Abstract
The National Institute for Health Research Co-ordinated System for gaining NHS Permission (CSP) has been mooted as “a system that standardises and streamlines the process for gaining NHS permissions for research studies in England”.1 We were optimistic that this new system would facilitate rapid startup for National Health Service (NHS) sites participating in a new multicentre trial comparing two types of emergency interventions for ruptured aortic aneurysm (the IMPROVE trial). Now, nearly 1 year later, we are feeling frustrated at the time taken to start the research, and we have had an independent audit done.
It took 8 months for CSP to approve the trial. The mean delay in getting NHS approval for sites is 6 months (figure). This delay is likely to increase, since we still have sites with unresolved issues. The delays engendered between local-site research and development departments and Comprehensive Local Research Networks are a major contributor. Delays vary from site to site, with some sites needing clearance from the Ionising Radiation Medical Exposure Regulations, which in itself can be a lengthy process, and others not. Additional delays come from the contracting process between the trial sponsor institution and NHS sites. The nature of the trial we are seeking to run is likely to add to some of the routine problems. The trial spans the disciplines of emergency medicine, radiology, surgery, and critical care and therefore many signatures are needed on documents and contracts.
It took 8 months for CSP to approve the trial. The mean delay in getting NHS approval for sites is 6 months (figure). This delay is likely to increase, since we still have sites with unresolved issues. The delays engendered between local-site research and development departments and Comprehensive Local Research Networks are a major contributor. Delays vary from site to site, with some sites needing clearance from the Ionising Radiation Medical Exposure Regulations, which in itself can be a lengthy process, and others not. Additional delays come from the contracting process between the trial sponsor institution and NHS sites. The nature of the trial we are seeking to run is likely to add to some of the routine problems. The trial spans the disciplines of emergency medicine, radiology, surgery, and critical care and therefore many signatures are needed on documents and contracts.
Original language | English |
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Journal | Lancet |
Publication status | Published - 12 Jun 2010 |
Structured keywords
- Centre for Surgical Research