title: Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial.
abstract: OBJECTIVE
  To examine the current ethical review process (ERP) of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.
  
  
  METHODS
  Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial (INterrupted or continuous Slowly absorbable sutures-Evaluation of abdominal Closure Techniques Trial, ISRCTN 24023541) between November 2003 and May 2005.
  
  
  METHODS
  Germany.
  
  
  METHODS
  18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics committees were located at university medical schools (MSU) and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required (primary approval acting as the reference standard).
  
  
  RESULTS
  The duration of the ERP ranged from 1 to 176 (median 31) days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was euro2947. 1 of 8 ethics committees at universities (euro250) and 8 of 10 at medical chambers charged a median fee of euro162 (mean euro269.70). The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval (37, 39, 42 and 104).
  
  
  CONCLUSIONS
  The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country.
authors.affiliation: Department of General, Visceral and Trauma Surgery, University of Heidelberg, Heidelberg, Germany. christoph_seiler@med.uni-heidelberg.de
authors.forename: C M
authors.initials: CM
authors.lastname: Seiler
authors.forename: P
authors.initials: P
authors.lastname: Kellmeyer
authors.forename: P
authors.initials: P
authors.lastname: Kienle
authors.forename: M W
authors.initials: MW
authors.lastname: Büchler
authors.forename: H-P
authors.initials: HP
authors.lastname: Knaebel
mesh_terms: D026724:Ethical Review; D028741:Ethics Committees, Clinical; D032984:Ethics, Research; D005858:Germany; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D013537:Sutures