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.Design: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.Setting:Germany.Participants: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 €2947. 1 of 8 ethics committees at universities (€250) and 8 of 10 at medical chambers charged a median fee of €162 (mean €269.70). The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval (37, 39, 42 and 104).Conclusion: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.

Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects

“…This may be a reason why many reports from the USA rarely mentioned ethical protection if patient data or records and/or pathological or diagnostic specimens were analysed. There are also variations in the ethical review procedures of REC, within and between countries, and these may influence research practice, especially in conducting a multi-centre study 3,7,20 .…”

Interrupted or Continuous Slowly Absorbable Sutures For Closure of Primary Elective Midline Abdominal Incisions

“…10 Prior to the enrolment of the first patient, all surgeons were trained in vitro with the help of an animal model and videos in the closure and knot techniques to standardize the interventions. 10 Prior to the enrolment of the first patient, all surgeons were trained in vitro with the help of an animal model and videos in the closure and knot techniques to standardize the interventions.…”

Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

“…failure to comply with correct procedures, missing information and discrepancies [ 6 ]. In studies on the evaluation process itself, the critical aspects have included the evaluation time [ 7 ], a lack of uniformity in application forms and variations in the approval procedures adopted by different committees within the same country [ 8 , 9 ].…”