. Web. 22 Feb. 2014. .) The most conventional of these was War Crimes, based largely on the Hague and Geneva Conventions. About the legality of these charges, which applied to atrocities committed against both military personnel and civilians, there was little dispute. And there has been little challenge over the question of tu quoque ("you did it too"). Crimes against Humanity were conceived of for largely technical reasons: they were an effort to include among the indictable offenses the persecution of various groups (such as German Jews, for example) - acts that might otherwise, because of the victims' nationality, escape prosecution. Much weaker, from a legal point of view, was the third of the indictment, Crimes against Peace, in which defendants were charged with participation in the planning, preparation, initiation, and waging of specific wars in violations of international treaties. Open to tu quoque arguments as well as to accusations that these charges were based on an ex post facto ("after the facts") definition of criminality, this count was never understood or accepted by the French, and carried with it the obvious potential of embarrassing the Russians. It was the United States that had insisted upon this charge. In both law and evidence, the weakest count against the accused was the first, that which charged defendants with conspiring to commit the other crimes. Even more than Crimes against the Peace, this charge was an American product from first to last, having emerged from planners in the United States War Department with a view to addressing some of the problems facing the Americans with subsequent trials of Nazi criminals. The indictment referred to six major organs of the Third Reich: the Reich Cabinet, Party leadership, the SS, the Gestapo, the General Staff, and the SA. Each was represented by counsel, and tens of thousands of Germans who had been members made submissions to the court. In retrospect, the identification of some of these groups seems to have been the result of overly hasty or careless research on the part of the prosecutors and reflected some misunderstanding of how the Reich worked. (Marrus)

The Ten Principles
The Nuremberg Code itself consists of ten separate principles:

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

Legacy
For many years, the Nuremberg Code played virtually no role in ethical discussions, public policies, and legal decisions within the United States. Ruth Faden (Chairman of the Advisory Committee on Human Radiation Experiments) and colleagues conclude: "the Code, at the time it was promulgated, had little effect on mainstream medical researchers engaged in human subjects research." (Childress) An indefensible reason was the failure by many physicians and investigators to view voluntary, informed consent as very important, especially in therapeutic research, in part because medical paternalism still reigned in therapeutic contexts. A more defensible reason is that the Code itself is imperfect and incomplete. While designed to close a gap--to articulate a formal, authoritative code of common medical morality in experimentation--it also left some gaps and filled others with rigid and unyielding principles. A few examples will illustrate the Code's deficiencies.

First, the Court conceded that it was mainly concerned with "those requirements which are purely legal in nature--or which at least are so clearly related to matters legal that they assist us in determining criminal culpability and punishment" [10]. Such a focus necessarily omits or at least downplays concerns that are more ethical in nature and have little to do with criminal culpability and punishment.

Second, the Nuremberg Code considered only non-therapeutic research, and it ruled out all research involving incompetent subjects because of its absolute rule of subject consent---only the subject could consent to his or her participation in research. (Incidentally, Dr. Alexander's memorandum for the court included proxy consent for incompetent subjects, but this was omitted by the judges. The Code's omissions are certainly understandable in light of the terrible non-therapeutic experiments the court had to address, but these gaps almost certainly contributed to the code's "marginalization in modern medicine" (Childress)

On December 4th and 5th, 1989, the Law, Medicine and Ethics Program of Boston University School of Medicine and Public Health sponsored a symposium entitled "The Nazi Doctors and the Nuremberg Code: Relevance for Modern Medical Research." George J. Annas, co-director of the conference, reviewed the use to which the Nuremberg Code has been put in U.S. courts since 1947, noting that it has rarely been cited and has never been used to award money damages to anyone injured in a human experiment in the U.S., or to provide the basis of criminal liability. Professor Leonard Glantz reviewed state statutes and federal regulations on human experimentation, noting especially the various conflicting definitions of "human experimentation and research" that are used, and the fact that in the U.S. fetuses are the most protected subject population, and children the least protected. (Grodin)