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Chapter 7: Guidelines and regulations in clinical research
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Chapter 7: Guidelines and regulations in clinical researchLearning from past experiences – The Nuremberg Code
In 1947, the Nuremberg Code was created, this was the result of the Nuremberg Trial. During war,
prisoners were being abused, they were used in clinical experiments. After the second World War,
the people involved in those trials, they wanted justice. The doctors were brought to court and they
were convicted because of their experiments they performed during the war. The outcome of post-
World War II crimes trials of 23 German doctors for unethical medical experimentation in Nuremberg
(1946). This code is the result of this trial which was intended to convict these German doctors. Some
principles of this code are still applied today. This code is kind of the basis of the ethical principles.
The Nuremberg Code is founded by Doctor Leo Alexander in April 1947. The first and most important
principle is the principle of Voluntary Informed Consent: The subjects involved in an experiment
need to have the opportunity to say ‘yes’ or ‘no’ to participate. They need to be informed about the
experiment. The Nuremberg Code state ten principles for human experimentation:
1. The voluntary consent of the human subject is absolutely essential
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 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. So, preclinical data is
needed before we can go into humans
4. The experiment should be 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. This is
also part of the Belgian law
8. The experiment should be conducted only by scientifically qualified persons
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 judgement required of him that a continuation of the
experiment is likely to result in injury, disability, or death to the experimental subject. In
other words: if things go wrong, the scientist can terminate the experiment in every stage
Challenge trials – Inducing infections
The syphilis experiments were experiments in where persons got infected spontaneously (even when
they didn’t know). In this case, the people didn’t know there was a cure available, so they could
perhaps die! In other (viral) challenge trials, people were deliberately exposed to infectious agents.
To study these agents and the treatment against these agents. For example, think about the Corona
SARS-CoV virus. The idea is that they give a lot of information about the transmission of the disease,
the therapeutic value, the potential to test the vaccines, etc.. The subjects did know where they are
participating in! They are only acceptable to perform on a condition where the risk is extremely small
that the subjects will die. So, you expose healthy people to viruses which are not too virulent! In this
case, the disease won’t be that heavy, they will get a mild disease.
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