インフォームド・コンセント成立の背景について

Abstract

The backgrounds of informed consent in the history are described with a special reference to human experimentation, clinical trials and physicians' morality and ethical codes. The first informed consent might be one by a Japanese surgeon Hanaoka Seishu (1760-1835), which included information of diagnosis, condition, and immunity to him in case of incidence. During the extensive development in medicine from the nineteenth to twentieth century, a number of inhumane experimentations were carried out in vulnerable subjects. Then, movement against cruel human experiments emerged, and headed toward establishment of human rights. The current concept of informed consent was introduced in 1900 by the Prussian government. In 1931, Reich Minister of the Interior issued the Guidelines for New Therapy and Human Experimentation, which included almost all informed consent rules in a current sense. However, these guidelines could not stop the abuse of people in medical research by doctors. After World War 2, the Nuremberg Code and Helsinki declaration have established the current form of informed consent. However, even this final form of informed consent could not stop the abuse of research subjects by doctors as exemplified by the Taskegee syphilis study, Willowbrook hepatitis trials and the Gelsinger case in the Pennsylvania University. We must remind ourselves the history of informed consent, which tells us that even the finest form of informed consent rule can be jeopardized easily by doctors resulting in the abuse of research subjects.