Due to their design of randomising interventions to clusters of participants, rather than individual participants, cluster randomised trials (CRTs) raise some additional ethical issues when compared  to many forms of research reviewed by committees. A group at the Rotman Institute of Philosophy, at the University of Western Ontario in Canada has had a project examining ethical and policy issues in cluster randomised trials running for five years and published guidelines in November 2012.

Below are links to resources about the design of CRTS and the ethical and policy issues they raise. We will be supplementing this with a specialist free online training course in 2013.

Lectures and other resources from a conference organised by the Rotman Institute

Cluster randomised trials: a primer

Empirical Articles about Ethical Issues in CRTs

Ivers N, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, Skea Z, Brehaut J, Boruch RF, Eccles M, Grimshaw JM, Weijer C, Zwarenstein M, Donner A.  Impact of the CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of a random sample of 300 trials from 2000 to 2008. British Medical Journal 2011; 343: d5886.

Mazor KM, Sabin JE, Boudreau D, Goodman MJ, Gurwitz, JH, Herrinton LJ,  Raebel MA, Roblin D,Smith DH, Meterko V, Platt R. Cluster Randomized Trials: Opportunities and Barriers Identified by Leaders of Eight Health Plans Medical Care 2007  45, 10 S29-38.

Osrin D, Azad K, Fernandez A, Manandhar DS, Mwansambo CW, Tripathy P, Costello AM. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia Bulletin of the World Health Organization 2009;87:772-779. doi: 10.2471/BLT.08.051060

Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, Skea Z, Brehaut J, Eccles MP, Donner A, Saginur R, Boruch RF, Grimshaw JM. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. British Medical Journal 2011; 342: d2496.

Ethical Analyses of Issues in CRTs

Binik A, Weijer C, McRae AD, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, Saginur R, Taljaard M, Zwarenstein M. Does clinical equipoise apply to cluster randomized trials in health research? Trials 2011: 12: 118.

Edwards SJL ,Braunholtz DA ,Lilford RJ ,Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999;318:1407

Gallo A, Weijer C, White A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, McRae AD, Saginur R, Zwarenstein M, Taljaard M. What is the role and authority of gatekeepers in cluster randomized trials in health research? Trials 2012; 13: 116.

Hutton, J.L. Are distinctive ethical principles required for cluster randomised controlled trials?Statistics in medicine 2001. 20: 473-488

McRae AD, Weijer C, Binik A, White A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles M, Saginur R, Zwarenstein, M Taljaard M. Who is the research subject in cluster randomized trials? Trials 2011; 12: 183.

McRae AD, Weijer C, Binik A, Grimshaw JM, Baruch R, Brehaut JC, Donner A, Eccles MP, Saginur R, White A, Taljaard M. When is informed consent required in cluster randomized trials in health research? Trials 2011; 12: 202.

Weijer C, Grimshaw JM, Taljaard M, Binik A, Boruch R, Brehaut JC, Donner A, Eccles MP, Gallo A, McRae AD, Saginur R, Zwarenstein M. Ethical issues posed by cluster randomized trials in health research. Trials 2011; 12: 100.

Guidelines and Reports

Campbell MK, Piaggio G, Elbourne DR, Altman DG; for the CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. Full text PDF. PMID: 22951546

Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M, and the Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Medicine 2012; 9(11): e1001346.

Medical Research Council. Cluster randomised trials - Methodological and ethical considerations (2002) MRC UK, London