The Nuremberg Code is the most important document in the history of medical research ethics, and arose out of the Nuremberg Military Tribunal’s decision in U.S. v. Karl Brandt, et. al — also known as, “The Doctor’s Trial.”
In 1947, an International Military Tribunal made up of judges from the four allied powers — the United States, Britain, France and the former Soviet Union — were tasked with trying Germany’s major war criminals.
The judges sat in judgment of twenty-three Nazi defendants, 20 of whom were physicians, accused of conducting horrific experiments on human subjects in concentration camps during the Holocaust.
According to Harvard Law, the specific crimes charged involved high altitude conditions, freezing, poison gas, sulfanilamide, bone, muscle and nerve regeneration, bone transplantation, saltwater consumption, epidemic jaundice, sterilization, poisons, incendiary bombs and “vaccine experiments” — carried out to test the effectiveness of vaccines against typhus, malaria, smallpox, cholera and other diseases.
The Nuremberg Code laid out ten points that defined permissible medical experimentation on human subjects and serves as a blueprint for today’s principles that ensure the rights of subjects in medical research. Accordingly, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that “satisfy moral, ethical and legal concepts.”
The Nuremberg Code states as follows:
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.
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 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.
Legal significance of the Nuremberg Code
According to the New England Journal of Medicine, the Nuremberg Code has not been officially adopted in its entirety as law by any nation or as ethics by any major medical association. However, it has significantly influenced global human-rights law and medical ethics.
Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966) which states: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”
The Nuremberg Code also serves as the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects — the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).
In addition, the Declaration of Helsinki — a set of ethical principles regarding human experimentation developed in 1965 by the World Medical Association –– acknowledged the Nuremberg Code’s authority.
Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations, which require the informed consent of the research subject and prior peer review of research protocols by a committee that includes a representative of the community
By insisting medical investigators alone could not set the rules for the ethical conduct of research, and by adopting a human-rights perspective with the concept of informed consent at its core, the Nuremberg Code forever changed the way physicians and the public view the proper conduct of medical research on human subjects.
To download a PDF version of the Nuremberg Code to use for your vaccine exemption or legal case, please click here.