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Full-Text Articles in Medicine and Health Sciences
Who Is The Research Subject In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Angela White, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard
Who Is The Research Subject In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Angela White, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard
Charles Weijer
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact …
Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein
Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein
Charles Weijer
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. …