title: Community consultation and public disclosure: preliminary results from a new model.
abstract: Emergency medicine research conducted under the exception from informed consent (EFIC) regulation enables critical scientific advancements. When EFIC is proposed, there is a requirement for broad community consultation and public disclosure (CC/PD) regarding the risks and benefits of the study. At the present time, no clear guidelines or standards exist for conducting and evaluating the CC/PD. This preliminary study tested the feasibility and acceptability of a new approach to CC/PD for a large-scale EFIC trial by engaging community members in designing and conducting the strategies. The authors enrolled key community members (called community advocates for research, or CARs) to use community-based participatory methods to design and implement CC/PD. By partnering with community members who represent target populations for the research study, this new approach has demonstrated a feasible CC/PD plan with greater community participation and less cost than previous studies. In a community survey, the percentage of community members reporting having heard about the EFIC trial more than doubled after employing the new approach. This article discusses initial implementation and results.
authors: Center for Clinical & Translational Research, Virginia Commonwealth University, Richmond, USA. caramsey@vcu.edu
authors: Cornelia A
authors: CA
authors: Ramsey
authors: Bonnie
authors: B
authors: Quearry
authors: Elizabeth
authors: E
authors: Ripley
mesh_terms: D055812:Community-Based Participatory Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D030881:Disclosure / Q000592:standards*; D004635:Emergency Medicine; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D017146:Models, Organizational; D016730:Program Development; D014481:United States