Research involving human subjects must undergo a medical ethics as it falls under the Law Medical Research with people (WMO).  In addition, there are many forms of “non-WMO Netherlands-map-colourcomplicit” research with people that needs to be reviewed. How do we guarantee the quality of these studies?
The parties in the Netherlands are convinced that all this research must be carefully designed with a relevant question, with adequate design and methodology to name a few. This can be achieved if a particular place of care test for such research.
The proposed Assessment for non-WMO complicit research supports physicians, researchers, hospitals and pharmaceutical companies in establishing responsible and relevant non-WMO complicit research. The Assessment consists of three elements:

  1.  A decision: WMO or non-WMO? (e.g., no prospective randomisation, treatment assignment, or effort for patient)
  2.  A set of (quality) criteria to assess the proposal content
  3.  The description of the process of the evaluation of non-WMO research.

On November 12, 2014, a workshop was organized in which various organizations a practical explanation has been given to the new procedures regarding non-WMO research. Also, the assessment framework discussed at this meeting and were able to bring the present suggestions for improvement. The program and presentations can be found by clicking on this link.
From Jan 1, 2015 until  July 1,  2015 there will be an interim period in which non-WMO protocols need to be submitted to the CGR. The CGR will evaluate the protocol for aspects of inducements and the CGR will also ask a pool of designated EC experts for an Ethical evaluation.
As of July 1 , 2015 the new procedure is effective: the protocol needs to be send to the portal of non-WMO obliged research and it will then be evaluated according to 3 criteria listed above
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