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

Gallo A, Weijer C, White A, Grimshaw JM, Boruch R, Brehaut JC, Donner A, Eccles MP, McRae AD, Saginur R, Zwarenstein M, Taljaard M.

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 cluster trial 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 cluster randomized trials in health research? Gatekeepers (also called guardians or cluster representation mechanisms) are unique to CRTs and 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 due to cluster randomization, cluster level interventions, and cluster size. In this paper, we argue for a more restrictive understanding of the role and authority of gatekeepers. Previous papers in this series have provided solutions to informed consent in CRTs without the need to invoke gatekeepers. We argued 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. 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 argue that the role of gatekeepers in protecting individual interests in CRTs is limited. Generally, gatekeepers do not have the authority to provides proxy consent for cluster members. When a municipality or other community has a legitimate political authority empowered to make such decisions, cluster consent 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 play an important role in the protection of the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization turns on resource implications and adherence to institutional policies.

TimAllenMDJD

Saturday, July 28, 2012