For research subject to the WMO a new template (in Dutch) for the Subject Information Sheet for subjects aged 16 and over (adults) is now available on the CCMO website. With this model investigators can draw up the information letter for adult research participants.
In addition to corrections of some ambiguities, adjustments have been made that were necessary due to changed and adapted legislation and regulations, such as the European Medicines Regulation (CTR) and amendments to the WMO and the Insurance Decree.
Researchers are requested to use the new model with immediate effect.