Differentiating between audit and research: postal survey of health authorities' views.

Access to patients and their records for non-clinical purposes has recently come under scrutiny. Research ethics committees control access for research purposes, but audit is explicitly excluded from their remit. Although there is consensus that locally organised audits do not need ethical approval, the status of larger scale audits designed to influence broader practice remains unclear; some journals do not publish papers based on clinical audit data if they do not have ethical approval. Guidelines published by the Royal College of Physicians suggest submission to a research ethics committee if doubt exists about whether a project is audit or research.