The Institutionalization of Research Ethics Committees in Germany – International Integration or in the Shadow of Nuremberg?

Abstract

Abstract Although already established in West Germany since the 1970s, with the introduction of research ethics committees (rec s) into the Tokyo revision of the Declaration of Helsinki, they gained in importance. From 1985, a duty to consult rec s in human subject research was written into West German physicians’ codes of conduct. In East Germany (“Deutsche Demokratische Republik”, ddr), a central rec was set up in 1981 within the ddr Ministry of Health, and after German reunification, a duty to consult rec s was introduced in the federal Medical Products Act (Arzneimittelgesetz). Since 2001, European regulations were incorporated into national laws which applied in Germany as in other member states. Regarding the institution and legal history of rec s in Germany, this contribution seeks to answer three questions: (1) Were rec s developed in response to a specifically German experience of medical crimes and the abuse of human research subjects, or were they part of an internationalization of medical research ethics and international integration of German research? (2) Was the setting up of rec s in Germany a more top-down, centralized process or a more bottom-up, grassroots undertaking, and what does this tell us about the status that biomedical researchers gave to the ethics of human subject research in that period? And (3) who has traditionally held authority over human subject research in Germany and who holds it today?