The Origin of Good Clinical Practices for the United States and European Union
Global health authorities (HAs), including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), adhere to a set of principles called Good Clinical Practices (GCPs), which are the basis of modern human medical experiments and were developed to ensure the protection of human subjects participating in clinical trials. The history of GCP dates back to the Nuremberg Trials of 1947 (post WWWII), which resulted in the Nuremberg code, a set of tenets describing ethical research and conditions under which medical experimentation on human subjects is acceptable. Today, GCPs are detailed in a guidance document, International Conference on Harmonization (ICH) E6(R2), generated by a consortium of global HAs.
Below are the 10 basic tenets of the Nuremberg code.
The voluntary consent of the human subject is absolutely essential.
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.
Mahin Arastu
Lead Medical Writer