Ethical Issues in Cluster-randomized Trials

*Ottawa is in Canada
Infection prevention studies, particular ones that aim to prevent transmission of resistant pathogens (or influenza) are typically carried out at the population (e.g. ICU) level.  Thus, the study design of choice is the cluster-randomized trial.  The Ottawa Hospital Research Institute has recently held a conference and developed a set of documents highlighting the key ethical issues in these trials.

These papers cover topics such as: (1) Who is the research subject in cluster randomized trials in health research? (2) When, and from whom, is informed consent required in cluster randomized trials? (3) Does clinical equipoise apply to cluster randomized trials in health research? (4) Assessing benefits and harms in cluster randomized trials and (5) Cluster randomized trials in vulnerable populations.  These papers have or will soon be published in the open-source journal Trials.

Source: OHRI CRT Ethics page


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