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The complexities associated with clinical research in the emergency setting are illustrated by the story recounted in this issue of the Journal of the trial proposed by investigators at Sydney's Royal North Shore Hospital (RNSH) to compare two models of care for patients with acute myocardial infarction (AMI).¹ While fibrinolysis has been standard treatment for AMI since the mid-1980s, evidence has suggested that coronary artery angioplasty with stenting produces better outcomes. However, the latter treatment requires advanced technology and skills, limiting its availability. Accordingly, it was proposed to conduct a randomised trial to compare outcomes for patients with AMI of transport to the nearest regional hospital for "conventional" treatment versus transport to RNSH for possible angioplasty.

• Patients assigned to RNSH would often experience increased transport times to hospital; and

• It would be difficult to obtain patients' fully informed consent.

The first issue is important because delays in initiating treatment after AMI increase the risk of death. The second issue of difficulty obtaining informed consent is encountered in research involving interventions for acute, life-threatening illness, because of shortness of time and the inevitable stress associated with the life-threatening circumstances.

Both these issues were taken up by the RNSH ethics committee that meticulously examined the study. After examination of preliminary data, the committee accepted the arguments of the investigators that the benefits of stenting would exceed any increased risk associated with transport delays. It was also decided that it was acceptable to delay provision of detailed information about the trial until the patients arrived at RNSH, even though, in reality, this would often exclude alternatives. Despite complaints provoked by concern within the medical community, approval was eventually granted, but before the trial could begin the Sydney Morning Herald published an article questioning this decision.² A storm of publicity followed and, months later, the trial has still not commenced.

There are several points raised by this case on which there is widespread agreement. In the emergency setting, as elsewhere, rigorous testing is important to identify the most effective treatments and to exclude ineffective, risky or unnecessarily expensive ones. However, the gravity and urgency of the circumstances will often limit the extent to which patients can make carefully considered judgements about whether to participate. Often compromises need to be found. It is the sometimes unenviable job of the responsible ethics committee to attempt to find such a compromise, after considering all the issues and balancing possible risks and benefits. In this case, the scientific questions are well founded and the answers are likely to carry significant implications for medical practice around the world. However, whatever decision is ultimately reached it is unlikely to find acceptance by all protagonists.

The complexity of the issues emphasises the importance of the ethics committee process. As with the courts, public confidence in the outcome of ethics committee deliberations depends on a belief that it is fair, free from interference and takes into account all relevant issues. The RNSH ethics committee appears to have acted with propriety and professionalism, but, like other ethics committees, its deliberations are not open to public scrutiny. In addition, it is possible that it did not consider issues affecting other hospitals within the region — for example, the interests of private providers of angioplasty and their patients who could be disadvantaged by the study. The absence of the need to justify decisions in contentious cases, and of a defined appeals process for most committees, creates an appearance of arbitrariness and peremptoriness.

The role of the media, which the investigators found so disturbing here, also raises important issues. Medical research is a matter of public interest, and ethics review is not a mere technical function, but a means by which the community ensures that research proposals are adequately evaluated and supervised. Press coverage may be of variable quality, and may itself represent undeclared vested interests. However, as cumbersome and inconvenient as the process may be, if a study has sufficient merit and the review process has been sufficiently robust it is unlikely that public debate and critical reflection will ultimately prevent it from proceeding.

This imbroglio provides several important lessons. There are no short cuts to the solution of difficult ethical problems and complete consensus may never be possible. What is most important is that discussions and decision-making processes be free, open and transparent. For these reasons, the tendency for ethics committees to keep their deliberations secret, in the mistaken belief that this is necessary to protect intellectual property, should be reassessed. Promising new models for ensuring public accountability and sharing of experience of committee processes should be examined, such as open access to meetings, chat rooms and the concept of the health ethics archive.^3,4 In addition, care must be taken to ensure that current efforts to streamline ethics review processes in the interests of cost and efficiency do not erode the democratic, decentralised nature of the system. In the case of the RNSH trial of treatment for AMI, the investigators should be encouraged to continue dialogue with their interlocutors until the best possible compromise can be reached.

Paul A Komesaroff
Director, Monash Centre for the Study of Ethics in Medicine and Society
Melbourne, VIC

Competing interests: None declared.

1. Rasmussen HH, Hansen PS, Koyama Y, et al. Trial of a trial by media. Med J Aust 2001; 175: 625-628.
2. Ryle G. A trial of the heart. Sydney Morning Herald 2001; 29 March: 11.
3. The Institutional Review Board — discussion and news forum. <http://www.irbforum.org> (accessed November 2001).
4. Health Ethics Archive. <http://www.ethics-archive.org> (accessed November 2001).

©MJA 2001
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