Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities - rather than individual themselves - are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders.
This is a mixed-methods (qualitative and quantitative) study incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers.
Zoe Skea; firstname.lastname@example.org (non-funded member of the wider project team)
McRae A, Taljaard M, Weijer C, Bennett C, Skea ZC, Boruch R, Brehaut J, Eccles M, Grimshaw J, and Donner A. (2013). Reporting of patient consent in healthcare cluster randomized trials is associated with the type of study interventions as well as publication features. Journal of Medical Ethics;39:2 119-124.
Chaudhry SH, Brehaut JC, Grimshaw JM, Weijer C, Boruch R, Donner A, Eccles MP, McRae AD, Saginur R, Skea ZC, Zwarenstein M, Taljaard M. (2013). Challenges in the research ethics review of cluster randomized trials: International survey of investigators. Clinical Trials 10(2):257-268.
Ivers N, Taljaard M; Dixon S; Bennett C; McRae A; Taleban J; Skea ZC, Brehaut J; Boruch R; Eccles M; Grimshaw J; Weijer C; Zwarenstein M; Donner A. (2011).Did the extension of CONSORT to cluster randomised trials result in improved quality of reporting and study methodology? Review of a random sample of 300 trials from 2000 - 2008. British Medical Journal;342:d5886.
Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, Skea ZC, Brehaut J, Eccles M, Donner A, Saginur R, Grimshaw J. (2011). Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. British Medical Journal;342:d2496.
Monica Taljaard, Charles Weijer, Jeremy M Grimshaw, Judith Belle Brown,, Ariella Binik,Robert Boruch), Jamie C Brehaut, Shazia H Chaudhry, Martin P Eccles, Andrew McRae, Raphael Saginur, Merrick Zwarenstein, and Allan Donner. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study (Study protocol). Trials 2009;10:61
Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, Skea Z, Brehaut J, Eccles M, Donner A, Saginur R, Grimshaw J. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. British Medical Journal (accepted for publication)