Interactive media-based community consultation for exception from informed consent trials: How representative should (and can) it be?

Abstract

Community consultation (CC) is a requirement for exception from informed consent (EFIC) research. This article explores the issue of how representative such consultations can and should be, with particular reference to the use of media-based activities. Interactive, media-based CC strategies are gaining traction, because they have much greater reach than traditional methods, but the increasing use of such methods has also led to calls to ensure that those contacted are representative of the community at risk. However, this is more complex than at first apparent. This article examines the question of how the "trauma community" should be defined, and what characteristics might be used to assess whether a sample of this community is representative. It also considers what data are actually available in order to satisfy such requirements.