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.
Highlights
The cluster randomized trial is an increasingly important method in health research
Who are gatekeepers? When cluster trials involve an intervention that is administered at the cluster level, difficulties in obtaining meaningful individual informed consent have led to the practice of using gatekeepers [49], guardians [32], and cluster representation mechanisms [33] to protect group and individual interests
Our project will provide a systematic analysis of the ethics of cluster trials
Summary
The cluster randomized trial is an increasingly important method in health research. Cluster trials randomize intact social units, such as households, primary care practices, hospital wards, classrooms, neighborhoods and entire communities, to differing intervention arms. Cluster trials may involve neither physician-researchers nor patient-subjects In both the NEXUS trial and the Keystone study, the targets of the study intervention were health care workers themselves. The risks of nontherapeutic procedures must not exceed a minor increase above minimal risk Cluster trials, those involving interventions applied at the level of the cluster, may further restrict the ability of vulnerable groups (or their surrogate decision makers) to choose research participation freely. When cluster trials involve an intervention that is administered at the cluster level, difficulties in obtaining meaningful individual informed consent have led to the practice of using gatekeepers [49], guardians [32], and cluster representation mechanisms [33] to protect group and individual interests. When does a gatekeeper possess the authority to consent on behalf of the cluster? When individual consent cannot be obtained, does a gatekeeper have the authority to consent on behalf of the individuals in the cluster? A subsequent paper in the series critically appraises the role, function, and authority of gatekeepers in CRTs
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