Abstract
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 CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers.
Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.
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1 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); University of Western Ontario, Schulich School of Medicine and Dentistry, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884)
2 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); University of Western Ontario, Department of Medicine, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); University of Western Ontario, Department of Epidemiology and Biostatistics, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884)
3 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884)
4 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); Clinical Epidemiology Program, Civic Campus, Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108); Faculty of Medicine, University of Ottawa, Department of Medicine, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000000121822255)
5 Wharton School, University of Pennsylvania, Graduate School of Education and Statistics Department, Philadelphia, USA (GRID:grid.25879.31) (ISNI:0000000419368972)
6 Clinical Epidemiology Program, Civic Campus, Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108); University of Ottawa, Department of Epidemiology and Community Medicine, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000000121822255)
7 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); University of Western Ontario, Department of Epidemiology and Biostatistics, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); Robarts Research Institute, Robarts Clinical Trials, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884)
8 Newcastle University, Baddiley-Clark Building, Institute of Health and Society, Newcastle upon Tyne, UK (GRID:grid.1006.7) (ISNI:0000000104627212)
9 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); University of Western Ontario, Department of Epidemiology and Biostatistics, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); Foothills Medical Centre, University of Calgary, Division of Emergency Medicine, Calgary, Canada (GRID:grid.22072.35) (ISNI:0000000419367697)
10 Ottawa Hospital Research Institute, University of Ottawa and Ottawa Hospital, Department of Medicine, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000000096065108)
11 Sunnybrook Health Sciences Centre, Centre for Health Services Sciences, Toronto, Canada (GRID:grid.413104.3) (ISNI:0000000097431587)
12 University of Western Ontario, Rotman Institute of Philosophy, London, Canada (GRID:grid.39381.30) (ISNI:0000000419368884); Clinical Epidemiology Program, Civic Campus, Ottawa Hospital Research Institute, Ottawa, Canada (GRID:grid.412687.e) (ISNI:0000 0000 9606 5108); University of Ottawa, Department of Epidemiology and Community Medicine, Ottawa, Canada (GRID:grid.28046.38) (ISNI:0000000121822255)