Research with people must undergo a medical ethical review when the Medical-Scientific Research with People Act (WMO) applies. In addition, there are many forms of “non-WMO-applicable” research with people for whom there is no legal assessment framework. How do we guarantee the quality of these studies?
This is a non-WMO study, which is an observational study in which no action or behavior is imposed on the participants in the study or in which the study does not count as a medical scientific study (but, for example, behavioral study). Quality criteria for non-WMO research do not have a legal foundation, unlike WMO research. The parties in the field (VIG, NFU, STZ, ACRON) consider it important that this type of research also meets jointly determined standards.
By review of these studies we contribute to:
From 1st January 2015 onward, non-WMO research that has been initiated and / or financed by pharmaceutical companies has been subject to mandatory preventive review based on the Assessment Framework (Toetsingskader). Applications for review must be submitted via nwmo@dcrfonline.nl. One of the expert advisory committees will perform this review and provide
The Assessment Framework (Toetsingskader) is implemented for pharma-initiated and / or funded research in therapeutic application or diseases. However, any other non-WMO research (for example with medical devices) that is currently outside the scope of this framework can be tested on a voluntary basis by an nWMO Advisory Committee.
These nWMO Advisory Committees perform a substantive assessment. These reviews asses the validity of the scientific research question, methodology, ethical aspects and compensation.
The Assessment Framework (which is similar to the ABR form for interventional research also known as WMO-research) has been set up with support from the Ministry of Health, Welfare and Sport (VWS).
