Change to the Permissions process for Clinical Research Health Research Authority & UCLH Response UCL/UCLH Joint Research Office 2015/16 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? 1 2 What does this mean for UCLH? What’s next: Divisions Support Next Steps 3 4 Who are the HRA? 1 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 More global first participants What are these changes and why? What are these changes and why? • 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 The typical process today • • • • • • • • • • Funding Risk Assessment 2008 Regulatory risks Management Site level questions Pharmacy input Radiology input Legal Contracts Oversight • • • • • • • Funding2009 Risk Regulatory risks Management Ethical considerations Legal Oversight • • • • • • • Funding Risk 2010 Management Ethical considerations Legal Contracts Oversight • • • • • • • • • • Site Funding 2011 Risk Assessment Regulatory Management Site level authorisations Pharmacy input Radiology input Legal Contracts Oversight The proposed new process (HRA) • Funding including site level funding 2008to template • Risk Assessment for all sites • Regulatory risks • Management • Site level questions/inputs • Pharmacy input • Radiology input • Legal • Contracts – identify all templates • Oversight • Funding2009 – 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 2010 Management Ethical considerations Legal Contracts Oversight Assess Arrange Confirm 2011 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 What is the Feasibility role for the site? • • • • • • • • • • • 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 does this mean for UCLH? 3 Our Aim’s at UCLH 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 Model at UCLH 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) Sponsor Site Interest Division Led Feasibility and Delivery assessment of the study Inputs from Service Support Departments R&D execute agreements Division oversight and monitoring of study to time and target Inputs from R&D and LCRN as required 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 Support and performance from R&D 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) 90 80 70 60 Q1 50 40 30 Q2 78.8 57 73 81.5 20 Q3 65 63 55 63 58 60 55 Q4 34 36 32 34 36 10 0 All boards (n = 69, 81, 61, 63) Specialist Hospitals (n=32,41,34,36) Surgery and Cancer (n= 26,28,21,22) Medicine (n=11,12,6,5) Our Aim’s at UCLH : Already started! • 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 What’s next: Role of Divisions and Research Groups Next Steps 4 Division led Feasibility Monitor your systems and Feedback 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 - Problems and deviations to JRO - Monitor study performance Division led Feasibility Reminder: what is feasibility? • • • • • • • • • • • 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 How? 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 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 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!
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