Medisch-ethische toetsing van multicentrisch onderzoek kan sneller: Nieuwe richtlijn biedt ruimte voor verbetering

Background: The procedure for approval of local feasibility of a study by the hospital management, which is needed to obtain ethical approval to start a study in the Netherlands, caused enormous delays in multicenter research. As a consequence of these delays the Central Commission for Human Research (CCMO) started a new procedure for local approval, laid down in the External Review Directive, which took effect on 1 March 2012. This procedure is mandatory and consists of 3 steps. In step 1, the head of the department signs the Declaration, in step 2, the research dossier has to be submitted to an accredited METC, in step 3, the boards of the participating centres have to provide written consent. When this is signed, the department can start their participation. Aim: To evaluate whether this External Review Directive improved the speed of the start of multicenter studies in The Netherlands. Design: Cohort study. Methods: We studied the time to approval of local feasibility of seven multicenter studies under the new procedure. All studies were run within the research consortium for Obstetrics and Gynecology in the Netherlands. We compared centers working or not working in accordance with the new directive. For comparison we also mentioned time to approval of local feasibility of 13 studies started under the former regulations. Time to approval was displayed in Kaplan-Meier curves, a log rank test was used to test for differences between centers working or not working in accordance with the new directive. Results: The median time of issue of the approval letter by the primary evaluative center to approval by the Board of Directors of the participating center was 93 days under the new procedure: 50 days for centers that perform the procedure in accordance with the directive (31 submissions) and 118 days for centers working not in accordance with the new directive (79 submission), Log rank test p-value 0.003. The group of hospitals that worked in accordance with the new directive approved 58% of the submissions within 60 days, in the group of hospitals that did not work according to the new directive this was 27%. Under the former procedure, the median time to approval was 103 days. Conclusion: The new External Review Directive for multicentre studies provides an improvement in time to approval of local feasibility for multicentre trials, if hospitals commit to the directive. However, many hospitals do not yet comply with this Directive, which still delays studies unnecessarily.