The assessment is carried out by a review committee for this type of research. These are not always CCMO certified. We strive to have a uniform composition of an assessment committee in the country and that the assessment performed by these committees is widely supported by all stakeholders. This means that a decision by a single committee can also be regarded as valid nationally.
Important aspects of the assessment are information to the participants (the patient information letter), privacy aspects, clinical relevance of the study, quality and funding of the researchers. In addition, ethical acceptability is crucial.
This document describes the minimum composition of a review committee for this type of research. Each committee describes these procedures in their standard operating procedures.