Published 22 May 2009, doi:10.1136/bmj.b1893
Cite this as: BMJ 2009;338:b1893

Analysis

Procedures for ethical review for clinical trials within the EU

Andreas A Schnitzbauer, clinical research fellow, Philipp E Lamby, clinical research fellow, Ingrid Mutzbauer, clinical study manager, Carl Zuelke, consultant, Hans J Schlitt, professor, Edward K Geissler, professor, for the SiLVER05 Study Group

1 Regensburg University Medical Centre, Department of Surgery, Franz-Josef-Strauss-Allee 11, 93053 Regensburg Germany

Correspondence to: E K Geissler edward.geissler@klinik.uni-regensburg.de

Despite European legislation to harmonise procedures for ethical approval, Andreas Schnitzbauer and colleagues found getting approval for their multinational study was still complex and time consuming

The first 150 words of the full text of this article appear below.

In April 2001 the European parliament passed a directive to promote good practice in the conduct of clinical trials.1 Article 7 of the directive refers to multicentre trials and prescribes an ethics submission procedure that consists of only one lead ethics commission in each country performing a detailed evaluation and judgment on the protocol. However, our experience of getting approval for a trial after September 2004 suggests wide variation remains in the ethics processes of European Union countries.

Our study was set up to evaluate the potential survival and anti-tumour benefits of using a mammalian target of rapamycin inhibitor (sirolimus) in liver cancer patients who had received transplants.2 The study is an investigator initiated trial in 10 European countries (Austria, Belgium, Finland, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom) and three non-EU countries (Australia, Canada, and Norway) with a total of 40 sites in the EU . . . [Full text of this article]


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Rapid Responses:

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