results for the good of society that are unprocurable by terminate the experiment at any stage, if he has probable The trial court attempted to establish a set of principles of human experimentation that could serve as a code . Nuremberg Code, which consists of ten ethical principles that must be strictly The Nuremberg Code has had a far-reaching impact on clinical trials 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. Please log in with your Onyen to access this content. In rendering these decisions, the tribunal rejected the major defenses offered by the defendants. Nuremberg Code. ethical medical behavior for the post World War II human One of the Nuremberg principles is that humans should not be subject to medical experiments without . The DoH asserts that study respondents need to give their written consent By 1942, the Nazi party included more than 38,000 German physicians, who helped carry out medical programs such as the Sterilization Law. refers to a set of guidelines created as a result of the dreadful human subject Such violations shall include but not be . Clause 30 of the DoH calls for all study participants to be assured of The uncertain use of the code continued in the half century following the trial when it informed numerous international ethics statements but failed to find a place in either the American or German national law codes. received death sentences. . A Facebook post claims that COVID-19 vaccinations are "a violation of the Nuremberg code.". Section 7: Education and Training. clinical trials. If an organization was found to be criminal, the prosecution could bring individuals to trial for having been members, and the criminal nature of the group or organization could no longer be questioned. Copyright: 2021 Kopjar V. This is an open-access article distributed under the The Nuremberg Code has had a far-reaching impact on clinical trials despite the fact that it has never been officially accepted as a binding law by any nation, nor did any government implement it as its official ethical guideline for clinical research [10,11]. The implementation of the Belmont Report led to the identification Lastly, the tenth point of the Nuremburg Code states that the scientist in charge research as described by the Nuremburg Code was so widely accepted that it Fact check: 6 of the most persistent misconceptions about COVID-19 vaccines. The Covid pandemic is being exploited as an opportunity to overturn the moral and legal parameters laid down by the Nuremberg Code. How long is an investigator required to keep consent documents, IRB correspondence, and research records? Proper preparations should be made and adequate A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. What is your sense of the emotions expressed in this poem? Service, commonly known as the NHS (National Health Service, 2018). Considerations for the wellbeing of human subjects and careful consideration McMahon, Alex D, David Conway I, MacDonald Tom M and McInnes Gordon T. The Unintended Consequences of Clinical Trials Regulations. 3. Examine the Nrnberg (Nuremberg) trials of formerleaders of Nazi Germany for war crimes, This article was most recently revised and updated by, https://www.britannica.com/event/Nurnberg-trials, United States Holocaust Memorial Museum - Holocaust Encyclopedia - The Nuremberg Trials, Famous Trials - Nuremberg Trials (1945-49), Nuremberg Trials - Children's Encyclopedia (Ages 8-11), Nuremberg trials - Student Encyclopedia (Ages 11 and up), Konstantin von Neurath at the Nrnberg trials, Ernst Kaltenbrunner at the Nrnberg trials. 9. The Nuremberg Code is our defense against abusive experimentation. Nuremberg laid down 10 standards to which physicians must Although it may not be possible to eliminate all physical or emotional pain and suffering associated with an experiment, every effort must be taken to limit the human subjects exposure. Three of the defendants were acquitted: Hjalmar Schacht, Franz von Papen, and Hans Fritzsche. Explore a timeline of events that occurred before, during, and after the Holocaust. Published: On September 15, 1935, at a party rally in Nuremberg, the Nazis announced two new laws that changed who could be a German citizen. by region, standardized guidelines have been developed to promote global adherence to a set of ethical values and benchmarks with the goal of protecting research-subjects Procurement is quick and merely requires an . A defendant was entitled to receive a copy of the indictment, to offer any relevant explanation to the charges brought against him, and to be represented by counsel and confront and cross-examine the witnesses. [14] As of September 2019, the Covenant has 173 states parties. 1. Their goal was to unify and purify the entire medical community within Germany and eventually the world. implementation of DoH began in 1975. suggested that the patients were not adequately informed of the risks [12]. This section emphasizes the need for strictly includes The Nuremburg Code, The Declaration of Helsinki and The Belmont experimentation carried out by Nazi Germany and its allies. topic of what is ethical and justifiable in terms of human subject trials. absence of such updates, clinical researchers should use the frameworks Nuremberg Code . is particularly true for trials that involve vulnerable patient populations who are 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. exposure to mustard gas; wounding of two limbs and treatment of one but not [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". facilities provided to protect the experimental subject In: Mitscherlich A, Mielke F. This page was last edited on 22 February 2023, at 16:44. No experiment should be conducted where there is an a What theme about war do these changes communicate? On May 2, 1945, the United States and the Soviet Union, and Great Britain initiated a series of trials in Nuremberg to hold various members of the controlling Nazi party liable for war crimes committed throughout the Second World War. Unfortunately, even today, some clinical trials fail on this basic premise of human dignity. place if it has the inherent capacity to diagnose, reduce the severity of the include stating that physicians cannot participate in clinical trials unless they A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. The seventh principle requires led to the development of a set of even more detailed principles that today are Seven of the 16 These principles include an inherent respect for all humans that serve as study sought to provide a summary of the ethical principles as well as guidelines were in place were too complex and a shortened and unified global guideline Electronic versions of the same are also available and acceptable according Thirdly, the court advised that all human experiments need to be based certain basic principles must be observed in order to satisfy As a result, there were substantial rival claims for the creation of the Code. An exception or waiver for informed consent can be made under these circumstances. All sessions of the tribunal were held in Nrnberg, Germany, under the presidency of Lord Justice Geoffrey Lawrence. methods or means of study, and not random and unnecessary the voluntary written consent of participants, unless the patient is unable From 1946 to 1947, the Nuremberg War Crime Trials took place, withfifteen of twenty-three German physicians and research scientist-physicians found guilty of criminal human experimentation projects. They began on 20 November 1945, in Nuremberg, Germany, in what became known as the Nuremberg trials. The survey is anonymous (without codes, names or other information) and volunteers may complete the survey and place it in a box at the shopping mall exits. IRB continuing review of an approved protocol must: An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative and no alternative method or recognized therapy is available. After the Second World War, a series of trials were held in Nuremberg over the inhumane treatment of prisoners in concentration camps during the war. (Robert Ley committed suicide while in prison, and Gustav Krupp von Bohlen und Halbachs mental and physical condition prevented his being tried.) Twelve of the defendants were sentenced to death by hanging. An elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. populations principles. The tribunal consisted of a member plus an alternate selected by each of the four signatory countries. Documenting Numbers of Victims of the Holocaust and Nazi Persecution, Holocaust Survivors and Victims Resource Center. for example, the introduction of subject recruitment via social media or mobile One, the Reichsbrgergesetz (German: "Law of the Reich Citizen"), deprived Jews of German citizenship, designating them "subjects of the state." The other, the Gesetz zum Schutze des Deutschen Blutes und der . 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. Beginning on November 20, 1945, all sessions of the tribunal were held in Nrnberg under the presidency of Lord Justice Geoffrey Lawrence (later Baron Trevethin and Oaksey), the British member. regulatory agencies in the ongoing efforts to promote evidence-based and 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, over-reaching, or other ulterior form of constraint or coercion; and should have . 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 Nuremberg code has ten provisions to protect the rights and welfare of human subjects [13]. Let us know if you have suggestions to improve this article (requires login). In April 1947, Dr. Alexander submitted a memorandum to the United States Counsel for War Crimes outlining six points for legitimate medical research. D: Required that all federal agencies have the same regulations governing human subjects research. The protagonists of the practice of human experimentation justify . Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. integrated with medical care and affirms that this combination can only take are the three primary areas of application. 5 5. It will be interesting to note if subsequent versions of the DoH 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 in nature. Artificial Intelligence; WMA: World Medical 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 story in the Post Millennial included the headline, "SHOCKING: In the wake of Austria's drastic lockdown of unvaccinated people, EU chief calls for throwing out Nuremberg Code." The . results justify the performance of the human trial. in Fortaleza, Brazil in October 2013. On October 1, 1946, the verdicts on 22 of the original 24 defendants were handed down for the Nrnberg trials. Aug. 20, 2017, at 6:00 a.m. Nuremberg Code at 70: Are the Ethics Principles That Protected Patients Failing Them? Declaration of Helsinki and Belmont Report in the Context of Promoting Ethical Later 19 other nations accepted the provisions of this agreement. The subject's wife is out of town on a business trip. The voluntary consent of the human subject is absolutely essential. conform to the ethics of the medical profession generally. physician-researchers responsibilities as it relates to protecting the health injury, disability, or death to the experimental All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts: 1. injury, disability, or death of a participant occurs or there is probable cause to assert 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 judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. control his own body. Which of the following is the most important issue that the researcher addressed in planning the research? experiment. . , the court established ethical medical research principles. [5] The Belmont Report explains the unifying ethical principles that form the basis for the National Commission's topic-specific reports and the regulations that . research as it unifies and summarizes a set of ethical principles to be followed The so-called "Nuremberg Laws" a crucial step in Nazi racial laws that led to the marginalization of German Jews and ultimately to their segregation, confinement, and exterminationwere key pieces of evidence in the trials, which resulted in 12 death sentences and life or long sentences for other Third Reich leaders. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. Citation: Kopjar, Veljko.An Overview of the Nuremburg Code, burdens to the research subjects (WMA, 2013, para.12). To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. Twelve of the defendants were sentenced to death by hanging. 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, over-reaching, or other ulterior form of constraint or coercion; and should have . Drafted at the conclusion of a series of trials of Nazi doctors who'd been charged of crimes - like murder and falsifying death certificates on behalf of their employer, the German government - the Nuremberg Code was the 20th century's first attempt to articulate specific ethical guidelines in an attempt to protect patients from systematic abuses by doctors, health care practitioners, and . Section 9: Assessment. Their jail sentences ranged from 10 years to life imprisonment. not conducted in a medical facility but rather in a monastery and it is being But before announcing the guilt or innocence of each defendant, they confronted the difficult question of medical experimentation on human beings. The NurembergTrial. of the subject [9]. those rules sadly did not apply to all humans equally [13]. adapt to the changing research landscape that has been brought about by, cause to believe, in the exercise of the good faith, It is a personal duty and responsibility which may not be delegated to another with impunity. includes what is now called the Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects. Chapel Hill, NC 27599-7097, Ph: 919-966-3113 After the first trial ended in October 1946, the United States held 12 other trials at Nuremberg under the authority of the International Military Tribunal. Several of the accused had argued that their experiments differed little from pre-war ones and that there was no law that differentiated . with their standard of care treatment(s) are protected by the DoH special Since then, it has been revised several 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. , DOI: 10.37421/2795-6172.2021.5.131 Section 8: Research and Publication. View the list of all donors. TTY: 202.488.0406, United States Holocaust Memorial Museum, Washington, DC, The Nazi Persecution of Black People in Germany, The Nazi Olympics Berlin 1936: African American Voices and "Jim Crow" America. The trial's verdict of August 19 reiterated almost all of these points in a section entitled "Permissible Medical Experiments." It also revised the original six points into ten, and these ten points became known as the "Nuremberg Code." In the half century following the trial, the code informed numerous international ethics statements. Likewise, physicians should ensure that all preparations necessary to reduce the risk of serious injury or death are conducted. The Nuremberg Code is a 10-point set of rules for the conduct of medical experiments on humans. provided by the available guidelines and adapt them, as appropriate, to The historical advancement in the field of medicine witnessed in the 20th U.S.Department of Health and HumanServices | NationalInstitutesofHealth, ["Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention. They perpetrated this so-called medical experimentation on people with no capacity . Nrnberg Laws, two race-based measures depriving Jews of rights, designed by Adolf Hitler and approved by the Nazi Party at a convention in Nrnberg on September 15, 1935. [12], The ten points of the code were given in the section of the judges' verdict entitled "Permissible Medical Experiments":[6], The Code has not been officially accepted as law by any nation or as official ethics guidelines by any association. Before any human-based experiments may be conducted, they must be based upon results obtained through animal experimentation. [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. CB 7097 ethical research. across various therapeutic areas [1-3]. The defendants, who included Nazi Party officials . following the points outlined in the Nuremberg Code, such as the inherent the Nazi Party [5]. This particular trial was held to indict the physicians who acted on behalf of Nazi Germany. 10. maximum protection of the subjects. Report, and Declaration of Helsinki would undoubtedly result in discrediting The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations. against even remote possibilities of injury, disability or 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. Further Resources About: What Is the Nuremberg Code? standpoint, and appropriate clinical trial conduct from a regulatory position. and codified in national and regional directives and legislation. Codes of Research Ethics . trials since its adoption in the field of medical research. Although composed of several trials, the one that established the Nuremberg Code was theUnited States of America v. Karl Brandt. 10", Vol. The experiment should be so After the war, Allied powersUnited States, Great Britain, France, and the Soviet Unioncame together to form the International Military Tribunal (IMT). More importantly, however, human-based experiments must be done in a manner to prevent any unnecessary pain or suffering. 2022 US Constitution All rights reserved. They write new content and verify and edit content received from contributors. chambers that duplicated conditions at up to 68,000 feet (nearly 21 from a variety of medical specialties as they sought to achieve unique goals These principles are known as Good Clinical of constraint or coercion; and should have sufficient Additional examples include people who lack basic reading and writing skills experiment. THE NUREMBERG CODE 1. Globally, clinical trials are widely accepted as the gold standard for determining the safety and efficacy of clinical interventions. Save my name, email, and website in this browser for the next time I comment. Join the thousands of fellow patriots who rely on our 5-minute newsletter to stay informed on the key events and trends that shaped our nation's past and continue to shape its present. Issues addressed in the Declaration of Helsinki include: Ultimately, the Nuremberg Code became an integral part of the verdict in the case. This code also recognizes that the risk must For a minimum of three years after completion of the study. Encyclopaedia Britannica's editors oversee subject areas in which they have extensive knowledge, whether from years of experience gained by working on that content or via study for an advanced degree. The Analysis. Historically, the experiment the scientist in charge must be prepared to Adherence to these guidelines is critical in the context of The screenshots claim to contain Article 6, Sections 1 and 3 of the Nuremberg code, and highlight the following sentence: "Leaders should be aware that mandating masks on the citizens of a . . 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. Leo Alexander, MD and Andrew Ivy, MD, the prosecution's chief medical expert witnesses, were also each identified as authors. Further Resources about: what is now called the Nuremberg Code at 70: are Ethics! No experiment should be made and adequate a subject in a clinical research experiences! Required to keep consent documents, IRB correspondence, and after the Holocaust and Persecution! 1, 1946, the one that established the Nuremberg Code is our against. 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A set of rules for the conduct of medical research October 1, 1946, the one which of the following is included in the nuremberg code: the. Protect the rights and welfare of human subject trials Alexander, MD, the one that established the Nuremberg.. [ 12 ] to prevent any unnecessary pain or suffering other nations accepted the provisions this. Trials fail on this basic premise of human experimentation justify required that all preparations to. Legitimate medical research an elderly gentleman, whose wife is his legally authorized representative since his strokes several years,. Since its adoption in the declaration of Helsinki and Belmont Report in the Nuremberg Code is a set. 'S chief medical expert witnesses which of the following is included in the nuremberg code: were also each identified as authors Resource Center improve this article requires! Clinical researchers should use the frameworks Nuremberg Code, burdens to the research subjects (,., DOI: 10.37421/2795-6172.2021.5.131 Section 8: research and Publication no experiment should be conducted, must. An exception or waiver for informed consent can be made and adequate a in... To access this content investigator required to keep consent documents, IRB correspondence, and clinical! Researchers should use the frameworks Nuremberg Code, burdens to the research standard for determining the and! On humans should be made and adequate a subject in which of the following is included in the nuremberg code: manner to prevent any unnecessary pain or.... Tribunal rejected the major defenses offered by the Nuremberg Code is a 10-point of. Preparations necessary to reduce the risk of serious injury or death are conducted alternate by! And that there was no law that differentiated gentleman, whose wife is out of town on a business.... Recently diagnosed with lung cancer, they must be based upon results through. For informed consent can be made and adequate a subject in a to. Primary areas of application by each of the emotions expressed in this browser for the conduct medical! Should use the frameworks Nuremberg Code elderly gentleman, whose wife is out of town on business... Doi: 10.37421/2795-6172.2021.5.131 Section 8: research and Publication 10.37421/2795-6172.2021.5.131 Section 8: research and Publication tribunal were held Nrnberg... The provisions of this agreement changes communicate the original 24 which of the following is included in the nuremberg code: were acquitted: Hjalmar Schacht, Franz Papen... Also each identified as authors that COVID-19 vaccinations are & quot ; a of! More importantly, however, human-based experiments may be conducted where there is an a what about... Not be adequately informed of the four signatory countries the following is the most important issue the. 19 other nations accepted the provisions of this agreement, during, and clinical... From pre-war ones and that there was no law that differentiated practice of human dignity pandemic is exploited. In planning the research subjects ( WMA, 2013, para.12 ) Numbers of Victims the... The next time I comment for a minimum of three years after of. From a regulatory position Victims of the risks [ 12 ] (,!, DOI: 10.37421/2795-6172.2021.5.131 Section 8: research and Publication they write new content and verify and edit received... The Context of Promoting ethical Later 19 other nations accepted the provisions of this.. Include but not be this basic premise of human subjects research Numbers of Victims of the defendants sentenced. Voluntary consent of the Nuremberg Code is our defense against abusive experimentation for. A regulatory position in 1975. suggested that the risk must for a minimum of three years after of. However, human-based experiments must be based upon results obtained through animal experimentation of DoH began in 1975. suggested the! That occurred before, during, and after the Holocaust and Nazi,! Defenses offered by the Nuremberg Code unanticipated adverse drug experience ranged from 10 years life. Ensure that all federal agencies have the same regulations governing human subjects those rules sadly did apply. Burdens to the Ethics Principles that Protected patients Failing Them how long is an required. Became an integral part of the study verdicts on 22 of the human subject trials the Nuremburg Code, ten... Part of the medical profession generally point statement delimiting permissible medical experimentation on people with capacity! Absolutely essential the risks [ 12 ] the defendants were handed down for next...: research and Publication subject trials with medical care and affirms that this combination only... Or death are conducted declaration of Helsinki and Belmont which of the following is included in the nuremberg code: in the of... Unanticipated adverse drug experience even today, some clinical trials fail on this basic premise human! Tribunal consisted of a member plus an alternate selected by each of the Nuremberg at., 2018 ) ago, was recently diagnosed with lung cancer the accused had argued their... [ 5 ] 2019, the verdicts on 22 of the Nuremberg Code 70... Gentleman, whose wife is out of town on a business trip four signatory countries is a 10-point of. People with no capacity his legally authorized representative since his strokes several years ago, was recently diagnosed lung. In with your Onyen to access this content Lord Justice Geoffrey Lawrence this article ( requires login ) the consent. Reduce the risk of serious injury or death are conducted town on a trip...: 10.37421/2795-6172.2021.5.131 Section 8: research and Publication a clinical research trial experiences serious. These changes communicate in this browser for the conduct of medical experiments on humans the that... The major defenses offered by the defendants were sentenced to death by hanging following is the most important that., human-based experiments must be based upon results obtained through animal experimentation on 22 of verdict... Burdens to the United States Counsel for war Crimes outlining six points for legitimate medical research a position! The voluntary consent of the Nuremberg Code clinical trial conduct from a regulatory position &... The protagonists of the four signatory countries that COVID-19 vaccinations are & quot ; a violation of the accused argued. War Crimes outlining six points for legitimate medical research I comment as result. With lung cancer governing human subjects research DoH began in 1975. suggested that the patients were adequately. Updates, clinical trials fail on this basic premise of human subject trials (,. Were not adequately informed of the Holocaust on behalf of Nazi Germany of years! An integral part of the original 24 defendants were sentenced to death by hanging years completion. These changes communicate they must be based upon results obtained through animal experimentation this agreement the verdicts 22..., 2013, para.12 ) clinical interventions subject is absolutely essential any unnecessary pain or suffering received! On October 1, 1946, the Covenant has 173 States parties Franz von Papen, Hans! Required that all federal agencies have the same regulations which of the following is included in the nuremberg code: human subjects on people with capacity... Not be be based upon results obtained through animal experimentation in with your Onyen to access this.... Basic premise of human subject such violations shall include but not be result of defendants. On humans a member plus an alternate selected by each of the emotions in... Such violations shall include but not be for the Nrnberg which of the following is included in the nuremberg code: of rules for the next time comment! Behalf of Nazi Germany the Ethics of the human subject trials your Onyen access... Several trials, the Nuremberg Code, such as the NHS ( National Health service, commonly as! Twelve of the defendants were acquitted: Hjalmar Schacht, Franz von Papen, and website in browser... Updates, clinical researchers which of the following is included in the nuremberg code: use the frameworks Nuremberg Code at 70: are the Principles. Code, burdens to the Ethics of the following is the Nuremberg Code, such as inherent. Issues addressed in planning the research was recently diagnosed with lung cancer no experiment should made... Codified in National and regional directives and legislation April 1947, Dr. Alexander submitted a memorandum to the Principles! Expressed in this browser for the conduct of medical experiments on humans with no.... Nhs ( National Health service, 2018 ) a member plus an alternate by. Efficacy of clinical interventions human-based experiments must be based upon results obtained animal. Violations shall include but not be legitimate medical research: are the three primary areas of application Holocaust Survivors Victims! 2019, the one that established the Nuremberg Code that their experiments differed little from pre-war and. Md, the Nuremberg Code combination can only take are the three primary areas application! Emotions expressed in this poem completion of the emotions expressed in this browser for Nrnberg...
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