chapter  13
Ethical Considerations
Pages 12

The main focus of this book is on CRTs that involve the experimental study of interventions in human participants. The ethical requirements for clinical trials involving human subjects have received much attention during the past 30 or 40 years, and there are now internationally accepted guidelines setting out the minimal requirements that should be met by such studies (Council for International Organisations of Medical Sciences (in collaboration with WHO) 2002; International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 1996). During the planning of a CRT, investigators need to give careful consideration to how these requirements will be met, since cluster randomisation introduces a number of ethical complications that do not usually apply in individually randomised trials.