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

doi:10.1016/j.ajem.2015.12.007

. 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 Polito¹, Jonathan E Sevransky², Neal W Dickert³

Affiliations

¹ Division of Pulmonary, Allergy and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA. Electronic address: cpolito@emory.edu.
² Division of Pulmonary, Allergy and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA.
³ Division of Cardiology, Emory University School of Medicine, Atlanta, GA; Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA.

PMID: 26851062
PMCID: PMC6025743
DOI: 10.1016/j.ajem.2015.12.007

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

Carmen C Polito et al. Am J Emerg Med. 2016 Mar.

. 2016 Mar;34(3):623-5.

doi: 10.1016/j.ajem.2015.12.007. Epub 2015 Dec 12.

Authors

Carmen C Polito¹, Jonathan E Sevransky², Neal W Dickert³

Affiliations

¹ Division of Pulmonary, Allergy and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA. Electronic address: cpolito@emory.edu.
² Division of Pulmonary, Allergy and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA.
³ Division of Cardiology, Emory University School of Medicine, Atlanta, GA; Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA.

PMID: 26851062
PMCID: PMC6025743
DOI: 10.1016/j.ajem.2015.12.007

No abstract available

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Figures

**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.
1. Biros M. Struggling with the rule: the exception from informed consent in resuscitation research. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2007;14:344–5. - PubMed
1. Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 1999;6:1272–82. - PubMed
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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[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....

[2] 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....

[3] US Department of Health and Human Services. 45 CFR 46. 2009 Jul; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

[4] US Department of Health and Human Services. 45 CFR 46. 2009 Jul; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

[5] Biros M. Struggling with the rule: the exception from informed consent in resuscitation research. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2007;14:344–5. - PubMed

[6] Biros M. Struggling with the rule: the exception from informed consent in resuscitation research. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2007;14:344–5. - PubMed

[7] Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 1999;6:1272–82. - PubMed

[8] Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration’s final rule for waiver of informed consent in certain emergency research circumstances. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 1999;6:1272–82. - PubMed

[9] 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

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

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

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