Study protocol
Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
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* Corresponding author: Monica Taljaard mtaljaard@ohri.ca
1 Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa Hospital, 1053 Carling Avenue, Civic Campus, C409, Ottawa, ON K1Y 4E9, Canada
2 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
3 Departments of Philosophy and Medicine, Joseph L. Rotman Institute of Science and Values, University of Western Ontario, London, Ontario, N6A 3K7, Canada
4 Ottawa Hospital Research Institute, Clinical Epidemiology Program, 1053 Carling Avenue, Civic Campus, ASB 2-018, Ottawa, Ontario K1Y 4E9, Canada
5 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Canada
6 Center for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, 245-100 Collip Circle, London, Ontario, N6G 4X8, Canada
7 Joseph L. Rotman Institute of Science and Values, Department of Philosophy, University of Western Ontario, London, Ontario, N6A 3K7, Canada
8 Graduate School of Education and Statistics Department, Wharton School, University of Pennsylvania, 3700 Walnut Street; Philadelphia; Pennsylvania 19104, USA
9 Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa Hospital, 1053 Carling Avenue, ASB 2-004, Ottawa, Ontario K1Y 4E9, Canada
10 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
11 Ottawa Hospital Research Institute, Clinical Epidemiology Program; Ottawa Hospital, 1053 Carling Avenue, F663a; Ottawa, ON K1Y 4E9, Canada
12 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
13 Institute of Health & Society, Newcastle University, 21 Claremont Place, Newcastle upon Tyne, NE2 4AA, UK
14 Joseph L. Rotman Institute of Science and Values, Department of Epidemiology and Biostatistics, Ontario, N6A 3K7, Canada
15 Department of Emergency Medicine, London Health Sciences Centre, 800 Commissioners Rd East, London, ON, N6A 5W9, Canada
16 Department of Medicine, University of Ottawa and Ottawa Hospital; Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON K1Y 4E9, Canada
17 Centre for Health Services Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, M4N 3M5, Canada
18 Department of Epidemiology and Biostatistics, University of Western Ontario, Kresge Building, Room K201, London, Ontario, N6A 5C1, Canada
19 Robarts Clinical Trials, Robarts Research Institute, London, ON, N6A 5K8, Canada
Trials 2009, 10:61 doi:10.1186/1745-6215-10-61
Published: 28 July 2009Abstract
Background
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.
Methods
We will use a mixed-methods (qualitative and quantitative) approach 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. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.