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:
Since January 1, 2015, non-WMO-required research initiated and/or funded by pharmaceutical companies must be proactively assessed based on the Evaluation and Standards Framework. The evaluation requests must be submitted through the Research Portal. One of the expert advisory committees provides advice on behalf of the DCRF.
These non-WMO advisory committees conduct the substantive evaluation. This includes assessing the validity of the scientific question, methodology, ethical aspects, and the issue of favoritism (sales-promoting purpose). The Evaluation and Standards Framework was established with support from the Ministry of Health, Welfare, and Sport (VWS)
