• Acad Emerg Med · Oct 2021

    Review

    Meeting Unique Requirements: Community Consultation and Public Disclosure for Research in Emergency Setting Using Exception from Informed Consent.

    • Neal W Dickert, Kathleen Metz, Michael D Fetters, Adrianne N Haggins, Deneil K Harney, Candace D Speight, and Robert Silbergleit.
    • Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
    • Acad Emerg Med. 2021 Oct 1; 28 (10): 1183-1194.

    BackgroundException from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature.MethodsScoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories.ResultsAmong 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two-way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what "communities" to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy.ConclusionsMultiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.© 2021 by the Society for Academic Emergency Medicine.

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