changes now and in the pipe line to support nhs/hsc research … · 2020-07-06 · england:...
TRANSCRIPT
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Changes now and in the pipe line to support NHS/HSC research across the UK
Mary Cubitt Four Nations Compatibility Programme Manager
Sally DohertyOperational Lead for Northern Ireland
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Working together
Four Nations Compatibility Programme• continuing to
streamline processes• to maintain
compatible health research systems across the UK
• to support cross border researchers
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IRAS Form
• delivered 28 June 2018– e-submission for
DA led studies
IRAS Formoutcome• rolling out joined up
validation
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UK Local Information Pack• consistent paperwork
across the UK• benefit to cross
border researchers• launches 5 June • guidance and
templates published in IRAS Help 15 April
• In future develop in IRAS
From 5 June 2019
• NHS/HSC SSI Forms removed from IRAS
• packs shared using standard templates
• commercial and non-commercial
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Site Specific Information
submission in Northern Ireland
and Scotland
Local Information Pack
IRAS Form
Documents as part of IRAS submission
Localised Organisation Information Document
Outline Organisation Information Document
Statement of Activities for non-
commercial in England and Wales
What are the main changes?
Organisation Information Document
• replaces SSI Form in Scotland and NI
• replaces Statement of Activities in England and Wales
• applies to both commercial and non-commercial
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Schedule of Events/SoECAT
• component part of non-commercial Local Information Packs
• clarity over cost attribution
Preparing for change
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Preparing for change
5 June 2019
Guidance
SOPs
Support
Non NHS SSI Formoutcome• for CTMIPs and
Medical Device studies
• from 5 June being replaced by a simple non-NHS/HSC Site Assessment Form
• reviewed by REC
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Study wide review standards -current position
• core UK study-wide review criteria, shared and accepted across nations since 2014
• updated for GDPR 2018
• national specific aspects undertaken in each nation
Study wide review standards - future• updated UK study-
wide criteria incorporating refreshed UK agreed study-wide aspects
• further strengthen consistency across Four Nations
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Study wide review standards - how we get there
• stakeholder consultation – we need your views
• look out for request later in the year
Combined Ways of Working Pilot
• piloting combined MHRA and REC review
• one application• one set of queries• one outcome• Integrating study wide
review • Being ready for CTR
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Ongoing IRAS development
• to accommodate the combined ways of working
• make more flexible for change
• update user interface• documents visible to
sponsors• respond to feedback
Quick round up of other UK wide activities
• Model agreements• GDPR• GAfREC• Radiation Technical
Assurance• Pharmacy Technical
Assurance• Amendments
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UK Operational LeadsEngland: Alastair Nicholson Northern Ireland: Sally DohertyScotland: Joanne RodgerWales: Rossela Roberts
Review of HR Good Practice Resource Pack
Liz CooteHR Good Practice Project Lead
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Background to HR Good Practice Resource Pack & Research Passport
• purpose: to minimise bureaucracy for those undertaking research in the NHS
• provides a streamlined approach for handling pre-engagement checks for those undertaking research in the NHS.
• implemented in UK 2009/2010
Other ArrangementsNHS to NHS ArrangementsResearch Passport System
HEI Substantive employees
Students carrying out research (no healthcare
placement)
HEI Employees with NHS honorary clinical contracts
(Clinical Academics)
Students on formal healthcare placements
HEI Students who are also employed by the NHS
NHS Substantive Employees
Trial Data Monitors
HR Good Practice Resource Pack
Commercial Research Staff
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Phase 1 – Review • compliance with GDPR
• data minimisation
• transparency statement included
• released 4th April 2019
• moved from NIHR website to IRAS Help
Phase 2 – Detailed Review
• Four Nations Working group
• Issues with HR Good Practice Resource Pack
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Workshop• group Sessions – mixed
• workshop topics
• experiences to date of HR Good Practice Pack & Research Passports
• feedback and recommendations
Workshop – Topics (1)
• general issues & concerns
• primary care & independent contractors
• recording information
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Workshop – Topics (2)
• causes of delays to RP/HRC/LoA
• cross border issues
• student research