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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- 1 Infection Management Services, Princess Alexandra Hospital,Queensland Health, Brisbane, QLD.
- 2 Cardio-Thoracic Surgery Program, The Prince Charles Hospital, Queensland Health, Brisbane, QLD.
- 3 Health Informatics Society of Australia, Melbourne, VIC
- 4 University of Queensland, Brisbane, QLD.
- 1. Australian Law Reform Commission. Australian Law Reform Commission Report 108. For your information: Australian privacy law and practice. Vol. 3. Part H. Health services and research. Canberra: ALRC, 2008. http://www.austlii.edu.au/au/other/alrc/publications/reports/108/ (accessed Feb 2009).
- 2. Singer A. Mandatory regular meetings of hospital staff would complement medical audit and revalidation. BMJ 2000; 320: 1072.
- 3. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007; 146: 666-673.
- 4. Candib LM. How turning a QI project into “research” almost sank a great program. Hastings Center Report 2007; 37(1): 26-30. http://muse.jhu.edu/login?uri=/journals/hastings_center_report/v037/37.1candib.pdf (accessed Feb 2009).
- 5. National Health and Medical Research Council. When does quality assurance in health care require independent ethical review?” Canberra: NHMRC, 2003. http://www.nhmrc.gov.au/health_ethics/human/conduct/guidelines/_files/e46.pdf (accessed Feb 2009).
- 6. National Health and Medical Research Council, Australian Research Council, and Australian Vice-Chancellors’ Committee. National statement on ethical conduct in human research. Canberra: NHMRC, 2007. http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf (accessed Feb 2009).