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Trials

, 15:48

First Online: 05 February 2014Received: 17 September 2013Accepted: 21 January 2014DOI: 10.1186-1745-6215-15-48

Cite this article as: Taljaard, M., Brehaut, J.C., Weijer, C. et al. Trials 2014 15: 48. doi:10.1186-1745-6215-15-48

Abstract

BackgroundCluster randomized trials CRTs present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently.

MethodsA web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required full, expedited, or no review and the identification of research subjects at cluster and individual levels.

ResultsA total of 189 35% of 542 chairs responded. Overall, 144 84%, 95% CI 79 to 90% agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 92%, 95% CI 88 to 96% agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement.

ConclusionsResearch ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.

KeywordsCluster randomized trials Informed consent Research ethics guidelines Research ethics review Web-based survey AbbreviationsCRTcluster randomized trial

GPgeneral practitioner

IORGInstitutional Review Board Organization

IRBInstitutional Review Board

NCEHRNational Council on Ethics in Human Research

NIHNational Institutes of Health

NRESNational Research Ethics Service

OHRPOffice of Human Research Protections

REBResearch Ethics Board

RECResearch Ethics Committee

TCPSTri-Council Policy Statement.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-48 contains supplementary material, which is available to authorized users.

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Author: Monica Taljaard - Jamie C Brehaut - Charles Weijer - Robert Boruch - Allan Donner - Martin P Eccles - Andrew D McRae - R

Source: https://link.springer.com/



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