Nuremberg Code

The Nuremberg Code (German: Nürnberger Kodex) is a set of research ethics principles for human
experimentation created by the U.S. v Brandt court as one result of the Nuremberg trials at the end of the
Second World War. In a review written on the 50th anniversary of the Brandt verdict, Katz writes that "a
careful reading of the judgment suggests that [the authors] wrote the Code for the practice of human
experimentation whenever it is being conducted."[1]

Contents
Background
Authorship 'controversy'
The ten points of the Nuremberg Code
Importance
See also
References
Further reading
External links

Background
The origin of the Code began in pre–World War II German politics, particularly during the 1930s and
1940s. 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 promote an Aryan race. 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 Nationalist 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.[2]

In response to the criticism of unethical human experimentation, the Weimar Republic (Germany's
government from 1919 to 1933) issued "Guidelines for New Therapy and Human Experimentation". 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.[3]
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 2 May 1945, and were
led by the United States, Great Britain, and the Soviet Union. They began on 20 November 1945, in
Nuremberg, Germany, in what became known as the Nuremberg trials. In the trial of USA v Brandt, 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.[4][5]

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.[6]

An early version of the Code known as the Memorandum, which stated explicit voluntary consent from
patients are required for human experimentation, was drafted on 9 August 1947.[7] On 20 August 1947, the
judges delivered their verdict against Karl Brandt and 22 others.[8] The verdict reiterated the
Memorandum's points and, in response to expert medical advisers for the prosecution, revised the original
six points of the Memorandum to ten points. The ten points became known as the 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.[9][10]

Authorship 'controversy'

The 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 Henry Pappworth, an English physician and the author of the 1967 book Human
Guinea Pigs, Andrew Ivy claimed sole authorship of the code. Leo Alexander, approximately 30 years
after the trial, also claimed sole authorship.[11] 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.[12]

The ten points of the Nuremberg Code

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.[13]
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.

Importance
The 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.[14] Katz observes that
the Western world initially dismissed the Nuremberg Code as a "code for barbarians, but unnecessary (or
superfluous) for ordinary physicians."[1][15] Additionally, the final judgment did not specify whether the
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
Code created an image that it was designed for singularly egregious transgressions.[1]

However, the Code is considered by some to be the most important document in the history of clinical
research ethics, which had a massive influence on global human rights. In America, the Code and the
related Declaration of Helsinki form the basis for the Code of Federal Regulations Title 45 Part 46,[16][17]
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 1966, the
International Covenant on Civil and Political Rights was adopted by the United Nations, and supposed to
be in force by 23 March 1976. Article seven prohibits experiments conducted without the "free consent to
medical or scientific experimentation" of the subject.[14] The Covenant has 173 states parties as of
September 2019.

In his 2014 review, Gaw observes that the Code "not only entered the legal landscape, but also became the
prototype for all future codes of ethical practice across the globe."[11] The idea of free or informed consent
also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human
Subjects proposed by the World Health Organization.[11] Another notable symposium review was
published by the Medical University of Vienna in 2017: "Medical Ethics in the 70 Years after the
Nuremberg Code, 1947 to the Present". President and Rector Markus Muller writes in his introduction that
the Code "constitutes one of the most important milestones in the history of medicine, providing for the first
time a proper framework for research on human subjects. Sadly, this milestone was not a voluntary,
precautionary measure resulting from enlightened humanity, it only came into existence in the aftermath of
dreadful Nazi atrocities. Following its conception, the Nuremberg Code bore rich fruit in multiple legal
regards, becoming a cornerstone of clinical research and bioethics."[18]

See also
Belmont Report
Civil rights
Declaration of Geneva
Declaration of Helsinki
Good clinical practice
Green report
Hippocratic Oath
Human experimentation in the United States
Human rights
Human subject research
Medical ethics
Medical torture
Nuremberg Principles
The Hague Ethical Guidelines
Universal Declaration of Human Rights
World Medical Association
Covid-19 vaccine

References
1. Katz, J. (1996). "The Nuremberg Code and the Nuremberg Trial. A reappraisal". JAMA. 276
(20): 1662–6. doi:10.1001/jama.1996.03540200048030 (https://doi.org/10.1001%2Fjama.19
96.03540200048030). PMID 8922453 (https://pubmed.ncbi.nlm.nih.gov/8922453).
2. 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.
 3. Vollmann, J.; Winau, R. (1996). "Informed consent in human experimentation before the
Nuremberg code" (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2352998). BMJ. 313
(7070): 1445–1447. doi:10.1136/bmj.313.7070.1445 (https://doi.org/10.1136%2Fbmj.313.70
70.1445). PMC 2352998 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2352998).
PMID 8973233 (https://pubmed.ncbi.nlm.nih.gov/8973233).
4. "Eugenics/Euthanasia" (http://www.credoreference.com/entry.do?ta=abcgeamrle&uh=eugen
ics_euthanasia). ABC-CLIO. Retrieved 16 September 2013.
5. "Archived copy" (https://web.archive.org/web/20131008125500/http://www.stanford.edu/grou
p/psylawseminar/The%20Nuremburg%20Code.htm). Archived from the original (http://www.
stanford.edu/group/psylawseminar/The%20Nuremburg%20Code.htm) on 8 October 2013.
Retrieved 5 October 2013.
6. "Nuremberg Code" (https://www.ushmm.org/information/exhibitions/online-exhibitions/speci
al-focus/doctors-trial/nuremberg-code). The Doctor's Trial: The Medical Case of the
Subsequent Nuremberg Proceedings. United States Holocaust Memorial Museum Online
Exhibitions. Retrieved 13 February 2019.
7. Mukherjee, Siddhartha (2010). The Emperor of All Maladies (https://en.wikipedia.org/wiki/Th
e_Emperor_of_All_Maladies) (First Scribner Hardcover ed.). Scribner. p. 33.
8. Annas, George J., and Michael A. Grodin. The Nazi Doctors and the Nuremberg Code. New
York: Oxford University Press, 1992.
9. Weindling, Paul (2001). "The Origins of Informed Consent: The International Scientific
Commission on Medical War Crimes, and the Nuremburg Code". Bulletin of the History of
Medicine. 75 (1): 37–71. doi:10.1353/bhm.2001.0049 (https://doi.org/10.1353%2Fbhm.2001.
0049). PMID 11420451 (https://pubmed.ncbi.nlm.nih.gov/11420451). S2CID 20239629 (http
s://api.semanticscholar.org/CorpusID:20239629).
10. 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.
11. Gaw, Allan (2014). "Reality and revisionism: New evidence for Andrew C Ivy's claim to
authorship of the Nuremberg Code" (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC410933
4). Journal of the Royal Society of Medicine. 107 (4): 138–143.
doi:10.1177/0141076814523948 (https://doi.org/10.1177%2F0141076814523948).
PMC 4109334 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4109334). PMID 24566934
(https://pubmed.ncbi.nlm.nih.gov/24566934).
12. Shuster, Evelyne (1997). "Fifty Years Later: The Significance of the Nuremberg Code". New
England Journal of Medicine. 337 (20): 1436–1440. doi:10.1056/NEJM199711133372006
(https://doi.org/10.1056%2FNEJM199711133372006). PMID 9358142 (https://pubmed.ncbi.
nlm.nih.gov/9358142).
13. "The Nuremberg Code (1949)" (https://research.wayne.edu/irb/pdf/2-2-the-nuremberg-code.
pdf) (PDF). research.wayne.edu.
14. Junod, Valérie (2005). Clinical drug trials Studying the safety and efficacy of new
pharmaceuticals (http://archive-ouverte.unige.ch/unige:43019). Genève: Schulthess. p. 545.
ISBN 9783725550227.
15. Jacobs, Noortje (1 August 2012). "Which Principles, Doctor? The early crystallization of
clinical research ethics in the Netherlands, 1947-1955" (https://dspace.library.uu.nl/bitstrea
m/handle/1874/253489/masterthesis_NJacobs_August2012.pdf?sequence=2&isAllowed=y)
(PDF). Utrecht University. Prof.dr Frank Huisman (Historical and Comparative Studies of the
Sciences and the Humanities).
16. Hurren, Elizabeth (May 2002). "Patients' rights: from Alder Hey to the Nuremberg Code" (http
s://web.archive.org/web/20131207022621/http://www.historyandpolicy.org/papers/policy-pap
er-03.html). History & Policy. United Kingdom: History & Policy. Archived from the original (ht
tp://www.historyandpolicy.org/papers/policy-paper-03.html) on 7 December 2013. Retrieved
9 December 2010.
17. "Public Welfare" (https://web.archive.org/web/20120204040720/http://www.access.gpo.gov/
nara/cfr/waisidx_00/45cfr46_00.html). Access.gpo.gov. 1 October 2000. Archived from the
original (http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html) on 4 February
2012. Retrieved 31 August 2013.
18. Czech, Herwig; Druml, Christiane; Weindling, Paul (2018). "Medical Ethics in the 70 Years
after the Nuremberg Code, 1947 to the Present" (https://doi.org/10.1007%2Fs00508-018-13
43-y). Wiener Klinische Wochenschrift. 130 (Suppl 3): 159–253. doi:10.1007/s00508-018-
1343-y (https://doi.org/10.1007%2Fs00508-018-1343-y). PMID 29926188 (https://pubmed.nc
bi.nlm.nih.gov/29926188).

Further reading
Weindling, Paul: Nazi Medicine and the Nuremberg Trials (Palgrave, Basingstoke 2004)
Schmidt, Ulf: Justice at Nuremberg: Leo Alexander and the Nazi Doctors' Trial (Palgrave,
Basingstoke 2004)
Schmidt, Ulf: Karl Brandt. The Nazi Doctor: Medicine and Power in the Third Reich
(Continuum, London, 2007)
Weindling, Paul (2001). "The Origins of Informed Consent: The International Scientific
Commission on Medical War Crimes, and the Nuremberg Code" (https://web.archive.org/we
b/20081023163909/http://www.geocities.com/travbailey/Paul_Weindling_The_Origins_of_In
formed_Consent_Nuremburg_Code.htm). Bulletin of the History of Medicine. 75 (1): 37–71.
doi:10.1353/bhm.2001.0049 (https://doi.org/10.1353%2Fbhm.2001.0049). PMID 11420451
(https://pubmed.ncbi.nlm.nih.gov/11420451). S2CID 20239629 (https://api.semanticscholar.o
rg/CorpusID:20239629). Archived from the original (http://www.geocities.com/travbailey/Paul
_Weindling_The_Origins_of_Informed_Consent_Nuremburg_Code.htm) on 23 October
2008.
Marrus, Michael R. (1999). "The Nuremberg Doctors' Trial in Historical Context" (https://web.
archive.org/web/20071201020045/http://www.geocities.com/travbailey/Michael_R_Marrus_
The_Nuremberg_Doctors_Trial.htm). Bulletin of the History of Medicine. 73 (1): 106–123.
doi:10.1353/bhm.1999.0037 (https://doi.org/10.1353%2Fbhm.1999.0037). PMID 10189729
(https://pubmed.ncbi.nlm.nih.gov/10189729). S2CID 29831220 (https://api.semanticscholar.o
rg/CorpusID:29831220). Archived from the original (http://www.geocities.com/travbailey/Mich
ael_R_Marrus_The_Nuremberg_Doctors_Trial.htm) on 1 December 2007.
BRITISH MEDICAL JOURNAL No. 7070, Volume 313: page 1448, 7 December 1996.
"The Nuremberg Code" (1947). In: Mitscherlich A, Mielke F. Doctors of Infamy: The Story of
the Nazi Medical Crimes. New York: Schuman, 1949: xxiii–xxv.
Carl Elliot's article "Making a Killing" (http://motherjones.com/environment/2010/09/dan-mar
kingson-drug-trial-astrazeneca) in Mother Jones magazine (September 2010) asks if the
Nuremberg Code is a valid legal precedent in Minnesota

External links
The Nuremberg Code (1947) (https://media.tghn.org/medialibrary/2011/04/BMJ_No_7070_V
olume_313_The_Nuremberg_Code.pdf) on the BRITISH MEDICAL JOURNAL
Nuremberg Code (https://www.ushmm.org/information/exhibitions/online-exhibitions/special-
focus/doctors-trial/nuremberg-code) at the United States Holocaust Memorial Museum

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This page was last edited on 4 December 2021, at 19:10 (UTC).