NETHERLANDS – New Submission Portal for Non-WMO (Observational) Research
Stuart McCully
Co-Founder @ RWR-Regs | Real World Evidence Solutions | Mental Health Advocate
From 3 February 2025, the Central Committee on Research Involving Human Subjects (CCMO) will introduce the Research Portal for submitting medical-scientific research applications in the Netherlands. The release was initially planned for December 2024.
Once the portal is operational, all medical studies, including non-WMO research (such as non-interventional and observational studies), must be submitted through it. This expanded scope is designed to streamline the approval process, addressing existing challenges in coordinating and assessing non-WMO research, particularly for studies involving multiple institutions.
The initiative aligns with the Ministry of Health, Welfare and Sport's (VWS) framework, which aims to establish a standardised and consistent assessment process for all non-WMO research.
Scope of the New Research Portal
The new Research Portal will be used to submit all medical-scientific research that falls under:?
Other non-WMO research can be registered via this portal. This means that the scope of the new portal will be broader than that of the current ToetsingOnline platform.?
Non-WMO Research - Background and Updates
WMO vs Non-WMO Research: Research with test subjects who are subjected to procedures (e.g., interventional clinical trials and surgical procedures) fall under the Medical Research Involving Human Subjects Act (WMO) and is classified as ‘WMO’ research this research and must be assessed by a recognized medical ethics review committee (METc). However, for the majority of medical research that does not fall under the Medical Research Involving Human Subjects Act (WMO) – so-called non-WMO research – this mandatory assessment does not exist.
Current Challenges Assessing Non-WMO Research: Ethics, privacy and the quality of the design are just as important for non-WMO research as for WMO-obligated research, according to Health-RI and the institutions involved that have to deal with non-WMO research. This type of research is therefore assessed in practice, but unfortunately the procedures and assessment criteria now differ greatly per institution. This leads, especially in research involving multiple institutions, to a lot of coordination, delay and duplication of work, both for the researchers involved, patients and for the institutions themselves.
Working Towards a National Uniform and Unambiguous Assessment for all non-WMO Research: The Ministry of Health, Welfare and Sport (VWS) has had a general assessment framework developed with the aim of ultimately arriving at a national uniform and unambiguous assessment for all nWMO research.?This framework was created in a collaboration between institutions, researchers and assessment bodies. It helps to clarify and harmonise the procedures, so that the research can start faster and more efficiently and the results can lead to better care for citizens and patients soone].
Next Step In Implementing the non-WMO Framework Nationally: The assessment framework contains clear guidelines and criteria to reduce the burden on researchers, patients and assessment institutions. However, this framework is not enough. Institutions must also start using it and agreements must be made about mutually adopting each other's assessment decision to prevent unnecessary double assessments. Attention must also be paid to bringing together the assessment of nWMO (retrospective) data research and nWMO (retrospective) research with body material. There is still a lot of work to be done, so a follow-up process is necessary. Health-RI is taking over the baton from VWS and will continue this in collaboration with the field.?
Non-WMO Research - National Uniform and Unambiguous Assessment for all non-WMO Research
The delay in implementing the Research Portal from Dec 2024 to February 2025 may mean that when it does go live, research institutes will have had sufficient time to implement policies that all mutual acceptance of non-WMO assessment and therefore help to introduce a single nation-wide approval for non-WMO studies. Only time will tell…
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About Stuart McCully...
Stuart is a real world research (RWR) regulatory scientist and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.
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