Clinical Audit and Reform of the UK Research Ethics Review System
Theoretical Medicine and Bioethics 2007; 28(3): 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.
Showing items related by title, author, creator and subject.
Protecting Research Participants Review of Institutional Review Boards: Management and Function, Edited by R.J. Amdur and E.A. Bankert; Institutional Review Board: Member Handbook, by R. Amdur; Study Guide for Institutional Review Board: Management and Function, by S. Kornetsky, A. Davis, and R.J. Amdur; Principles of Clinical Research, Edited by I. Di Giovanna and G. Hayes; Informed Consent in Medical Research, Edited by L. Doyal and J.S. Tobias; the Complete Guide to Informed Consent in Clinical Trials, Edited by T. Hartnett; Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study, Edited by S.M. Reverby; European Neonatal Research: Consent, Ethics Committees and Law, Edited by S. Mason and C. Megone; the Ethics of Medical Research on Humans, by C. Foster; Ethical Issues in Biomedical Publication, Edited by A. Hudson Jones and F. McLellan; Fraud and Misconduct in Biomedical Research (3rd Edition), Edited by S. Lock, F. Wells, and M. Farthing; Biomedical Research Ethics: Updating International Guidel Nicholson, Richard (2002-11)
Should There Be an Accredited Ethics Committee System for Centralised Review of Multicentre Clinical Research? Beran, Roy G. (1998-02-16)
Abbasi, Kamran; Heath, Iona (2005-02-26)