1. UK Wide Working Mary Cubitt Programme Implementation Manager
15 May 2019

2. Working across the UK Role of the HRA in a UK context
Four Nations Compatibility Programme

3. Role of the HRA in a UK wide context

4. Functions of the HRA
The co-ordination and standardisation of practice relating to the regulation of health and social care research
Functions relating to research ethics committees
A member of the United Kingdom Ethics Committee Authority
Functions relating to approvals for processing confidential information relating to patients
Paraphrased from Care Act 2014 para 110

5. Remit England – but ….
The HRA and each devolved authority must co-operate with each other …
The HRA must consult with the devolved authorities, and such other persons as it considers appropriate.
Care Act 2014 paras 111 (4) and 112 (7)

6. Working together UK wide
Globally the UK is seen as one country
Cross border research is common
Actively support research across the UK – Ethics and study wide
Four Nations Policy Leads Group
Four Nations Operational Leads
UKREDG
Joint UKREDG/Operational Leads

7. Challenges Legislative differences Scale Resourcing Political focus
Tissue
Adults lacking capacity to consent
Access to data without consent
Applications for which England is lead = 4185, Scotland 413, Wales 174, NI 88
Also at different stages in each nation so balance of learning from each other (eg E&W learning from scientific officers in Scotland), and being prepared to develop what appears to be working but could be improved by being UK-wide eg technical assurances
England and Wales – HRA centralised approval – this enables more easily the Trusts to take assurances from the Authority.
Scotland – Distributed model – 4 large health boards do the work with a small coordinating team, - This also leads to perception in Scotland that the Boards are responsible for REC and study wide review
NI – Distributed model but working towards centralised with a small coordinating team
Money to support delivery is embedded in delivery institutions and moving it is non trivial
England - closely linked to Sector Deal and global impact and work with the CRN. Scale makes it easy to fall into the England is UK trap
Scotland – track record of differences in NHS delivery bringing rewards. Caution over UK integration.
Wales – Ensuring the best for Wales and the UK
NI – working in a political vacuum – legislation regarding mental capacity passed but not enacted.

8. HRA publishes on behalf of the UK
Policy Framework
GAfREC and REC SOPs
GDPR
Applicant guidance
HRA

9. UK applicant facing research systems
Partners Board

10. UK review supporting research systems

11. Development work UK wide
Transparency
Combined Ways of Working
Model agreements
Technical Assurance
Radiation and Pharmacy
Expectations for Public Involvement

12. Four Nations Compatibility Programme

13. Four Nations Compatibility
Continuing to streamline processes
To maintain compatible health research systems across the UK
To support cross border researchers
In Jan 2017 I took up seconded post of Four Nations Compatibility Programme Managers - small contribution to my costs
Continuing to streamline processes
To maintain compatible health research systems across the UK
To support cross border researchers
All four nations involved in planning, testing and delivery

14. Delivered April 2019 June 2017 April/May 2018 June 2018
Single IRAS Form across UK
April/May 2018
Wales align with HRA Approval + Joined up Validation
June 2018
E-submission of IRAS Form for DAs
April 2019
Use of HARP for study wide review as well as REC

15. 2015 study wide processes
REC Form
CSP England
R&D Form
(Lead)
DAs

16. 2016 – England led study
IRAS Form

17. 2016 – DA led study
REC Form
R&D Form
(Lead)
DAs

18. 2019 study wide processes
IRAS Form

19. UK Local Information Pack
About to be delivered
June 2019
UK Local Information Pack
5 June 2019

20. UK Local Information Pack
IRAS Form
Statement of Activities in England and Wales
Local Information Pack
Outline Organisation Information Document
Documents as part of IRAS submission
Site Specific Information Form in Northern Ireland and Scotland
Localised Organisation Information Document
At a high level, there is a outline and localised version of the Organisation Information Document

21. Outstanding - Amendments
Challenges
Volume
Study wide review or not
Distribution mechanism to NHS/HSC
Differences in approaches to single centre studies
Opportunities
IRAS and HARP development

22. HRA Summary Continue to work closely Regular calls and meetings
NRS
HCRW
HSC
Summary
HRA
Continue to work closely
Regular calls and meetings
Maintain common goals
Shared leadership
Maintain focus on researcher experience