Foddis, Antonella; Ippoliti, Roberto --- "The American and the European market of human experimentation: A comparative study on regulation and competitiveness" [2016] ELECD 341; in Eisenberg, Theodore; Ramello, B. Giovanni (eds), "Comparative Law and Economics" (Edward Elgar Publishing, 2016) 456

Book Title: Comparative Law and Economics

Editor(s): Eisenberg, Theodore; Ramello, B. Giovanni

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9780857932570

Section: Chapter 19

Section Title: The American and the European market of human experimentation: A comparative study on regulation and competitiveness

Author(s): Foddis, Antonella; Ippoliti, Roberto

Number of pages: 21

Abstract/Description:

The matter of research subjects’ rights was first addressed after the end of World War II, when Nazi experiments on Jews and prisoners were discovered. Those inhuman researches were motivated by racial conflict and the idea of rights for those kept in German concentration camps held no meaning. The subjects were coerced into participating and there was no informed consent about potential related risks (i.e. expected and unexpected adverse events). The Nazi experiments were aimed at improving the survival and rescue of German troops, by testing medical procedures and pharmaceuticals, as well as at supporting the Nazi racial ideology (Bernadac, 1978; Cohen, 1990, Pasternak, 2006). After that experience, society felt that it was its duty to prevent research involving people who were used as test subjects not of their own free will and to check the scientific aims of research studies. Thus, The Nuremberg Code of Ethical Human Subjects Research Conduct (1947) was drafted. This was the first international document on human experimentation and research subjects which highlighted the main right of patients: voluntary consent of human subjects involved in clinical trials. Obviously, this information concerns risk-benefit outcomes of experiments.