Abstract
BACKGROUND: Community consultation activities are required by the Food and Drug Administration prior to conducting research using exception from informed consent (EFIC) for emergency research and aim to provide additional participant protections. However, it is difficult for institutional review boards (IRBs) to assess the efficacy of such activities. In this study, our primary aim was to evaluate the efficacy of the PediDOSE trial's consultation activities by answering key questions about whether consultation efforts reached a relevant community and if the perspectives of the consulted community coincided with those of parents actually enrolled in the study. METHODS: Qualitative findings of semistructured interview data collected during community consultation efforts were compared with interview responses from parents of children enrolled in the PediDOSE trial to identify common themes. RESULTS: Most themes were identified in both groups, but additional themes emerged with parents of enrolled participants that may be important for future study teams and IRBs to consider. Even with an overrepresentation of White and non-Hispanic/Latino participants in the community consultations compared to those who were enrolled in the EFIC study there was common overlap of themes. CONCLUSIONS: Parent interviews added to our understanding beyond the themes identified in the consultation interviews. The theme of therapeutic misconception was not found in the consultation interviews, possibly due to the child's emergency medical care being theoretical. With modest accommodations, collection of additional demographic and follow-up interview data can successfully assess key elements of community consultation efficacy for EFIC trials.