Nuremberg Code

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, the Nazi party included more than 38,000 German physicians, 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 on May 2, 1945 and were led by the United States, Great Britain, and the Soviet Union. They began on November 20, 1945 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 who 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. This worried Drs. Andrew Ivy and Leo Alexander, who worked with the prosecution during the trial. In April 1947, Dr. Alexander submitted a memorandum to the United States Counsel for War Crimes outlining six points for legitimate medical research.[5]

The Nuremberg code, which stated explicit voluntary consent from patients are required for human experimentation was drafted on August 9, 1947.[6] On August 20, 1947, the judges delivered their verdict against Karl Brandt and 22 others.[7] The verdict reiterated the memorandum's points and, in response to expert medical advisers for the prosecution, revised the original six points to ten. The ten points became known as 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.[8]

The ten points of the code were given in the section of the verdict entitled "Permissible Medical Experiments":[5]

1. The voluntary consent of the human subject is absolutely essential.
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 judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

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.[9] 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.[10]

Dr. Ravindra Ghooi from India has written a paper on this code and in his opinion, the code borrows heavily from the 1931 guidelines without acknowledging its source and thus could be considered plagiarized.[11]

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 judgment 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.[12]

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,[13][14] 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.[9]