Carrying out Research > Research & Development Approval
The following list outlines what we need from you in order to provide R&D approval for your study. Please note that research must not commence without a formal letter of R&D approval being received.
Please make your submissions to the R&D Directorate, Wythenshawe Hospital (contact) - you can send everything in one package, or send parts at any stage of the process (e.g. at the same time as applying to the ethics committee). We will happily accept documentation via email. Download GMRA checklist.
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IMPORTANT CHANGES FOR RESEARCHERS FROM 18 NOVEMBER |
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The new National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permissions (NIHR CSP) is being introduced in the NHS in England from 18 November 2008 for NIHR Clinical Research Network Portfolio studies.
NIHR CSP will streamline the processes by which NHS Trusts provide permission (sometimes known as R&D approval) for new research and reduce duplication in NHS review processes. NIHR CSP will have a single entry point, via the Integrated Research Application System (IRAS), so that researchers will be able to apply for permission from all NHS sites in England through a single gateway.
Researchers wishing to gain NHS permissions from 18 November 2008 should note the following important changes:
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From 18 November, researchers submitting a new application for NHS permission for a study that is automatically eligible for the NIHR Clinical Research Network Portfolio, or that requires formal consideration prior to acceptance on the Portfolio, should apply for NHS permissions via NIHR CSP.
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Initially, NIHR CSP will not be available for studies not included in the NIHR Clinical Research Network Portfolio. Researchers whose study is not eligible for the Portfolio should continue to seek permission directly from the NHS Trusts involved in the study.
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The eligibility criteria for inclusion of studies on the NIHR Clinical Research Network Portfolio have been set out by the Department of Health and this guidance can be accessed at: http://www.ukcrn.org.uk/index/clinical/portfolio_new/P_eligibility/mainColumnParagraphs/00/document/Eligibility.pdf.
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Applications for NHS Permission through NIHR CSP must be made via the Integrated Research Application System (IRAS) at the following link: http://www.myresearchproject.org.uk.
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Further information on NIHR CSP is available at: http://www.ukcrn.org.uk. Please email queries to csp@ukcrn.org.uk.
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Researchers who have submitted an application for NHS Ethical Review via the NRES on-line application form (i.e. not via IRAS) should continue to seek permission directly from the NHS Trusts involved in the study.
Researchers who have started to complete applications in IRAS but have not yet made applications to R&D offices should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.
Investigators based in Scotland, Wales or Northern Ireland and conducting a study with sites in England should contact the NIHR CSP Unit at csp@ukcrn.org.uk for guidance.
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For all studies: |
 Pan Manchester R&D Notification form (download form and guidance notes) NB - this is now the 2007 version |
Copy of Research Ethics Committee (REC) Application form (all sections) |
| New: Site-specific information (SSI) form (available via REC application) with investigator CVs |
Copy of REC approval letter |
Study protocol |
Patient Information sheets and Consent forms (REC-approved version) |
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| For commercially contracted studies |
For non-commercial studies |
Three pre-signed copies of clinical trial agreement - to include form of indemnity & financial details |
Evidence of independent peer review (further information) |
(further information) |
Grant application and award letter (if applicable) |
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Study agreement (if applicable) |
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| For studies involving a medicinal product (further information) |
Copy of MHRA approval letter OR evidence from the MHRA that a Clinical Trials Authorisation is not required |
If the Trust is sponsor for the study, a copy of the Clinical Trials Authorisation |
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| When non-NHS employees are involved in the research |
Research Passport application form (further information) and accompanying documentation where applicable |
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Registration of Clinical Trials
"In 2004, the International Committee of Medical Journal Editors (ICMJE) gave notice that it will consider a clinical trial for publication only if it has been registered in an appropriate registry. The ICMJE confirmed in May 2005 that this policy takes effect for new clinical trials on 1 July 2005 and for ongoing trials on 13 September 2005."
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