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Research Governance Delays - Who to blame?
Research governance delays for a multicentre non-interventional study
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Paul Chester, Visiting Academic Oxford Centre for Diabetes Endocrinology and Metabolism, Dornhorst Anne
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paul.chester{at}ocdem.ox.ac.uk Paul Chester, et al.
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In the May 2009 edition of JRSM your headline article was 'Research governance delays for a non-interventional study' a sentiment which many researchers may share (1). The authors put the reasons for delay clearly in the arms of research and development departments (RDD) where significant variation in processes leads to variation in delay. While we do not defend the sometimes over bureaucratic system for research approval in the UK our findings suggest that the reason for delay must be shared among those involved in the study. In 2006 we published an article which examined the delays in a similar multicentre observational study which involved 178 sites across the UK of which 159 were hospital trusts (2). We examined the reason for delay at all sites taking more than 60 days for approval (ie more than the legally specified time currently required for ethics committee review) (3). We found that the mean approval time was 82 days with a range from 0-259 days, thus supporting the wide variation identified by Mallick and O'Callaghan. In our analysis more than half the hospital sites took longer than 60 days (n= 86, mean 126 days) to obtain local approval. We examined the source of the delay and found that of those cases taking more than 60 days, 25 (29%) were delayed at the RDD while 22 (26%) were delayed while awaiting investigators to respond to queries and 11 (13%) delayed at the trust level awaiting sign off. The remaining 28 had mixed reasons for delay beyond 60 days. We therefore support the call for an improved approval system but would suggest that all parties involved in the approval process must be prepared to support change and act in a timely manner. 1. Research governance delays for a multicentre non-interventional study. Andrew A Mallick and Finbar JK O'Callaghan. J R Soc Med 2009 102 195-198 2. Local Clinical Trial Approval Times in the UK. Paul Chester, Sadiah Aalam, Pauline Cooper, Catherine Risley, Anne Dornhorst. Int J Pharm Med 2006 20 317-320 3. Medicines for Human Use (Clinical Trials) Regulations 2004 Anne Dornhorst Hammersmith Hospital London UK Paul Chester Oxford Centre for Diabetes Endocrinology and Metabolism Churchill Hospital Oxford UK |
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Janet Messer, Policy Associate - IRAS NRES, Maria Palmer
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janet.messer{at}nres.npsa.nhs.uk Janet Messer, et al.
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Although papers such as this one are self-selected, nevertheless, it has been acknowledged by the health departments and others that improvements to the process of R&D review can be made, and streamlining the process is a high priority [1]. Although the study was set up relatively recently, arrangements are already in place to address a number of the issues encountered. The Integrated Research Application System (IRAS) [2] was launched in January 2008. Not only does it provide a central point for researchers to prepare applications to review bodies, it also provides extensive guidance. According to the information supplied in the paper, this study involved a large number of centres that were identifying and referring potential participants, with only nine research sites. IRAS provides clear guidance on different processes for seeking agreement from centres to identify and refer potential participants, and for seeking permission from NHS organisations to host research. The widest variation in time to “RDD approval” (the term used in the paper) was for the centres identifying participants and not for the research sites. Although a number of NHS organisations had previously been adopting a proportionate approach to agreeing to refer potential participants, the guidance in IRAS was only published at the time that approvals for this study were being sought so the mechanism in IRAS for adopting this approach was therefore not used by the research team. It should now be feasible for agreement to refer potential participants to a well-designed high quality study to be provided in a similar timescale to that given by the first 20 or so collaborating centres in this study. As noted in the paper, the National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP) is now available for studies that are eligible for adoption to the NIHR portfolio [3]. Although still at an early stage of development, CSP has the potential to reduce the variation in time to issue NHS permission for research sites. For some time, researchers have been recommended to apply for R&D review in parallel to research ethics review. The duplication of Site-Specific Assessment (SSA) through ethics committees with aspects of R&D review has also now been removed. In due course, it should therefore be possible to obtain NHS permission for a well-managed and well-designed study as soon as a favourable ethical opinion has been issued. 1. http://www.ukcrc.org/regulationgovernance/rdperm.aspx 2. www.myresearchproject.org.uk 3. http://www.crncc.nihr.ac.uk/index/clinical/csp.html Conflicts of interest: Janet Messer is involved in the development of the Integrated Research Application System and supported the transfer of Site-Specific Assessment to R&D offices. Maria Palmer is Director of the NHS R&D Forum. Maria Palmer and Janet Messer have advised the NIHR Clinical Research Network Coordinating Centre on the development of the Coordinated System for gaining NHS Permission. |
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