For implementation of 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 are not covered by the Medical Research Involving Human Subjects Act (WMO),
Research subject to WMO
The law defines when there is an investigation that is subject to WMO. The requirements for this are:
- Medical scientific research with people
- 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 WMO is a mandatory examination that is assessed by a recognized Medical Ethics Review Committee (METC).
If only the first requirement from the definition of mandatory WMO investigation is met, the investigation does not fall under the WMO and possibly within the scope of the nWMO assessment.
The scope of the testing framework described here for nWMO research consists of:
- medical scientific research into therapeutic applications or disease areas where no action or behavior is imposed on test subjects / patients and
- initiated and / or financed by the pharmaceutical industry.
This means that not only traditional safety or effectiveness studies fall within the scope, but that (RWE) patient registrations / databases also fall within the scope.
In addition, any other non-WMO research (for example with medical devices) that is currently outside the scope can be submitted on a voluntary basis by one of our nWMO Advisory Committees.
Outside the scope of the Assessment Framework nWMO
Sponsoring without influence
nWMO research that is sponsored by a pharmaceutical company, but where the company has no influence whatsoever on the content or execution of the research, falls outside the scope of the assessment. Nonetheless, the Code of Conduct of the CGC (and in particular Chapter VI Grace and other financial relationships) remains fully in force.