Introduction

Ethical considerations should apply to all medical practice, but many people act as if they apply only to research. For example, all research studies have to be scrutinised by an ethics committee (institutional review board in the United States), but most ethics committees specifically exclude audit studies from their remit. Similarly, journal editors and funding agencies will require evidence of ethical review before accepting research for publication or funding but do not require this for audit studies. Consequently, the distinction between audit and research can have important implications, and the temptation to label research as audit is considerable.1 Unfortunately, the distinction is at best difficult. This article reviews the distinction between audit and research, and the nature of ethics.

Audit or research?

Research and audit have many similarities. They both start with a question, both expect the answer to change or influence clinical practice, both require formal data collection on patients, and both depend on using an appropriate method and design to reach sound conclusions. The standards expected of audit in terms of design, data collection, and analysis should be at least as high as for research, if only because audit potentially leads to change more often than research does and often much greater change. It is also clear that both audit and research differ from normal clinical practice because clinical practice rarely achieves a high standard of data collection and analysis.

The major bureaucratic distinction drawn between audit and research is that research investigates what should be done, whereas audit investigates whether it is being done (and if not, why not).2 Guidance on making the distinction between audit and research is available,3 4 but the …