The Nuremberg Code: From Ethics To Law

The Nuremberg Code is a set of ethical research principles for human experimentation. It was formulated in August 1947 in Nuremberg, Germany, by a panel of American judges during the trials of 23 Nazi doctors accused of conducting experiments on humans in concentration camps during World War II. The Code was included in the Nuremberg Military Tribunal's decision in the case of the United States v. Karl Brandt et al., one of the Subsequent Nuremberg trials that were held after the Second World War. The Code has not been officially adopted as law by any nation or as ethics guidelines by any association, but it is considered a landmark document in medical and research ethics and has influenced global human rights law and medical ethics.

The Nuremberg Code's influence on global human rights law and medical ethics

The Nuremberg Code is a set of ten ethical research principles for human experimentation. It was created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War. The Code was included in the Nuremberg Military Tribunal's decision in the case of the United States v Karl Brandt et al.

The Code's influence on global human rights law and medical ethics has been significant. While it has not been officially accepted as law by any nation or as official ethics guidelines by any association, its impact has been far-reaching. The Nuremberg Code is considered by some to be the most important document in the history of clinical research ethics due to its massive influence on global human rights.

In the United States, the Code played a crucial role in shaping the Common Rule, a set of regulations promulgated by the United States Department of Health and Human Services to ensure the ethical treatment of human research subjects. These regulations are now codified in Part 46 of Title 45 of the Code of Federal Regulations and are enforced by Institutional Review Boards (IRBs).

Additionally, the Nuremberg Code has influenced international law and guidelines. The International Covenant on Civil and Political Rights, adopted by the United Nations in 1966, includes Article Seven, which prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject. This Covenant has been ratified by 173 states as of September 2019. The Code also served as a basis for the World Health Organization's International Ethical Guidelines for Biomedical Research Involving Human Subjects.

The Nuremberg Code has set a precedent for ethical medical research and experimentation, emphasizing the importance of informed consent, absence of coercion, properly formulated scientific experimentation, and beneficence towards experiment participants. It has raised awareness and set standards for the protection of human subjects in research, ensuring that their rights and well-being are respected.

The Code's authorship

The Nuremberg Code was created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War. The code was articulated as part of the court's verdict in the trial, which became known as the "Doctors' Trial".

The authorship of the code is a matter of some controversy. Some sources claim that Harold Sebring, one of the three U.S. judges who presided over the Doctors' trial, was the author. Leo Alexander, MD, and Andrew Ivy, MD, the prosecution's chief medical expert witnesses, have also been identified as authors. In a letter to Maurice Henry Pappworth, an English physician, Andrew Ivy claimed sole authorship of the code. Leo Alexander also claimed sole authorship approximately 30 years after the trial.

However, after a careful reading of the transcript of the Doctors' trial, background documents, and the final judgments, it is now more widely accepted that the authorship was shared and the code grew out of the trial itself. Andrew Ivy, the American physiologist who assisted the court at the Doctor’s trial and suggested at least three points for the Nuremberg Code, claimed during cross-examination that there were no written principles of research in the United States or elsewhere before December 1946. This statement was, at best, a misrepresentation of facts and, at worst, an act of perjury.

The Nuremberg Code is considered by some to be the most important document in the history of clinical research ethics, due to its massive influence on global human rights. It has been described as a cornerstone of clinical research and bioethics.

The Doctors' Trial

The defendants were accused of four charges: conspiracy to commit war crimes and crimes against humanity; war crimes, namely performing medical experiments without the subjects' consent; crimes against humanity, including German nationals; and membership in a criminal organisation, the SS. Twenty of the 23 defendants were medical doctors, and they were accused of involvement in Nazi human experimentation and mass murder under the guise of euthanasia. The prosecution's opening statement described the defendants' crimes:

> "The defendants in this case are charged with murders, tortures, and other atrocities committed in the name of medical science. The victims of these crimes are numbered in the hundreds of thousands. A handful only are still alive; a few of the survivors will appear in this courtroom. But most of these miserable victims were slaughtered outright or died in the course of the tortures to which they were subjected. 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."

The Code's applicability to modern medical research

The Nuremberg Code is a set of ethical research principles for human experimentation. It was created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War. The Code is not officially accepted as law by any nation or as official ethics guidelines by any association. However, it is considered by some to be the most important document in the history of clinical research ethics due to its massive influence on global human rights. The Code has influenced the drafting of regulations to ensure the ethical treatment of human research subjects, such as the Common Rule in the United States.

The Nuremberg Code's ten points outline the ethical principles that should be followed when conducting human experimentation. These points include the voluntary consent of the human subject, the duty to ascertain the quality of consent, the potential benefits of the experiment for society, the need to avoid unnecessary suffering and injury, the degree of risk, the qualifications of the scientists conducting the experiment, and the right of the human subject to terminate the experiment.

Secondly, the Code emphasises the need for humane experimentation that is justified by its potential benefits to society. This means that the experiment should be designed to yield fruitful results that cannot be obtained by other means and should be based on prior animal experimentation and a thorough understanding of the problem under study. This principle ensures that human subjects are not subjected to unnecessary risks or harm.

Thirdly, the Code addresses the issue of risk and potential harm to human subjects. It states that no experiment should be conducted if there is an a priori reason to believe that death or disabling injury will occur. The degree of risk should be proportional to the humanitarian importance of the problem being addressed. This principle ensures that human subjects are not subjected to excessive risk and that their safety and well-being are prioritised.

Finally, the Code highlights the responsibilities of the scientists conducting the experiment. It states that the experiment should be conducted by scientifically qualified persons who possess the highest degree of skill and care. This ensures that human subjects are protected from potential harm or injury due to incompetence or negligence. Additionally, the Code gives the scientist in charge the authority to terminate the experiment at any stage if they believe that it is likely to result in injury, disability, or death to the human subject.

In conclusion, the Nuremberg Code has had a significant impact on the ethical conduct of modern medical research. Its principles, including informed consent, beneficence, avoidance of harm, proportionality of risk, and qualifications of researchers, have become widely accepted and have shaped the development of ethical guidelines and regulations for human subject research. While the Code is not officially recognised as law, it continues to serve as a foundational document in the field of clinical research ethics and human rights.

The Code's impact today

The Nuremberg Code has never been officially accepted as law by any nation or as official ethics guidelines by any association. However, it is considered by some to be the most important document in the history of clinical research ethics, because of its massive influence on global human rights.

In the United States, the Code and the related Declaration of Helsinki influenced the drafting of regulations to ensure the ethical treatment of human research subjects, known as the Common Rule. These regulations are now codified in Part 46 of Title 45 of the Code of Federal Regulations and are enforced by Institutional Review Boards (IRBs).

In 1966, the International Covenant on Civil and Political Rights was adopted by the United Nations, and after enough nations had ratified the Covenant, it came into force on 23 March 1976. Article Seven prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject. As of September 2019, the Covenant has 173 state parties.

In his 2014 review, Gaw observes that the Code "not only entered the legal landscape, but also became the prototype for all future codes of ethical practice across the globe." The idea of free or informed consent also served as the basis for International Ethical Guidelines for Biomedical Research Involving Human Subjects proposed by the World Health Organization.

In 1995, Judge Sandra Beckwith ruled in the case In Re Cincinnati Radiation Litigation (874 F. Supp 1995) that the Nuremberg Code may be applied in criminal and civil litigation in the Federal Courts of the United States.

Frequently asked questions