Abstract
BackgroundCluster 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.MethodsWe 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.
Highlights
Cluster randomized trials are an increasingly important methodological tool in health research
Identify challenges arising in the ethical review of cluster randomized trials through elicitation of the views and experiences of researchers and research ethics boards (REBs); Overview Empirical work will include: a systematic review of a random sample of published cluster randomized trials; a survey of cluster randomization trialists supplemented by indepth interviews; a survey of REBs; and focus group discussions and in-depth interviews with trial participants and gatekeepers
There has been a proliferation of cluster randomized trials in health research in recent years and their use is likely to increase in both primary and secondary care and public health
Summary
Cluster randomized trials are an increasingly important methodological tool in health research. 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 observed on individual cluster members. In health services implementation research [1] for example, the intervention may be administered to the health professional or may involve changes to the health care organization; and in trials of infectious disease interventions, a vaccine may be administered at the individual level but its effects observed among those in the wider community as a consequence of herd immunity. The cluster randomized design [2] has become an increasingly important methodological tool in health and health services research: in cluster randomized trials ( known as group randomized or place randomized trials), intact social units or clusters of individuals, such as medical practices, communities, schools or villages are randomized to intervention or control conditions. Outcomes are observed on individuals, they may be aggregated at the cluster-level, for example, percentage of X-ray requests by physicians
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