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. (shrink)

Researchers have frequently complained that the NHS ethical review system stifles good research. At last measures are being put in place to address this criticism, but will they undermine the protection of research participants? The Declaration of Helsinki recognizes that medicine will not progress without good quality research, but also demands that the well-being of research participants takes precedence over the interests of science and society. This article examines the implications of the ongoing reform of the NHS research ethics review (...) system for researchers, ethics committees and research participants. (shrink)