Medical research ethics committees in the Federal Republic of Germany: establishment and integration into medical research

Abstract

In Germany, the only research ethics committees (RECs) that are entitled to assess all fields of biomedical research are those set up according to state law by faculties of medicine, medical associations or state authorities. In amultidisciplinary review, research projects are evaluated against the criteria of "scientific quality," "conformity with law" and "ethical and medical acceptability."Since 2004, the "favourable opinion" of anREC and the approval by the competent federal drug authority, jointly constitute alegal condition to conduct drug trials. As aconsequence of EU Regulation 536/2014, the importance of the decision of anREC for drug research will be diminished. For all other fields of biomedical research that are not covered by legislation, as is the case in drug research or in research with medical devices, the opinion of anREC is only considered as legally non-binding advice for the researcher.The local, independent RECs established the "Permanent Working Party of German Research Ethics Committees" to share experiences, to harmonise their work and to establish partnership with the public. This working party functions similarly to national research ethics committees in other states.