%0 Journal Article
%T Who is the research subject in cluster randomized trials in health research?
%A Andrew D McRae
%A Charles Weijer
%A Ariella Binik
%A Angela White
%A Jeremy M Grimshaw
%A Robert Boruch
%A Jamie C Brehaut
%A Allan Donner
%A Martin P Eccles
%A Raphael Saginur
%A Merrick Zwarenstein
%A Monica Taljaard
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-183
%X We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. CRTs are used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. While a small and growing literature explores ethical aspects of CRTs, cluster trials raise difficult issues that have not been adequately addressed. 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 [1]. These include identifying human research subjects, obtaining informed consent, the applicability of clinical equipoise, benefit-harm analysis, the protection of vulnerable populations, and the role and authority of gatekeepers in CRTs. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research?CRTs are used in a range of fields, including education, criminology, publi
%U http://www.trialsjournal.com/content/12/1/183