Broadening of the possibilities for medical research with minors and incapacitated subjects

On Tuesday the 25th of October 2016 the Upper House approved the proposal to amend the Medical Research Involving Human Subjects Act (WMO). The new legislation is expected to come into effect on the 1st of March 2017. An important alteration concerns the broadening of the possibilities for carrying out medical research with minors and incapacitated subjects which is not of direct benefit to the individual subjects (so-called non-therapeutic research). The new legislation allows for this type of research to be carried out as long as the risks and burdens are minimal in comparison to the standard treatment. The amendment is expected to offer more room for development of new treatment methods, in particular with regards to paediatrics.

Previously, non-therapeutic medical research with minors and incapacitated subjects could only be carried out if it was not possible to carry out the same research with a group of legally capable  subjects. Furthermore, an extra requirement was stipulated stating that the risks of the research had to be negligible and the objections (such as pain and discomfort) had to be deemed minimal.

The paediatrician profession, patient associations and the Central Committee on Research Involving Human Subjects (CCMO) had repeatedly argued that this strict extra requirement meant that important new research could not be carried out which in turn hindered the development of new methods in paediatrics. These signals and arguments eventually led to a broadening of the possibilities for carrying out non-therapeutic research with minors and incapacitated subjects.

Under the new legislation the minimum age requirement for being deemed able to independently give consent for participation in research will be lowered from eighteen to sixteen years. In relation to this the rules regarding compensation for 16 and 17 year old subjects has also been altered. Another alteration concerns the make-up of the Medical Ethical Reviewing Committees (METC): METCs that review research with minor subjects must have an appointed paediatrician in the committee.