The Handbook for the nWMO Assessment Framework contains the agreements regarding the design, standards and procedure for the assessment

 

Assessment Framework

Healthcare benefits from conducting dependable medical research. Legal standards have been set for research that falls under the Medical Research Examination Act (Wet Medisch Onderzoek – WMO). For research that is not covered by this law, no specific legal requirements apply. In consultation with field parties, an Assessment Framework has been drawn up to ensure that such non-WMO research is conducted for with solid background and proper methodology. These standards aim to provide a framework for both those who initiate the research, those who assess the research for legitimacy and for those who conduct the research.

The current Assessment Framework applies to non-WMO-mandatory research initiated and / or funded by pharmaceutical companies and can be downloaded here.

Scope of the Assessment Framework

To implement the Assessment Framework for non-WMO research it is important to have a clear understanding of what is meant by non-WMO research and what falls within the scope of this Assessment Framework.

The group of investigations that are not subject to WMO are first and foremost investigations that do not fall under the Medical-Scientific Research Act  with humans (Wet Medisch Onderzoek – WMO). The distinction between WMO research and non-WMO research is as follows:

Research subject to WMO

The law defines when an investigation is subject to WMO. The requirements for this are:

  1. Research with people that can lead to new and relevant insights in the field of medical sciences.
  2. Action or behavior is imposed on test subjects / patients

If one or both of these conditions are not met, the investigation does not fall under the scope of the WMO. If both conditions are met, the research is subject WMO and must be reviewed by an accredited Medical Ethics Review Committee (METC).

If only the first requirement from the definition of a mandatory WMO investigation is met, the investigation is not subject to the WMO and is subject to nWMO-assessment.

non-WMO research

The scope of the Assessment Framework for research not subject to WMO includes:

  1. medical scientific research into therapeutic applications or diseases where no action or behavior is imposed on test subjects / patients, and
  2. research initiated and / or financed by the pharmaceutical industry.

This means that not only traditional safety or efficacy studies fall within the scope, but also (Real World Evidence – RWE) patient registrations / databases.

Furthermore, non-WMO-compliant research (for example with medical devices) that is currently outside this scope can be tested on a voluntary basis by an nWMO Advisory Committee.