London (South) Comprehensive Local Research Network Clare Gillott Lead RM&G Manager

Agenda Background to NIHR and the CLRN CLRN funding NIHR Coordinated System for gaining NHS Permission (NIHR CSP) Dementia research

Overview of NIHR CRN PCRN CCRN 25 NIHR Clinical Comprehensive Research 6 TCRNs Stroke, Cancer, Diabetes, Mental Health, Medicines for Children, Dementias and neurodegenerative diseases CCRN 25 Comprehensive Clinical Research Networks NIHR Clinical Research Network Coordinating Centre PCRN

Our Goals To ensure all areas of healthcare can take part in clinical research Remove barriers to research within the NHS Streamline administrative procedures associated with regulation, governance, reporting and approvals Strengthen research collaboration with industry

NIHR Clinical Research Network Portfolio Eligibility Funded by peer reviewed open national competition or commercial Of benefit to NHS Advantages Access to NHS Service Support Access to set up support (CLRN, TCRN, PCRN) Access to NIHR Coordinated System for gaining NHS permission (CSP)

CLRN funding allocation Clinical Research Coordinating Centre allocates funding to CLRNs based on uploaded accrual to the NIHR Portfolio L(S) CLRN allocates funding to member Trusts based on accrual uploads (70%) and # Studies (30%) – This is currently being re-modelled for 2011/12

Funding Flow 2010/11 NIHR CRN £258m L(S) CLRN £18m Member Trusts 10% 60% 20% Institution costs HR Finance Estates Facilities Research Management & Governance Service Support Sessions for clinicians, nurses and other support staff Routine service support Key service Support Imaging Pharmacy Research passport CSP (R&D approval) Costing Study management

Open funding calls: CLRN Contingency funding available to support: Salary costs for staff recruiting to CLRN portfolio studies which cannot be covered by any other sources (devolved CLRN funding via Trust R&D departments, research grants, Trust FSF allocations etc) Existing NIHR faculty members who are “between grants” Research-related time of NHS-employed administrative and secretarial staff that are supporting recruitment to CLRN portfolio studies

Service support costs for studies that commence in year and cannot be funded by R&D departments Unforeseen in year costs where recruitment would fail without additional support. More information and details on how to apply are on the London (South) CLRN website: http://www.crncc.nihr.ac.uk/about_us/ccrn/slondon/Funding

Coordinated System for Gaining NHS Permission (NIHR CSP) The next initiative we are going to look at is CSP – the coordinated system for gaining NHS permission. I’ve already mentioned this when talking about IRAS, so now we’ll look at what it actually involves and how it will help you in getting permission from NHS organisations (also called R&D approval) 10

NIHR CSP Benefits Consistency – consistent and comprehensive set of NHS research governance checks Speed – streamlining and rationalising processes to reduce NHS R&D approval times Predictability – a single system for processing and reviewing applications for NHS permission, centrally coordinated and supported through NIHR Comprehensive Local Research Networks These are the three key benefits of CSP.

CSP principles All instructions and submissions through IRAS Study wide activity: CI makes study wide submission through IRAS Lead CLRN completes global governance Documents and governance made available to all sites taking part in the study Local activity: Local PI makes local submission through IRAS, includes; Signed SSI form Localised PIS and consent forms Research team CVs Local site completes local governance

Global governance undertaken once for the whole study Local governance undertaken at each site Once global and local review complete site issues NHS Permission Substantial amendments managed through the system – no need for PIs to submit to local R&D Offices However it is still the sponsors responsibility to provide PI’s with documentation

London (South) CLRN CSP functionality devolved out to member trusts Trust R&D Departments assume roles of Lead and Host CLRN contact R&D Departments able to provide full advice on CSP and IRAS submission process All documentation submitted to the R&D Department will be uploaded to CSP (including substantial amendments) R&D Department responsible for undertaking governance checks within CSP and issuing NHS Permission

Dementia research: Identified as the only priority area by the Government for 2011/12 In response to this the CLRN have: Set up a Dementia Specialty group Funded a dementia nurse to help with the set-up and delivery of Dementia studies If interested in being part of the Dementia Specialty Group please contact the CLRN for meeting details

Any questions?