Abstract TP50: Exception From Informed Consent (EFIC) In Emergency Research: Developing A Community Consultation Plan

Abstract

Background: In emergent situations where patients are neurologically impaired, obtaining informed consent is a challenge. Research-related interventions that may optimize patient outcomes may be delayed or not given. Under the Final Rule, emergency research studies can proceed without informed consent granted that certain criteria are first met. One criteria is that researchers must conduct community consultation activities. Objective: We share the various mechanisms used in outreach to our catchment area and their respective views of EFIC research. Methods: As part of community consultation efforts for an emergent hemorrhagic stroke trial, our research team first developed a comprehensive plan to seek out the best platforms to disseminate study information and obtain diverse input (all while recognizing the heterogeneity of the community). A survey tool developed by the study’s sponsor National Institute of Health StrokeNet team was used to elicit feedback related to the value of the trial, participants’ understanding of EFIC, and trust in physician-investigators. Results: A total of 700 individuals participated across all the proposed community consultation events (e.g. focus groups, local support groups, forums). Two-hundred five participants completed the survey, with 96% agreeing that the trial is an important study to do; 80% were in favor of themselves or a loved one being included in the trial without consent. Community members responding included seniors, those at higher risk of suffering a stroke, and medical providers. Minority communities (i.e. Hispanic & African American populations) were contacted to ensure that their voice was heard. We used public disclosure to assist in reaching minority groups. Despite receiving only 22% turnout from these community members, the feedback received demonstrated the need to continue to make a collective effort in gaining the trust of these populations through community liaisons. Conclusion: Overall, community members expressed high levels of support for this EFIC trial. By incorporating a wide variety of mechanisms into a community consultation and public disclosure plan, maximal support for EFIC can be achieved.