Are the Votes of Ethics Committees in Germany for

Authors: HansPeter Graf

Publish Date: 2011/08/05

Volume: 19, Issue: 2, Pages: 341-354

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Abstract

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 socalled “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 suborgans 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 longsought goal of having a statesanctioned monopoly The private ethics committees are not recognized as being authoritative bodies nor are they to be seen as such in the future ie such a status has been denied the Freiburg Ethics Commission International FEKI in BadenWürttemberg This political mistake must be corrected otherwise conducting clinical research will become increasingly difficult

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