Healthcare benefits from conducting responsible medical research. Legal standards have been set for research that falls under the Medical Scientific Research Act (WMO). For research that is not covered by this law (non-WMO), no specific legal requirements apply. A Standards Framework has been drawn up in consultation with parties in the field.
For the 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 do not fall under the Medical-Scientific Research with People Act.
Procedure and Assessment Framework
The Assessment Framework is a word document that must be fully completed. The DCRF is responsible for the review from 1 July 2016. The Keuringsraad (Inspection Board) has an administrative function receiving the submission. The procedure for submitting the request for advice with the Assessment Framework for non-WMO sponsored drug research takes place as follows.
Non-WMO Declaration by recognized METC
A “gray” area will continue to exist. If an applicant doubts whether an investigation falls under the WMO, a so-called non-WMO Declaration can be requested from a recognized Medical Ethics Review Committee (METC).
Composition of the nWMO Advisory Committee
The assessment is carried out by a review committee for this type of research. These are not always CCMO certified. We strive to have a uniform composition of an assessment committee in the country