What research is subject to the WMO?

A specific type of research is subject to the Medical Research Involving Human Subjects Act (WMO) and can only be conducted if reviewed by a Medical Research Ethics Committee (MREC).This applies to research in which people participate (either healthy people or patients) who are subjected to medical activities or who are subjected to behavioral rules. 

 

The Medical Research Involving Human Subjects Act (WMO) is meant to provide protection to research persons, also due to the interests of other stakeholders in this type of research, such as the interests of the pharmaceutical industry. The act contains special attention for incapacitated persons. The WMO determines among others how research persons should be informed and how consent should be given. The act also provides a framework for how Medical Research Ethics Committees should conduct their review of research projects. 

When is research subject to the WMO? 

Research is subject to 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.

The website of the CMMO provides more information about whether the research is subject to the WMO.

Medical Research Ethics Committees (MRECs)

Before research with human subjects can commence in the Netherlands the research file must first be approved by an accredited MREC or the CCMO. Carrying out a study which falls under the WMO without a positive decision from an accredited MREC/CCMO is an illegal offence.

 

In addition to the CCMO, the Netherlands has 15 accredited Medical Research Ethics Committees (MRECs) that review medical scientific research with human subjects, such as the MREC University Medical Center Groningen.

Hanze Ethical Review Board

The Hanze Ethical Review Board gives advice about the ethical aspects of research, among which advise about research subject to the WMO and application for an MREC. The MREC can provide a formal letter of approval to researchers which supports their ethical accountability.

 

Please note that the Hanze Ethical Review Board only gives advise about whether you are required to apply at a MREC but no advice on the ethical aspects of research subject to the WMO. This can only be done by a MREC. 

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