Editorial comment

Abstract

The question of institutional ethics approval for research, with a particular emphasis on quality assurance and practice improvement studies, is an issue which occupied quite some time at a recent meeting of the ANZJOG Editorial Board. The NHMRC Council has now approved the final version of a paper on this subject, which is to be found at http://www.nhmrc.gov.au/issues/pdfcover/qualassu.htm. I urge prospective authors to read this document. The document poses nine questions that authors should consider when designing/implementing a quality assurance project, related to consent, any risks and burdens the project might pose for patients beyond those of their routine care, patient privacy and confidentiality both in relation to medical records and to contact with patients for the purpose of the project, the possible use of randomisation or the use of a control group or a placebo, the gathering of information about the patient beyond that collected in routine clinical care, and broader issues related to potential infringement of the rights, privacy or professional reputation of carers, health care providers or institutions? It concludes that, in many cases, there is not a need for a detailed application to, and review by, a full institutional ethics committee, but that investigators should discuss the project with a delegated member of the institutional ethics committee to ensure that consideration by the full committee is not needed. In general terms, if tests or other activities have been undertaken as part of routine care, that is normal care and does not require patient consent for research or institutional ethics committee review. However, once data collected for clinical purposes is subjected to statistical analysis and is presented for publication this is no longer routine care and may be classified as research.