Three articles in the Christmas issue of the Journal,1-3 responding to media coverage of a proposed clinical trial,4 failed to address the objections raised to conducting the trial without patient consent. The proposed trial, the Royal North Shore (RNSH) and Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction (RARE SALAMI), was to be conducted in Sydney's Northern Area Health Service. The aim was to compare two regimens of management of patients with acute myocardial infarction and determine whether, despite some additional transit time, diverting ambulances past local hospitals (where patients would receive thrombolytic treatment) and on to the services at RNSH (where patients would be treated with percutaneous coronary intervention) would be beneficial to patients (Box 1).1 The trial would involve the ambulance service, RNSH and the emergency departments of four district hospitals within the health area. Senior medical staff from two of the emergency departments were among those who expressed concerns in the media reports.4
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- 1. Rasmussen HH, Hansen PS, Koyama Y, et al. Trial of a trial by media. Med J Aust 2001; 175: 625-628. <eMJA full text>
- 2. Chapman S. Media milking of sacred cows: a heart-stopping tale. Med J Aust 2001; 175: 629. <eMJA full text>
- 3. Komesaroff, PA. Clinical research in the emergency setting: the role of ethics committees. Med J Aust 2001; 175: 630-631. <eMJA full text>
- 4. Ryle G. A trial of the heart . Sydney Morning Herald 2001; 29 March: 11.
- 5. Pittwater Council. Mayoral minute. July 2, 2001.
- 6. The Nuremberg Code (1947). BMJ 1996; 313: 1448.
- 7. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. October 2000. Available at: http://www.wma.net/e/policy/17-c_e.html (accessed June 2002).
- 8. National Statement on Ethical Conduct in Research Involving Humans. Available at: http://www.health.gov.au/nhmrc/publications/humans/contents.htm (accessed June 2002).
- 9. Department of Health and Human Services. Food and Drug Administration Office of the Secretary. 21 CFR Part 50, et al. 45 CFR Part 46. Protection of human subjects and waiver of informed consent requirements in certain emergency research; Final rules: 51497-51531. Federal Register (FR), 61 FR 51498, October 2, 1996.
- 10. Silverman H, Chandros S, Sugerman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 2001; 29: 235-241.
- 11. Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam, diazepam, and placebo for the treatment of out-of-hospital status epilepticus. N Engl J Med 2001; 345: 631-637.
The author wishes to thank the four MJA reviewers and Judith Kennedy for helpful suggestions.