The WMO applies the ‘no, unless’ principle for research subjects under the age of 16 years and for incapacitated subjects. Scientific research with subjects in this category is in principle prohibited.
This prohibition does not apply to:
- Research which is of direct benefit to the research subject (therapeutic);
- Non-therapeutic research which can only be conducted with that group of people (group restricted). In non-therapeutic research, it is required that the risks and the burden are minimal compared to the standard treatment of the research subject. If there is no standard treatment, the nature and severity of the condition of the research subject should be considered.
Therapeutic research and non-therapeutic, observational research with minors or incapacitated subject must be reviewed by the METc.
Non-therapeutic, interventional research with minors or incapacitated adult subjects must be reviewed by the CCMO.
Research with subjects younger than 16 years.
The same conditions for clinical research with subjects younger than 16 years apply as for adult incapacitated subjects. The difference is in the informed consent procedure.
The decision to participate of the minor (or adult) incapacitated subject must be demonstrated in writing.
In case of research with children under the age of 12 years, both parents/legal guardian must give consent for participation in the research.
Adolescents aged 12 to 16 years give consent (or ‘assent’) together with their parents/legal guardian, and adolescents aged 16 years and older give consent by themselves.
The subject information sheet should be appropriate for the level of understanding so the potential subject can understand what the trial entails and what this means for him/her.
When does reconsent of children apply?
- If a child is included before the age of 12, both parents/legal representatives or guardian must give written informed consent.
- As soon as the child turns twelve, the child must also give written informed consent (assent). The parents/legal representatives or guardian do not have to give written informed consent again.
- When the child turns 16, written informed consent (reconsent) does not need to be given again. Not even if the child transfers as a patient from pediatrics to an adult department in practice.
Research with (temporarily) incapacitated adult subjects.
Incapacitated subjects are, for example, elderly people with advanced dementia, mentally handicapped, coma patients or people with a severe psychological disorders.
Sometimes adult subjects are temporarily unconscious in which case they can not decide for themselves. Others, so-called a legal representative, must provide consent for these subjects.
This legal representative could be someone appointed by a judge, such as a curator or mentor, a spouse, registered partner, parents, adolescents who are deemed able to understand the context, brother or sister.
The information sheet for the legal representative contains all the relevant information which would be presented to the subject him-/herself. The difference is the salutation and method of recruitment.
In case the subject is temporarily incapacitated, the subject should give consent at a later moment. It is possible the subject may not consent to participate after all.
For that reason, the information sheet for the representative and the subject should describe the course of action in this situation. For instance, will the collected research data be used of destroyed?
More information about the recruitment of minor or incapacitated subjects can be found on the website of the CCMO: (https://english.ccmo.nl/investigators/types-of-research)