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Best Research: Bottleneck in local NHS research governance approval could be rapidly overcome.
- David A van Heel, Utsav Reddy, Dominic C. Heaney, Raymond J. Playford (15 March 2006)
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David A van Heel, Wellcome Clinician Scientist Fellow Imperial College London, Du Cane Road, London, W12 0NN, Utsav Reddy, Dominic C. Heaney, Raymond J. Playford
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EDITOR - In its recently published £650m strategy Best Research for Best Health, aimed at establishing the NHS as an internationally recognised centre of patient based research excellence, the Department of Health recognises significant bureaucratic blocks to clinical research and barriers to the collection and use of patient data[1,2]. We find these obstacles particularly evident when performing multi-site collaborative research. A National Institute for Health Research will be established after 5 years, and one of its aims is to reduce the bureaucratic burden on researchers whilst involving and protecting patients - but we believe that some barriers might be rapidly removed now. Standardising national NHS Research & Development application procedures (using for example the NHS R&D Forum's document), is one small step that would produce a giant reduction in the time-consuming, bureaucratic process where multiple and varying applications are made to individual trusts, which may include separate finance, data protection and risk assessment forms as well as human resources requirements for honorary contracts and Criminal Records Bureau clearance[3]. As an example, we surveyed the approval procedures of 102 NHS Trusts in England regarding a hypothetical externally funded multi-site study involving patient identifiable clinical data with collection of a blood sample for central laboratory analyses. Only 35 (34%) of trusts had details of R&D approval procedures readily accessible on the internet. A further 22 Trusts responded to email or telephone requests. All Trusts required much of the material previously submitted for ethical approval (COREC ethics application form, patient information sheet, consent form, investigator CVs etc.). Only the COREC form and/or the NHS R&D forum document was required by 32 Trusts, however 18 Trusts (32%) required unique application forms (average 7.7 pages). We recognise Trusts' responsibilities with respect to research governance, but contrast the process of R&D approval with the introduction (March 2004) of a single national ethics procedure, overseen by the Central Office for Research Ethics Committees (COREC). Previously highlighted difficulties in obtaining ethical approval in the UK for multi -centre trials have been overcome[4]. For example, decisions on ethics applications are made within a 60 day time limit; a comprehensive review is performed at a single site with limited local assessments considering only local investigators, support staff and research environments; and submissions are simplified by a web-supported process of application. The latter in particular saves substantial time on multi-site applications by “auto-completing” previous answers to questions, and indeed already links to the NHS R&D Forum's document. We hope that as well as establishing a NIHR tomorrow, the Department of Health takes opportunities to implement simple, "bureaucracy-busting" measures today. References [1] Pollock AM, McNally N, Kerrison S. Best Research: The new UK medical research strategy helps industry, but will it improve health? BMJ 2006;332:247-248 [2] Boyd R, Burrows M. Best research: New strategy is warmly welcomed. BMJ 2006;332:491 [3]Bond ME. Research governance is important. BMJ 2006;332:365 [4] Hearnshaw H. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ:2004;328:140-141 Competing interests: None declared |
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