What are local issues? The problem of the local review of research
- 1Centre for Philosophy, Humanities and Law in Health Care, University of Wales, Swansea, UK
- 2Centre for Philosophy, Humanities and Law in Health Care and Nevill Hall Hospital, Abergavenny, UK
- Correspondence to: P Wainwright Centre for Philosophy, Humanities and Law in Health Care, University of Wales Swansea, Singleton Park, Swansea SA2 8PP, UK; p.wainwrightswansea.ac.uk
- Received 17 March 2003
- Accepted 1 July 2003
- Revised 27 June 2003
Abstract
Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European Union directive or in the guidelines on good clinical practice, and there is little evidence of it anywhere else in Europe. The idea that there can be “local”, as opposed to “central” ethical issues in research is an interesting one, which raises important issues about the nature of research ethics and ethical review. The aim of this paper is to argue that there are no such things as local issues in research ethics, and suggest that those questions currently addressed as local issues properly belong within the research governance framework.
- EU, European Union
- GAFREC, governance arrangements for research ethics committees
- GCP, good clinical practice
- REC, research ethics committee
Footnotes
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Dr Saunders is Chairman, and Dr Wainwright is a member, of the Multi-Centre Research Ethics Committee for Wales. However the views expressed in this article are personal and do not represent the views of the Committee, or of the National Assembly for Wales.
