Non-therapeutic observational research with incapacitated participants 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 participants 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 participants must be submitted for review to the CCMO.
In the case of observational research, the investigator does not alter the existing situation, but merely wants to describe and document it. This is the case with research into patient check-ups, transverse (cross-sectional) studies and cohort research. The CCMO considers burden tests and exertion tests, being part of an observational study, as non-therapeutic interventions. Consequently, these studies have to be submitted to the CCMO for review.