Abstract

Implementation research is increasingly common in developing countries as a way of studying the introduction to the population of health interventions that have been proven to be effective elsewhere. Implementation studies are often conducted as cluster randomized trials, a design that raises ethical and conceptual questions different from those in conventional randomized controlled trials. It is often unclear who the subjects of the research are, informed consent may be difficult or impossible to obtain and controversy surrounds the use of comparison clusters that provide substandard care to the population where the research is carried out. An examination of protocols for this type of research reveals uncertainty on the part of researchers themselves about whom or what they are studying and from whom (if anyone) informed consent is required