Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-25T09:35:21.272Z Has data issue: false hasContentIssue false
  • English
  • Français

Ethical challenges of informed consent in prehospital research

Published online by Cambridge University Press:  21 May 2015

James Thompson
James Thompson*
Affiliation:
Department of Emergency Medicine, Dalhousie University, Halifax, NS
*
Department of Emergency Medicine, QE II Health Science Centre, Halifax Infirmary Site, 1796 Summer St., Halifax NS B3H 3A7; 902 473-2020, fax 902 473-3617, [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.

Informed consent to participation in research is an important protector of potential subjects’ rights and autonomy. Ethical research involving critically ill people is challenging because their medical condition often makes obtaining informed consent impossible. This is especially true in the prehospital setting, where additional barriers to obtaining informed consent exist. A recently published Canadian policy (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) specifies circumstances under which an exception to the requirement for informed consent may be granted so that vulnerable individuals are not denied the potential benefits of participating in research. This article reviews the rationale for the Tri-Council Policy Statement and illustrates some problems with its application in the context of a Canadian prehospital study on continuous positive airway pressure. A new risk analysis model and a national research ethics board are discussed as possible ways to facilitate interpretation and application of the current exception of informed consent policy.

Keywords

prehospitalresearchinformed consentexception to informed consentcontinuous positive airway pressure
Type
Methodology: The Science of EM • Méthodologie: Science De La MU
Information
Canadian Journal of Emergency Medicine , Volume 5 , Issue 2 , March 2003 , pp. 108 - 114
Copyright
Copyright © Canadian Association of Emergency Physicians 2003

References

1.Gray, JD.The problem of consent in emergency medicine research. CJEM 2001;3(3):213–8.CrossRefGoogle ScholarPubMed
2.Burdick, WP, Cassell, EJ, Leon, AC, Kaufman, SG.Preliminary evidence of impaired thinking in sick patients. Ann Intern Med 2001;134:1120–3.Google Scholar
3.Smithline, H, Mader, TJ, Crenshaw, BJ.Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? Acad Emerg Med 1999;6:776–80.CrossRefGoogle ScholarPubMed
4.Prentice, ED.Informed consent: the most important predictor. Acad Emerg Med 1999;6:774–5.CrossRefGoogle Scholar
5.Fitten, LJ, Waite, MS.Impact of medical hospitalization on treatment: decision-making capacity in the elderly. Arch Intern Med 1990;150:1717–21.Google Scholar
6.Fitten, LJ, Lusky, R, Hamann, C.Assessing treatment decision-making capacity in elderly nursing home residents. J Am Geriatr Soc 1990;38:1097–104.CrossRefGoogle ScholarPubMed
7.Smith, HL.Myocardial infarction: case studies of ethics in the consent situation. Soc Sci Med 1974;8:399–404.Google Scholar
8.Silverman, HJ.Ethical considerations of ensuring an informed and autonomous consent in research involving critically ill patients. Am J Respir Crit Care Med 1996;154:582–6.Google Scholar
9.Coppolino, M, Ackerson, L.Do surrogate decision makers provide accurate consent for intensive care research? Chest 2001; 119:603–12.CrossRefGoogle ScholarPubMed
10.Grim, PS, Singer, PA, Gramelspacher, GP, Feldman, T, Childers, RW, Siegler, M.Informed consent in emergency research: prehospital thrombolytic therapy for acute myocardial infarction. JAMA 1989;262:252–5.CrossRefGoogle ScholarPubMed
11.Hsieh, M, Dailey, MW, Callaway, CW.Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med 2001;8:851–3.CrossRefGoogle ScholarPubMed
12.Emergency Cardiac Care Committee, American Heart Association. Standards and guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiac care (ECC). JAMA 1986;255: 2841–57.Google Scholar
13.Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Gruppo Italiano per lo Studio della Streptochinasi nell’Infarcto Miocardico (GISSI). Lancet 1986;1:397–402.Google Scholar
14.Pepe, PE, Bonnin, MJ, Mattox, KL.Regulating the scope of EMS. Prehosp Disas Med 1990;5:59–63.Google Scholar
15.Callaham, M.Quantifying the scanty science of prehospital emergency care. Ann Emerg Med 1997;30:785–90.Google Scholar
16.Morrison, LJ, Verbeek, PR, McDonald, AC, Sawadsky, BV, Cook, DJ.Mortality and prehospital thrombolysis for acute myocardial infarction: a meta-analysis. JAMA 2000;283:2686–92.CrossRefGoogle ScholarPubMed
17.Weaver, WD, Cerqueira, M, Hallstrom, AP, Litwin, PE, Martin, JS, Kudenchuk, PJ, et al. Prehospital-initiated vs hospital-initiated thrombolytic therapy. The Myocardial Infarction Triage and Intervention Trial. JAMA 1993;270:1211–6.CrossRefGoogle ScholarPubMed
18.Gibler, WB, Kereiakes, DJ, Dean, EN, Martin, L, Anderson, L, Abbottsmith, CW, et al. Prehospital diagnosis and treatment of acute myocardial infarction: a north-south perspective. The Cincinnati Heart Project and the Nashville Prehospital TPA Trial. Am Heart J 1991;121(1 Pt 1):1–11.Google Scholar
19.Gausche, M, Lewis, RJ, Stratton, SJ, Haynes, BE, Gunter, CS, Goodrich, SM, et al. Effect of out-of-hospital pediatric endotracheal intubation on survival and neurological outcome: a controlled clinical trial. JAMA 2000;283:783–90.CrossRefGoogle ScholarPubMed
20.Stiell, IG, Wells, GA, Field, BJ, Spaite, DW, De Maio, VJ, Ward, R, et al. Improved out-of-hospital cardiac arrest survival through the inexpensive optimization of an existing defibrillation program: OPALS study phase II. Ontario Prehospital Advanced Life Support. JAMA 1999;281:1175–81.CrossRefGoogle ScholarPubMed
21.Alpert, S.Implementing the final rule. Acad Emerg Med 1999; 6:1188–9.Google Scholar
22.Passamani, ER, Weisfeldt, ML. 31st Bethesda Conference. Emergency Cardiac Care. Task force 3: Special aspects of research conduct in the emergency setting: Waiver of informed consent. J Am Coll Cardiol 2000;35:862–80.Google Scholar
23.Title 21 of the Code of Federal Regulations, Section 50.24 (21CFR50.24). Exception from informed consent requirements for emergency research (61 FR 51528). US Food and Drug Administration Department of Health and Human Services; Oct 2, 1996. Available: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=50.24(database updated 2002 Apr 1; site accessed 2003 Jan 17).Google Scholar
24.Tri-Council Policy Statement: ethical conduct for research involving humans. Ottawa: Medical Research Council, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 1998. Available: www.nserc.ca/programs/ethics/english/ethics/policy.htm (updated 2000 Nov 21; accessed 2003 Jan 17).Google Scholar
25.Free and informed consent: Research in emergency health situations. Article 2.8. In: Tri-Council Policy Statement: ethical conduct for research involving humans. Ottawa: Medical Research Council, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada; 1998. Available: www.nserc.ca/programs/ethics/english/sec02.htm#F (accessed 2003 Jan 17).Google Scholar
26.Shah, AN, Surgarman, J.Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Ann Emerg Med 2003; 41:72–8.Google Scholar
27.Schmidt, TA.The legacy of the Tuskegee syphilis experiments for emergency exception from informed consent. Ann Emerg Med 2003;41:79–81.CrossRefGoogle ScholarPubMed
28.Alldredge, B, Gelb, A, Isaacs, S, Corry, MD, Allen, F, Ulrich, SKet al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. N Engl J Med 2001;345:631–7.CrossRefGoogle ScholarPubMed
29.Ochs, M, Davis, D, Hoyt, D, Bailey, D, Marshall, L, Rosen, P.Paramedic-performed rapid sequence intubation of patients with severe head injuries. Ann Emerg Med 2002;40:159–67.CrossRefGoogle ScholarPubMed
30.Dorian, P, Cass, D, Schwartz, B, Cooper, R, Gelaznikas, R, Barr, A.Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation [published erratum appears in N Engl J Med 2002;347:955]. N Engl J Med 2002;346:884–90.CrossRefGoogle ScholarPubMed
31.Abu-Laban, RB, Christenson, JM, Innes, GD, van Beek, CA, Wanger, KP, McKnight, RD, et al. Tissue plasminogen activator in cardiac arrest with pulseless electrical activity. N Engl J Med 2002;346:1522–8.Google Scholar
32.Smithline, HA, Gerstle, ML.Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med 1998;16:90–1.Google Scholar
33.McRae, A, Weijer, C.Lessons from everyday lives: a moral justification for acute care research. Crit Care Med 2002;30:1146–51.CrossRefGoogle Scholar
34.Fost, N.Can acutely ill patients consent to research? Resolving an ethical dilemma with facts. Acad Emerg Med 1999;6:772–3.Google Scholar
35.Evaluation of NIH implementation of Section 491 of the Public Health Service Act, mandating a program of protection for research subjects. Review draft final report. NIH contract no. N01-OD-2–2109. Bethesda (MD): Office of Extramural Research, National Institutes of Health; May 1998.Google Scholar
36.Steinbrook, R.Improving protection for research subjects. N Engl J Med 2002;346:1425–30.Google Scholar
37.Christian, MC, Goldberg, JL, Killen, J, Abrams, JS, McCabe, MS, Mauer, JK, et al. A central institutional review board for multi-institutional trials. N Engl J Med 2002;346:1405–8.CrossRefGoogle ScholarPubMed
38.Tully, J, Ninis, N, Booy, R, Viner, R.The new system of review by multicentre research ethics committees: prospective study. BMJ 2000;320:1179–82.CrossRefGoogle ScholarPubMed
39.Ferris, L.Industry-sponsored pharmaceutical trials and research ethics boards: Are they cloaked in too much secrecy?. CMAJ 2002;166:1279–80.Google ScholarPubMed
40.Slater, EE.IRB reform. N Engl J Med 2002;346:1402–4.CrossRefGoogle ScholarPubMed