Last week, on March 1, 2017, the amended Medical Research Involving Human Subjects Act (WMO) went into effect. The Dutch Association of Medical Ethical Testing Commissions (NVMETC) and the Central Commission of Human-Related Research (CCMO) have written a testing framework to clarify current regulations about which medical ethical review committees (METCs) should assist in the assessment of non-therapeutic research with children and mentally incapacitated adults. This testing framework is naturally also useful as a guide for researchers designing studies.
The testing framework describes how the METCs can assess the risks and burdens and how they can weigh them against the interests of science, society, the subjects themselves, and/or the groups to which the subjects belong. The NVMETC and CCMO have made a handy decision tree in which the considerations are presented schematically.
Testing Decision Tree for research with under-age subjects; source: http://www.ccmo.nl/
Interested in learning more about the new WMO update? The latest changes to this law are covered in the online WMO/GCP training and the WMO/GCP re-registration course in myGCP. The NVMETC and CCMO testing framework can be downloaded here.