Open Access Research

What is the role and authority of gatekeepers in cluster randomized trials in health research?

Antonio Gallo12, Charles Weijer134*, Angela White1, Jeremy M Grimshaw156, Robert Boruch7, Jamie C Brehaut58, Allan Donner149, Martin P Eccles10, Andrew D McRae1114, Raphael Saginur12, Merrick Zwarenstein13 and Monica Taljaard158

Author Affiliations

1 Rotman Institute of Philosophy, University of Western Ontario, London, ON, N6A 5B8, Canada

2 Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, N6A 5C1, Canada

3 Department of Medicine, University of Western Ontario, 339 Windermere Road, London, ON, N6A 5A5, Canada

4 Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, N6A 5C1, 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 Division of Emergency Medicine, Foothills Medical Centre, University of Calgary, 1403 29th Street NW, Calgary, AB, T2N 2T9, Canada

12 Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa and Ottawa Hospital, 1053 Carling Avenue, Ottawa, ON, K1Y 4E9, Canada

13 Centre for Health Services Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada

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Trials 2012, 13:116  doi:10.1186/1745-6215-13-116

Published: 26 July 2012

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.