Two insurances (cont’d)
In January 2008 the UMC Utrecht announced an increased mortality in patients who participated in a double-blind randomized multicenter trial (i.e., the PROPATRIA trial). In the trial the effect of a probiotic preparation was studied in patients suffering from an acute and severe pancreatitis. The results were published in the Lancet.
As a result of the increased mortality rate in the probiotic arm of the study, the Dutch authorities launched an investigation. One of the findings was that the UMC
Utrecht (who was the sponsor of this investigator-initiated trial) did not take care of a proper research subject insurance for the patients that were included in one of the participating hospitals. In those days it was still possible that in a multicenter trial each participating hospital arranged its own research subject insurance. This created a lot of bureaucracy and room for confusion.
As a result of the findings by the authorities, the Dutch government amended the Insurance Decree in 2014 so that the sponsors of future multicenter trials are responsible for the arrangement of a single research subject insurance for the research subjects in all participating centers. The amended Insurance Decree went into force on July 1st in 2015.