Streamlining Research Management and Governance Arrangements Single Assessment Service & Research Passport pilot

1. Streamlining Research Management and Governance ArrangementsSingle Assessment Service &Research Passport pilot Dr Althea Allison, Senior Manager, West Midlands North CLRN Dr Trevor Allen, Lead RM&G Manager, West Midlands North CLRN

2. Single Assessment Service • West Midlands North CLRN has an on-going programme for streamlining RM&G and improving services to researchers • A common reason of delay in gaining NHS Permission was the time taken for Trusts to agree costs & contracts with sponsors • Idea for CLRN-wide pilot of single assessment service for commercial studies • Edwin Swarbrick sought NHS Trust senior engagement (CEOs / Finance Directors / R&D Directors) • Trevor Allen and Cathryn Love-Rouse ran workshops with local R&D Managers to seek in-principle agreement

3. Progress • Short-Life Working Group (CLRN, Finance & R&D Director, SG Lead) with remit to develop a strategic plan to support the introduction of a Single Assessment Service • Workshops with R&D Managers of local acute and mental health Trusts • single costing process (April 2013) • single contract review process (October 2013) • Identification of 3 candidate studies for pilot - all are commercial multi-site randomised blinded CTIMP studies • A different Trust acting as Prime Local Site for each candidate study (single point of contact with sponsor) aim: one cost one contract

4. Process Prime Local Site (PLS) completes NIHR costing template for study and reviews standard agreements PLS distributes completed costing template and contract to other local Trusts involved in study Other local sites briefly review costing and contract and feed back issues to PLS for discussion / agreement PLS captures any minor adjustments and returns amended documents to the sponsor PLS leads final negotiation if required PLS completes data capture tool for analysis

5. Plans for SAS • identify more studies for piloting in collaboration with industry sponsors • collate feedback from data capture tool completed by RM&G staff • review and revise SOP to include comms for supporting services • continue engagement of senior staff in Trusts (Finance Leads + R&D Directors) • report to WMN CLRN Executive Q4 2013-14 ↓ costs and time ↑ activity and performance

6. West Midlands Region Research Passport Pilotin Primary Care

7. Background • The Research Passport provides evidence of the pre-engagement checks undertaken on the researcher in line with NHS Employment Check Standards • Honorary Research Contracts (HRCs) are required by researchers that have no contractual relationship with the NHS wanting to undertake research within the NHS • NHS England identified the need to develop a joint improvement programme with the Department of Health relating to the impact on research projects due to changes in the commissioning landscape (abolition of Primary Care Trusts in March 2013) • The most immediate priority area identified was the issue of Honorary Research Contracts (HRC) and Letters of Access (LoA) in primary care

8. Research Passport pilot • West Midlands North CLRN had already developed a process for issuing HRCs and LoAs in Primary Care through a collaboration with Shropshire and Staffordshire NHS England Area Team • Working with our partner CLRNs in the West Midlands this progressed to the current process now being piloted by NHS England, the Department of Health and the Health Research Authority • The long term plan is to streamline, standardise and simplify the overall process to enable primary care research to take place nationally. ‘one researcher one set of checks one access agreement’

9. How it will work • Standardised SOP enables NHS England Area Teams to delegate authority for the issuing of HRC/LOAs to West Midlands CLRNs • CLRNs will collaborate across boundaries; a ‘Lead’ will act on behalf of all other teams • Lead advises, processes, validates and issues all relevant documentation associated with the Passport Scheme as described in the HR Good Practice Resource Pack http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx • Participating CLRNs accept the checks / documentation from the Lead (Information captured on shared database by the Lead)

10. Core Principles • All teams will accept the appropriate assurances of others • The SOP does not confer any other rights or obligations in terms of indemnity than those set out in existing guidance • For clarity NHS England is a member of the Clinical Negligence Scheme for Trusts (CNST) and this extends to Area Teams • CLRN staff are, as employees of NHS Trusts, supported for any negligence by them by the Liabilities to Third Parties Scheme (LTPS) • Area Teams are accountable for any HRCs and LoAs issued under these arrangements • CLRNs will keep accurate records to enable reporting

11. Next Steps for RP pilot • The pilot will run from November 2013 until end of January 2014 across the three West Midlands CLRNs • Completion of lessons learned log during the pilot • Timeliness metrics will be collated via the database • The 3 CLRNs will prepare a report at the end of the pilot that will include performance data and feedback from stakeholders • The final report will be sent to the National Institute for Health Research CRN Co-ordinating Centre, the Department of Health and NHS England for consideration