Keynote Address: Toward a Pragmatic Model for Community Consultation in Emergency Research

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 dear...

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Bibliographic Details
Published in:Academic emergency medicine 2005-11, Vol.12 (11), p.1019-1021
Main Authors: McGee, Glenn, McErlean, Mara, Triner, Wayne, Verdile, Vincent
Format: Article
Language:English
Subjects:
bioethics
community consultation
emergency research
ethics
public notification
research ethics
resuscitation research
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Summary: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.
ISSN:1069-6563
1553-2712
DOI:10.1197/j.aem.2005.07.023