Informed consent in human experimentation before the Nuremberg Code.

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that them were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in Various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

First Prussian directive on informed consent

The introduction of scientific and experimental methodology into clinical medicine in the nineteenth century brought with it an increased demand for experimentation on human subjects, particularly in bacteriology, immunology, and physiology. This research was done mainly on patients in hospital, often without their consent, under an "ethos of science and medical progress." As a result of injury to some patients subjected to non-therapeutic research, however, controversy and public debate ensued about the ethics of human experimentation.[1-4]

In 1891 the Prussian minister of the interior issued a directive to all prisons that tuberculin for the treatment of tuberculosis "must in no case be used against the patient's will."[5] But the first detailed regulations about non-therapeutic research in Western medicine came from the Prussian minister for religious, educational, and medical affairs in 1900. They were issued after critical public discussion and political debate on the Neisser case in the Prussian parliament and set forth the legal basis of disclosure and unmistakable consent.[1 2] Of particular interest is the debate within the medical profession and the political circumstances.

The Neisser case

In 1898 Albert Neisser, discoverer of the gonococcus and professor of dermatology and venereology at the University of Breslau, published clinical trials on serum therapy …