If your research does not fall under the scope of the WMO then it does not have to be reviewed by an accredited MREC or the CCMO. However, there may be rules which have to be taken into account. Below you can find some examples of the forms of non-WMO research. Does your research not fall under the scope of the WMO? Then ask your own institution about the local policy and the applied procedures.
Retrospective research/patient file research does not fall under the WMO. Such research is only subject to the Agreement on Medical Treatment Act (Wet op de geneeskundige behandelingsovereenkomst (WGBO), in Dutch) and, in certain cases, the Personal Data Protection Act (Wet bescherming persoonsgegevens, in Dutch). See for more information file research.
A legal framework is currently not available for the (further) use of human tissue for medical/scientific research. The regulation regarding the medical treatment contract does however contain a stipulation on the use of anonymous human tissue. Section 7:467 of the Dutch Civil Code (Burgerlijk Wetboek) states: ‘Anonymous tissues and parts which have been separated from the body can be used for medical statistics or other medical/scientific research as long as the patient, from who the human tissue originates, has no objections against such research and the research is carried out with the necessary care’. (Non-official translation).
The second paragraph of section 7:467 of the Dutch Civil Code states that the human tissue used in the study, and any data generated from this, may not be traced back to the person. It also states that general information (issued prior to the treatment) and the possibility for the patient to object is sufficient for further use of non-traceable human tissue. (Oral) Information and consent is repeatedly needed for human tissue which can be traced back to an individual (directly identifying or via a code).
The Federa (Dutch Federation of Biomedical Scientific Societies) set up the Code of Conduct for Responsible Use. This is a manual on responsible use of human tissue with regards to medical research.
Non-WMO research with a medicinal product
Research with a medicinal product which does not fall under the scope of the WMO must be reviewed by the license holder on whether the activities stemming from the research are in compliance with the rules with regards to medicinal product advertising. The CGR Foundation (Stichting Code Geneesmiddelen Reclame) has set up the Code of Conduct Medicinal Product Advertising (in Dutch) for this and the execution (in Dutch) of this. The CGR has also developed a guideline (in Dutch) on this.
Non-WMO safety studies after authorisation
of a medicinal product
Safety studies after authorisation are studies with an authorised medicinal product (authorised for trade) which are carried out to confirm the safety profile of a medicinal product, determining the safety risk, to characterise or quantify, or to measure the effectiveness of risk management measures. The Medicinal Product Act (section 80) mentions this in the context of ‘non-interventional safety studies after authorisation’. (Non-official translation)
If a safety study is to be carried out on the order of an authorisation authority then a separate review is carried out by the Risk Assessment Committee (section 107 of the EU guideline 2001/83) or by the CCMO.
In the case of multinational safety studies the research must be submitted for review to the Risk Assessment Committee or the Pharmacovigilance Risk Assessment Committee (PRAC).
The CCMO is the reviewing authority for national safety studies on the order of the Medicines Evaluation Board (MEB), as is laid down in section 8.8 of the Regulation Medicinal Product Act (Regeling Geneesmiddelenwet, in Dutch). The CCMO review consists of determining whether the research falls under the scope of the WMO, whether the execution of the research stimulates use of the medicinal product and whether the study question can be answered with the chosen set-up.
A model is available on the website of the European Medicines Agency (EMA) that may be used to write the protocol for a post authorisation safety study.