Analysis

Procedures for ethical review for clinical trials within the EU

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

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  1. Andreas A Schnitzbauer, clinical research fellow,
  2. Philipp E Lamby, clinical research fellow,
  3. Ingrid Mutzbauer, clinical study manager,
  4. Carl Zuelke, consultant,
  5. Hans J Schlitt, professor,
  6. Edward K Geissler, professor
  7. for the SiLVER05 Study Group
  1. 1Regensburg University Medical Centre, Department of Surgery, Franz-Josef-Strauss-Allee 11, 93053 Regensburg Germany
  1. Correspondence to: E K Geissler edward.geissler{at}klinik.uni-regensburg.de
  • Accepted 8 January 2009

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

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.

Study

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 and four sites outside the EU. Regensburg University Hospital is the trial sponsor and thus is responsible for its conduct; this point is a foundation of our trial and we made this clear to all parties involved. Although the manufacturer of the study drug provides funds for the trial, it is not the study sponsor and therefore does not conduct or administer the study, including relations with ethics committees.

Procedures for ethical approval

The procedures for ethical approval varied substantially among EU countries. In general, four different approval procedures were used: submission and approval for each site, approval from a lead or national committee serving as approval for all participating sites in the country, lead ethics approval from a central site and confirmatory approval at the …

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