Regulatory framework | Cambridge University Hospitals
 
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Regulatory framework

All projects that involve CUH patients, their data or tissue, facilities or staff require NHS Permission in accordance with the NHS Research Governance Framework before they can be carried out on our site.

NHS permission is given to projects under the Trust's policy entitled Research Studies - Review and Set Up Process which can be downloaded at the bottom of this page.

Research in the Trust is managed according to Standard Operating Procedures (SOPs) as detailed in the document library.

Delivering clinical research to time and target

The Government wants to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research; and to enhance the nation’s attractiveness as a host for research.

The Government published its Plan for Growth in March 2011 which included specific aims and incentives to improve efficiency in the initiation and delivery of research. Since 2012 the NIHR has published metrics to measure those efficiencies, including a benchmark of 70 days or fewer for the time taken for a valid research application to be processed to first patient recruitment. Within the R&D department we work on processes to achieve the 70 day target and to do that we need your cooperation.

So what does this mean for those working in research and how will it affect current research applications and future proposals?

For those thinking about starting a research project, take the opportunity to speak to the R&D department as early as you can, even if all you have is an idea. They can offer advice and help with protocol submission and advise you on what information you will need to submit a research application.

If you are an investigator of a study or have been asked to head up a study for another organisation, again seek advice from the R&D team.

If we fail to meet the targets set the penalties are very high, and indeed we may be fined. In addition we may not be allowed to apply for future NIHR funding and the research and reputation of the hospital will suffer. For more information please contact Stephen Kelleher or Tracy Cripps.

Health Research Authority – approval process

HRA Approval is required for all research to commence in the NHS in England. This comprises a review by a Research Ethics Committee (REC) as well as an assessment of regulatory compliance and related matters, undertaken by staff of the HRA located in centres around England. Further details can be found here.