Comment: Tomlinson raises two important ethical issues in clinical research. While there are several ethical issues which may arise in acquiring and applying evidence to clinical practice and health administration, as outlined previously by Kerridge et al1 and picked up well by Leeder and Rychetnik,2 it is misleading if Tomlinson wishes to imply that the two issues he has raised can be attributed to the evidence-based medicine (EBM) movement.

His first issue could be summarised as "badly designed clinical research should be seen as unethical", for reasons which may include wasting scarce resources or placing participants at discomfort or risk when the likelihood of benefit is slight. He alleges that poorly designed studies are "frequently published in reputable peer-reviewed journals", a statement which would surprise most editors. Peer review prior to publication, and the earlier independent prospective scrutiny of research proposals by human research ethics committees (HRECs) (according to updated national guidelines published by the National Health and Medical Research Council [NHMRC] in 19993), are two processes designed to prevent this. Assessment of the quality of design and execution of clinical research protocols is to some extent subjective, so these processes will never be perfect.

His second issue relates to the definition of quality improvement/assurance and clinical audit, and whether such studies should be regarded as clinical research, and thus subject to prospective ethical review by an HREC. His own conclusion "that internal hospital quality assurance activities should undergo a similar level of scrutiny by ethics committees" is not consistent with the NHMRC guidelines,3 which, in the context of outlining the difficulties in defining research, state (on page 6) "such lists risk including activity that would not normally be included, like quality assurance activities or audits".

Nevertheless, there are definitional uncertainties. The Australian Health Ethics Committee (AHEC) of the NHMRC has recognised that clinicians, HRECs and their hospitals need clear advice on how quality assurance and audit activities, which may not need ethical review, are to be separated from clinical research, which does need review. We are not the only country considering this matter.4 AHEC has established a working party to prepare such advice. The working party includes members drawn from AHEC, HRECs, consumer groups, medical colleges and health administrators. Draft advice will be subject to wide stakeholder consultation. The working party commenced its task in November 2001 and its final report is expected by mid-2002.

To the Editor: We consider that Leeder and Rychetnik make several mistakes in their exploration of the relationships between ethics and evidence-based medicine (EBM).1 We share some of their ethical concerns about the determinants of the research agenda — lack of consumer input, emphasis on the benefits of interventions rather than harms, and funding structures favouring commercially promising interventions or biased by the status of the methodology to be used. However, these are criticisms that relate to producing new research, not using available research.

The definition of EBM used by Leeder and Rychetnik2 values evidence that is non-quantitative, and explicitly demands the inclusion of patient preferences in clinical decision-making. Evidence about effects comes from research, while evidence about concerns and values comes from individual patients. To incorporate a patient's pre-ferences in the consultation is crucial to ethical practice, but quite independent of any particular hierarchy of evidence.

Similarly, in claiming that treatment may be denied those of low social utility if patient autonomy is not valued, they mistakenly confuse preference or value with the quality of the evidence. The sin of old-fashioned paternalism is falsely attributed to EBM. The suggestion that EBM can exclude the importance of patient narrative is also at odds with the authors' chosen definition, which emphasises the "identification and compassionate use of patients' predicaments, rights, and preferences".

Next, they worry that EBM might be misused in public health policy by neglecting areas where evidence is difficult to obtain, offering mental illness as an example. In fact, mental health attracts considerable attention3 and funding as one of the Commonwealth's current priority health areas.4 It has also been an area of considerable activity in EBM, with the Cochrane Mental Health groups and the BMJ's evidence-based summary journal Evidence-Based Mental Health. It may be that EBM has done the opposite of their prediction by highlighting an area of "evidence need".

We agree that patients require support when they confront ambiguity and uncertainty. Nevertheless, doctors are ethically and legally obliged5 to provide full disclosure. Patients should be given correct information — warts, uncertainty and all — as often as possible. To suggest that the time spent seeking evidence threatens other elements of clinical practice is misleading. Clinical practice requires judgement to balance all its competing demands. We suggest that, by increasing the efficiency of continuing education, EBM should actually release more time for other requirements.

Leeder and Rychetnik also misinterpret the relation between EBM and the law. They suggest that some practitioners who consult evidence, but practise against published guidelines, may be compromised. The point of EBM is to find the best available evidence. If that is clinical experience, consensus or narrative, rather than quantitative data, then so be it. Similarly, it is wrong to imply that those who practise EBM may be sued because they fail "to try everything". EBM, which is simply the getting of the best available information, changes nothing in the formal relationship between clinical evidence and the legal standard of care. Moreover, we believe that, by fostering patient involvement in decision-making, EBM should help protect clinicians from medicolegal dispute.

We are always at risk of using new tools overzealously. But the champions of EBM temper its promotion with words like "judgement", "incorporating patient preference" and "conscientiousness". EBM involves a sensible and systematic search for the best information to include in the decision-making process. Great care should be exercised in issuing warnings about how it might be misused, in case EBM becomes unfairly caricatured, which may reduce the motivation of health professionals to find and apply the best treatment.

In reply: Much of the literature about evidence-based medicine (EBM) has focused on the science of generating evidence, or the technical process of critically appraising and interpreting evidence for individual patients. In our article1 we opted to discuss EBM as a social activity with inherent potential for multiple manifestations. To describe EBM as a social activity is to emphasise how its definition, interpretation and application, and the ethical implications of those factors, are dependent on societal values and priorities — be they explicit or implicit.

Debate about what EBM means, or should mean, in the context of Australian policy and practice does not degrade or negate the clearly ethical practice of consulting the best available research when making clinical or policy decisions. We challenge the view of Parker et al that by identifying and discussing how the concepts or language associated with EBM could be misused or misappropriated we will somehow reduce the motivation of health professionals to find and apply the best treatments. Indeed, our proposition is quite the opposite.

Few of today's readers of the MJA will be unfamiliar with the benefits of systematic reviews of the best available research in their clinical area, and few are likely to be dissuaded of that view by our article.

Our exploration of the relationship between ethics and EBM does not "misinterpret" EBM, but, rather, purposefully describes scenarios or social consequences about which there may be ethical concerns. If we can articulate clearly what we do not want EBM to mean, and describe the processes and consequences that we would consider unethical, it can only strengthen the development of an ethical and acceptable notion of what we do want from evidence-based policy and practice.