Nieuwe richtlijn toetsing multicentrisch onderzoek

In 2012 the Dutch Central Committee on Research Involving Human Subjects (CCMO) introduced a new procedure to obtain medical ethics committee approval for multicentre studies in the Netherlands. A recent cohort study demonstrated that the 2012 procedure is a more efficient one. Our additional prospective evaluation of two multicentre trials confirmed this finding; the implementation of the 2012 procedure in 16 participating centres shortened the local review procedure by a median of 20 days (from 45 to 25 days). However, 6 of the 16 centres (38%) apparently did not follow the new procedure. Strict procedural adherence has the potential to further streamline the process for obtaining ethical approval for multicentre trials in the Netherlands.

Conflict of interest and financial support: the work of Nicolien Schepers is financially supported by the Netherlands Organization for Health Research and Development (ZonMw) programme ‘DoelmatigheidsOnderzoek’ (grant nr. 837002008) and the NutsOhra Fund (grant nr. 1203-052). Disclosure forms provided by the authors are available along with the full text of this article at www.ntvg.nl, search for A7328; click on ‘Belangenverstrengeling’ (‘Conflict of interest’).