title: Keynote address: Toward a pragmatic model for community consultation in emergency research.
abstract: Under the Final Rule enacted in 1996 by the United States Food and Drug Administration and Office of Health and Human Services, community consultation and public notification are required when emergency research is to be conducted in the absence of prior informed consent by subjects. There is a dearth of published recommendations concerning the degree to which communities must be aware of the existence and parameters of a study for which informed consent might not be obtained prior to enrollment. It is argued that effective community consultation requires empirical measurement of the dynamics of community, and that ordinary notions of community may not capture the populations at greatest risk or those who might for other reasons figure most prominently in community consultation. A pragmatic approach to community consultation would establish benchmarks for such measures, and it is argued that such an approach is possible given the correct empirical measures.
authors.affiliation: Alden March Bioethics Institute, Albany Medical Center, Albany, NY, USA. mcgee@amc.edu
authors.forename: Glenn
authors.initials: G
authors.lastname: McGee
authors.forename: Mara
authors.initials: M
authors.lastname: McErlean
authors.forename: Wayne
authors.initials: W
authors.lastname: Triner
authors.forename: Vincent
authors.initials: V
authors.lastname: Verdile
mesh_terms: D003159:Community-Institutional Relations; D003245:Consensus Statements as Topic; D004632:Emergency Medical Services / Q000941:ethics*; D004635:Emergency Medicine / Q000458:organization & administration*; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D017146:Models, Organizational; D018579:Patient Selection / Q000941:ethics; D014481:United States