Abstract
Informed consent is a vital part of ethical research. In emergency health care research environments such as ambulance services and emergency departments, it is sometimes necessary to conduct trial interventions or observations without patient consent. At times where treatment is time critical, it may be impossible or inappropriate to seek consent from next of kin. Emergency medicine is one of the few areas where the process of informed consent can be waived to allow research to proceed without patient consent. This article will explore the ethics of informed consent in the prehospital emergency research context. This will include an overview of current Australian guidelines for ethical research, and recent changes in law internationally which have affected the conduct of international emergency health research. An overview of the ethical reasoning behind the waiver of informed consent in emergency research is presented, also addressing issues relating to emergency health research such as proxy consent, unconscious patients, and patient decision making capacity. The unusual circumstances encountered in the prehospital ambulance environment will also be discussed, including the dependent and coercive relationship between patients and ambulance professionals, and a lack of alternatives for care and transport for patients who refuse consent. The conflict arising from differences in medical culture and values between patients and health care professionals will also briefly be discussed. It will be argued that, while emergency care research should not require informed consent due to the restrictions of time and dependent nature of the relationship between patient and health professional, emergency health researchers still have a responsibility to consider the patients’ perspective when considering the ethical issues of an emergency research project, particularly in the prehospital environment.
Article PDF
Similar content being viewed by others
References
Adams, J. 1993. ‘Ethical challenges in emergency medical services. A special contribution of the Ethics Committee, National Association of Emergency Medical Services Physicians’. Prehospital and Disaster Medicine 8(2): 179–182.
Adams, J G; Arnold, R; Siminoff, L; Wolfson, A B. 1992. ‘Ethical conflicts in the prehospital setting’. Annals of Emergency Medicine 21(10): 1259–1265.
American Medical Association. 2003. E-8.085 Waiver of Informed Consent for Research in Emergency Situations. Washington: American Medical Association.
Australasian College of Emergency Medicine. 2000. Policy Document: The Australasian Triage Scale. 2000. Accessed 14 February 2003. Available from: http://www.acem.org.au/open/documents/triage.htm
Biros, M; Lewis, R; Olson, C; Runge, J; Cummins, R O; Fost, N. 1995. ‘Informed consent in emergency research: Consensus statement from the coalition conference of acute resuscitation and critical care researchers’. Journal of the American Medical Association 273(16): 1283–1287.
Braunack-Mayer, A. 2002. ‘The ethics of participating in research’. Medical Journal of Australia 177: 471–472.
Campbell, D A; Yellowlees, P M; McLennan, G; Coates, J R; Frith, P A; Gluyas, P A. et al. 1995. ‘Psychiatric and medical features of near fatal asthma’. Thorax 50(3): 254–259.
Chan, H. 2004. ‘Sharing death and dying; advance directives, autonomy and the family’. Bioethics 18(2): 87–103.
Cochrane Collaboration. 2010. ‘Prehospital and emergency health field’. Cochrane Collaboration (4 March 2010). Available from: www.cochranepehf.org http://www.cochranepehf.org.
Commonwealth of Australia. 2007. National Statement on Ethical Conduct in Research Involving Humans. Canberra: Commonwealth of Australia.
Cooper, A; Lloyd, G; Weinman, J; Jackson, G. 1999. ‘Why patients do not attend cardiac rehabilitation: Role of intentions and illness beliefs’. Heart 82(2): 234–236.
Davis, M A; Keerbs, A; Hoffman, J; Baraff, L. 1996. ‘Admission decisions in emergency department chest pain patients at low risk for myocardial infarction: Patient versus physician preferences’. Annals of Emergency Medicine 28(6): 606–611.
Edwards, S; Ashcroft, R; Kirchin, S. 2004. ‘Research ethics committees: Differences and moral judgement’. Bioethics 18(5): 409–427.
Foex, B. 2001. ‘The problem of informed consent in emergency medicine research’. Emergency Medicine Journal 18(3): 198–204.
Herlitz, J. 2002. ‘Consent for research in emergency situations’. Resuscitation 53(3): 239.
Hsieh, M; Dailey, M W; Callaway, C. 2001. ‘Surrogate consent by family members for out-of-hospital cardiac arrest research’. Academic Emergency Medicine 8(8): 851–853.
Irvine, R; McPhee, J; Kerridge, I. 2002. ‘The challenge of cultural and ethical pluralism in medical practice’. Medical Journal of Australia 176(4): 174–175.
Ji, L.-J; Zhang, Z; Usborne, E; Guan, Y. 2004. ‘Optimism across cultures: In response to the severe acute respiratory syndrome outbreak’. Asian Journal of Social Psychology 7(1): 25–34.
Kerridge, I; Pearson, S; Rolfe, I E; Lowe, M. 1998. ‘Decision making in CPR: Attitudes of hospital patients and healthcare professionals’. Medical Journal of Australia 169: 128–131.
Kowey, P; Ornato, J. 2000. ‘Resuscitation research and emergency waiver of informed consent’. Resuscitation 47(3): 307–310.
Metropolitan Ambulance Service and Rural Ambulance Victoria. 2001. Time Critical Guidelines (Clinical Practice Guidelines). Melbourne: Metropolitan Ambulance Service and Rural Ambulance Victoria.
Metropolitan Ambulance Service and Rural Ambulance Victoria. 2009. Time Critical Guidelines (Clinical Practice Guidelines). Melbourne: Metropolitan Ambulance Service and Rural Ambulance Victoria.
Mkhize, N. 2004. Indigenous Selves and Ethical Decision Making: Towards Dialogue Between Universalism and Communalism in Ethics. Paper presented at the 7th World Congress of Bioethics, Sydney, Australia. 9th–12th November 2004.
Moreno, J; Caplan, A L; Wolpe, P R. 1998. ‘Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group’. Journal of the American Medical Association 280(22): 1951–1958.
Moscati, R. 2002. ‘Protection of human subjects in prehospital research’. Prehospital Emergency Care 6(2 Suppl): S18–S23.
Office of the Health Services Commissioner. 2002. Health Records Act 2001 (Vic): Statutory Guidelines on Research. Melbourne: Office of the Health Services Commissioner.
Olson, C. 1994. ‘The letter or the spirit: Consent for research in CPR’. Journal of the American Medical Association 271(18): 1445–1447.
Simpson, C. 2004. ‘When hope makes us vulnerable: A discussion of patient healthcare provider interactions in the context of hope’. Bioethics 18(5): 428–447.
Steer, B. 2007. ‘Paramedics, consent and refusal — are we competent?’ Journal of Emergency Primary Health Care 5(1): 1–10.
United States Government Printing Office. 2000. Code of Federal Regulations, Title 21; Food and Drugs; Part 50 — Protection of Human Subjects. Washington: United States Government Printing Office.
Welie, S. 2001. ‘Criteria for patient decision making (in)competence: A review of and commentary on some empirical approaches’. Medicine, Health Care and Philosophy 4(2): 139–151.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Morgans, A. Waiver of Informed Consent in Prehospital Emergency Health Research in Australia. Monash Bioethics Review 29, 49–64 (2010). https://doi.org/10.1007/BF03351323
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03351323