CiRA Reporter vol.21
January 30, 2020
Taichi Hatta

The History of Informed Consent

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CiRA Reporter

For new drugs and medical treatments to reach the market, they must be first tested for their safety and efficacy on a number of human volunteers in clinical trials. To perform the trials, the participating doctors and researchers must adequately explain to the volunteers the purpose and risk of the trial and receive agreement from the volunteers. This agreement is commonly known as “informed consent” and is used throughout the world. Because it is now standard, it is easy to forget that informed consent is only a recent invention that comes from an ugly history of human experimentation.

The term “informed consent” is considered to have first appeared in 1957 in a malpractice suit in the U.S. (Salgo decision). However, it was World War II and the human experimentation done by Nazi Germany doctors that pushed forward the idea of informed consent. Along with judging war criminals, the Nuremberg trials declared 10 ethical principles (the Nuremberg Code), with informed consent listed first. The Nuremberg Code is the foundation of research and medical ethics and impacts all international ethical guidelines including the Declaration of Helsinki.

To understand better the origin of informed consent I visited the Auschwitz-Birkenau extermination camps in August 2018. Human experiments were done in the first camp. It is now a museum and includes pictures and notes about the conditions (Photo 1). As for the second camp, which was a “death factory,” the Nazis destroyed much of it and the accompanying evidence of their crimes at the end of the war (Photo 2). Now it is a massive amount of open space with only traces of its gruesome past. Everyone has their own way of feeling to be in a place where something brutal had happened but only traces remain. For me, those traces resonate in my body.

Medical discoveries and medical practices are often the result of overcoming great challenges. Informed consent is continuously being developed to support these advances while protecting the patient. Informed consent is one example of the importance of bioethics. While research must benefit society, it must do so in an ethical way.


Photo 1: The entrance to Camp 1

Photo 2: Tracks leading to where Camp 2 once existed