Medical Research in the U.K. is Being Suffocated by Excessive Governance and Ethical Review

Medical Research in the U.K. is Being Suffocated by Excessive Governance and Ethical Review

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Medical Research in the U.K. is Being Suffocated by Excessive Governance and Ethical Review



This report will explore and focus on the recent overhaul and complete
reform of the face of research ethics in the UK (United Kingdom).[1]
Researchers and research ethic committees have been waiting for these
changes for a considerable amount of time but will they increase
quality of research or the quantity of it. This report also will try
to examine whether the new changed aid in the safety and dignity of
participants or hinder these in favour of interesting research
protocols.

History of UK’s Research Ethics

The first signs of a “centralised” research governance system of
ethics occurred in 1991. These were however set up as local branches
known as LREC (Local Research Ethics Committees) and were involved in
the regulation of research in their respective local NHS
establishments.1,[2] They are funded by local health authorities and
made up by twelve members consisting of medical professionals to lay
persons.[3] There seemed to be no standardising of directives between
each LREC and hence led to inconsistencies in approving research
proposals, especially multicentre trials.[4]

This led to an uprising in researches complaining about the procedures
in place which inevitably led to calls for a reform. The main concern
was that for a multicentre approval the application was time consuming
and was surrounding with “red tape” and bureaucracy which hindered the
advance of research itself.[5],[6],[7] This called for one regulatory
body in the UK to have the final approval, if granted this meant that
the approved research protocol could...


... middle of paper ...


...rers Association, 1996.

[34] Directive 2001/20/EC of the European Parliament and of the
Council of 2001 April 4. Article 7. On the approximation of the laws,
regulations and administrative provisions of the Member States
relating to the implementation of good clinical practice in the
conduct of clinical trials on medicinal products for human use.
Official Journal of the European Communities 2001; L121:34–41.

[35] Ayres I, Braithwaite J. Responsive regulation: transcending the
deregulation debate. Oxford: OUP, 1992.

[36] Ashcroft R, Pfeffer N. Ethics behind closed doors: do research
ethics committees need secrecy? British Medical Journal 2001; 322:
1294-6.

[37] Barber SG. Ethical ethics committees? Journal of Medical Ethics
2000; 26:142.
(Guidance for BMedSci Students, Tutors and Examiners Booklet 2005; 5)

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