Hostname: page-component-586b7cd67f-r5fsc Total loading time: 0 Render date: 2024-11-26T06:11:00.603Z Has data issue: false hasContentIssue false
  • English
  • Français

The problem of consent in emergency medicine research

Published online by Cambridge University Press:  21 May 2015

Jonathan D. Gray
Jonathan D. Gray*
Affiliation:
First-year resident in Family Medicine, University of Toronto, Toronto, Ont
*
1534 Featherston Dr., Ottawa ON K1H 6P2; [email protected]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

This paper outlines some of the ethical and practical dilemmas of securing true informed consent in resuscitation research in the prehospital or emergency department setting. Possible substitutes to such consent are discussed and evaluated. The Canadian Tri-Council Policy Statement guidelines for emergency medicine research are compared to the US Food and Drug Administration rules, and the former are assessed and critiqued. Modifications to the current Tri-Council guidelines are suggested.

Keywords

emergency medicinemedical researchinformed consentbiomedical ethics
Type
Methodology: The Science of EM • Méthodologie: Science de la MU
Information
Canadian Journal of Emergency Medicine , Volume 3 , Issue 3 , July 2001 , pp. 213 - 218
Copyright
Copyright © Canadian Association of Emergency Physicians 2001

References

1.Tri-Council Policy Statement: ethical conduct for research involving humans. Ottawa: Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 1998. Available: www.nserc.ca/programs/ethics/english (accessed 15 May 2001).Google Scholar
2.Biros, MH, Lewis, RJ, Olson, CM, Runge, JW.Informed consent in emergency research: consensus statement from the coalition conference of acute resuscitation and critical care researchers. JAMA 1995;273:1283–6.Google Scholar
3.Fost, N, Robertson, JA.Deferring consent with incompetent patients in an intensive care unit. IRB Rev Hum Subj 1980;Res 5:2.Google Scholar
4.Office for Protection from Research Risks. Informed Consent – Legally Effective and Prospectively Obtained: OPRR Reports. Publ no 93–3. Washington: The Committee; 1993.Google Scholar
5.Prentice, ED.An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB Rev Hum Subj 1994;Res 16:16.Google Scholar
6.Olson, CM, Rennie, D.Plungers and polemics: active compressiondecompression CPR and federal policy. JAMA 1995;273:1299.CrossRefGoogle ScholarPubMed
7.Sachs, GA, Cassel, CK.Biomedical research involving older human subjects. Law Med Health Care 1990;18:234–6.Google Scholar
8.Fost, N.Waived consent for emergency research. Am J Law Med 1998;24:163–75.Google Scholar
9.Freedman, B.Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141.Google Scholar
10.Pellegrino, ED.Autonomy, beneficence, and the experimental subject’s consent: a response to Jay Katz. St Louis Law J 1993; 38:55–8.Google Scholar
11.Smithline, HA, Gerstle, ML.Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med 1998;16:90.CrossRefGoogle ScholarPubMed
12.Statute. Waiver of informed consent requirements in certain emergency research. US Fed Registry 1996;61:51531.Google Scholar
13.Statute. Protection of human subjects: informed consent. US Fed Registry 1996;60:49–95.Google Scholar
14.Kremers, MS, Whisnant, DR, Lowder, LS.Initial experience using the food and drug administration guidelines for emergency research without consent. Ann Emerg Med 1999;33:224–8.Google Scholar
15.Research in emergency health situations. Article 2.8. In: Tri-Council Policy Statement: ethical conduct for research involving humans. Ottawa: Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 1998. Available: www.nserc.ca/programs/ethics/english (accessed 15 May 2001).Google Scholar
16.Katz, J.In case of emergency: no need for consent. Hastings Cent Rep 1997;27:9.CrossRefGoogle Scholar