Description of the REC system
There are 53 ethics committees in Germany, whereas 33 are attached to Faculties of Medicine at Universities, 17 are attached to Medical Associations in the States and three committees are attached to States governments. These RECs are legally competent ethics committees to review all kind of biomedical research, including drug research and research using removed biological materials of human origin and/or using personal data for epidemiologic research (European Network of Research Ethics Committees).
For studies performed by researchers attached to a university, the REC of the Faculty of Medicine or of that University is entitled to assess the research. For studies carried out by researchers outside a university, the REC of the regional Medical Association is legally competent. In the States Berlin, Bremen and Sachsen-Anhalt, RECs are attached to the Government with the competence to assess clinical drug trials and trials on medicinal devices (Medical Ethics Committees in Germany).
Clinical trials involving drugs are covered by the German Drug Law. Research involving medical devices is covered by Medical Device Law. There is no specific legislation concerning other biomedical research, except general data protection laws. Medical researchers are however obligated by the code of deontology, which, in the German States is a legally binding instrument, and /or by the "Intramural Right" of Universities to submit any biomedical research project to the competent REC. Regarding drug research and research on medicinal devices, REC approves or disapproves the project. Regarding other biomedical research, the decision of the REC is to be considered as an advice (Medical Ethics Committees in Germany).
Medical Ethics Committees in Germany (provides overview and links to the different ethics committees)
The German Reference Centre for Ethics in the Life Sciences (gives opinions on general ethical issues and may give advice to the Ethics Committees of the Medical Associations at their request)
The National Council for Ethics
European Network of Research Ethics Committees [online]. Available at: <http://www.eurecnet.org/information/germany.html>. [Accessed 18. June 2014].
Medical Ethics Committees in Germany [online]. Available at: < http://www.ak-med-ethik-komm.de>. [Accessed 18. June 2014].