naa a22 4500 510778968 CHVBK 20180411083240.0 cr unu---uuuuu 180411e20130601xx s 000 0 eng 10.1007/s11948-011-9299-6 doi (NATIONALLICENCE)springer-10.1007/s11948-011-9299-6 Graf Hans-Peter Mozartstrasse 21, 79104, Freiburg, Germany aut Are the Votes of Ethics Committees in Germany for the Protection of Clinical Study Trial Subjects "Sovereign Acts?” [Elektronische Daten] [Hans-Peter Graf] A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called "revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then "sovereign acts” or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee's vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult. Springer Science+Business Media B.V., 2011 Ethics committee nationallicence Medical association nationallicence German medical device regulation ( Deutsches Medizinproduktegesetz — MPG ) nationallicence German drug law ( Deutsches Arzneimittelgesetz — AMG ) nationallicence Sovereign act nationallicence Monopoly nationallicence Research subject protection nationallicence Science and Engineering Ethics Springer Netherlands 19/2(2013-06-01), 341-354 1353-3452 19:2<341 2013 19 11948 https://doi.org/10.1007/s11948-011-9299-6 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11948-011-9299-6 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Graf Hans-Peter Mozartstrasse 21, 79104, Freiburg, Germany aut NATIONALLICENCE 773 0- Science and Engineering Ethics Springer Netherlands 19/2(2013-06-01), 341-354 1353-3452 19:2<341 2013 19 11948 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer