Regulation and governance of clinical research in the UK

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

• Download figure
• Open in new tab
• Download powerpoint

There is widespread recognition of, and frustration with, this unsatisfactory situation. The National Institute for Health Research (NIHR) has implemented several initiatives to reduce bureaucracy, including plans to support more efficient operation of research ethics committees and a coordinated process to streamline permission for clinical research studies from NHS organisations.3 4 These and other initiatives have brought incremental benefits, and the establishment of the NIHR Clinical Research Network in England and similar initiatives in the UK devolved administrations represented a substantial investment in an infrastructure to support efficiency and quality in clinical research. Indeed, in England, the numbers of patients recruited to clinical studies more than doubled in a two year period—from 208 200 in 2007-8 to 454 138 in 2009-10. In the North West Exemplar Programme, a project that aimed to show, through active management of certain exemplar studies, that the NHS could support the conduct of commercial clinical trials, the median time to obtain NHS permission to conduct studies at individual sites fell from 98 days to 53 days. Seven of 20 studies recruited the first patient in the world from an exemplar site.5

The Academy of Medical Sciences’ report makes 17 recommendations, which are based on four principles that should underpin the UK’s future regulation and governance framework (box).2 The key recommendation is the formation of a new health research agency, with two main functions—to streamline all the current arrangements for ethical approval and to provide a national research governance service. Thus, the agency would not only assume responsibility for the national research ethics service, but also specialist ethical approvals and licences. By undertaking all study-wide research governance checks, such a national research governance service would eliminate inefficiency and ensure consistency across study sites. These checks would include review of the arrangements for indemnity and processing of Criminal Records Bureau checks on the principal investigator and other research staff. This would leave individual trusts to focus on assessment of local research feasibility and to confirm their capacity to conduct the study within an agreed time frame.

The report also recognises that further initiatives beyond the Health Research Agency and outside the UK will be needed. Most importantly, many of the unintended consequences have been blamed on the European Clinical Trials Directive and its rigorous implementation by the Medicines and Healthcare products Regulatory Agency. The European Commission is planning a revision of the directive, and the report urges that the revised directive should take into account the proportionality of each study’s risk. Similarly, the legislative framework, which relates to access to and use of patient data in clinical research, is complex. The report calls for a thorough review of both the UK’s Data Protection Act in relation to health research and the EU Data Directive. The Caldicott guardian is a senior person in each trust who has responsibility for protecting the confidentiality of patient identifiable information and for enabling information to be shared. The report outlines the need for Caldicott guardians to avoid making further requests before approval for those setting up research studies and to focus on facilitating the performance of research studies. It calls for clear guidance to make it clear that researchers should be considered part of a clinical care team and therefore able to access patient information so that they can decide if patients are eligible for recruitment to a clinical study.

The report devotes a whole chapter to how the culture that supports clinical research in the UK can be more positive and promote the attitude that good research is good for patients. It makes several recommendations to help embed research as a core function in the NHS. There are outstanding opportunities in the UK for discoveries from medical research to translate efficiently into clinical applications that would benefit patients. The combination of research excellence from some of the best universities in the world and a large and well organised healthcare system provides a strategic advantage that is widely acknowledged. Recognition of this by NIHR and similar initiatives in the UK devolved administrations has led to the establishment of a research infrastructure within the NHS to support clinical studies for the benefit of patients. The designation of several academic health science centres and systems in the UK is further evidence of the intention to span discovery and translation sciences and provide integrated health delivery and improve global health. It is hoped that, if the recommendations of this report are implemented, better regulation and governance processes will facilitate UK clinical research, while continuing to provide the oversight needed to protect patients and the public to the highest possible degree.