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The Nuremberg Code 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.

Contents

BackgroundEdit

The origin of the Nuremberg Code began in pre-World War II German politics, particularly during the 1930s and 40s. The prewar 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, since the mid-1920s, German physicians, usually proponents of racial hygiene, were accused by the public and the medical society of unethical medical practices. Racial hygiene was supported by the German government and racial hygiene extremists merged with National Socialism. Biology became a core concept in the Nazi ideology, referring National Socialism as applied biology. 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 situation, but for non-therapeutic purposes any administration without consent was strictly forbidden. However, the guidelines from Weimar were negated by 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 the World War II, German physicians responsible for the unethical medical conducts were brought into trial. On August 20, 1947,[3] the judges delivered their verdict in the "Doctors' Trial" against Karl Brandt and 22 others.[3] These trials focused on doctors involved in the human experiments in concentration camps.[4] The suspects were involved in over 3,500,000 sterilizations of German citizens.[4] The trials began on December 9, 1946 in Nuremberg, Germany and were led exclusively by the United States. Harry Truman approved these trials in January 1946.[5] Several of the accused argued that their experiments differed little from pre-war ones and that there was no law that differentiated between legal and illegal experiments. In May of the same year, six points defining legitimate medical research were submitted to the Counsel for War Crimes. The three judges, in response to expert medical advisors for the prosecution, adopted these points and added four. The ten points constituted the “Nuremberg Code”. 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 Nuremberg code includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants.

The ten points of the Nuremberg CodeEdit

These are:

  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.
  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.

AuthorshipEdit

The Code was initially ignored, but about 20 years later gained much greater significance. As a result, there were substantial rival claims for the creation of the Nuremberg Code. Some claimed that Harold Sebring, one of the three U.S. Judges responsible for the Nuremberg Medical Trial is the author. Leo Alexander, MD and Andrew Ivy, MD, the prosecution’s chief medical expert witnesses, were also each identified as author. 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 Doctor’s 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]

SignificanceEdit

The Nuremberg Code has not been officially accepted as law by any nation or as ethics by any association. In fact, the Code’s reference to Hippocratic duty to the individual patient and the need to provide information was not in favor with the American Medical Association in the beginning. In fact, 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, 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 the clinical research ethics which had a massive influence on global human rights. The Nuremberg Code and the related[10] Declaration of Helsinki are the basis for the Code of Federal Regulations Title 45 Part 46,[11] which are the regulations issued by the United States Department of Health and Human Services. Furthermore, 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 alsoEdit

ReferencesEdit

  1. ^ Grodin MA.  Historical origins of the Nuremberg Code.  In: The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. Annas GJ and Grodin MA (Eds). Oxford University Press, Oxford, 1992.
  2. ^ Vollmann, Jochen, and Rolf Winau. "Informed consent in human experimentation before the Nuremberg code." BMJ: British Medical Journal 313.7070 (1996): 1445.
  3. ^ a b Annas, George J., and Michael A. Grodin. The Nazi Doctors and the Nuremberg Code. New York, NY: Oxford University Press Inc., 1992. Print.
  4. ^ a b "Eugenics/Euthanasia". ABC-CLIO. Retrieved 2013-09-16. 
  5. ^ http://www.stanford.edu/group/psylawseminar/The%20Nuremburg%20Code.htm
  6. ^ Weindling, Paul. "The origins of informed consent: The international scientific commission on medical war crimes, and the Nuremberg code." Bulletin of the History of Medicine 75.1 (2001): 37-71.
  7. ^ a b Gaw, Allan. "Reality and revisionism: new evidence for Andrew C Ivy's claim to authorship of the Nuremberg Code." Journal of the Royal Society of Medicine 107.4 (2014): 138-143.
  8. ^ Shuster, Evelyne. "Fifty years later: the significance of the Nuremberg Code." New England Journal of Medicine 337.20 (1997): 1436-1440.
  9. ^ Katz, Jay. "The Nuremberg code and the Nuremberg trial: A reappraisal." Jama 276.20 (1996): 1662-1666.
  10. ^ Hurren, Elizabeth (May 2002). "Patients' rights: from Alder Hey to the Nuremberg Code". History & Policy. United Kingdom: History & Policy. Retrieved 9 December 2010. 
  11. ^ "Public Welfare". Access.gpo.gov. 2000-10-01. Retrieved 2013-08-31. 

Further readingEdit

External linksEdit