Falling research in the NHS

The recently published Department of Health leaflet entitled A Junior Doctor’s Guide to the NHS includes a statement that the director general of research and development is responsible for establishing the NHS as an international centre for research excellence.1 Although medical research in the United Kingdom is clearly excellent and world leading, the NHS has underperformed as a leader in clinical research. In 2003 a government sponsored report described how the NHS would be transformed to produce high quality global clinical trials, giving the UK a competitive edge in clinical research.2 Unfortunately, the UK’s participation in global clinical trials dropped from 6% in 2002 to 2% by 2009.3 Other initiatives to support clinical research have also failed to stimulate research by NHS clinicians, including the establishment of the UK Clinical Research Collaboration in 2004, and the inauguration of the NHS research and development strategy under the auspices of the National Institute for Health Research in 2006.4

Despite concern that the introduction of the European Clinical Trials Directive might negatively influence research,5 6 the directive has had a positive, albeit marginal, effect on the number of clinical trials conducted in the European Union, except in the UK, where the number is falling.7 So this directive cannot be blamed for the underperformance of the NHS in research.

Clinical trials are an indicator of the health of the nation’s research, but they are not the only aspect of clinical research that has been affected. The National Research Ethics Service (NRES) confirms that the number of research applications fell from 9670 to 6321 between 2004 and 2010.8 So, clinical research into devices and techniques and any projects involving human subjects have also decreased. But why is this happening?

In part, the answer lies in the system of research governance in the UK, which despite attempts to harmonise and facilitate research has created barriers by allowing local trusts and other health organisations to create their own rules. Researchers may have to apply for multiple honorary contracts to carry out multicentre research. This may necessitate multiple CRB (Criminal Record Bureau) checks and even multiple medical examinations; they may also have to follow local procedures, which often differ at each site, and all of this requires multiple submissions of the same research proposal.9

Another factor is the failure to develop a research culture and management targets. In 2002 the Strategic Learning and Research Advisory Group (established between the Department of Health and the Department for Education and Skills) attempted to stimulate research training and capacity, but this initiative failed.10 Consequently, doctors and other clinical staff have little support or time to conduct research.

Local NHS research and development governance imposes an additional hurdle to overcome once approval has been given by a research ethics committee and clinical trial authorisation has been obtained from the competent licensing authority. This additional hurdle has resulted in fewer new research projects being carried out and existing ones taking longer to complete, with the consequence that the competitiveness of UK researchers has been reduced and costs are rising in comparison with other countries.

The solution might be to standardise and streamline research governance in the same way as the NRES and the Medicines and Healthcare products Regulatory Agency (MHRA) have done. Currently under NRES, research ethics committees have to follow standard operating procedures, which include a requirement to complete their deliberations within 60 days of submission of any research project application; in parallel the MHRA has clear procedures and time lines.

A common application form, produced as part of the Integrated Research Application System (IRAS) is now used for a simultaneous application to a research ethics committee and to the MHRA, but NHS research and development governance is excluded from this procedure. The NHS research and development strategy under the auspices of the National Institute for Health Research, mentioned above, has failed to grasp the problem in governance that has arisen from the fragmentation of the NHS. This has meant that research ethics committees, guided by the NRES, are under the administrative care of strategic health authorities, but individual NHS trusts are responsible for research and development governance. This has resulted in no single organisation being able to tell NHS trusts exactly what to do with an application to conduct a research project. Without proper guidance, the interpretation and implementation of clinical governance arrangements in research have put delivery of clinical targets above the delivery of research. Doctors have become demotivated about research, and major drug companies have started to withdraw clinical research from the UK.11

There are signs that the National Institute for Health Research is taking action, by introducing systems designed to reduce bureaucracy and streamline governance.12 However, effective implementation will depend on reducing local barriers to research by removing the ability of trusts to create their own local rules in addition to national systems.