[Obtaining medical ethical approval for a multicentre, randomised study: prospective evaluation of a ponderous process].
OBJECTIVE
To evaluate the procedure to obtain medical ethical approval for a multicentre study in the Netherlands.


METHODS
Prospective and descriptive.


METHODS
The application procedure for medical ethical approval of a nationwide randomised multicentre trial (the 'Pancreatitis: surgical necrosectomy versus step up approach' (PANTER)-trial) from the ethics committees (EC) of 9 Dutch hospitals during 2004-2007, was prospectively evaluated. Several predefined variables regarding the duration of the ethical review process, the time invested and material and the type of queries raised by the ECs in all centres were collected.


RESULTS
Primary approval by the central EC of the coordinating hospital was obtained after 192 days. The duration of the review process for each of the 18 local participating centres was 105 days (range: 35-361). The maximum review term of 30 days, as defined in the national guideline, was reached by only one centre. It took two years to obtain approval for all participating centres. A median of 14 different documents (range: 5-23) were submitted to the EC of each participating centre. A total of 8314 A4 size papers (about 42 kg) were sent by post, 172 telephone calls were made and 136 e-mail messages were sent by the research fellow coordinating the application procedure. Of the local ECs in the participating centers, 95% requested additional revision of the patient information sheet and 78% requested changes in the informed consent form.


CONCLUSIONS
Obtaining medical ethical approval for this multicentre trial in the Netherlands was a long and inefficient process, requiring a considerable investment of time and resources. Streamlining the application procedure may lead to a substantial reduction in the current unnecessary delay of starting a multicentre study.
Universitair Medisch Centrum Utrecht, afd. Heelkunde, Huispost G.04.288, Postbus 85.500, 3508 GA Utrecht.
H C
HC
van Santvoort
M G H
MG
Besselink
H G
HG
Gooszen
D026724:Ethical Review; D017041:Ethics Committees / Q000458:organization & administration* / Q000592:standards; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic; D009426:Netherlands; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
Her verkrijgen van medisch-ethische goedkeuring voor een multicentrische, gerandomiseerde trial: prospectieve evaluatie van een moeizaam proces.