The WMO applies the ‘no, unless’ principle for incapacitated subjects. Scientific research with these people is in principle forbidden.
Research subjects are capacitated if they:
- are 16 years or older, and
- are able to make a reasonable judgement of their own interests with regards to the study.
Subjects aged 16 years and older who are not able to do this are deemed to be incapacitated. The same applies to subjects under the age of 16 years.
The WMO applies the 'no, unless' principle for incapacitated subjects. Scientific research with these people is in principle forbidden. The only exception to this is research which is of direct benefit to the research subject (therapeutic) or (in the case of non-therapeutic research) research which is conducted with a selected population (group restricted) and for whom the risks are negligible and the objections minimal.
Therapeutic research with incapacitated subjects must be submitted for review to an accredited MREC. See also the CCMO-note therapeutic versus non-therapeutic research. In the case of research with a medicinal product the following generally applies:
- phase I research is non-therapeutic;
- phase II, III en phase IV research are therapeutic.
Observational versus intervention research
Non-therapeutic observational research with incapacitated subjects must also be submitted for review to an accredited MREC. An accredited MREC can transfer the review of a proposal for non-therapeutic observational research with incapacitated subjects to the CCMO as long as it has reason to do so. If this occurs, the MREC will inform the submitting party.
In the case of intervention research the investigator deliberately alters conditions to be able to pass judgement on the consequences of the intervention. Non-therapeutic intervention research with incapacitated subjects must be submitted for review to the CCMO.
In the case of observational research, the investigator does not alter the existing situation, but only wants to describe and document it. Examples of this are research into patient check-ups, transverse (cross-sectional) studies and cohort research. The CCMO does not view burden and exertion tests which are part of an observational study as non-therapeutic interventions. It is for this reason that these studies have to be submitted for review to the CCMO.
Incapacitated subjects are, for example, elderly people with advanced dementia, mentally handicapped, coma patients or people with a severe psychological disorders. These are vulnerable people. They quite often have difficulty forming an idea of what the research entails, if at all. Others must do that for them.
To participate in a research, a representative must provide consent for these subjects. That person could be someone appointed by a judge, such as a curator or mentor. If there is no such person, an authorised person can give consent. And if such a person also does not exist, then the spouse, registered partner or other life partner can give consent on behalf of the participant. If these do also not exist, then adolescents who are deemed able to understand the context are allowed to give context. And lastly, if there is/are no such person(s), then brothers or sisters who are deemed able to understand the context may provide consent on behalf of the participant.