1. A single approval for research in the NHS Wendy Fisher Research Applications Limited

2. HRA Approval Health Research Authority – started 2011 Now a Non Departmental Public Body Responsible for Ethics Committees Addressing NHS Approval HRA will assume liability for the assessment of research as fit to run in the NHS

3. Why a single approval Currently:  Duplication of information requests  Slow  Variance between sites  Duplication of reviews

4. How will it work? Single application via Integrated Application System (IRAS) for ethics and R&D Medical Exposure statements to be requested prior to submission Single technical Pharmacy review Model contracts to be used Research Passport – who needs what type of access

5. Local sites No longer “approve” studies Feasibility needs to be more robust Local Capacity and Capability assessment – Can we deliver and manage this study appropriately and on time CSP will be turned off when HRA Approval fully implemented

6. Sponsor - Site Sponsor will be responsible for liaising with sites and providing all study information and documentation. HRA looking to sponsors to provide all information required for a valid application. Where Medical Exposure is involved – come to the HRA not local MPE or CRE

7. Predicted impacts Reduction of duplication in the system Predictable timescales Quicker set up time

8. Implementation Cohort 1 – staff studies May 2015 – no single site studies or educational studies until cohort 5 Cohort 2 – Primary care including medicinal trials Cohort 3 – all other clinical trials not CTIMPs Cohort 4 – All studies including CTIMPs by end 2015 Cohort 5 - All studies including educational and single site

9. What do you need to do? Sign up for HRA alerts – when implementation is happening Review your sponsor activities – may need to be more robust Provide all the information about a study at the application stage: – Investigator brochure (CTIMPs) – Radiation manual

10. Don’t expect sites to be able to agree to take on a study until HRA Approval is in place Work with sites to be ready to open Inform the HRA if sites are duplicating R&D assessment – the site will take the liability

11. Any help or advice on the new process: Wendy Fisher 07742597904 wendy@researchapplications.co.uk