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- The text of the Nuremberg Code
- Context about the Code (the trials, the reception of the code)
The text of the Nuremberg Code (back to top) As published by the court at the end of the Nuremberg trials of 20 Nazi doctors.
- 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. The 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 rest upon the 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 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.
About the Code (last updated August 27, 2002) (back to top) The Nuremberg Code, a 10-point declaration setting standards for human experimentation but not actually law itself, stems from the Nuremberg Medical Trial (sometimes known as "The Doctors' Trial" or "The Medical Case"), one of 12 supplementary cases that the United States prosecuted against Nazi officials after World War II (the United States initially participated with other Allied powers in prosecuting 24 high-ranking Germans in the first Nuremberg trials, conducted from October 1945 to October 1946). In the Nuremberg Medical Trial, the United States prosecuted 23 defendants, 20 of whom were doctors, for war crimes, conspiracy, crimes against humanity, and membership in criminal organizations. American prosecutors sought to show that Nazi medical experiments were unacceptable by the standards of the medical profession and of the German government itself. The defendants countered that there was no such thing as a fully informed volunteer and that the United States itself conducted experiments on prisoners, such as the malaria experiments conducted on state prisoners in 1945. At the time the trial began, the United States had no formal position on human experimentation. Eager to close this potential point in the German defendants' favor, expert witness Dr. Andrew C. Ivy, the AMA's official consultant to the Nuremburg prosecutors, set forth rules that the AMA distilled into a three-point policy it adopted on December 11, 1946, the day after the Nuremburg Medical Trial opened. The AMA policy required the human subject's voluntary consent, that animal experimentation precede any human experimentation, and that the experiment be managed under proper medical protection and management. Ultimately, the judges in the tribunal did not need to decide the medical-experimentation question and instead convicted 15 of the 23 defendants on murder charges. Seven were sentenced to death, and eight to prison terms. Karl Brandt, Hitler's personal physician, offered to avoid being hung by participating in a fatal medical experiment, but he was executed nonetheless. The judges also issued the set of principles now known as the Nuremburg Code. Owing something to Dr. Ivy's principles and the AMA's new policy, the code require the voluntary consent of a human subject, that animal experiments precede human ones, the avoidance of undue risk, and the right of the subject to terminate the experiment at any time. The Nuremberg Code is the most famous articulation of how ethical research involving human subjects should be conducted, but, on its own, it is not actually law in the United States or the world (for more on the code, go here). In the years following the Nuremberg trials, some branches of the U.S. government began adopting rules for ethical research along the lines of the Nuremberg Code. The National Institutes of Health opened its Clinical Center in 1953 with a policy requiring "voluntary agreement based on informed understanding" from all research subjects. That same year, the U.S. military adopted a formal policy reiterating the principles of the Nuremberg Code, requiring the written and witnessed consent from human subjects, and prohibiting the use of prisoners of war. The military policy was to govern the "use of human volunteers by the Department of Defense in experimental research in the fields of atomic, biological and/or chemical warfare," and it was implemented with additional protections by the Army in June 1953 (for example, about 2,300 Seventh-Day Adventist Church members who objected to combat did volunteer for experiments from 1954 into the 1970s), but it was not fully communicated among those it covered. Similarly, the head of the Atomic Energy Commission, Carroll Wilson, wrote two letters in 1947 expressing that clinical testing with patients was permissible only when the patient might benefit medically from the experiment and when the patient had been informed and given his consent to the experiment, but the policy was not disseminated and radiation experiments nonetheless were conducted in violation of such principles. This patchwork of unevenly-implemented policies showed that some people were thinking about how to conduct ethical research, but that the Nuremberg Code was not yet doctrine. In any case, some doctors and government agents in the 1950s and 1960s conducted a variety of controversial experiments on human subjects, often without their knowledge or consent. Public reaction to such experiments led to more widespread changes in the 1970s (for more, go here. Some have criticized the code for not going far enough, and others have criticized it for not providing sufficient guidance. For example, Henry Beecher, a doctor who published a vehement attack in 1966, argued that informed consent was meaningless because few subjects would have the expertise to truly understand the science involved, and because the Code would prevent the kinds of random experiments that led to breakthroughs such as x-rays and penicillin. Sources: Jonathan D. Moreno, Undue Risk: Secret State Experiments on Humans (W.H. Freeman and Company, 2000). The Department of Energy published a comprehensive report of human experimentation in February 1995; this report, Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records, is on-line here.
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