When is informed consent required in cluster randomized trials in health research?
1 Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, N6A 5C1, Canada
2 Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, 1403 29th Street NW, Calgary, AB, T2N 2T9, Canada
3 Rotman Institute of Philosophy, Department of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada
4 Department of Medicine, University of Western Ontario, 339 Windermere Road, London, ON, N6A 5A5, Canada
5 Ottawa Hospital Research Institute, Clinical Epidemiology Program, Civic Campus, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada
6 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8L6, Canada
7 Graduate School of Education and Statistics Department, Wharton School, University of Pennsylvania, 3700 Walnut Street, Philadelphia, PA, 19104, USA
8 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, K1H 8M5, Canada
9 Robarts Clinical Trials, Robarts Research Institute, London, ON, N6A 5K8, Canada
10 Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK
11 Department of Medicine, University of Ottawa and Ottawa Hospital, Ottawa Hospital Research Institute, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada
Trials 2011, 12:202 doi:10.1186/1745-6215-12-202Published: 9 September 2011
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?
We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.