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To the Editor: There is danger of a perception developing that, to ensure patient confidentiality, quality assurance (QA) activities in health care should be regarded as research. The Australian Law Reform Commission (ALRC) has delivered proposals for the review of the federal Privacy Act 1988 (Cwlth) that may lead to all but the most basic monitoring of health care activities being characterised as research.1 Recommendation 65–3 emphasises that “research” should include “the compilation or analysis of statistics” and the ALRC also stated that “some funding, management, planning, monitoring, improvement and evaluation activities also may be characterised as research”. This drives the possibility for policy interpretation of QA activities into the realm of research necessitating ethics approval and/or informed consent, rather than retaining the current level of exemption. Australian governments are crying out for increased transparency to improve safety, but labelling QA activities as formal research could seriously compromise and retard patient safety efforts.
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©The Medical Journal of Australia 2009 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377