The Nuremberg Code

A brief introduction of The Nuremberg Code.

1. The Nuremberg Code By Himanshu Yadav M. Pharm. 2 nd Semester Pharmacology Roll No. 201408006

2. Nuremberg Code The Nuremberg Code ( German :  Nürnberger Kodex ) is a set of research ethics principles for human experimentation created by the USA v Brandt  court as one result of the Nuremberg trials at the end of the Second World War.

3. History Before the formation of Nuremberg Code there were 3 drafted codes First Prussian directive on informed consent (1891) Berlin Code (1900)- directed its attention to beneficence and autonomy. Guidelines to Human experimentation (1931)- Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines

4. Requirement of Ethics: Evidence From Nazi Experiments In Nazi Germany, German physicians planned & enacted the "Euthanasia" Program ignoring the drafted codes The systematic killing of those they deemed "unworthy of life“ The victims included the mentally retarded, the institutionalized mentally ill & the physically impaired During World War II, German physicians conducted pseudoscientific medical experiments utilizing thousands of concentration camp prisoners without their consent. Most victims died or were permanently crippled

5. Nuremberg Trials (1946-1947) Held from 9 Dec 1946 to 19 Aug 1947 22 men & 1 woman tried for participation in experiments The defendants in this case were charged with murders, tortures & other atrocities committed in the name of medical science

6. Nuremberg Code Voluntary Consent 2. Scientific Studies 3. Prior Knowledge 4. Injury and Suffering 5. Protection against Risk 6. Qualified Investigators 7. Freedom to Withdraw 8. Termination of Studies

7. Nuremberg Code Voluntary Consent The voluntary consent of the human subject is absolutely essential. It means that the person involved should have legal capacity to give consent ; without the intervention of any element of force, fraud or other ulterior form of constraint. Subject should have sufficient knowledge of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. 

8. Nuremberg Code Scientific Studies 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. Prior Knowledge 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.

9. Nuremberg Code Injury and Suffering 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 prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

10. Nuremberg Code Protection against risk 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.

11. Nuremberg Code Qualified Investigators 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. Freedom to withdraw 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.

12. Nuremberg Code Termination of Studies 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.

13. Significance of 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 . The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects. 

14. References The Nuremberg Code (1947) In: Mitscherlich A, Mielke F.  Doctors of infamy: the story of the Nazi medical crimes . New York: Schuman, 1949: xxiii-xxv. Ghooi RB. The Nuremberg Code-A critique. Perspect Clin Res. 2011 Apr;2(2):72-6. doi : 10.4103/2229-3485.80371. PMID: 21731859; PMCID: PMC3121268.

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