Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent
| Autor: | Neal W. Dickert, Michael D. Fetters, Candace D. Speight, Kathleen Metz, Adrianne N. Haggins, Deneil K. Harney, Robert Silbergleit |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Medical education
Informed Consent Web of science business.industry Research context 030208 emergency & critical care medicine General Medicine Disclosure Multiple methods Article 03 medical and health sciences 0302 clinical medicine Exchange of information Informed consent Emergency Medicine Medicine Humans Public disclosure Literature study Public acceptance Emergencies business Emergency Service Hospital Referral and Consultation |
| Zdroj: | Acad Emerg Med |
| Popis: | BACKGROUND: Exception 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. METHODS: Scoping 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. RESULTS: Among 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. CONCLUSIONS: Multiple 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. |
| Databáze: | OpenAIRE |
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