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In order to discuss the Nuremberg Code, one must first define what it is. What follows is the complete Nuremberg code.
Permissible Medical Experiments
The great weight of the evidence before us is to the effect that certain types of medical
experiments on human beings, when kept within reasonably well-defined bounds, conform to the
ethics of the medical profession generally. The protagonists of the practice of human
experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:
- 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, over-reaching, 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.
- 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.
- 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.
- The experiment should be so conducted as to avoid all unnecessary physical and mental
suffering and injury.
- 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.
- 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.
- Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability, or death.
- 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.
- 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.
- During the course of the experiment the scientist in charge must be prepared to terminate he
experiment at any stage, if he has probably 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.
Of the ten principles which have been enumerated our judicial concern, of course, is with those requirements which are purely legal in nature — or which at least are so clearly related to matters legal that they assist us in determining criminal culpability and punishment. To go beyond that point would lead us into a field that would be beyond our sphere of competence. However, the point need not be labored. We find from the evidence that in the medical experiments which have been proved, these ten principles were much more frequently honored in their breach than in their observance. Many of the concentration camp inmates who were the victims of these atrocities
were citizens of countries other than the German Reich. They were non-German nationals,
including Jews and “asocial persons”, both prisoners of war and civilians, who had been
imprisoned and forced to submit to these tortures and barbarities without so much as a semblance of trial. In every single instance appearing in the record, subjects were used who did not consent to the experiments; indeed, as to some of the experiments, it is not even contended by the defendants that the subjects occupied the status of volunteers. In no case was the experimental subject at liberty of his own free choice to withdraw from any experiment. In many cases experiments were performed by unqualified persons; were conducted at random for no adequate scientific reason, and under revolting physical conditions. All of the experiments were conducted with unnecessary suffering and injury and but very little, if any, precautions were taken to protect or safeguard the human subjects from the possibilities of injury, disability, or death. In every one of the experiments the subjects experienced extreme pain or torture, and in most of them they suffered permanent injury, mutilation, or death, either as a direct result of the experiments or because of lack of adequate follow-up care. Obviously all of these experiments involving brutalities, tortures, disabling injury, and death were performed in complete disregard of international conventions, the laws and customs of war, the general principles of criminal law as derived from the criminal laws of all civilized nations, and Control Council Law No. 10. Manifestly human experiments under such conditions are contrary to “the principles of the law of nations as they result from the usages established among civilized peoples, from the laws of humanity, and from the dictates of public conscience.”
Whether any of the defendants in the dock are guilty of these atrocities is, of course, another
question Under the Anglo-Saxon system of jurisprudence every defendant in a criminal case is presumed to be innocent of an offense charged until the prosecution, by competent, credible proof, has shown his guilt to the exclusion of every reasonable doubt. And this presumption abides with the defendant through each stage of his trial until such degree of proof has been adduced. A “reasonable doubt” as the name implies is one conformable to reason — a doubt which a reasonable man would entertain. Stated differently, it is that state of a case which, after a full and complete comparison and consideration of all the evidence, would leave an unbiased, unprejudiced, reflective person, charged with the responsibility for decision, in the state of mind that he could not say that he felt an abiding conviction amounting to a moral certainty of the truth of the charge. If any of the defendants are to be found guilty under counts two or three of the indictment it must be because the evidence has shown beyond a reasonable doubt that such defendant, without regard to nationality or the capacity in which he acted, participated as a principal in, accessory to, ordered, abetted, took a consenting part in, or was connected with plans or enterprises involving the commission of at least some of the medical experiments and other atrocities which are the subject matter of these counts. Under no other circumstances may he be convicted. Before examining the evidence to which we must look in order to determine individual culpability, a brief statement concerning some of the official agencies of the German Government
and Nazi Party which will be referred to in this judgment seems desirable.
Fifty Years Later: The Significance of the Nuremberg Code
1.The voluntary consent of the human subject is absolutely essential. 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.
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 is the most important document in the history of the ethics of medical research. The Code was formulated 50 years ago, in August 1947, in Nuremberg, Germany, by American judges sitting in judgment of Nazi doctors accused of conducting murderous and torturous human experiments in the concentration camps (the so-called Doctors’ Trial). It served as a blueprint for today’s principles that ensure the rights of subjects in medical research. Because of its link with the horrors of World War II and the use of prisoners in Nazi concentration camps for medical experimentation, debate continues today about the authority of the Code, its applicability to modern medical research, and even its authorship. The chief prosecutor at the Doctors’ Trial, General Telford Taylor, believed that one of the three U.S. judges, Harold Sebring, was the author of the Code.2 Two American physicians who helped prosecute the Nazi doctors at Nuremberg, Leo Alexander and Andrew Ivy, have each been identified as the Code’s author. A careful reading of the transcript of the Doctors’ Trial, background documents, and the final judgment reveals that authorship was shared and that the famous 10 principles of the Code grew out of the trial itself.
In this article I will explain the important role that physicians had in the prosecution of the Nazi doctors and in the formulation of the Nuremberg Code and summarize how medical researchers have used the Code as a guide over the past five decades.
The Doctors’ Trial
The main trial at Nuremberg after World War II was conducted by the International Military Tribunal. The tribunal was made up of judges from the four allied powers (the United States, Britain, France, and the former Soviet Union) and was charged with trying Germany’s major war criminals. After this first-of-its-kind international trial, the United States conducted 12 additional trials of representative Nazis from various sectors of the Third Reich, including law, finance, ministry, and manufacturing, before American Military Tribunals, also at Nuremberg. The first of these trials, the Doctors’ Trial, involved 23 defendants, all but 3 of whom were physicians accused of murder and torture in the conduct of medical experiments on concentration-camp inmates.7
The indictment of the defendants was filed on October 25, 1946, 25 days after the conclusion of the first Nuremberg trial by the International Military Tribunal. The Doctors’ Trial began on December 9, 1946, and ended on July 19, 1947. The case was heard by three judges and one alternate. Thirty-two prosecution witnesses and 53 defense witnesses, including the 23 defendants, testified. A total of 1471 documents were introduced into the record. Sixteen of the 23 defendants were found guilty; 7 of them were sentenced to death by hanging, 5 to life imprisonment, 2 to imprisonment for 25 years, 1 to imprisonment for 15 years, and 1 to imprisonment for 10 years. Seven were acquitted. The sentences were confirmed by the military governor, and, after the U.S. Supreme Court declined to review the case, the executions were carried out at the Landsberg prison.
For the United States and its chief prosecutor, Telford Taylor, the trial was a murder trial (and murder had been identified by the International Military Tribunal as a crime against humanity). Nonetheless, as Taylor pointed out in his opening statement, this was “no mere murder trial,” because the defendants were physicians who had sworn to “do no harm” and to abide by the Hippocratic Oath. He told the judges that the people of the world needed to know “with conspicuous clarity” the ideas and motives that moved these doctors “to treat their fellow human beings as less than beasts,” and that “brought about such savageries” so that they could be “cut out and exposed before they become a spreading cancer in the breast of humanity.” One recurring theme was the relevance of Hippocratic ethics to human experimentation and whether Hippocratic moral ideals could be an exclusive guide to the ethics of research without risk to the human rights of subjects. In the trial’s exploration of ideas that shaped medical-research ethics, three physicians had central roles: Leo Alexander, an American neuropsychiatrist, Werner Leibbrand, a German psychiatrist and medical historian, and Andrew Ivy, a renowned American physiologist.
Leo Alexander, a Viennese-born American physician, had joined the U.S. Army Medical Corps in 1942, before being stationed in England at the American Eighth Air Force base. At the end of the war, Alexander was sent on a special mission under the Combined Intelligence Objectives Sub-Committee, an intelligence organization with members from several nations, and charged by orders from Supreme Headquarters of Allied Expeditionary Forces to gather evidence for the Nuremberg trials. Two days before the opening of the Doctors’ Trial, Alexander gave Taylor a memorandum entitled “Ethical and Non-Ethical Experimentation on Human Beings,” in which he identified three ethical, legal, and scientific requirements for the conduct of human experimentation. The first requirement established the right of the competent experimental subject to consent or refuse to participate in these terms: “the subject should be willing to undergo the experiment of his own free will. . . .” The second focused on the duty of physicians as expressed in the Hippocratic Oath, which Alexander restated in research terms: “the medical Hippocratic attitude prohibits an experiment if the foregone conclusion, probability or a priori reason to believe exists that death or disabling injury of the experimental subject will occur.” The third characterized good research practices.
On April 15, 1947, Alexander gave Taylor a second memorandum. In it he set forth in greater detail six specific conditions for ethically and legally permissible experiments on human beings. The first stated that
the legally valid voluntary consent of the experimental subject is essential. This requires specifically the absence of duress, sufficient disclosure on the part of the experimenter and sufficient understanding on the part of the experimental subject of the exact nature and consequences of the experiment for which he volunteers, to permit an enlightened consent.
The five other conditions established the humanitarian nature and purpose of the experiment and the scientific integrity and obligations of the investigator to the welfare of the subject.
On January 27, 1947, Werner Leibbrand, a German psychiatrist and medical historian at Erlangen University, opened the debate on medical ethics at Nuremberg. He explained to the court that German physicians at the beginning of the 20th century had adopted a “biologic thinking” according to which a patient was a series of biologic events, and nothing more than “a mere object, like a mail package.2 Leibbrand insisted that such a view precluded any human relation between physicians and their patients and that it represented a perversion of Hippocratic ethics and “a lack of morality and reverence for human life.”12 He strongly condemned physicians who conducted experiments on subjects without their consent, and testified that this was also the result of biologic thinking.
During cross-examination, defense lawyers asserted that “civilized” nations such as France, the Netherlands, Britain, and the United States had performed dangerous medical experiments on prisoners, often without their consent. They cited American malaria experiments12-14 to argue that Nazi physicians had followed common research practices. Leibbrand replied that this American research also was wrong because “prisoners were in a forced situation and could not be volunteers.” Leibbrand insisted that “the morality of a physician is to hold back his natural research urge which may result in doing harm, in order to maintain his basic medical attitude that is laid down in the Oath of Hippocrates.” This strong accusation of American research by the prosecution’s first medical-ethics witness created major unanticipated problems for the prosecution. It therefore became necessary to broaden the scope of the trial by defining the conditions under which risky human experimentation is ethically permissible.
Defense lawyers explained that Nazi doctors were ordered by the state to conduct such experiments as the high-altitude, hypothermia, and seawater experiments on inmates at the Dachau concentration camp to determine how best to protect and treat German fliers and soldiers. They contended that these experiments were necessary and that the “good of the state” takes precedence over that of the individual. Leibbrand replied that “the state could order deadly experiments on human subjects, but the physicians remained responsible for [not] carrying them out.” Once these physiologic experiments became the centerpiece of the trial, reliance on psychiatrists alone was not possible. The prosecution needed a prestigious medical scientist who was an authority on research physiology and whose wartime scientific interests corresponded to those of the Nazi doctor defendants. This expert was Andrew Ivy.
Andrew Ivy was an internationally known physiologist and a noted scientist. He also had first-hand knowledge of the Stateville Penitentiary experiments on malaria12,13 in his home state of Illinois, which the Nazi defendants attempted to liken to those performed on concentration-camp inmates. When the secretary of war, through the surgeon general of the army, asked the board of trustees of the American Medical Association to nominate a medical advisor to the Nuremberg prosecution, Ivy emerged as the natural nominee. On June 12, 1947, Ivy came to Nuremberg for the third time, this time to testify in rebuttal for the prosecution. His testimony, the longest of the trial, lasted four days.
In direct examination, Ivy presented to the judges three research principles that he had formulated at the request of the American Medical Association and which, he said, reflected common research practices. His document entitled “Principles of Ethics Concerning Experimentation with Human Beings,” adopted by the American Medical Association House of Delegates in December 1946, read in part:
1. Consent of the human subject must be obtained. All subjects have been volunteers in the absence of coercion in any form. Before volunteering, subjects have been informed of the hazards, if any. Small rewards in various forms have been provided as a rule.
2. The experiment to be performed must be based on the results of animal experimentation and on a knowledge of the natural history of the disease under study, and must be so designed that the anticipated results will justify the performance of the experiment. The experiment must be such as to yield results for the good of society, unprocurable by other methods of study, and must not be random and unnecessary in nature. The experiment must be conducted only by scientifically qualified persons and so as to avoid all unnecessary physical and mental suffering and injury and only after the results of adequate animal experimentation have eliminated any a priori reason to believe that death or disabling injury will occur. . . .15
Ivy explained that these common-sense principles mirrored the understanding shared by everyone in practice in the medical community. The first principle was that a physician would never do anything to a patient or subject before obtaining his or her consent. Ivy also asserted that, unlike Leibbrand, he did not consider prisoners to be in an inherently coercive situation and thus unable to give consent, because in democratic countries where the rights of individuals are respected, prisoners can always say yes or no without fear of being punished. He testified:
The American malaria experiments with 800 or more prisoners were absolutely justified, scientifically, legally and ethically even if they bring with them danger to human life. To treat malaria was an important scientific problem, and so long as the subjects volunteer and are explained the hazards of the experiments, there is no ethical reason against it. . . . If prisoners condemned to death are volunteers, then it was ethical to do just that.
During cross-examination, Ivy acknowledged that there were no written principles of research in the United States or elsewhere before December 1946 and that the principles adopted by the American Medical Association were expressly formulated for the Doctors’ Trial. Ivy also recognized that the right of the research subject to withdraw from an experiment may not always exist, as in the malaria experiments in which the subjects had already been infected, or in dangerous experiments in which the subjects could be severely injured or fatally harmed. Ivy agreed with Leibbrand that researchers must refuse to conduct experiments on human beings when ordered by the state in order “to save lives,” because in such cases subjects would not be volunteers. He declared that “[t]here is no justification in killing five people in order to save the lives of five hundred” and that “no state or politician under the sun could force [him] to perform a medical experiment which [he] thought was morally unjustified.” Ivy also stressed that the state may not assume the moral responsibility of physicians to their patients or research subjects, arguing that “[E]very physician should be acquainted with the Hippocratic Oath [which] represents the Golden Rule of the medical profession in the United States, and, to [his] knowledge, throughout the world.”12 When, finally, defense counsel asked Ivy to reconcile the Hippocratic moral maxim that forbids physicians to “administer a poison to anyone even when asked to do so” with conducting potentially lethal experimental interventions on volunteer subjects, Ivy replied, “I believe this Hippocratic commandment refers to the function of the physician as a therapist, not as an experimentalist, and what refers to the Hippocratic Oath is that he must have respect for life and the human rights of his experimental patient.”
Medical Ethics and Human Rights
The judges at Nuremberg, although they realized the importance of Hippocratic ethics and the maxim primum non nocere, recognized that more was necessary to protect human research subjects. Accordingly, the judges articulated a sophisticated set of 10 research principles centered not on the physician but on the research subject. These principles, which we know as the Nuremberg Code, included a new, comprehensive, and absolute requirement of informed consent (principle 1), and a new right of the subject to withdraw from participation in an experiment (principle 9). The judges adopted much of the language proposed by Alexander and Ivy but were more emphatic about the necessity and attributes of the subject’s consent and explicitly added the subject’s right to withdraw.
In the traditional Hippocratic doctor–patient relationship, the patient is silent and dutifully obedient to the beneficent and trusted physician. Obviously, the patient must seek the physician’s help and initiate the therapeutic relationship with the physician. But once patients agree to be treated, they trust that the physician will act in their interest, or at least will do no harm. In research, which is outside the beneficent context of the physician–patient relationship, this trust may be misplaced, because the physician’s primary goal is not to treat; rather, it is to test a scientific hypothesis by following a protocol, regardless of the patient-subject’s best interest. It is therefore only through a conflation of treatment and research that Alexander and Ivy believed they could expand on Hippocratic ethics to protect the rights of subjects in human experimentation. Their Hippocratic view of medical research may have prevented them from adequately appreciating the risks to research subjects, which are many times greater than the risks to patients who are merely being treated. Hippocratic ethics, even when supplemented with informed consent, tend to submerge the subject’s autonomy into what the physician-investigator thinks is best for the subject.
Informed consent, the core of the Nuremberg Code, has rightly been viewed as the protection of subjects’ human rights. The key contribution of Nuremberg was to merge Hippocratic ethics and the protection of human rights into a single code. The Nuremberg Code not only requires that physician-researchers protect the best interests of their subjects (principles 2 through 8 and 10) but also proclaims that subjects can actively protect themselves as well (principles 1 and 9). Most strikingly, for example, in Hippocratic ethics the subject relies on the physician to determine when it is in the subject’s best interest to end his or her participation in an experiment. In the Nuremberg Code, the judges gave the subject as much authority as the physician-researcher to end the experiment before its conclusion (principle 9).
50 Years after Nuremberg
The Nuremberg Code has not been officially adopted in its entirety as law by any nation or as ethics by any major medical association. Nonetheless, its influence on global human-rights law and medical ethics has been profound. Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the Uni Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).
The World Medical Association, established during World War II, has been accused of purposely trying to undermine Nuremberg in order to distance physicians from Nazi medical crimes. The election of a former Nazi physician and SS member, Hans-Joachim Sewering, to the presidency of that organization in 1992 added credibility to that accusation. (Because of public criticism, Sewering later withdrew.) Nonetheless, the various versions of the Declaration of Helsinki promulgated by the World Medical Association since 1964, although attempting to have peer review supplement informed consent and even supplant it as their central principle in the context of “therapeutic research,” all implicitly acknowledge Nuremberg’s authority. Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations, which require not only the informed consent of the research subject (with proxy consent sometimes acceptable, as for young children), but also prior peer review of research protocols by a committee (the institutional review board of the hospital or research institution) that includes a representative of the community.
The Nuremberg Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions that receive federal funds. Nonetheless, by insisting that medical investigators alone cannot set the rules for the ethical conduct of research, even when guided by beneficence and Hippocratic ethics, and by adopting a human-rights perspective that acknowledges the centrality of informed consent and the right of the subject to withdraw, the Nuremberg Code has changed forever the way both physicians and the public view the proper conduct of medical research on human subjects. Fifty years after Nuremberg, we recognize the human-rights legacy of the Nuremberg Code and are better able to face the critical challenge of applying the Code in its entirety and enforcing its human-rights provisions.
What Are The Nuremberg Code’s Ethical Guidelines For Research?
The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are:
- Voluntary consent is essential
- The results of any experiment must be for the greater good of society
- Human experiments should be based on previous animal experimentation
- Experiments should be conducted by avoiding physical/mental suffering and injury
- No experiments should be conducted if it is believed to cause death/disability
- The risks should never exceed the benefits
- Adequate facilities should be used to protect subjects
- Experiments should be conducted only by qualified scientists
- Subjects should be able to end their participation at any time
- The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur
The Significance Of The Nuremberg Code
The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP).
Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide.
Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects.
Nuremberg Code Addresses Experimentation, Not Vaccines
A bogus claim that “[v]accines are in direct violation of The Nuremberg Code” has been circulating on social media. Actually, the Nuremberg Code addresses the treatment of human subjects in medical experiments and says nothing about the use of tested and authorized vaccines on patients.
The code of medical ethics created in response to Nazi experiments during the Holocaust has been misrepresented by those pushing an anti-vaccine message during the COVID-19 pandemic.
This is just the latest example of a falsehood aimed at discrediting vaccines during the outbreak of the novel coronavirus, or SARS-CoV-2. Since April, we’ve debunked at least three other claims aimed at the same thing.
That’s not true.
The Nuremberg Code was written in 1947 during the trial in Nuremberg, Germany, of doctors who conducted medical experiments on more than 7,000 concentration camp prisoners during World War II. They tested ways to improve the chances of survival for Nazi soldiers in the field. They tested medical procedures and drugs. They conducted experiments to support their ideological view of racial superiority.
All of these experiments were done without the consent of the subjects.
That’s what the Nuremberg Code addressed — the treatment of human subjects in medical experiments.
“It’s about human experiments,” Jonathan Moreno, a medical ethics professor at the University of Pennsylvania, said of the Nuremberg Code in an email to FactCheck.org, emphasizing that the claim is false.
The code says nothing about the use of tested and authorized vaccines or treatments on patients.
“The purpose of the code was to say that what the Nazi doctors did would never happen again,” George Annas, director of the Center for Health Law, Ethics & Human Rights at Boston University School of Public Health, said in an interview with FactCheck.org.
Both Moreno and Annas said that the code could not be interpreted to bar vaccination.
The basis for this claim goes back much further than the pandemic, though. As is often the case with false claims like this, it appears to have evolved from a more vague suggestion made years ago.
In the 1990s, a prominent vaccine critic, Barbara Loe Fisher, cited one of the core principles stated in the Nuremberg Code — informed consent — to support her argument that parents should have more freedom to choose whether or not to vaccinate their children. All 50 states require children to be vaccinated in order to start school, according to the National Conference of State Legislatures. All 50 states also have medical exemptions, while 45 states and the District of Columbia offer religious exemptions.
But Loe Fisher appears to have mixed up two different lineages of informed consent — the one that applies to subjects of medical experimentation (as in the case of the Nuremberg Code) and the one that applies to patients in a regular health care setting (as in the case of vaccines).
In a television appearance in 1997, Loe Fisher said: “Informed consent has been the gold standard in medical practice ever since the Nuremberg Codes were passed after World War II. There should be no exception for vaccination.”
The website for her organization — the National Vaccine Information Center, which we’ve written about before — has a post that acknowledges that the code “speaks most specifically to the use of human beings in medical research.” But it goes on to claim that the code “has been viewed by bioethicists and U.S. courts as the basis for the right to informed consent to medical procedures carrying a risk of injury or death.”
That’s not true.
The Nuremberg Code has “only been used by courts in the human experimentation context,” Annas told us. And the principle of informed consent in the regular doctor-patient relationship, outside of medical experimentation, doesn’t come from the Nuremberg Code, he said. That developed separately.
The concept of informed consent in medical research grew largely out of unethical research projects conducted in the early 20th century, including the experiments during the Holocaust and the syphilis study done on black men without their consent in Tuskegee, Alabama, according to a paper from the Presidential Commission for the Study of Bioethical Issues, which distinguishes between the idea of informed consent for medical research and regular treatment.
The concept of informed consent in the health care setting, however, “developed from the intentional tort of battery, which protects individuals from an unwanted physical touching of the body by others having neither express nor implied consent of the person touched,” according to a paper published in the Mayo Clinic’s peer-reviewed journal.
In support of the bogus claim that the Nuremberg Code would apply to the use of vaccines, the National Vaccine Information Center’s post includes out-of-context quotes from two bioethicists.
One of them, Arthur Caplan, a professor of bioethics at New York University, told us in an email that the use of a quote from his 1992 article is “[c]ompletely erroneous” and is a “[f]lat out Reflection of both ignorance of history and ethics.”
It is “a gross disservice to the victims of brutal Nazi experiments to distort my words for lame anti-science that will kill people if this bilge is taken seriously,” Caplan said.
Jay Katz, the other professor whose work was cited by the National Vaccine Information Center, died in 2008. But his article was about the informed consent of human subjects in medical research. It had nothing to do with vaccines or informed consent among ordinary patients.
We asked the National Vaccine Information Center about the claims in its post, but it responded with the same information given on its website.
Despite the dubious claims it makes, the National Vaccine Information Center’s post is still being shared on social media and has been used to support other, related falsehoods about vaccines over the years.
As we’ve explained, the Nuremberg Code says nothing about the use of already tested and authorized medicine or prevention, like vaccines.
Why is the Nuremberg Code being used to oppose Covid-19 vaccines?
As the UK Covid-19 vaccine roll out has gathered pace, and the use of “vaccine passports” continue to be debated, an increasing number of social media users are voicing their opposition to these moves and claiming they are an infringement of their rights under the Nuremberg Code.
The Nuremberg Code is a set of ethical research principles, developed in the wake of Nazi atrocities—specifically the inhumane and often fatal experimentation on human subjects without consent—during World War Two.
We spoke to experts in medical ethics, healthcare law and social epidemiology about the Nuremberg Code and whether its principles are applicable to the current vaccine roll out or vaccine passports. We also discussed whether the code is legally binding and the darker links the claims seem to draw between the current pandemic and the Nazi era.
The Nuremberg Code and Covid-19 vaccines
We have seen several examples of posts on social media claiming that Covid-19 vaccines violate the Nuremberg Code because they are somehow “experimental” and, as people receiving the vaccines are not made aware of this, they are unable to give their informed consent.
This claim that the Covid-19 vaccines are experimental is simply not true, and something we have corrected multiple times. The three Covid vaccines currently given temporary authorisation for use in the UK have been shown to be safe and effective in large scale clinical trials.
Dr Alexis Paton, lecturer in social epidemiology and the sociology of health at Aston University, Birmingham, told Full Fact that the Nuremberg Code is “very specifically about experimentation” and so although its principles would be applicable when discussing clinical vaccine trials, it is no longer relevant once a vaccine has been authorised.
She said: “The Nuremberg Code is about the active experimentation on humans, for the most part during some sort of clinical trial of some description. So when we talk about Pfizer or AstraZeneca [vaccines], we’re out of the auspices of the Nuremberg Code because this is a product that has been trialled, with appropriate ethics in place, and has been approved and is now in production and being used globally.”
Informed consent is still required for those receiving the Covid-19 or any other vaccine. But Professor Emma Cave, professor of healthcare law at Durham University, explained that the need for this does not come from the Nuremberg Code.
She said: “The Nuremberg Code relates to research, where the emphasis of informed consent requirements is on preventing the research participants from being used as a means to an end.
“Informed consent for treatment serves a slightly different purpose. It prevents a battery or negligence, and protects the autonomy rights of the patient. So informed consent is doing slightly different things in relation to research and treatment.”
Arguments that the vaccines are experimental usually hinge on the fact that data is being collected on any side effects in recipients, although it is normal that authorities continue to monitor the safety of all vaccines once they are approved. Data on the long term protection and safety of the Covid-19 will continue to be collected over the coming years.
Dr Julian Sheather, special advisor in ethics and human rights to the British Medical Association, told Full Fact it would be “impossible” and “unethical” to roll out any medical intervention without collecting data on it.
“It’s true of all drugs. The same would be true of something like [the anti-depressant] Prozac. There will still be people out there gathering data. Are we going to say that every single drug in circulation is an experiment?”
Other claims about the ‘experimental’ nature of the vaccines hinge on the fact they were given temporary authorization to allow them to be distributed faster (although the vaccines still went through extensive clinical testing) and the fact the vaccines were developed so quickly (thanks in part to extra funding made available and ongoing work from before the pandemic).
The Nuremberg Code and vaccine passports
At the time of writing, the government has said that people who have had both doses of the vaccine can use the NHS app (separate to the NHS Covid-19 app) to demonstrate proof of vaccination when travelling to another country, if the country requires it. No other firm plans for ‘vaccine passports’ to gain access to certain places or events within the UK have been confirmed by the government, but discussion of their potential use has proved controversial.
A number of posts on social media have claimed that vaccine passports are a violation of the Nuremberg Code, on the grounds that if you have to have a vaccine in order to do something like travel or work, you are not actually consenting but are being forced.
Professor Cave said the Nuremberg Code was not relevant to vaccine passports. “You could still say it’s unethical or it’s problematic, but not by focusing on the Nuremberg Code. It’s not an experimental product in that context.
“If restrictions are applied in relation to those who haven’t been vaccinated against Covid, consideration needs to be taken of the potential impact on people’s ability to choose freely and on the possibility that such a policy might discriminate against some groups within society.
“We should be debating these matters, but we need to be accurate about the principles that we’re calling upon and the laws that we’re calling upon when we’re saying whether or not something is justifiable.”
Dr Paton told Full Fact: “The Nuremberg Code is all about experimental subjects’ rights and the responsibilities of those doing the experiment. A vaccine passport is a policy document.
“It’s not unprecedented either. For example, anyone who has ever travelled to a lot of the countries in Africa knows that you won’t be granted a visa if you don’t have proof of a Yellow Fever vaccination. But that’s not experimentation. That has nothing to do with us being human subjects of a trial of any kind. It’s about the government and politics.”
Is following the Nuremberg Code a legal requirement?
Although the Nuremberg Code is not relevant in the case of the current vaccine roll out or vaccine passports, there is still the question of whether a government could be forced by law, to halt or alter its vaccine programme if it is found to be in violation of the Code’s principles.
Professor Cave told Full Fact: “The Code isn’t and wasn’t legally binding. It’s not legally enforceable, it’s a guideline rather than law.
“But it is really important because it’s a blueprint for many of today’s legal and ethical standards, internationally and nationally […] the Nuremberg Code isn’t legally enforceable in itself, but its legacy has changed the way research is conducted and safeguarded to protect the human rights of research participants.”
We’ve seen multiple claims that various groups are attempting to take legal action using the Nuremberg Code over vaccination. Some international claims about this have already been fact checked. One is that a complaint has been filed with the International Criminal Court against the Israeli government, arguing that its vaccination programme is in violation of the Nuremberg Code, although Reuters has recently disproved claims that the court has “accepted” this allegation. Similarly, reports that a Canadian court ruled that anyone who tries to force someone to be vaccinated can be prosecuted under the Nuremberg Code have been debunked.
It is important to note that the Nuremberg Code is not the only set of ethical guidelines for human experimentation. For example, social media users could have drawn on the more recent Declaration of Helsinki (adopted in 1964, last updated 2013), UNESCO’s Universal Declaration on Bioethics and Human Rights (2005) or the International Ethical Guidelines for Health-Related Research Involving Humans (fourth version published 2016) to make similar (albeit also incorrect) claims.
But what is specific to the Nuremberg Code is the direct association with the atrocities committed by the Nazis during World War Two, and the emotional response this triggers. Although the social media posts don’t explicitly say it, by evoking the Nuremberg Code to talk about the Covid-19 pandemic, they link the horrors of concentration camps to the current vaccine roll out.
Misinformation thrives when feelings are manipulated in this way, as claims which create an emotional response are most likely to be shared.
The Nuremberg Code would only be relevant at the research trial stage of a vaccine’s development, not its roll out to the general public. But even then, experts told us they felt it would not be an appropriate link to draw.
Dr Paton said: “I think it really does a disservice to people who volunteered to be part of the Covid-19 trials. The Nuremberg Code was developed because of really truly horrific atrocities that we found humans can inflict on other humans.
“And to compare volunteers who want to help develop a vaccine, where the risks have been mitigated and they are being closely monitored, with the decisions of Nazi doctors to perform experiments on humans without anaesthetic, without safety, without regard for whether the human subject lived or died, I think is really inappropriate.”
Dr Sheather added: “It’s terrible bad faith, to be honest with you. Because the Nuremberg trials were investigations into the most brutal forms of medical violation of human beings in the name of some form of research. These research subjects were tested to death and destruction.
“Drawing a link between this final roll out of these vaccines and what the Nazi doctors were doing is morally grotesque.”
It’s right that medical ethics should be highly scrutinized, especially in cases like the Covid-19 vaccine roll-out where the process has been accelerated. However, it’s important not to mix up the atrocities of the past with current debates about medicine and policy.
The Nuremberg Code–A critique
The Nuremberg Code drafted at the end of the Doctor’s trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.
http://www.fhi360.org, ” The Nuremberg Code”; nejm.org, “Fifty Years Later: The Significance of the Nuremberg Code,” By Evelyne Shuster, Ph.D.; fullfact.org, “Why is the Nuremberg Code being used to oppose Covid-19 vaccines?” By Pippa Allen-Kinross; massdevice.com, “The Nuremberg Code and its impact on clinical research,” By Danielle Kirsh; factcheck.org, “Nuremberg Code Addresses Experimentation, Not Vaccines,” By Saranac Hale Spencer; researchgate.net, “The Nuremberg Code–A critique,” By Ravindra B. Ghooi; dal.ca.libguides.com, “Bioethics,” By Daniel Callahan;
The modern field of bioethics emerged in the 1950’s and 1960’s and represents a radical transformation of the much older, and traditional domain of medical ethics. The Dalhousie Department of Bioethics defines bioethics as the “critical analysis of emerging moral issues in health”. A good overview is presented in the section “Bioethics” in the Encyclopedia of Bioethics. 3rd ed. New York: Macmillan Reference USA, 2004. p278-287.
The term “bioethics” was first used by the biologist Van Rensselaer Potter (Potter, Van Rensselaer. Bioethics: bridge to the future. Englewood Cliffs, N.J.: Prentice-Hall, 1971. DALKIL QH 333 P66). Potter used the term to refer to a new field devoted to human survival and an improved quality of life. Gradually, the term “bioethics” came to refer to “the broad terrain of the moral problems of the life sciences, ordinarily taken to encompass medicine, biology, and some important aspects of the environmental, population and social sciences. The traditional domain of medical ethics would be included within this array, accompanied now by many other topics and problems.” (Encyclopedia of Bioethics. 1995. p. 250)
Four general areas of inquiry can be identified:
- Theoretical bioethics which deals with the intellectual foundations of the field.
- Clinical ethics which refers to the day-to-day moral decisions confronted in caring for patients.
- Regulatory and policy bioethics which seeks legal and policy solutions for moral problems concerning life and death. Examples of issues falling into this area would be use of fetal tissue in research, defining death, guidelines for do-not-resuscitate (DNR) orders in hospitals, euthanasia, cloning, rationing health care resources, and so on.
- Cultural bioethics
The moral questions of bioethics can also be viewed within broader theories of ethics, such as utilitarianism. A utilitarian approach asks which consequences of a choice or action or a policy would promote the best outcome. In this view, the broader good might be deemed the greatest good. The utilitarian view would, in the context of health care rationing, for example, look for the collective social benefit rather than advantages to individuals.
A deontological perspective, on the other hand, would argue that “good consequences may have to be set aside to respect inalienable human rights”. An example would be subjecting individuals to medical research that may do harm to that individual, while providing the potential to help others.
“Other moral theories, such as that of Aristotle, stress neither principles nor consequences but see a combination of virtuous character and seasoned practical reason as the most likely source of good moral judgement.” (Ibid., p. 252)
The approach of casuistry is to carefully examine individual cases in the solving of practical moral problems, and to let principles emerge from these over time. This process is similar to case-based English common law.
Robert Veatch, in his 1981 book, A Theory of Medical Ethics (DALWKK W 50 V395t 1981), proposed a new social contract between medicine and society. This “contract comprises basic ethical principles for society as a whole, a contract between society and the medical profession about the latter’s social role,and a contract between professionals and laypersons that spells out the rights and prerogatives of each”. (Ibid., p. 253)
“Contemporary feminist approaches to bioethics reject… the top-down rationalistic and deductivist model of an ethic of principles.” This approach puts much more emphasis on the context of moral decisions, on human relationships, and on the importance of feeling and emotion in making a moral decision. (Sherwin, Susan. No Longer Patient: Feminist Ethics and Health Care. Philadelphia: Temple University Press, 1992. DALWKK W 50 S554 1992)
Daniel Callahan suggests (Encycopedia of Bioethics, 1995, p. 254) that “the first task of bioethics…is to help clarify what should be argued about. A closely related task will be to suggest how these issues should be argued so that sensible, moral decisions can be made. Finally, there will be the more advanced, difficult business of finding and justifying the deepest theories and principles.” He suggests that there will be contention in each of these stages, but perhaps over time broad agreement on many issues will/can be reached. He points to such concepts as “patient rights”, “informed consent”, and “brain death”, all hotly debated at one time, have now achieved widespread acceptance.
Callahan identifies two kinds of fundamental questions that bioethics asks (Ibid., p. 255):
- “First, what kind of medicine and health care, what kind of stance toward nature and our environment, do we need for the kind of society we want?”
- “The second question reverses the first: What kind of a society ought we to want in order that the life sciences will be encouraged and helped to make their best contribution to human welfare?”
The late nineteenth century and first half of the the twentieth century revelled in an aura of triumphal positivism. The predominant attitude was that science produced facts which were solid, authoritative and didn’t need to be questioned. Ethics and values occupied a back room of intellectual pursuit, or fell into the domain of religion. Science and medicine in the past half century, however, in forging new frontiers have exposed questions relating to human experience that are soft, relativistic and personal. It is now generally agreed that facts cannot be considered separately from values. Rachel Carson in her book Silent Spring (1962) awoke society to the environmental hazards which have been posed by the human appetite for economic progress and the domination of nature. Today, in the medical and health fields health practitioners are frequently called on to make moral decisions as well as medical decisions. Indeed, it may be held that a good medical decision should be tantamount to a good moral decision. It is in this context that the field of bioethics has emerged as a vitally important field.
“What distinguishes ethics from science is not any special kind of knowledge but merely desire. The knowledge required in ethics is exactly like the knowledge elsewhere; what is peculiar is that certain ends are desired, and that right conduct is what conduces to them.” (Russell, Bertrand. What I Believe. New York: Dutton, 1925, pp. 19-24)
“Primum non nocere” (First do no harm)
Codes, oaths and prayers guiding health practitioners in caring for patients have been extant for centuries. Codes of ethics have been expressed in the form of prayers, oaths, creeds, institutional directives, and statements. “Prayers state a very personal commitment of duty; oaths publically pledge the oath taker to uphold specified responsibilities; and codes provide more comprehensive standards to guide the practicing health practitioner, patient, or other decision maker. Each form of ethical statement implies a moral imperative, either to be accepted by the individual personally or to be enforced by a practitioner organization, religious community, or governmental body.” (Veatch, Robert. 1995. “Medical Codes and Oaths” in vol. 1,pp. 1419-1435, Encyclopedia of Bioethics. 2nd ed. New York: Macmillan : Simon & Schuster Macmillan ; Prentice Hall International.
One of the earliest oaths is one for medical students taken from the Charaka Samhita manuscript of ancient India. This oath called upon the student to follow a path of personal sacrifice and commitment to duty. In western Medicine, the Hippocratic Oath has had great influence. The Oath of Asaf, from a seventh-century Hebrew medical manuscript, reveals Hippocratic influences in its injunctions against administering poisons or abortifacient drugs, performing surgery, committing adultery, and betraying practitioner confidences. In China, medical ethics appear in the Taoist writer Sun Szu-miao, whose writing stresses the importance of preserving life and serving the interests of the patient. The most widely known Jewish text is the Daily Prayer of a Physician, once ascribed to the Jewish philosopher and phyisician Moses Maimonides (1135-1204).
I swear by Apollo Physician and Asclepius and Hygieia and Panaceia and all the gods and goddesses, making them my witnesses, that I will fulfil according to my ability and judgment this oath and this covenant:
To hold him who has taught me this art as equal to my parents and to live my life in partnership with him, and if he is in need of money to give him a share of mine, and to regard his offspring as equal to my brothers in male lineage and to teach them this art – if they desire to learn it – without fee and covenant; to give a share of precepts and oral instruction and all the other learning to my sons and to the sons of him who has instructed me and to pupils who have signed the covenant and have taken an oath according to the medical law, but no one else.
I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.
I will neither give a deadly drug to anybody who asked for it, nor will I make a suggestion to this effect. Similarly I will not give to a woman an abortive remedy. In purity and holiness I will guard my life and my art.
I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.
Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves.
What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.
If I fulfil this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot.
Translation from the Greek by Ludwig Edelstein. From The Hippocratic Oath: Text, Translation, and Interpretation, by Ludwig Edelstein. Baltimore: Johns Hopkins Press, 1943.
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug.
I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.
Note: Students decide each year on the exact wording of the oath they will take for their convocation. The version presented here was the one taken for the 2002 convocation.
At this time of being admitted as a member of the medical profession, I solemnly swear by that which I hold most sacred, that I shall consecrate my life to the service of humanity;
That I shall maintain by all the means in my power, the honor and the noble traditions of the medical profession;
That I shall ever remember with gratitude my teachers in medicine;
That I shall constantly strive to add to my knowledge and skills, and be ever willing to assist others to the same end;
That I will use my knowledge to help the sick to the best of my ability and judgment, and will abstain from practices that would bring harm to my patients;
That I shall not undertake to perform tasks beyond my ability and competence;
And that in the practice of my profession, I shall preserve inviolate the confidences of my patients.
These promises I make solemnly, freely and upon my honor.
Major & Historical Codes
Charaka Samhita – one of the main texts of Ayurveda (“science of life”) – For a discussion see: Menon, I.A., and Haberman, H.F. 1970 “The Medical Students’ Oath of Ancient India.” Medical History 14, no.3: 295-299
Hippocratic Oath – Classical and modern versions (full text) – Dalhousie’s version
Oath of Maimonides and the Daily Prayer of a Physician (full text)
Thomas Percival. Medical Ethics. (1803) (DALWKK W 50 P429 1803F)
The English physician, Thomas Percival (1740-1804) in 1803 published his Medical Ethics; or, a Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons. This code, following in the tradition of the Hippocratic Oath was to influence the development of later codes of medical ethics. Indeed, the American Medical Association (AMA) adapted and adopted Percival’s code for use by American physicians in 1847. The Percivalian code asserted the moral authority and independence of physicians in service to others, affirmed the profession’s responsibility to care for the sick, and emphasized individual honor.
American Medical Association (AMA) Code of Ethics (1847) (full text – pdf)
The AMA Code of Ethics was adapted from the ethical code of conduct published in 1794 by Thomas Percival. This was the first code to be adopted by a national professional organization. The current AMA code of ethics (2001) has nine articles which is two more than the previous version (1980). These additions stress the responsibility the doctor has to the patient and the support of universal access to medical care. Provisions are also added to the revised Oath regarding a commitment to medical education and a responsibility for the betterment of public health. Other features of the Code are:
- dedication, competence, compassion and respect
- honesty and duty to report fraud or deception
- respect for the law
- respect for the rights of patients and colleagues
- respect for privacy and patient confidentiality
- continued education, study, and consultation with other professionals
- freedom of association and environment in the practice of the Art
- responsibility to make efforts to improve the community
Nuremberg Code (1947) (full text)
The product of international law, this code deals with medical research on human subjects and arose out of the post-WWII trial of Nazi doctors for crimes against humanity committed in the name of research. The Nuremberg Code sets out 10 principles outlining the ethics of medical research and ensuring the rights of human subjects::
- informed, voluntary consent
- research must be purposeful and necessary for the benefit of society
- research must be based on animal studies or other rational justification
- avoidance and protection from injury, and unnecessary physical and mental suffering
- risks to the subject shall not be greater than the humanitarian importance of the problem
- investigators must be scientifically qualified
- subject may terminate the experiment at any time
Declaration of Geneva (1948 – rev. 2002) (full text)
This oath for physicians was adopted by the newly established (1948) World Medical Association largely in response the atrocities committed in the name of research in WWII Nazi concentration camps. It was also meant to update the Hippocratic Oath to make it more applicable to the modern era.
World Medical Association International Code of Medical Ethics (1949)(full text)
This was an attempt to develop international standards of medical ethics and sought to summarize the most important principles of medical ethics.
Declaration of Helsinki (Adopted 1964; latest amendment 2013)(full text)
This document has been revised several times since its publication in 1964 as a response to unethical medical experiments of the Nazis during WWII. The latest revision of the declaration (2000) states that “the well-being of the human subject should take precedence over the interest of science and society.” Other of the Helsinki principles are that the doctor should only act in the patients best interest and that the health of the patient is the first concern. Many of the principles are incorporated in national research regulations.
The revised declaration also discusses the use of placebo, recommends that ethics committees have the obligation to monitor ongoing trials, and requires that researchers disclose to subjects details of funding and possible conflicts of interest. Finally, there is a recommendation that publishers decline studies not carried out in accordance with the declaration.
In addition to professional associations and governmental bodies, other organizations such as the Catholic Church have issued codes concerning matters of human health.
Religious Directives for Catholic Health Facilities (5th ed. 2009) (full text)
This document is written by the United States Conference of Catholic Bishops and is considered binding on not only Catholics but also non-Catholics who are associated with Catholic health facilities.
Instruction on Respect for Human Life (1987) (full text)
The Vatican’s Congregation for the Doctrine of the Faith makes known its stance concerning “biomedical techniques which make it possible to intervene in the initial phase of the life of a human being and in the very processes of procreation and their conformity with the principles of Catholic morality”.
Patient’s Bill of Rights (1973, rev. 1992) (full text)
The Patient’s Bill of Rights was first adopted by the American Hospital Association with the expectation that hospitals and health care institutions would support these rights in the interest of delivering effective patient care. It was also written partly as a response to the growing consumer health movement.
The Nuremberg Military Tribunal’s decision in the case of the United States v Karl Brandt et al. includes what is now called the Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects. According to this statement, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that “satisfy moral, ethical, and legal concepts.” To some extent the Nuremberg Code has been superseded by the Declaration of Helsinki as a guide for human experimentation.
–“Permissible Medical Experiments.” Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg October 1946 – April 1949, Washington. U.S. Government Printing Office (n.d.), vol. 2., pp. 181-182.
- 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 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 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 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.
- 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.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- 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.
- 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.
- Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury disability or death.
- 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.
- 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.
- 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 by him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Oath and Prayer of Maimonides
Moses Maimonides (1135/38-1204) (in Hebrew: Rav or Rabbi Moshe Ben Maimon, or “RaMBaM” — the acronym of his name), was the most important Jewish philosopher of the Middle Ages. Maimonides was born in the Spanish city of Cordoba at a time when about one-fifth of the people in southern Spain were Jews. However, Maimonides and his family fled to Fustat (now Cairo) because of rising anti-Semitism in Spain. There Maimonides worked as a physician, but also became a scholar of Jewish law and a philosopher.
The “Daily Prayer Of A Physician” is attributed to Maimonides, but was probably written by Marcus Herz, a German physician, pupil of Immanual Kant, and physician to Moses Mendelssohn. It first appeared in print in about 1793.The Oath of Maimonides
The eternal providence has appointed me to watch over the life and health of Thy creatures. May the love for my art actuate me at all time; may neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to Thy children.
May I never see in the patient anything but a fellow creature in pain.
Grant me the strength, time and opportunity always to correct what I have acquired, always to extend its domain; for knowledge is immense and the spirit of man can extend indefinitely to enrich itself daily with new requirements.
Today he can discover his errors of yesterday and tomorrow he can obtain a new light on what he thinks himself sure of today. Oh, God, Thou has appointed me to watch over the life and death of Thy creatures; here am I ready for my vocation and now I turn unto my calling.The Prayer of Maimonides
Almighty God, Thou has created the human body with infinite wisdom. Ten thousand times ten thousand organs hast Thou combined in it that act unceasingly and harmoniously to preserve the whole in all its beauty the body which is the envelope of the immortal soul. They are ever acting in perfect order, agreement and accord. Yet, when the frailty of matter or the unbridling of passions deranges this order or interrupts this accord, then forces clash and the body crumbles into the primal dust from which it came. Thou sendest to man diseases as beneficent messengers to foretell approaching danger and to urge him to avert it.
Thou has blest Thine earth, Thy rivers and Thy mountains with healing substances; they enable Thy creatures to alleviate their sufferings and to heal their illnesses. Thou hast endowed man with the wisdom to relieve the suffering of his brother, to recognize his disorders, to extract the healing substances, to discover their powers and to prepare and to apply them to suit every ill. In Thine Eternal Providence Thou hast chosen me to watch over the life and health of Thy creatures. I am now about to apply myself to the duties of my profession. Support me, Almighty God, in these great labors that they may benefit mankind, for without Thy help not even the least thing will succeed.
Inspire me with love for my art and for Thy creatures. Do not allow thirst for profit, ambition for renown and admiration, to interfere with my profession, for these are the enemies of truth and of love for mankind and they can lead astray in the great task of attending to the welfare of Thy creatures. Preserve the
strength of my body and of my soul that they ever be ready to cheerfully help and support rich and poor, good and bad, enemy as well as friend. In the sufferer let me see only the human being. Illumine my mind that it recognize what presents itself and that it may comprehend what is absent or hidden. Let it not fail to see what is visible, but do not permit it to arrogate to itself the power to see what cannot be seen, for delicate and indefinite are the bounds of the great art of caring for the lives and health of Thy creatures. Let me never be absent- minded. May no strange thoughts divert my attention at the bedside of the sick, or disturb my mind in its silent labors, for great and sacred are the thoughtful deliberations required to preserve the lives and health of Thy creatures.
Grant that my patients have confidence in me and my art and follow my directions and my counsel. Remove from their midst all charlatans and the whole host of of ficious relatives and know-all nurses, cruel people who arrogantly frustrate the wisest purposes of our art and often lead Thy creatures to their death.
Should those who are wiser than I wish to improve and instruct me, let my soul gratefully follow their guidance; for vast is the extent of our art. Should conceited fools, however, censure me, then let love for my profession steel me against them, so that I remain steadfast without regard for age, for reputation, or for honor, because surrender would bring to Thy creatures sickness and death.
Imbue my soul with gentleness and calmness when older colleagues, proud of their age, wish to displace me or to scorn me or disdainfully to teach me. May even this be of advantage to me, for they know many things of which I am ignorant, but let not their arrogance give me pain. For they are old and old age is not master of the passions. I also hope to attain old age upon this earth, before Thee, Almighty God!
Let me be contented in everything except in the great science of my profession. Never allow the thought to arise in me that I have attained to sufficient knowledge, but vouchsafe to me the strength, the leisure and the ambition ever to extend my knowledge. For art is great, but the mind of man is ever expanding.
Almighty God! Thou hast chosen me in Thy mercy to watch over the life and death of Thy creatures. I now apply myself to my profession. Support me in this great task so that it may benefit mankind, for without Thy help not even the least thing will succeed.
~ Translated by Harry Friedenwald, Bulletin of the Johns Hopkins Hospital28: 260-261, (1917)
Patient’s Bill of Rights
Patient’s Bill of Rights (American Hospital Association)
The Patient’s Bill of Rights was first adopted by the American Hospital Association in 1973 and revised in October 1992. Patient rights were developed with the expectation that hospitals and health care institutions would support these rights in the interest of delivering effective patient care. The American Hospital Association encourages institutions to translate and/or simplify the bill of rights to meet the needs of their specific patient populations and to make patient rights and responsibilities understandable to patients and their families.
According to the American Hospital Association, a patient’s rights can be exercised on this or her behalf by a designated surrogate or proxy decision-maker if the patient lacks decision-making capacity, is legally incompetent, or is a minor.Bill of Rights
- The patient has the right to considerate and respectful care.
- The patient has the right and is encouraged to obtain from physicians and other direct caregivers relevant, current, and understandable information about his or her diagnosis, treatment, and prognosis.
- Except in emergencies when the patient lacks the ability to make decisions and the need for treatment is urgent, the patient is entitled to a chance to discuss and request information related to the specific procedures and/or treatments available, the risks involved, the possible length of recovery, and the medically reasonable alternatives to existing treatments along with their accompanying risks and benefits.
- The patient has the right to know the identity of physicians, nurses, and others involved in his or her care, as well as when those involved are students, residents, or other trainees. The patient also has the right to know the immediate and long-term financial significance of treatment choices insofar as they are known.
- The patient has the right to make decisions about the plan of care before and during the course of treatment and to refuse a recommended treatment or plan of care if it is permitted by law and hospital policy. The patient also has the right to be informed of the medical consequences of this action. In case of such refusal, the patient is still entitled to appropriate care and services that the hospital provides or to be transferred to another hospital. The hospital should notify patients of any policy at the other hospital that might affect patient choice.
- The patient has the right to have an advance directive (such as a living will, health care proxy, or durable power of attorney for health care) concerning treatment or designating a surrogate decision-maker and to expect that the hospital will honor that directive as permitted by law and hospital policy.
- Health care institutions must advise the patient of his or her rights under state law and hospital policy to make informed medical choices, must ask if the patient has an advance directive, and must include that information in patient records. The patient has the right to know about any hospital policy that may keep it from carrying out a legally valid advance directive.
- The patient has the right to privacy. Case discussion, consultation, examination, and treatment should be conducted to protect each patient’s privacy.
- The patient has the right to expect that all communications and records pertaining to his/her care will be treated confidentially by the hospital, except in cases such as suspected abuse and public health hazards when reporting is permitted or required by law. The patient has the right to expect that the hospital will emphasize confidentiality of this information when it releases it to any other parties entitled to review information in these records.
- The patient has the right to review his or her medical records and to have the information explained or interpreted as necessary, except when restricted by law.
- The patient has the right to expect that, within its capacity and policies, a hospital will make reasonable response to the request of a patient for appropriate and medically indicated care and services. The hospital must provide evaluation, service, and/or referral as indicated by the urgency of the case. When medically appropriate and legally permissible, or when a patient has so requested, a patient may be transferred to another facility. The institution to which the patient is to be transferred must first have accepted the patient for transfer. The patient also must have the benefit of complete information and explanation concerning the need for, risks, benefits, and alternatives to such a transfer.
- The patient has the right to ask and be told of the existence of any business relationship among the hospital, educational institutions, other health care providers, and/or payers that may influence the patient’s treatment and care.
- The patient has the right to consent to or decline to participate in proposed research studies or human experimentation or to have those studies fully explained before they consent. A patient who declines to participate in research or experimentation is still entitled to the most effective care that the hospital can otherwise provide.
- The patient has the right to expect reasonable continuity of care and to be informed by physicians and other caregivers of available and realistic patient care options when hospital care is no longer appropriate.
- The patient has the right to be informed of hospital policies and practices that relate to patient care treatment, and responsibilities. The patient has the right to be informed of available resources for resolving disputes, grievances, and conflicts, such as ethics committees, patient representatives, or other mechanisms available in the institution. The patient has the right to be informed of the hospital’s charges for services and available payment methods.
The collaborative nature of health care requires that patient and/or their families and surrogates participate in their care. The effectiveness of care and patient satisfaction with the course of treatment depends, in part, on the patient’s fulfilling certain responsibilities:
- Patients are responsible for providing information about past illnesses, hospitalizations, medications, and other health-related matters. .
- Patients must take responsibility for requesting additional information or clarification about their health status or treatment when they do not fully understand the current information or instructions.
- Patients are responsible for making sure that the health care institution has a copy of their written advance directive if they have one.
- Patients are responsible for informing their physicians and other caregivers if they anticipate problems in following prescribed treatment.
- Patients also should be aware that the hospital has to be reasonably efficient and equitable in providing care to other patients and the community. The hospital’s rules and regulations are designed to help the hospital meet this obligation.
- Patients and their families are responsible for being considerate of and making reasonable accommodations to the needs of the hospital, other patients, medical staff, and hospital employees.
- Patients are responsible for providing necessary information for insurance claims and for working with the hospital as needed to make payment arrangements.
- A patient’s health depends on much more than health care services. Patients are responsible for recognizing the impact of their lifestyles on their personal health.
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