When must the Ethics Committee (not) be involved
The Belgian law on experiments requires an advice from an EC on any prospective study, i.e., a study that starts in the present and will continue in the future with the aim to collect new patient data that are not yet available in patient files.
The Belgian law on experiments is, however, not applicable to retrospective studies. Retrospective studies rely on patient data that have already been collected in the past and that are already present in patient files. Patients are not explicitly implicated in the study upfront and no new data are collected.
Data valorisation projects are retrospective studies. Therefore, the Belgian law on experiments is not applicable to them, hence no advice from the EC is required.
Establish Data Assessment Committee to advice on RWD queries
Our recommendation to hospitals is, however, to establish a specific data assessment committee that is competent enough to evaluate RWD queries. By integrating a delegation of the EC in such data assessment committee, the EC is still informed, yet relieved and can focus on its legal obligations.