Modified from original article on www.CCMO.nl
On Tuesday, October 25, 2016, the Dutch Senate approved a bill to amend the Medical Research Involving Human Subjects Act (WMO). It is expected that in practice, this amendment will allow more room to develop new treatment methods, particularly in pediatrics. Expectations are that the amended WMO will go into effect March 1, 2017.
Previously, non-therapeutic medical-scientific research with minors and mentally incapacitated subjects could only take place when the research could not be carried out with competent subjects (group-related). Furthermore, there was the extra restriction that the risks of the research must be negligible and the burdens – such as pain and discomfort – minimal.
The professional group of pediatricians, patient associations, and the Central Committee for Human Research (CCMO) have indicated multiple times that these strict restrictions were preventing important research from being carried out, hindering the development of new treatment methods in pediatrics. These protests have led to an expansion of the possibilities for conducting non-therapeutic research with minors and incapacitated subjects.
Under the new regulations, the age limit for independently consenting to participate in research will also be lowered from 18 to 16. In line with this, the rules for compensating 16- and 17-year-old subjects are also being amended. Furthermore, the composition of medical ethics committees (METCs) will also change: METCs whose research involves underaged subjects must have a pediatrician sitting in the committee.
The WMO/GCP training modules from GCP Central will be updated by February 1, 2017 to reflect these changes, so that everyone involved in medical scientific research can update their training before this legislation goes into effect. Students will be automatically notified that they need to complete the update training. Are you not yet a student, or do you not have an active license (anymore)? It’s easily to purchase your WMO/GCP training or extension online via myGCP.