User:Dsun15/sandbox

Instructions for the Directors of Clinics, Outpatient Clinics and Other Medical Facilities

In 1892, Albert Ludwig Sigesmund Neisser, a German physician who is credited with the discovery of Neisseria gonorrhoeae, performed two sets of clinical trials attempting to find a method of prevention for syphilis. Neisser first inserted serum obtained from a single patient who had begun exhibiting the early signs of syphilis under the skin of four female patients , similar to the procedure for smallpox inoculation. Neisser did not obtain consent from these patients, but none of them developed the disease. Neisser then conducted the second set of trials on four prostitutes. This time, the serums were injected intravenously and each serum was obtained from a different syphilis patient, each at various stages of the disease. The prostitutes from the second set of trials also neither consented nor were informed of the experimentation. Unlike the first set of trials, all four of the subjects developed syphilis at varying times after the injection.

In 1898, Neisser published his results from the clinical experiments he conducted, triggering a public outcry in which Neisser was accused of “maliciously inoculating innocent children with syphilis poison.” Neisser defended his actions, arguing that the prostitutes contracted syphilis from their line of work rather than his experiments, and had the general support of academic physicians. One notable exception was the German psychiatrist Albert Moll, who believed informed consent to be necessary in human trials.

Later that year, the Royal Disciplinary Court fined Neisser, ruling that he was negligent in obtaining consent from patients. In 1899, the Prussian minister for religious, academic, and medical affairs sought advice regarding the ethicality of Neisser’s experiments in response to a request from the Prussian parliament to take measures regarding the scandal, and commissioned a report from the Scientific Medical Office of Health. In 1900, the minister issued the “Instructions for the Directors of Clinics, Outpatient Clinics and Other Medical Facilities” for all medical directors regarding any medical procedure “other than for diagnosis, therapy, and immunization”.

The instructions state that medical experimentation would be prohibited if:

• the subject is a minor.
• the subject has not provided unambiguous consent.
• possible negative consequences have not been explained.
• there is no authorization from the medical director.

These instructions were not committed to law and as such were not legally binding. To this day, it remains unclear if the Prussian directive had any effect on human experimentation; however, these were still the first regulations regarding human medical experimentation in Western medicine.

Guidelines for Human Experimentation

One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt (translating roughly to National Health Service), under the Ministry of the Interior formulated a list of 14 points detailing these ethical principles.

The main points of the 1931 Guidelines for Human Experimentation are as follows:

• Full unambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances.
• Risks should be balanced out by potential benefits.
• Caution should be taken for subjects under 18 years old.
• Extreme caution should be taken if microorganisms are involved.
• Poor or socially disadvantaged subjects should not be exploited.
• Animal testing should be conducted first, and human experiments are to be avoided if other means of collecting data are still available.

The Guidelines were formed under the context of reforming criminal law in Germany and in partial response to public criticism of human experimentation. They also outline specific definitions for both therapeutic and non-therapeutic research in human subjects (dubbed “innovative therapy” and “scientific experimentation”), and set forth detailed boundaries for both. However, the vast majority of the physicians discussing the regulations prior to their instantiation were concerned primarily with the proper advancement of medical science rather than the protection of vulnerable patients.

The Guidelines shares similarities with the 1900 Prussian Instructions for the Directors in that both contain clauses for needing consent and for subjects who are underage. The Nuremberg Code would also later specify a requirement for informed consent, and contains other additional similarities to the Guidelines – for instance, both require risk to be balanced out by potential benefits, and both discourage the use of human experimentation if other means of obtaining the desired results are available. While the two are similar , the Guidelines contain more clauses and requirements regarding human experimentation. For example, the Guidelines also necessitate the creation of a report detailing the purpose and justification of the experiment. Ravindra Ghooi was critical of the Nuremberg Code, arguing that it bears too strong of a resemblance to the 1931 Guidelines to pass as coincidence, and that the 1931 Guidelines must have been used as reference in creating the Code. However, the Nuremberg Code does contain stipulations not found in the Guidelines – the clause requiring subjects be given the freedom to leave the experiment at any time is one such example.

The Guidelines for Human Experimentation remained in effect through the end of the Third Reich in 1945, and continued to exist in the law until 1948 . Notably, Nazi human experimentation occurred under the existence of these laws.