The Foundation for the Ethical Conduct of Clinical Research

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The Foundation for the Ethical Conduct of Clinical Research
2010-10-22 15:32:22
Nuremberg Code

The modern history of human subject protections begins with the discovery of the atrocities committed by Nazi physicians. The judges at the trial had no basis in law by which to judge the Nazi physicians. They developed 10 principles for this purpose, and these principles formed the basis of what came to be known as the Nuremberg Code for research involving human subjects.
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  1. When was the Nuremburg Code adopted
    August 1947
  2. 10 Principles of the Nuremberg Code
    • voluntary informed consent
    • benefits to individuals or society
    • based on prior animal experiments
    • risks must be minimized
    • conducted to avoid physical and mental suffering and injury
    • will not be conducted if death or disabling injury will occur
    • preparations and adquate facilities to protect the subject from injury
    • conducted by scientifically qualified personnel
    • subject may withdraw at any time
    • scientist must be prepared to terminate the study if it is likely to result in injury or death
  3. Totally voluntary, informed consent.
    This means that the person involved should beable to give consent; is able to exercise free power of choice, without the intervention ofany element of force, fraud, deceit, duress, overreaching, or other form of coercion; andshould have sufficient knowledge to make an enlightened decision. This requires thatbefore the acceptance of a decision to participate by the experimental subject, she or heshould know the nature, duration, and purpose of the experiment; the method and meansby which it is to be conducted; all inconveniences and hazards reasonably to be expected;and the effects upon health, which may possibly come from participation in the experiment.
  4. Justification of benefit to individuals or society.
    The experiment should yield results for the good of society, unobtainable by other means of study, and not random andunnecessary in nature. The degree of risk to be taken should never exceed thatdetermined by the humanitarian importance of the problem to be solved by the experiment.
  5. Absolute avoidance of physical and mental suffering and injury.
    The experimentshould be conducted avoiding all unnecessary physical and mental suffering and injury.During the experiment, the scientist in charge must be prepared to terminate theexperiment at any time, if she or he has reason to believe, in the exercise of good faith,superior skill, and careful judgment, that a continuation of the experiment is likely to resultin injury, disability, or death to the experimental subject. No experiment should beconducted if there is a prior reason to believe that death or disabling injury will occur,except, perhaps, in those experiments in which the experimental physicians also serve assubjects. Proper preparations should be made and adequate facilities provided to protectthe experimental subject against even remote possibilities of injury, disability, or death.
  6. Conducted only by qualified scientists.
    The experiment should be conducted only byscientifically qualified persons. The highest degree of skill and care should be required ofthose who conduct or engage in the experiment.
  7. Ability of subjects to withdraw at any time.
    During the experiment, the humansubject should be able to bring her or his participation in the experiment to an end if she orhe has reached the physical or mental state in which continuation of the experiment seemsto be impossible.
  8. Unfortunately, it did not have much impact in the United States outside of the scholarly community