RANDOMISED CONTROLLED TRIALS AND QUASI-EXPERIMENTAL DESIGNS

Randomised control trials (RCTs) and quasi-experimental designs (such as natural experiments) provide solid evidence for evaluating the efficacy and safety of an intervention or new policy because of their potential for making stronger causal claims than for other types of data analysis. This chapter describes some common approaches to RCTs and explores key ethical challenges specific to experimental designs. Four ethical issues specific to this context are considered: (a) justice (i.e., fairness, equity); (b) free, prior (and ongoing) informed consent, (c) publication bias; and (d) research merit—most notably appropriateness. We argue that there are research questions where RCTs and their close cousins, quasi-experimental designs, are the only valid research designs, and steps can be undertaken for them to be conducted ethically. That said, we recognise that RCTs are not always appropriate and can create additional respondent burdens and foster perceptions of unfairness—in which case alternative approaches should be considered.