From: What is the role and authority of gatekeepers in cluster randomized trials in health research?
Recommendation | Remarks |
---|---|
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 |