Multicentre research: negotiating the ethics approval obstacle course

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.