Quality assurance is a broad concept that includes activities termed audit, quality improvement, and clinical governance. Both quality assurance and research require the systematic collection and analysis of data from all (relevant) patients. However, whereas research activities are generally required to undergo independent ethical review, audit activities are exempt from such review. How can we ensure that quality assurance activities are ethical?

Patients using any healthcare system have an ethical responsibility to help with quality assurance activities,1 2 3 and with epidemiological research based on population-wide databases, such as the United Kingdom's new National Health Service programme,4 because they will benefit from such activities. However, involvement in quality assurance and epidemiological research usually involves using patients' data without their consent. In return for this loss of autonomy and potential risk (of disclosing information that might harm), patients should expect quality assurance activities to be ethically sound, healthcare resources to be committed to quality assurance, and benefits to justify any risks and burdens.

Two national working parties, in the United …