Nuremberg Code

The Nuremberg Code (German: Nürnberger Kodex) is a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War.

Background

The origin of the Nuremberg Code began in pre-World War II German politics, particularly during the 1930s and 1940s. The pre-war German Medical Association was considered to be a progressive yet democratic association with great concerns for public health, one example being the legislation of compulsory health insurance for German workers. However, starting in the mid-1920s, German physicians, usually proponents of racial hygiene, were accused by the public and the medical society of unethical medical practices. The use of racial hygiene was supported by the German government in order to create an Aryan "master race," and to exterminate those who did not fit into their criteria. Racial hygiene extremists merged with National Socialism to promote the use of biology to accomplish their goals of racial purity, a core concept in the Nazi ideology. Physicians were attracted to the scientific ideology and aided in the establishment of National Socialist Physicians' League in 1929 to "purify the German medical community of 'Jewish Bolshevism.'" Criticism was becoming prevalent; Alfons Stauder, member of the Reich Health Office, claimed that the "dubious experiments have no therapeutic purpose," and Fredrich von Muller, physician and the president of the Deutsche Akademie, joined the criticism.^[1]

In response to the criticism of unethical human experimentation, the Reich government issued "Guidelines for New Therapy and Human Experimentation" in Weimar, Germany. The guidelines were based on beneficence and non-maleficence, but also stressed legal doctrine of informed consent. The guidelines clearly distinguished the difference between therapeutic and non-therapeutic research. For therapeutic purposes, the guidelines allowed administration without consent only in dire situations, but for non-therapeutic purposes any administration without consent was strictly forbidden. However, the guidelines from Weimar were negated by Adolf Hitler. By 1942, more than 38,000 German physicians were in the Nazi party, who helped carry out medical programs such as the Sterilization Law.^[2]

After World War II, a series of trials were held to hold members of the Nazi party responsible for a multitude of war crimes. The trials were approved by President Harry Truman in January 1946 and were led exclusively by the United States. They began on December 9, 1946 in Nuremberg, Germany, in what became known as the Nuremberg trials. In one of the trials, which became known as the "Doctors' Trial," German physicians responsible for conducting unethical medical procedures on humans during the war were tried. They focused on physicians that conducted inhumane and unethical human experiments in concentration camps, in addition to those who were involved in over 3,500,000 sterilizations of German citizens.^[3][4] Several of the accused argued that their experiments differed little from those used before the war, and that there was no law that differentiated between legal and illegal experiments. On August 20, 1947, the judges delivered their verdict against Karl Brandt and 22 others.^[5]

In May 1947, while the trials were being held, six points defining legitimate medical research were submitted to the Counsel for War Crimes. Three judges, in response to expert medical advisers for the prosecution, adopted these points and added four additional points. The 10 points constituted the "Nuremberg Code," which includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants. It is thought to have been mainly based on the Hippocratic Oath, which was interpreted as endorsing the experimental approach to medicine while protecting the patient.^[6]

The ten points of the Nuremberg Code

1. Required is the voluntary, well-informed, understanding consent of the human subject in a full legal capacity.
2. The experiment should aim at positive results for society that cannot be procured in some other way.
3. It should be based on previous knowledge (e.g., an expectation derived from animal experiments) that justifies the experiment.
4. The experiment should be set up in a way that avoids unnecessary physical and mental suffering and injuries, except, in experiments where the experimental physicians also serve as subjects.
5. It should not be conducted when there is any reason to believe that it implies a risk of death or disabling injury.
6. The risks of the experiment should be in proportion to (that is, not exceed) the expected humanitarian benefits.
7. Preparations and facilities must be provided that adequately protect the subjects against the experiment's risks.
8. The staff who conduct or take part in the experiment must be fully trained and scientifically qualified.
9. The human subjects must be free to immediately quit the experiment at any point when they feel physically or mentally unable to go on.
10. Likewise, the medical staff must stop the experiment at any point when they observe that continuation would be dangerous.

Authorship

The Nuremberg Code was initially ignored, but gained much greater significance about 20 years after it was written. As a result, there were substantial rival claims for the creation of the Code. Some claimed that Harold Sebring, one of the three U.S. judges who presided over the Doctors' Trial, was the author. Leo Alexander, MD and Andrew Ivy, MD, the prosecution's chief medical expert witnesses, were also each identified as authors. In his letter to Maurice H. Pappworth, an English physician and the author of the book Human Guinea Pigs, Andrew Ivy claimed sole authorship of the Code. Leo Alexander, approximately 30 years after the trial, also claimed sole authorship.^[7] However, after careful reading of the transcript of the Doctors' Trial, background documents, and the final judgements, it is more accepted that the authorship was shared and the Code grew out of the trial itself.^[8]

Significance

The Nuremberg Code has not been officially accepted as law by any nation or as official ethics guidelines by any association. In fact, the Code's reference to Hippocratic duty to the individual patient and the need to provide information was not initially favored by the American Medical Association. The Western world initially dismissed the Nuremberg Code as a "code for barbarians" and not for civilized physicians and investigators. Additionally, the final judgement did not specify whether the Nuremberg Code should be applied to cases such as political prisoners, convicted felons, and healthy volunteers. The lack of clarity, the brutality of the unethical medical experiments, and the uncompromising language of the Nuremberg Code created an image that the Code was designed for singularly egregious transgressions.^[9]

However, the Code is considered to be the most important document in the history of clinical research ethics, which had a massive influence on global human rights. The Nuremberg Code and the related Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Part 46,^[10][11] which are the regulations issued by the United States Department of Health and Human Services for the ethical treatment of human subjects, and are used in Institutional Review Boards (IRBs). In addition, the idea of informed consent has been universally accepted and now constitutes Article 7 of the United Nations' International Covenant on Civil and Political Rights. It also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization.^[7]

See also

References

Further reading

External links

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