Table 2 Summary of recommendations for the appropriate use of gatekeepers in cluster randomized trials (CRTs)

Gatekeepers should not provide proxy consent on behalf of individuals in CRTs

The fact that cluster members are typically competent and gatekeepers do not have detailed knowledge of cluster members’ decision-making history, interests, and values undermines the legitimacy of gatekeepers as a proxy decision-makers

Gatekeepers should not provide permission to randomize or proxy consent on behalf of cluster members, and CRTs should not proceed on the basis of such permission or proxy consent

When a fiduciary relationship exists between the gatekeeper and cluster members, as in a physician–patient or teacher–student relationship, the gatekeeper may provide permission to approach cluster member

Gatekeepers who are fiduciaries may deny permission to approach cluster members whose interests are likely to be unduly compromised by study participation

Gatekeeper permission to approach cluster members is not appropriate where no fiduciary relationship exists between the gatekeeper and cluster members

When a CRT may substantially affect group-based interests, and a gatekeeper possesses the legitimate authority to make decisions on behalf of the cluster, gatekeeper permission to enroll the cluster in the trial should be sought

When a gatekeeper possesses legitimate authority with respect to the individuals involved and the decision at hand, the gatekeeper’s permission to enroll the cluster in the study should be sought

Ambiguity about the authority of a gatekeeper may be reason for consultation with cluster members

When a gatekeeper does not have the requisite authority, researchers should not approach the gatekeeper for permission to enroll the cluster in research, and a CRT ought not proceed on the basis of such permission

Cluster permission does not supplant the need for individual informed consent from cluster members

When a CRT may substantially affect group-based interests, researchers should seek to protect these interests through cluster consultation to inform study design, conduct and reporting

Cluster consultation may be used to seek input on how the CRT ought to be conducted so as to enhance study protections and benefits for clusters

Mechanisms may include open public forums, meetings with opinion leaders, presentations at religious or civic organizations, and the use of radio, television, or the internet

Recommendations from cluster consultation are not binding and, where there are good reasons to do so, researchers may decline to make suggested changes to a study

When a CRT may substantially affect organizational interests, and a gatekeeper possesses the authority to make decisions on behalf of the organization, organizational permission should be sought from the gatekeeper.

Organizational interests may be separable from cluster interests in a CRT

The gatekeeper will consider the effect on the organization, including availability of staff, financial implications of participation, and compliance with organizational policies

Organizational permission does not supplant the need for individual informed consent from cluster members