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.
Highlights
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research
The use of gatekeepers stems primarily from the difficulty of obtaining informed consent from study participants [2,4]. Previous articles in this series have called for a more restrictive view of who counts as a research subject, and from whom and when informed consent must be obtained in a CRT [5,6]
In our paper on informed consent, we considered circumstances in which it may be difficult to obtain the informed consent of cluster members because of cluster-level interventions or large cluster size [6]
Summary
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. When a CRT involves a well-defined community, and when the CRT may substantially affect group-based interests, the protections required by the principle of respect for communities may be applied directly In such cases, researchers may be required to obtain permission from gatekeepers to enroll the cluster, prior to seeking individual informed consent from cluster members (Table 2). Consider the example of a community-based CRT investigating a breastfeeding education program in India, which sought consent from community leaders and health-system authorities to include their communities in the study [20] Whether those who acted as gatekeepers in this trial had the authority to provide cluster consent depends on two conditions: whether the members of the community understood the gatekeepers’ roles as including the authority to make these decisions, and whether they were largely satisfied with the institutions involved, that is, the political system used to select community leaders and the local health system. These decisions fall within the remit of the general-practice partners and midwifery managers, they have the authority to legitimately fulfill the role of gatekeeper
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