What are the most historical and influential clinical research records in the world? It is the Nuremberg code. You have not heard it before? Well, you are not the only one. In these times of quarantine life, this may be the best time to uncover the truth behind it!
Let’s go back in history.
The creation dated during the 1930s and 1940s, wherein the German politics was rising in pre-World War II. A specific time in which the pre-war German Medical Association showed progress in the field. However, the democratic association did not fail to express their immediate concerns for public health. Before the mid-1920s, the exposure of such German physicians involved in unethical medical practices. The apparent goal was for them to produce an Aryan “master race”. Biology was profoundly used to push their agenda to produce “racial purity”, an ideology by the National Socialism. What happens when you do not fit the criteria? Never forget the Holocaust.
The Reich government took action and issued the “Guidelines for New Therapy and Human Experimentation”. It distinguishes the concrete difference between non-therapeutic and therapeutic research. What’s more, emphasizing the constitutional principle of informed consent.
Both German citizens and Jews, millions, suffered from such unethical medical practices but, justice was achieved. It was on August 20, 1947, where the verdict was handed through the revised ten points which then became the notable “Nuremberg Code”.
What are the ten points of the Nuremberg Code which were entitled “Permissible Medical Experiments” of the verdict?
- The essence of voluntary consent is indispensable.
- Any experimentation and outcomes must be for the greater good of society.
- Carrying out animal testing is imperative as the previous bases before human experiments.
- The conducted experiments should avoid any physical and psychological suffering or harm.
- There should be no human trials performed if it is believed to cause disability or death.
- The risks must never surpass the benefits.
- To protect the subjects the sufficient amenities must be used.
- The only eligible individuals to perform the clinical trials and experimentations are qualified scientists.
- The subjects of the trials have every right to end their partaking at any time.
- The in-charge scientist must be prepared to cease all trials when injuries, disabilities or death is liable to happen.
What’s its relation to the Good Clinical Practice (GCP)?
The Nuremberg Code is the biggest principle influence of GCP. It is the standard for the design in studying, implementations, conducting and analysis clinically. Supplementary texts that expound the ten points can be found in the Common Rule, Declaration of Helsinki and Belmont Report. Indeed, the GCP continues to update its guidance on clinical research to mirror the latest technologies and trends.
Despite all these advancements, it is imperative to remind the people that ethical clinical trials are important and protecting human subjects is crucial!
Featured Image: https://www.britannica.com/event/Nurnberg-trials