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. 2016 Mar;34(3):623-5.
doi: 10.1016/j.ajem.2015.12.007. Epub 2015 Dec 12.

Ethical and regulatory challenges in advancing prehospital research: focus on sepsis

Carmen C Polito  1 , Jonathan E Sevransky  2 , Neal W Dickert  3
Affiliations

Ethical and regulatory challenges in advancing prehospital research: focus on sepsis

Carmen C Polito et al. Am J Emerg Med. 2016 Mar.
No abstract available

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Figures

Figure 1
Figure 1. Spectrum of patient involvement and trial-related risk
Definitions: CER – comparative effectiveness research
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References

    1. US Department of Health and Human Services, Food and Drug Administration. 21 CFR 50.24 Exception from informed consent requirements for emergency research. 1996 Oct; http://www.ecfr.gov/cgi-bin/text-idx?SID=fc2af8cd382623988c30aa3cd612d09....
    1. US Department of Health and Human Services. 45 CFR 46. 2009 Jul; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
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    1. Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. The New England journal of medicine. 2003;348:1546–54. - PubMed

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