If a study falls under the scope of the Medical Research Involving Human Subjects Act (WMO), it must undergo a review by an accredited MREC or the CCMO.
Research falls under the WMO if the following criteria are met:
1. It concerns medical/scientific research and
2. Participants are subject to procedures or are required to follow rules of behaviour
1. It concerns medical-scientific research
The WMO does not offer a definition of the term medical-scientific research. As a result, it is not always clear if the research protocol must be submitted for review by law. A comparable matter is the case with studies with (leftover) embryos and the Embryo Act. The CCMO assists in this by offering the following definition:
‘Medical/scientific research is research which is carried out with the aim of finding answers to a question in the field of illness and health (etiology, pathogenesis, signs/symptoms, diagnosis, prevention, outcome or treatment of illness), by systematically collecting and analysing data. The research is carried out with the intention of contributing to medical knowledge which can also be applied to populations outside of the direct research population.’ (Non-official translation)
Research with a medicinal product is also categorised as medical-scientific research. And behavioural-scientific research can in certain cases also be deemed medical-scientific. Furthermore, nursing, physiotherapy and psychology research can in some cases fall under the WMO. The kinds of studies that do not fall under the WMO are, for example, studies relating to quality analysis of two different laboratory instruments with the aim of researching the possibility of switching to a cheaper instrument or research on the improvement of existing techniques for new applications. An example is research on the configurations and conditions of MRI to visualize certain organs, or on fMRI to be able to measure brain activity during certain tasks. However, as soon as such research is aimed at improving diagnostic possibilities of (f)MRI, it does fall within the definition of medical-scientific research.
Another type of research which is not considered as medical-scientific research is a student practical during which they carry out certain procedures on one another. Such a study does not contribute to new insights in the field of medicine and does not lead to the publication of scientific articles.
2. Participants are subjected to procedures
or are required to follow rules of behaviour
In general, research with human subjects only falls under the WMO if there is an infringement of the physical and/or psychological integrity of the subject. The subject himself/herself must be physically involved in the research for the research to fall under the WMO. Therefore retrospective research/file research does not fall under the WMO. In that case the data are already available and not collected specifically for a medical-scientific research. The subject does not have to do or abstain from something on behalf of the research.
A blood sample being taken from the participant for the purpose of scientific research: this always falls under the WMO as the participant is subjected to a procedure. If additional blood is taken for the research as part of a planned vene puncture or from an existing line, then the research also falls under the WMO.
Research during which a participant must provide one urine sample once, generally does not fall under the WMO. However, research during which urine samples must be provided over the course of a three-week period does.
Randomized studies and the WMO
In a randomized clinical trial subjects are being assigned at random to one of the treatment or control groups. By doing so the subjects are required to follow certain rules of behaviour. It depends on the nature of this rule if the research will or will not fall under the WMO – assuming the study meets the first criterium of medical-scientific research.
The degree to which the rules of conduct or the abstinence from treatment(s), interventions or procedures may cause an infringement of the physical and/or psychological integrity of the subject determines whether the study is subject to the WMO. Generally this is the case if the research concerns a treatment with a medicinal product, but also if a invasive psychological treatment is given. Medical-scientific research whereby standard of care therapies are compared by randomisation of the participating subject can also fall under the WMO, provided that the therapy infringes on the physical and/or psychological integrity of the subject.
An example. In a study on the prevention of decubitus subjects are randomized to the use of mattress A or B in their bed. Within the meaning of the WMO no rule of conduct is imposed. The use of another mattress is not considered as an infringement of the physical and/or psychological integrity of the subject. Such randomized studies do not fall under the WMO, providing that no other procedures or rules of behaviour are imposed (for instance taking blood samples).
Population research and the WMO
The WMO is not applicable to population screening programmes which meets the criteria of the WMO though for which a license is needed on the grounds of the Population Screening Act (Wet op het Bevolkingsonderzoek) (in Dutch).
If in doubt
In practice there will always be cases in which it is not clear immediately if a study does or does not fall under the WMO: the so-called grey area. When in doubt it is best you contact an accredited MREC or the CCMO. In conclusion
If you are certain your research falls under the WMO go to 'My research falls under the WMO' (in Help-me-on-my-way) (for inexperienced investigators) or to Review procedure or Primary submission (for experienced investigators).
Carrying out a study which falls under the WMO without a positive decision from an accredited MREC/CCMO is an illegal offence.