[Responsibility and function of Research Ethics Committees]

In Germany, only Research Ethics Committees (REC) set up according to States law at Faculties of Medicine, Medical Associations or States authorities are entitled to assess all areas of biomedical research. In a multidisciplinary review, research projects are evaluated using the criteria "scientific quality", "accordance with law" and "ethical acceptability". Since 2004, the "favorable opinion" of a REC is together with the approval by the competent Federal Authority a legal requirement for drug trials. For all other fields of biomedical research, the opinion of a REC is considered legally not binding advice for the researcher. For sharing of experiences, for harmonization of their work and for partnership with the public, the local-independent RECs established the "Permanent Working Group of German Research Ethics Committees". This group functions to a certain degree like central RECs in other States.