UK Wide Working Mary Cubitt Programme Implementation Manager 15 May 2019

Working across the UK Role of the HRA in a UK context Four Nations Compatibility Programme www.hra.nhs.uk | @HRA_Latest 

Role of the HRA in a UK wide context

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

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)

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

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.

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

UK applicant facing research systems Partners Board

UK review supporting research systems

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

Four Nations Compatibility Programme

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

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

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

2016 – England led study IRAS Form

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

2019 study wide processes IRAS Form

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

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

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

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