The revised Human Research Act (WMO) is effective as of 1 March 2017. For more detailed information, please see the news item about the amendment.
To ensure a smooth transition from the 'old' to the 'new' legislation, the following transition procedure has been set up:
Research files (and amendments) submitted prior to 1 March 2017
These files will be assessed according to the legislation that was in effect at the moment of submission (i.e. the ‘old’ regulation), regardless of whether the decision is taken before or after 1 March 2017.
Research files submitted on or after 1 March 2017
These files are assessed based on the new legislation.
Amendments submitted on or after 1 March 2017
Amendments that are submitted on or after 1 March 2017 are assessed based on the new legislation (these amendments are related to research files that were assessed prior to 1 March 2017, based on the current legislation). The legislation that was in effect at the moment the amendment was submitted is leading.
Note: if, from 1 March 2017, 16- and 17-year-old subjects are added to ongoing research protocols with test subjects of a legal age, by way of an amendment, this must be checked against the specific remuneration rules (if applicable) for this age category (art. 3, section one, (new) element g, WMO).
Mandatory paediatrician in MREC
The mandatory presence of a paediatrician is only applicable for research files and amendments that are assessed on or after 1 March 2017.
Informed consent and ongoing research
Minors that turn 16 during the course of the research trial will not have to explicitly give informed consent (again). In most cases, the child will already have given consent for participation in the trial (as well as his/her parents).
Even if the child has not actually given co-consent for participation (for instance if it was included in the trial at the age of 11), it is not necessary to ask for consent when the test subject reaches the age of 16, due to the fact that the parent already gave consent at the time, on behalf of the child.
Exception: if an amendment is submitted that changes the content of the research protocol to such an extent that the test subjects will have to be asked for their renewed consent, the 16- and 17-year-old test subjects must also give their informed consent again.