Source: Dutch Senate website
There is currently a bill in the Dutch Senate to amend the Medical Research Involving Human Subjects Act (WMO). The aim of this amendment is to expand the possibilities for conducting (non-therapeutic) medical-scientific research with minors and adults who are mentally incapacitated. This expansion should lead to more innovation in the field of, among others, pediatrics. This bill was discussed in the Dutch Senate on Tuesday, October 11, 2016.
What will change? The requirement of negligible risk and minimal burden will be dropped for medical-scientific research with minors where the participating minors do not benefit directly. This makes it possible, in cases where the risks and burdens of this type of research are (slightly) more than minimal, to weigh these risks and burdens against the interests of the research and thus the interests of public health, with a clear upper limit put in place. The same will apply for incapacitated adults.
To further clarify the protection of minors and incapacitated adults, a detailed testing framework is being developed for medical ethics review committees (METCs) and the Central Commission on Human-Related Research (CCMO), among others, to help them evaluate scientific studies with children and incapacitated adults. This testing framework will describe how considerations of proportionality can carefully be made.
In the discussion on October 11, Annelien Bredenoord (D66) gave her support for the bill, but expressed concern over whether there are sufficient checks to appropriately determine the boundaries for acceptable risk and whether sufficient protection measures have been built in. The Socialist Party (SP) also has questions about the new criterion “minimal risk and minimal burden in comparison with the standard treatment.” Minister Schippers offers detailed answers to the questions posed and the cases referenced. Read the full report on the website of the Dutch Senate. This bill will be put to a vote Tuesday, October 25.