British journal of anaesthesia
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Editorial Comment
The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?
Clinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI). Whether a QI project requires informed consent (written or oral) is a function of the risk-benefit analysis of the study; such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research.
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Safe delivery of patient care in the operating theatre is complex and co-dependent of many individual, organisational, and environmental factors, including patient, task and technology, individual, and human factors. The Six Sigma approach aims to implement a data-driven strategy to reduce variability and consequently improve safety. Analytical data platforms such as a Black Box ought to be embraced to support process optimisation and ultimately create a higher level of Six Sigma safety performance of the operating theatre team.