Consent issues

It is not always clear how consent issues - relating to the administration of an intervention and the collection and analysis of patient data - are handled in a cluster randomized trial. In this respect they have issues in common with the Zelen designs described in Section 4.3. They may potentially involve no individual patient consent at all; certainly if individuals are asked to consent to receive (or not) an intervention, the very reasons for setting up a cluster-randomized trial may mean it is not possible to offer them the alternative. These issues are discussed further by Hutton [16].

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