BMJ  2004;329:622 (11 September), doi:10.1136/bmj.329.7466.622

Letter

Research bureaucracy in the United Kingdom

Seeking a balance: response from the Department of Health and COREC

The first 150 words of the full text of this article appear below.

EDITOR—Several articles about research ethics committees in the issue of 31 July have been constructive in advising about the need for change. Others have been less helpful, especially when based on error or misconception.

Nicholson claimed that research ethics committees may be unable to function because of political control.1 There is not, and never has been, a proposal for "direct political control" of research ethics committee membership. The European Directive on Clinical Trials (directive 2001/20/EC) legally obliges all member states, including the United Kingdom, to "take the measures necessary for establishment and operation of ethics committees." The newly created United Kingdom Ethics Committee Authority simply comprises the four ministers of the countries in the United Kingdom who have until now been separately responsible for their NHS research ethics committee systems. His claim that results of UK research could not now be used for regulatory purposes is simply unfounded.

. . . [Full text of this article]

John Pattison, director of research and development

Department of Health, London SW1A 2NS Sally.Bishop@doh.gsi.gov.uk

Terry Stacey, director

Central Office of Research Ethics Committees, London W2 3QR


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Relevant Articles

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This article has been cited by other articles:

  • Larkin, P. J, de Casterle, B. D., Schotsmans, P. (2008). A Relational Ethical Dialogue With Research Ethics Committees. Nurs Ethics 15: 234-242 [Abstract]  
  • Califf, R. M (2006). Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 3: 496-502 [Abstract]  
  • Hill, J., Foster, N., Hughes, R., Hay, E. (2005). Meeting the challenges of research governance. Rheumatology (Oxford) 44: 571-572 [Full text]  

Rapid Responses:

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New ethics form will kill off normal volunteer studies in the universities and the NHS - is change possible?
Jan K. Melichar
bmj.com, 14 Sep 2004 [Full text]
Research Bureacracy-- a damaging divide between researchers and administrators
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