A team led by our friend and colleague Charles Weijer at the University of Western Ontario has just issued guideliens for what are known as “cluster randomized trials” (CRTs).
See the story here:
Western-led team delivers world-first ethics guidelines.
CRTs are clinical trials in which randomization occurs across groups of participants, or across institutions, rather than across individual participants. In other words, each participant is not randomized into one arm of the trial or another. Rather, randomization is done at the higher level — an entire institution’s patient, population is treated as a unit for purposes of randomization. This raises a number of interesting ethical issues. These new guidelines will surely help advance our understanding, as well as highlighting an important range of issues for those of us not previously aware of them.