title: [Responsibility and function of Research Ethics Committees].
abstract: 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.
authors.affiliation: Vorsitzender des Arbeitskreises Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland, Ottostrasse 12, 50859, Köln. med.ethik.komm@netcologne.de
authors.forename: E
authors.initials: E
authors.lastname: Doppelfeld
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017041:Ethics Committees / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D005858:Germany; D006801:Humans; D018579:Patient Selection; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence