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Streamlining ethics review for multisite quality and safety initiatives: national bariatric surgery registry experience

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The current ethics review process is inappropriate for clinical quality registries

Rigorous methods for assessing and improving the quality of health care have proven difficult to develop by traditional research approaches.1 Clinical quality registries (CQRs) systematically collect an agreed minimum dataset of data across multiple sites on clinically relevant outcome measures. Data are analysed, comparing procedures, providers and institutions.2 Feedback to practitioners has been shown to drive performance improvement, especially if the data are perceived to be high quality.3

Because CQRs collect and store health information, protocols require human research ethics committee (HREC) approval to ensure that they comply with the Australian Privacy Act 1988 (Cwlth). Principle 6 of this Act states that stored personal information must not be used or disclosed for a secondary purpose unless patient consent is obtained or there is a permitted health situation. Section 16B of the Act defines the permitted health situations, which include research relevant to public health or public safety. The use or disclosure of personal information must be conducted under guidelines approved under section 95A of the Act. Current National Health and Medical Research Council guidelines state that ethical review is required at each contributing…