NHS research governance procedures
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Editor – Haynes, Bowman, Rahimi and Armitage (Clin Med April 2010 pp 127–9) usefully highlight the need for research governance procedures to be modified in order to improve the conduct of clinical research in the UK. A programme of changes to the research governance process has made further progress since the cases referred to in this article and is beginning to have a demonstrable impact on the practice of clinical research.
Significant progress has been made in streamlining research governance through the introduction of the Integrated Research Application System (IRAS) (January 2008), which provided a single entry point for permissions and approvals for health research in the UK. In addition, the National Institute for Health Research Clinical Research Network (NIHR CRN) has been working with the NHS and regulatory agencies since April 2007 on the Coordinated System for Gaining NHS Permission (CSP), which was introduced in the NHS in November 2008.
CSP is a managed system that uses a standardised, transparent and risk-based approach to NHS permissions for research, and is provided for every NHS trust in England through the NIHR CRN. CSP is streamlining trial set-up. There is evidence now that it is helping to quicken the process and increasing engagement by leading research and development departments is ensuring its continuous improvement. The introduction of the Research Passport scheme to simplify the contractual arrangements for researchers working in the NHS has also addressed one of the key delays in the study set-up process.
The North West Exemplar programme is demonstrating the impact NIHR CRN systems can have on commercial study performance and reliability. Although still in its early stages, the programme is impressing industry partners with set-up times – median time for approval of Exemplar studies is 53 days – and in several instances studies have recruited the first global or EU patient. Full data for phase one of the programme – focusing on effective study set-up – will become available at the end of June (http://nwexemplar.nihr.ac.uk/)1
The authors are correct in saying that post-permission study management issues – particularly recruiting to time and to target – need to be addressed, but the twin initiatives of the NIHR Research Support Service (RSS) and ongoing support for delivery of studies from NIHR CRNs will create a much more efficient research support system.
There is still much work to be done, but the NIHR has recognised the issues outlined in the article and is addressing them through a range of initiatives. For more information, see www.crncc.nihr.ac.uk
Footnotes
Please submit letters for the editor's consideration within three weeks of receipt of the Journal. Letters should ideally be limited to 350 words, and sent by email to: clinicalmedicine{at}rcplondon.ac.uk
- Royal College of Physicians
Reference
- Goodacre J
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