Intended for healthcare professionals


Regulation and governance of clinical research in the UK

BMJ 2011; 342 doi: (Published 13 January 2011) Cite this as: BMJ 2011;342:d238
  1. Rosalind L Smyth, Brough professor of paediatric medicine
  1. 1Alder Hey Children’s NHS Foundation Trust, Liverpool L12 2AP, UK
  1. r.l.smyth{at}

New report aims to remove unnecessary burdens and bureaucracy

The recent growth in bureaucracy associated with clinical research in the United Kingdom has been a classic example of the law of unintended consequences. The regulatory framework, which has evolved in a piecemeal and uncoordinated fashion over the years, requires the proposed study to undergo a range of assessments (approvals, authorisations, or permissions) by diverse local or national bodies, who generally implement their processes without adjusting for risk. As a result, the regulatory processes are slow, costly, and disincentivising. Measures that were designed to protect patients and improve the quality of UK clinical research have unintentionally placed burdens on commercial and publicly funded studies that result in the studies being conducted less efficiently, or not at all. Between 2000 and 2006, the proportion of patients recruited from the UK to the world’s commercial clinical trials fell from 6% to 2%.1

In recognition of these problems, the UK government invited the Academy of Medical Sciences to conduct a review of the regulation and governance of clinical research in the UK. The report of the review’s working group, chaired by Sir Michael Rawlins, was published on 11 January.2

Sir Michael Rawlins

There is widespread recognition of, and frustration with, this unsatisfactory situation. The National Institute for Health Research …

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