Ethics and evidence-based medicine

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.