title: Ethical issues posed by cluster randomized trials in health research.
abstract: The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
authors.affiliation: Rotman Institute of Philosophy, Department of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada. cweijer@uwo.ca
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Grimshaw
authors.forename: Monica
authors.initials: M
authors.lastname: Taljaard
authors.forename: Ariella
authors.initials: A
authors.lastname: Binik
authors.forename: Robert
authors.initials: R
authors.lastname: Boruch
authors.forename: Jamie C
authors.initials: JC
authors.lastname: Brehaut
authors.forename: Allan
authors.initials: A
authors.lastname: Donner
authors.forename: Martin P
authors.initials: MP
authors.lastname: Eccles
authors.forename: Antonio
authors.initials: A
authors.lastname: Gallo
authors.forename: Andrew D
authors.initials: AD
authors.lastname: McRae
authors.forename: Raphael
authors.initials: R
authors.lastname: Saginur
authors.forename: Merrick
authors.initials: M
authors.lastname: Zwarenstein
mesh_terms: D016000:Cluster Analysis; D003627:Data Interpretation, Statistical; D032984:Ethics, Research; D019317:Evidence-Based Medicine / Q000941:ethics* / Q000706:statistics & numerical data; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D028701:Patient Rights / Q000941:ethics; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000706:statistics & numerical data; D035842:Research Subjects; D018570:Risk Assessment; D057212:Therapeutic Equipoise; D035862:Vulnerable Populations