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.