Streamlining Research
Management and Governance
Arrangements
Single 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
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network
West Midlands Region
Research Passport Pilot
in Primary Care
West Midlands (North) Comprehensive Local Research Network
Background
 The Research Passport provides evidence of the preengagement 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
West Midlands (North) Comprehensive Local Research Network
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’
West Midlands (North) Comprehensive Local Research Network
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)
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network
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
West Midlands (North) Comprehensive Local Research Network