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Epidemiology

2011

Cluster Randomized Trials

Articles 1 - 2 of 2

Full-Text Articles in Public Health

When Is Informed Consent Required In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Angela White, Monica Taljaard Sep 2011

When Is Informed Consent Required In Cluster Randomized Trials In Health Research?, Andrew Mcrae, Charles Weijer, Ariella Binik, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Angela White, 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 cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT …


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 Jul 2011

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 …