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Nuremberg code


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The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War

Nuremberg code

  1. 1. The Nuremberg Code
  2. 2. Objectives <ul><ul><li>Codes on Human Experimentation before Nuremberg Trial </li></ul></ul><ul><ul><li>Violation of rights of subjects at the hands of the Nazi’s </li></ul></ul><ul><ul><li>The investigations in war crimes and crimes against humanity </li></ul></ul><ul><ul><li>Formulation of the Nuremberg code and its basic tenets </li></ul></ul>
  3. 3. History <ul><li>During the Nuremberg trial it was made out that no code of medical ethics existed </li></ul><ul><li>Experts at the Doctor’s Trial ( Leo Alexander, Werner Liebrand and Andrew Ivy) submitted points which were incorporated in what is known as the Nuremberg Code. </li></ul>
  4. 4. Earlier Codes <ul><li>First Prussian directive on informed consent(1891) </li></ul><ul><li>The introduction of scientific and experimental methodology into clinical medicine in the nineteenth century </li></ul><ul><li>Increased demand for experimentation on human subjects, particularly in bacteriology, immunology, and physiology </li></ul>
  5. 5. Earlier Codes cont…1 <ul><li>This research was done mainly on patients in hospital, often without their consent </li></ul><ul><li>Injury to some patients subjected to non-therapeutic research, however, controversy and public debate ensued about the ethics of human experimentation </li></ul>
  6. 6. Earlier Codes cont…2 <ul><li>In 1891 the Prussian minister of the interior issued a directive to all prisons that tuberculin for the treatment of tuberculosis &quot;must in no case be used against the patient's will.” </li></ul>
  7. 7. The Neisser case <ul><li>Albert Neisser (1855-1916), discoverer of the gonococcus and professor of dermatology and venereology at the University of Breslau, published clinical trials on serum therapy in patients with syphilis </li></ul><ul><li>Injected cell free serum from patients with syphilis into patients who were admitted for other medical conditions. </li></ul>
  8. 8. The Neisser case cont.. <ul><li>Albert Moll, a psychiatrist in private practice in Berlin opposed the Neisser Trial. </li></ul><ul><li>Developed a legally based, positivistic contract theory of the patient-doctor relationship, which is widely ignored in current bioethics publications. </li></ul><ul><li>In 1898 the public prosecutor investigated the case, and Neisser was fined by the Royal Disciplinary Court. </li></ul>
  9. 9. Berlin Code (1900) <ul><li>In 1899, Minister for religious, educational, and medical affairs commissioned a detailed report from the Scientific Medical Office of Health, which was composed of leading German physicians such as Rudolf Virchow. </li></ul><ul><li>The commission directed its attention to beneficence and autonomy. </li></ul>
  10. 10. Berlin Code (1900) cont..1 <ul><li>It concluded that a physician who recognised that an injected serum might cause infection had no right to inject such a serum. In any case, both informing the subject and obtaining the subject's consent were preconditions to experimentation. </li></ul><ul><li>Emil von Behring argued that, self experimentation should always precede experiments on patients. </li></ul><ul><li>In 1900 the Minister for religious, educational, and medical affairs issued a directive to all hospitals and clinics. </li></ul>
  11. 11. Berlin Code (1900) code..2 <ul><li>Medical directors were advised that all medical interventions other than for diagnosis, healing, and immunization were excluded under all circumstances if &quot;the human subject was a minor or not competent for other reasons&quot; or if the subject had not given his or her &quot;unambiguous consent&quot; after a &quot;proper explanation of the possible negative consequences&quot; of the intervention. </li></ul>
  12. 12. Berlin Code (1900) cont..3 <ul><li>All research interventions could be performed only by the medical director or with his or her authorisation. </li></ul><ul><li>In all cases fulfilment of these requirements as well as all further circumstances of the case had to be &quot;documented in the medical history.“ </li></ul><ul><li>Despite all this, however, the directive was not legally binding and little is known of its impact on human experimentation. </li></ul>
  13. 13. Guidelines for Human Experimentation (1931) <ul><li>In 1931 in Germany, the Reich government issued detailed &quot;guidelines for new therapy and human experimentation </li></ul>
  14. 14. Guidelines for Human Experimentation (1931) cont..1 <ul><li>Besides the principles of beneficence and nonmaleficence, the regulations were based on patient autonomy and a legal doctrine of informed consent. </li></ul><ul><li>&quot; The guidelines clearly distinguished between therapeutic (&quot;new therapy&quot;) and nontherapeutic research (&quot;human experimentation&quot;) and set out strict precautions. </li></ul>
  15. 15. Guidelines for Human Experimentation (1931) cont..2 <ul><li>&quot;New therapy may be applied only if consent or proxy consent has been given in a clear and undebatable manner following appropriate information </li></ul><ul><li>New therapy may be introduced without consent only if it is urgently required and cannot be postponed because of the need to save life or prevent severe damage to health....&quot; In those cases a written report must clearly outline the preconditions. </li></ul>
  16. 16. Guidelines for Human Experimentation (1931) .cont..3 <ul><li>But non-therapeutic research was &quot;under no circumstances permissible without consent.” </li></ul><ul><li>Written documentation and a clear structure of responsibility for each clinical trial were required. </li></ul>
  17. 17. The Nazi Experiment <ul><li>Though several codes were published earlier had never been officially repealed, and were in force during WW-II, but were ignored. </li></ul><ul><li>The excesses committed by the Nazis horrified the world </li></ul>
  18. 18. The Nazi Experiment cont..1 <ul><li>In Nazi Germany, German physicians planned and enacted the &quot;Euthanasia&quot; Program, the systematic killing of those they deemed &quot;unworthy of life“ </li></ul><ul><li>The victims included the mentally retarded, the institutionalized mentally ill, and the physically impaired </li></ul>
  19. 19. The Nazi Experiment cont..2 <ul><li>Further, during World War II, German physicians conducted pseudoscientific medical experiments utilizing thousands of concentration camp prisoners without their consent. </li></ul><ul><li>Most died or were permanently crippled as a result. Most of the victims were Jews, Poles, Russians, and also Roma (Gypsies). </li></ul>
  20. 20. The Nazi Experiment cont..3 <ul><li>For the most part they are nameless dead. To their murderers, these wretched people were not individuals at all. They came in wholesale lots and were treated worse than animals. </li></ul><ul><li>Some of the medical experiments, including those for typhus, sea water, high-altitude, bone transplantation, extreme cold, sterilization, poison bullets, and skeleton collection. </li></ul>
  21. 21. The Nuremberg Trial (1947)
  22. 22. The Nuremberg Trial (1947) <ul><li>On December 9, 1946, an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. </li></ul><ul><li>known as the &quot;Doctors' Trial&quot; and the &quot;Medical Case,&quot; the trial was officially designated United States of America v. Karl Brandt . </li></ul>
  23. 23. The Nuremberg Trial (1947) cont..1 <ul><li>Held at the Palace of Justice in Nuremberg, Germany, the trial began on December 9, 1946. </li></ul><ul><li>Four American judges presided - Walter Beals, Johnson Crawford, Harold Sebring, and Victor Swearingen. </li></ul><ul><li>The trial described and documented some of the most gruesome and painful medical experiments carried out by Nazi Doctors. </li></ul>
  24. 24. The Nuremberg Trial (1947) cont..2 <ul><li>On trial were 22 men and one woman for their participation in these experiments. Most were doctors, though three were not. Some had been eminent physicians </li></ul><ul><li>The defendants in this case are charged with murders, tortures, and other atrocities committed in the name of medical science </li></ul>
  25. 25. <ul><li>The victims of these crimes are numbered in the hundreds of thousands. </li></ul><ul><li>A handful were alive; a few of the survivors appeared in the courtroom. </li></ul><ul><li>But most of these miserable victims were slaughtered outright or died in the course of the tortures to which they were subjected. </li></ul>The Nuremberg Trial (1947) cont..3
  26. 26. <ul><li>After hearing 85 witnesses and examining 1,471 documents that were presented, judgment was pronounced on August 19, 1947 with sentencing following on the next day. </li></ul><ul><li>Of the 23 defendants, 7 were sentenced the death by hanging (carried out at Landsberg Prison), 9 were given prison terms, and 7 were found not guilty. </li></ul>The Nuremberg Trial (1947) cont..4
  27. 27. The Nuremberg Trial (1947) cont..6 <ul><li>The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must confirm when carrying out experiments on human subjects in a new code that is now accepted worldwide. </li></ul><ul><li>This judgment established a new standard of ethical medical behavior for the post World War II human rights era. </li></ul>
  28. 28. The Nuremberg Trial (1947) cont..7 <ul><li>Amongst other requirements, this document set forth the requirement of voluntary informed consent of the human subject. </li></ul><ul><li>The principle of voluntary informed consent protects the right of the individual to control his own body. </li></ul>
  29. 29. The Nuremberg Trial (1947) cont..8 <ul><li>This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided. </li></ul><ul><li>This code recognizes that doctors should avoid actions that injure human patients. </li></ul>
  30. 30. Nuremberg Code <ul><li>The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War </li></ul>
  31. 31. Nuremberg Code cont..1 <ul><li>Permissible Medical Experiments </li></ul><ul><li>The principles established by this code for medical practice now have been extened into general codes of medical ethics. </li></ul><ul><li>Most Important is “Voluntary Consent” </li></ul>
  32. 32. Voluntary Consent <ul><li>1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. </li></ul>
  33. 33. Voluntary Consent cont..1 <ul><li>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 which may possibly come from his participation in the experiment. </li></ul>
  34. 34. Voluntary Consent cont..2 <ul><li>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. </li></ul>
  35. 35. Scientific Studies <ul><li>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. </li></ul>
  36. 36. Prior Knowledge <ul><li>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 justify the performance of the experiment </li></ul>
  37. 37. Injury & Suffering <ul><li>4. The experiment should be conducted so as to avoid all unnecessary physical and mental suffering and injury. </li></ul><ul><li>5. No experiment should be conducted where there is any prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. </li></ul>
  38. 38. Protection against Risks <ul><li>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. </li></ul><ul><li>7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death. </li></ul>
  39. 39. Qualified Investigators <ul><li>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. </li></ul>
  40. 40. Freedom to withdraw <ul><li>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. </li></ul>
  41. 41. Termination of Studies <ul><li>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. </li></ul>
  42. 42. Legal Status <ul><li>Nazi Doctors were not prosecuted on the basis of this code </li></ul><ul><li>Its publication made no difference to ongoing trials which were in violation of this code </li></ul><ul><li>The code was not accepted all over the world </li></ul>
  43. 43. Fallacies <ul><li>It is erroneously believed that the concept of Informed Consent was first introduced in this code </li></ul><ul><li>(Both the Berlin Code and 1931 Guidelines had the condition of consent) </li></ul>
  44. 44. Article 5 <ul><li>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. </li></ul>
  45. 45. Article 5 <ul><li>Use of the word “also” suggests that the physician can risk the lives of other subjects, so long he is also a subject. </li></ul><ul><li>Had the word used been “only” it would have made sense </li></ul>
  46. 46. Article 10 <ul><li>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. </li></ul>
  47. 47. Article 10 <ul><li>The words “must be prepared to terminate” are rather weak, and should have demanded termination of the experiment. </li></ul><ul><li>Substitution of these words with “must terminate” would have made this article stronger and enforceable. </li></ul>
  48. 48. Thank You