Comprehensive Local Research Networks, IRAS, CSP, and the Research Passport

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Comprehensive Local Research Networks, IRAS, CSP,
and the Research Passport

• Imran Malik
• Lead RM G Manager
• London NW CLRN
• 16/11/09

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Background

• National Cancer Research Network
  (2001) and the Cancer Plan. (Success)
• 2006 saw the expansion of the networks to cover
  other topics( Mental Health dementias and
  neurodegerative diabetes medicines for
  children stroke and primary care).
• 2007 Establishment of the Comprehensive Clinical
  Research Networks ( CCRN).

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What is the Comprehensive Clinical Research
Network?

• CCRN is made up of 25 Comprehensive Local
  Research Networks (CLRNs)
• CLRNs facilitate the conduct of clinical research
  and provide a wide range of support to the local
  research community.
• Ensure that patients and healthcare professionals
  from all parts of the country are able to
  participate in, and benefit from, clinical
  research in all areas of disease and healthcare.

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Aims of the CCRN

• This improves patient care by
• encouraging the development of new and innovative
  treatments
• giving patients access to these cutting edge
  treatments closer to home
• embedding research into the day to day care and
  provision of healthcare
• improving the overall quality, speed and
  coordination of research in the NHS
• close working with pharmaceutical and health
  technology companies.

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A Whole System
Network Infrastructure in the NHS
Industry Funders
Academic Funders
INDUSTRY FUNDERS
Patients
Portfolio- Clinical Studies Groups
Clinical Trials Units/ RDS
NATIONAL COORDINATING CENTRE(S)
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CLRN Emerging performance measures

• Increase in patients recruited into NIHR
  portfolio studies (across ABF bands)
• Comparison of recruitment with CLRN population
• Increase in recruitment by member organisations
  within CLRNs
• Proportion of industry studies on the NIHR
  portfolio
• Proportion of local specialty groups achieving
  recruitment targets
• Proportion of industry studies recruiting to
  target
• Balanced budget and robust financial management.

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As a researcher working closely with all the NIHR
Clinical Research Networks, you will have

• access to experienced Research Management and
  Governance staff
• access to a local network of dedicated skilled
  research support staff
• support to ensure that your study can be
  successfully undertaken in the NHS
• local and national networking opportunities
• access to free training opportunities

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Streamlining research governance

• Initiatives
• IRAS
• CSP
• Research Passport

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Streamlining NHS Permission

• IRAS - reduces duplication in form filling
• CSP - one application point for NHS permission,
  consistent review
• Research Passport - clarifies the HR arrangements
  for researchers working across NHS Trusts

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IRAS
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Integrated Research Approvals System

• Captures information needed for the relevant
  permissions and approvals for health and social
  care/ community care research in the UK.  
• Uses filters to ensure required data is collected
  and collated appropriately based on
• Type of study
• Approvals/permissions required.

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IRAS Format

• Web-based system
• www.myresearchproject.org.uk
• Requires user account
• Help section
• Single integrated dataset
• Filter selects appropriate questions
• Questions grouped to create application forms
• No duplication of information

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Creating an account/logging in
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Create new project and help
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Project Filter
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IRAS project filter

• Short list of questions about the project
• Dynamic subsequent filter questions may alter
  depending on responses
• Generates project dataset questions and
  application forms required for study type
• Answer all the questions carefully and refer to
  question specific guidance as necessary

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CSP entry questions Q3 5
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Forms and question range
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Form submission
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Other functions on IRAS tabs

• Submission tab
• Checklists available e.g. on NHS RD Form tab is
  checklist of docs that should be submitted for
  NHS approval
• Printing completed/submitted application forms -
  if print from other areas of IRAS, will have a
  draft watermark (need to allow pop-ups)
• Tracking submissions - once submitted, given a
  submission code and an audit trail starts (all
  versions can be seen)
• Authorisation tab
• Electronic authorisations for Sponsor and CI
  currently cant use for SSIs

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Useful functions in IRAS

• CV template
• Personal address book
• Access via green icon
• Add details entered into forms using blue icon
• Contacts for review bodies
• Blank application forms and examples
• E-learning module

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Preparing applications

• Complete project filter to find out which
  applications to make
• Print off blank integrated dataset to find out
  what information you need to gather
• Find out who will need to authorise your forms
  and check if you can use electronic authorisation
  (they need an IRAS account)
• Print off checklists and gather documents for
  applications

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Coordinated System for Gaining NHS Permission
(NIHR CSP)
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Gaining Permission for NHS Research

• A single system for processing and reviewing
  applications for NHS permission

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What is NIHR CSP?

• A consistent, quality assured standardised
  process for gaining NHS permission
• Single application point through IRAS
• Multi-centre single site studies
• Managed nationally by CSP Unit CLRNs
• Coordinated approach with local input

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Who is CSP for?

• Initially only for studies eligible for NIHR
  portfolio
• Can be used for UK-wide studies - compatible with
  similar systems in devolved nations

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NIHR CSP Benefits

• Consistency consistent and comprehensive set of
  NHS research governance checks
• Speed streamlining and rationalising processes
  to reduce NHS RD approval times
• Predictability a single system for processing
  and reviewing applications for NHS permission,
  centrally coordinated and supported through NIHR
  Comprehensive Local Research Networks

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www.myresearchproject.org.uk
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Form requirements for CSP

• Forms electronically submitted via IRAS
• Portfolio Adoption Form (PAF)
• 3 days to let you know if potentially eligible
• Further 30 days to assess for adoption
• NHS RD Form
• Once emailed to say potentially eligible, can
  submit RD Form
• Form is reviewed and if validated is imported
  into CSP ReDA
• If not validated, reasons why will be sent to CI
  (ccd to Coordinator if listed on RD Form)
• Site Specific Information Form (SSI)
• Can only submit once RD Form validated and
  imported
• 1 per NHS Trust/ PCT

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How Does CSP Work? (1)

• All instructions through IRAS
• CI submits RD Form to CSP via IRAS
• CI emails documents to Lead CLRN
• Lead CLRN does global governance checks
• PI submits SSI form to CSP via IRAS
• PI emails local study documents to local CLRN

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How does CSP Work? (2)

• Local CLRN does local governance checks
• When checks complete for a site Governance Report
  generated
• Trust uses evidence in Governance Report to issue
  permission letter
• Study begins at each site in turn

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www.myresearchproject.org.uk
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• Global checks
• (CSPU and Lead
• CLRN)
• Confirm eligibility

• Local checks
• (Local CLRN)

• Assess eligibility
• Early advice

www.myresearchproject.org.uk
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What are the Governance Checks?

• Depends on type of study
• Uses IRAS filter so essential it is correct
• Global checks
• Ethics Approval
• MHRA
• Sponsor insurance/ indemnity
• Local Checks
• Local teams CVs training appropriate
• Resources available

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Passports, model agreements and advice
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Streamlining honorary contracts

• Research Passport
• Allows researcher to share pre-engagement check
  information across organisations
• Relies on assurances of those who have done
  checks
• Removes duplication and speeds up start-up
• Research in the NHS
• HR Good Practice Resource Pack

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The Passport benefits researchers, NHS
organisations and Universities because it

• Promotes the consistent use of honorary research
  contracts by the NHS
• Provides clear guidance on their use
• Provides a streamlined standard system to apply
  for the contracts
• Avoids repeat checks for each contract
• Clarifies responsibilities of NHS hosts and
  Higher Education Institution employers

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Any questions?