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.
One notable exception was the German psychiatrist Albert Moll, who believed informed consent to be necessary in human trials.
[4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior[6] formulated a list of 14 points detailing these ethical principles.
[1] 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.
[7] 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.
[8] 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.
In the early 1940s in Germany doctors conducted Nazi human experimentation on unwilling test subjects; one way of describing the procedures could be to call it medical torture.
The panel recommended that federal regulations be designed and implemented to protect human research subjects in the future.
This report identifies respect for persons, beneficence, and justice as ethical principles which must underlie human subject research.
[12][13] It defines the laws, criteria for exemption, as well as definition and formulation of institutional review boards, though some agencies have established their own implementation of this code that supersedes portions or all of 45 CFR 46.
The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected.