Guidelines for human subject research

Various organizations have created guidelines for human subject research for various kinds of research involving human subject research and for various situations.

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:

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.

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.

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