Which of the following was one of the main points of the Nuremberg code Quizlet

Which of the following was one of the main points of the Nuremberg code Quizlet

The Nuremberg Code is one of the most influential documents in the history of clinical research.

Natalie Jarmusik, Clinical Research Associate, IMARC Research

The Nuremberg Code is one of the most influential documents in the history of clinical research.

Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects.

We’ll take a closer look at its origins, its guidelines and its enduring impact.

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945.  As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas.  The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war.  Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany.  The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war.  It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party.  Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted.

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation.

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:

  1. Voluntary consent is essential
  2. The results of any experiment must be for the greater good of society
  3. Human experiments should be based on previous animal experimentation
  4. Experiments should be conducted by avoiding physical/mental suffering and injury
  5. No experiments should be conducted if it is believed to cause death/disability
  6. The risks should never exceed the benefits
  7. Adequate facilities should be used to protect subjects
  8. Experiments should be conducted only by qualified scientists
  9. Subjects should be able to end their participation at any time
  10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

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.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule.

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.

The opinions expressed in this post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

On August 19, 1947, the judges of the American military tribunal in the case of the USA vs. Karl Brandt et. al. delivered their verdict. Before announcing the guilt or innocence of each defendant, they confronted the difficult question of medical experimentation on human beings. Several German doctors had argued in their own defense that their experiments differed little from previous American or German ones. Furthermore they showed that no international law or informal statement differentiated between legal and illegal human experimentation. This argument worried Drs. Andrew Ivy and Leo Alexander, American doctors who had worked with the prosecution during the trial. On April 17, 1947, Dr. Alexander submitted a memorandum to the United States Counsel for War Crimes which outlined six points defining legitimate research. The verdict of August 19 reiterated almost all of these points in a section entitled "Permissible Medical Experiments" and revised the original six points into ten. Subsequently, the ten points became known as the "Nuremberg Code." Although the code addressed the defense arguments in general, remarkably none of the specific findings against Brandt and his codefendants mentioned the code. Thus the legal force of the document was not well established. 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. Nevertheless, it remains a landmark document on medical ethics and one of the most lasting products of the "Doctors Trial."

[from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]

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:

1. The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, 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.

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 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