To the Editor: Roberts et al1 state that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans2 clearly outlines that, once approval has been gained from one human research ethics committee (HREC), other sites should accept that approval. Nowhere does the national statement state this.

What Roberts et al appear not to appreciate is that research projects may consume resources within a health service. The HREC might also have the responsibility of ensuring that the tasks required for successful completion of research can be performed without compromising the standard of care of the health facilities in which the research is to be performed. The project in question required the extraction of medical records — someone has to do this and be paid for the task. While centralisation of human research ethics approval might make the task of approval of research faster, each administrative unit has to be able to decide whether to allow participation in a project given its current level of service demand. Approval for multicentre research will therefore still take time whether or not central ethics approval is obtained, and researchers will not find an easy solution to this.

Comment: It is correct that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans1 (paragraph 3.4) does not say that other sites should accept ethics review of a research proposal from another human research ethics committee (HREC). However, the national statement is written to permit and encourage this, but not to enforce it.

Dickson’s letter also raises the issue of the terms of reference of HRECs. He alludes to an additional role — as gatekeeper of an institution’s resources — which some may feel is beyond the domain of HRECs. The national statement provides the framework for the composition and role of HRECs in their work of ethical review, but does not prevent an institution from asking its committee to also be the steward of access to resources regularly used (eg, medical records, pathology laboratories). The national statement requires an institution to set out the terms of reference for its HREC, “including the scope of its responsibilities” (paragraph 2.2). The prime function of HRECs is to make recommendations about whether a research proposal is ethical, but the final approval about whether the research can proceed rests with each individual institution.

Thus, there is more to getting approval for a research proposal than just the ethical review.

To the Editor: We are currently coordinating the New South Wales arm of a national quality assurance (QA) project to improve the management of community-acquired pneumonia in Australian hospital emergency departments (CAPTION project: Community-Acquired Pneumonia: Towards Improving Outcomes Nationally, funded by the National Prescribing Service). In the project drug usage evaluation methods are used, and it involves an audit (retrospective review of patient medical records) as well as feedback and targeted education of healthcare professionals about national management guidelines for community-acquired pneumonia.1 There is no direct patient contact at any stage.

Because this is a QA project, we did not request that participating NSW hospitals seek human research ethics committee (HREC) review. However, we did request that the project proposal be supported by HRECs as a QA activity. Further endorsement from the Chief Executive Officer, Director of Emergency, Director of Pharmacy and other key people and groups was also required.

According to the National Health and Medical Research Council (NHMRC),2 an appropriately planned QA activity can proceed without HREC review and patient consent if:

• there is consistency with National Privacy Principle 2.1(a); and

• all people involved in the activity are unlikely to suffer burden or harm.

To assist hospitals reviewing this QA project proposal, we developed a number of tools that explicitly outlined the nature of the project and provided answers to the questions in the NHMRC document. 2 These tools were provided to emphasise that this QA project was consistent with NHMRC requirements.

The NHMRC further describes the establishment of hospital policies to allow efficient review of QA proposals that involve minimal risk, burden, alteration of care or invasion of privacy. It is recommended that a member of the HREC be appointed to review such proposals.

Despite the NHMRC recommendations and the provision of tools as described above, full HREC submissions have still been required by four out of eight hospitals to date (recruitment still ongoing). After receipt of an initial expression of interest, completing the HREC submission and obtaining approval in three of these hospitals has taken an average of 5 months. The HREC review has not yet been completed in the fourth hospital. As the project is only funded for a 2-year period, this has resulted in a significant delay in the progress of the project.

We do not challenge the vital role of HRECs, and we value the importance of ensuring the safety and privacy of all involved in human research. If QA coordinators and HRECs work together within the NHMRC recommendations, valuable time and resources could be saved, for both parties. In doing so, the Australian Research Ethics Committees’ belief that “quality assurance activities are an essential and integral part of health care delivery that should be encouraged and facilitated” would be one step closer to becoming a reality.

Comment: The distress conveyed by Maxwell and Kaye is the latest in a litany of concerns and complaints to the Journal over recent years about the workings of ethics committees.1

At the centre of the protests is the perceived tardiness and inefficiency of human research ethics committees (HRECs) in Australia.2,3

But the past decade has also seen reform. The National Health and Medical Research Council (NHMRC) has clarified the relationship between research and quality assurance and when quality assurance proposals require ethical scrutiny.4 Furthermore, the NHMRC’s National statement on ethical conduct in research involving humans is clear in its advice that HRECs must establish working procedures that include “timely consideration and review of research protocols”, and it also outlines procedures for expediting review of minimal-risk research.5

On multicentre research, the statement is also clear, stressing the need to minimise unnecessary duplication in review of such research, and calling for “prompt and efficient consideration of multi-centre research protocols” and adoption of “other administrative procedures to accelerate timely consideration and avoid unnecessary duplication”.5

With such clear enunciations, what could go wrong? But, as Maxwell and Kaye attest, things do go wrong. It seems that either the NHMRC recommendations have yet to be translated into reality or the “silo” mentality of HRECs is deeply ingrained. The time may well have arrived to consider performance indicators for HRECs, or even an accreditation process.

After all, clinical research and quality assurance should not be at the mercy of inefficient HRECs.