Transition procedure for revised WMO per 1 March 2017

The revised Human Research Act (WMO) will be effective as of 1 March 2017. One major change is the expansion of options for performing medical scientific research on under-aged and legally incapable test subjects that cannot benefit from the research (so-called non-therapeutic research). Under the new regulation, this type of research will be allowed, in principle, if the risks and burden on the test subject are limited to a minimum, as compared to the standard treatment for the test subject's disorder.

To ensure a smooth transition from the 'old' to the 'new' legislation, a transition procedure has been set up. In general, the files and amendments will follow the legislation that is in effect at the moment of submission, regardless of whether the decision is taken before or after 1 March 2017.