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Clinical audit and reform of the UK research ethics review system.

Cave, Emma and Nichols, Christopher (2007) 'Clinical audit and reform of the UK research ethics review system.', Theoretical medicine and bioethics., 28 (3). pp. 181-203.


There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.

Item Type:Article
Keywords:Audit, Research, Ethics, Publication ethics, Ethics committees.
Full text:(AM) Accepted Manuscript
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Publisher statement:The final publication is available at Springer via
Date accepted:No date available
Date deposited:16 March 2015
Date of first online publication:June 2007
Date first made open access:No date available

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