chapter  13
13 Pages

Ethical Considerations

WithRichard J. Hayes, Lawrence H. Moulton

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 Organizations 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. For at least two decades there has been recognition that CRTs have their own set of special ethical considerations (Glanz et al. 1996). It is only recently, however, that specific guidelines have been developed. The Ottawa Statement (Weijer et al. 2012), as the result of a lengthy consensus process, produced a set of 15 recommendations for CRTs. In Section 13.2, we briefly review the general ethical principles that apply to any randomised clinical trial involving human participants. The following sections focus on the application of these principles to CRTs. Section 13.3 considers special issues relating to risks and benefits of trial participation in the context of group allocation. The requirement for fully informed consent lies at the heart of accepted ethical guidelines for clinical trials, but this involves a number of specific issues in CRTs that are discussed in Section 13.4. Finally, Section 13.5 considers other ethical issues in CRTs, including scientific validity, phased intervention designs and trial monitoring.316