1. Change to the Permissions process for Clinical Research Health Research Authority & UCLH Response UCL/UCLH Joint Research Office 2015/16

2. National Changes, led by the Health Research Authority (HRA), will affect the process by which clinical research is approved Who are the HRA?What are these changes and why? What does this mean for UCLH? 3 1 2 What’s next: Divisions Support Next Steps 4

3. Who are the HRA? 1

4. More global first participants Established as a Strategic Health Authority in December 2011 “promote and protect the interests of patients in health research and to streamline the regulation of research” Leading improvements that make it easier to conduct good quality research in the UK Improving efficiency and effectiveness of systems, and of advice and guidance Building and consolidating productive relationships with public and professional stakeholders HRA have, and will, be implementing changes to the way research studies are managed through regulatory approvals (e.g., Ethics and NHS permissions). + guide sponsors on regulatory requirements, use of standardised templates, transparency in research findings and outputs Less time and effort setting up studies

5. What are these changes and why?

6. A new process which makes undertaking research easier and reduces the time and cost of setting up studies New single applications for regulatory approvals, which will avoid duplication of work and efforts by different organisations Reduce the number of studies reaching their targets by improving quality submissions, increasing speed of approvals and focusing research sites on feasibility and assurances of delivery What are these changes and why?

7. 2008 Funding Risk Assessment Regulatory risks Management Site level questions Pharmacy input Radiology input Legal Contracts Oversight 2009 2010 2011 Sponsorship Review and site selection Regulatory Reviews NIHR Global and local reviews Costing, Contracts, NHS permissions Funding Risk Regulatory risks Management Ethical considerations Legal Oversight Funding Risk Management Ethical considerations Legal Contracts Oversight Site Funding Risk Assessment Regulatory Management Site level authorisations Pharmacy input Radiology input Legal Contracts Oversight The typical process today

8. 2008 Funding including site level funding to template Risk Assessment for all sites Regulatory risks Management Site level questions/inputs Pharmacy input Radiology input Legal Contracts – identify all templates Oversight 2009 2010 2011 Sponsorship Review and site selection Regulatory Reviews and HRA assessment NIHR CSP Global and local reviews Costing, Contracts, NHS permissions Funding – confirm in place Risk - regulatory and confirm sponsor has considered these Management – has the sponsor a plan? Ethical considerations + HTA, CAG Legal – has sponsor outlined all templates and “risks” Oversight – is there a plan? Global Pharmacy and Radiology Funding Risk Management Ethical considerations Legal Contracts Oversight Assess Arrange Confirm The proposed new process (HRA) Site Feasibility

9. What does this practically mean for individual Researchers? One IRAS application for regulations (except for MHRA) HRA will conduct a number of governance and consistency checks alongside the review of ethics Sponsor will liaise with sites (PI) to ensure they have all the necessary resource to run the study and are ready to start and able to meet time and target (active discussions on what is feasible for the site) Pharmacy and Radiology reviews are conducted at “global level” by the HRA. Local teams take these assurances and focus on ability to deliver and on set-up R&D/LCRN department will not need to review your study documents – researchers (and R&D) take assurances from the HRA review No CSP – CLRN divisions will work with local R&D’s and Divisions to support requests for support and the set-up of NIHR adopted studies R&D will execute finances and contracts based on local feasibility R&D escalation point for problems, bottlenecks, issues during the assessment and approval stages

10. Resource (staff, space, equipment) and have these been supported by the Sponsor in the available “templates” Sufficient Capacity Management of the study Availability of patients Any competing studies Likelihood of delivering to time and target Ensure all relevant departments are aware and on-board All staff are adequately trained and able to work at UCLH Strategic fit/appetite for the study Division is happy to proceed (including Clinical Director) All documents and materials available What is the Feasibility role for the site?

11. What does this mean for UCLH? 3

12. To be ready for these new procedures and expectations 1: Have a seamless transition All relevant groups are aware and comfortable Clear and unified approaches across UCLH Identifying (removing) erroneous and /or outdated systems and practices which may impede successful delivery Our Aim’s at UCLH

13. Inputs from R&D and LCRN as required Division Led Feasibility and Delivery assessment of the study Sponsor Site Interest R&D execute agreements Division oversight and monitoring of study to time and target Support and performance from R&D Inputs from Service Support Departments 2: Supporting a “new” way of working: Local (divisions and hubs) systems for assessment and oversight JRO support, guidance and direction for divisions (tools such as templates and SOPs to follow) R&D/Hubs supporting the resolution of bottlenecks and system issues Focus on delivery and rapid start up of studies Ability to Plan the study set-up and delivery Ability to influence/address performance Model at UCLH

14. Can local feasibility and input’s affect Performance? Performance against 70 day benchmark all providers (mean), UCLH and comparable Trusts (%) UCLH: Q2 (14/15) = 72.7% Q3 (14/15) = 80.5% Q4 (14/15) = 78.8% Q1 (15/16) = 85.5 % Q2 (15/16) = 88% (tbc)

15. Focusing on performance, understanding the portfolio and identifying key infrastructural support/issues (JRO, Hubs) Supported increases in local capacity for research (specialist posts appointed via RCF funding) Develop closer working practices/relationships with larger research groups and piloted new ways of working – including feasibility Identified and eradicating unnecessary hurdles to setting up research Feasibility Champions – change leads Our Aim’s at UCLH : Already started!

16. What’s next: Role of Divisions and Research Groups Next Steps 4

17. How will you Division determine if a study is feasible or not? - Tools/procedures -Mechanisms -JRO support -Discuss model with the JRO Set up and run Feasibility System -In-line with requirements (including JRO inputs) -On-going support and training from the JRO Monitor your systems and Feedback -Problems and deviations to JRO -Monitor study performance Division led Feasibility

18. Resource (staff, space, equipment) and have these been supported by the Sponsor in the available “templates” Sufficient Capacity Management of the study Availability of patients Any competing studies Likelihood of delivering to time and target Ensure all relevant departments are aware and on-board All staff are adequately trained and able to work at UCLH Strategic fit/appetite for the study Division is happy to proceed (including Clinical Director) All documents and materials available Division led Feasibility Reminder: w hat is feasibility?

19. Each Division to determine best model: a group (TFC) a remote process a combined process but should: Address key points of “feasibility” Be “quick” and responsive Work to common SOP’s for UCLH JRO will support throughout including working with Divisions to conduct joint-feasibility until Divisions are ready/comfortable Division led Feasibility How?

20. R&D support throughout JRO provide all templates and expectations (SOPS and guidance) for Divisions to follow for costings and contracts and “safety” JRO issue permission at site and will complete contracting and finalise and add “corporate” costs – based on the direction of the Division/Research Group JRO escalation point and support Study is sponsored by UCL or UCLH – JRO will combine the sponsorship review with the Divisions assessments Support in seeking additional funding/resources from the LCRN and others Audit, monitor Performance Management

21. Next Steps Inviting you to consider setting up local research feasibility assessments (or let us know if you wish JRO to do so for a period of time) Research Officer support to determine which type of feasibility assessment suits your division and the core (trust) expectations Research Officer support with setting up new systems/refining existing systems (in line with other departments) Research Officer/other JRO support with new studies JRO training and awareness “modules” on the detail of feasibility and sponsorship and finances (amongst others) JRO drop in sessions for support and guidance JRO support with performance oversight, reporting and invoicing Invite units to join feasibility champions/change leads HRA cohorts now rolling out!