R&I LEADS - ESSENTIAL DUTIES

1. R&I LEADS - ESSENTIAL DUTIES • Attend the Trust R&I Forum. • Encourage participation in NIHR Portfolio Research. • NEWWork with R&I to ensure the Trust meets NIHR benchmarks for performance in initiating and delivering clinical research. NEW • Review, disseminate and act on R&I integrated performance reports. • Act as the Intellectual Property contact in the Directorate supported by R&I. • Review and approve research applications on behalf of the Directorate by sign off the Site Specific Information (SSI) Form. • Support the Directorate Manager in the review and approval of grant applications and delivery of successful awards. • Be aware of audit and monitoring visits in the Directorate and work with R&I as required on any audit outcomes and follow up actions.

2. Trust R&I Forum • The R&I Forum is: • Currently a lunchtime meeting (1-2pm) held quarterly at LGI and SJUH (alternate meetings). • A forum in which Directorate R&I Leads and other key researcher staff and managers address research governance, performance and development issues. • Attended by: • R&I Director (chair) • Directorate R&I Leads or nominated deputies • University of Leeds representatives • West Yorkshire Comprehensive Local Research Network (WYCLRN) representatives • Leeds Musculoskeletal Biomedical Research Unit (LMBRU) representative

3. TRUST R&I FORUM • Terms of Reference • Development and implementation of R&I strategy and supporting policies • Review of research governance arrangements including receipt of reports from Clinical Trials Group and Biological Safety Group • Review of R&I integrated performance reports • Provision of regular governance assurance report on R&I to the Clinical Effectiveness & Outcomes Sub-Committee • What do you need to do? • Attend the Forum. • Liaise with researchers and groups in the Directorate on strategic issues and provide feedback via the Forum. • Support R&I in its initiatives to implement strategy.

4. NIHR Portfolio Research • The National Institute for Health Research (NIHR) Clinical Research Network Portfolio is a database of high-quality clinical research studies that are eligible for service support funding from the NIHR Clinical Research Network. • What is the benefit of having a study on the Portfolio? • Your Directorate receives the necessary service support funding for the NIHR based on the number of studies it has on the Portfolio. • Which studies are eligible for the Portfolio? • Automatically eligible studies are those that have some of their research funding provided by the NIHR, other areas Government and NIHR non-commercial Partners (http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_eligibility/index). • Potentially eligible studies include commercially funded and commercially sponsored, non-commercial studies, investigator initiated trials (i.e. commercial collaborative research), and studies funded by overseas Governments and overseas charities.

5. NIHR Portfolio Research • How to get a study included on the Portfolio? • Route of entry is via NIHR Co-ordinated System for Gaining NHS Permission (CSP) • What do you need to do? • Encourage researchers to • Secure NIHR and other high quality grants in partnership with University of Leeds and other academic partners. • Maximise submissions to NIHR Portfolio by submitting studies for Trust R&I approval using CSP. • Meet recruitment targets and report recruitment information promptly to the NIHR once the project is underway at http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_recruitment/index

6. NIHR Performance Benchmarks • What are they? • LTHT clinical trial performance is now measured against 2 national benchmarks to improve the initiation and delivery of clinical trials. • Initiation – it should take no more than 70 days from receipt of a valid research application (signed SSI form) to the recruitment (consent) of the 1st patient to the trial (all clinical trials) • Delivery – the agreed target number of patients must be recruited within the agreed recruitment period (all commercial clinical trials) • The Trust is now required to submit quarterly performance reports to the Department of Health and from April 2013 funding to the Trust will be conditional on meeting these benchmarks. • What do you need to do? • Encourage researchers to • Provide recruitment information when requested by R&D on the Clinical Trial Tracker (available on Sharepoint from April 2013) • Work with R&I to resolve blocks and delays on red and amber rated trials to ensure that LTHT meets the NIHR benchmarks.

7. R&I Integrated Performance Reports • Integrated performance reports: • Provide outcome information on key R&I performance indicators including activity, finance and governance. • Issued by the R&I Department to Directorate Managers, R&I Leads and Divisional General Managers. • Reviewed at the Trust R&I Forum • What do you need to do? • Review the report, identify and act on any issues. • Disseminate report to Directorate Managers, Clinical Directors and other members of the Directorate management team. • Work with R&I to ensure any actions following audit/monitoring visits take place.

8. Intellectual Property • What is IP? • IP is a novel or previously undescribed tangible output of an intellectual activity. It has an owner and can be bought, sold or licensed and must be adequately protected. • Examples - devices and equipment, diagnostics and therapies, software, guidelines and training materials, pharmaceutical products and processes. • Why is IP important? • IP may lead to improvements in patient care through new innovations and bring significant financial benefits to the inventor and the NHS. • IP Rights are legally protected rights which give owners of the IP control over exploiting the IP (usually for commercial gain). • Ownership - IP created by a Trust employee during the course of his/her employment is owned by the Trust. The Trust is committed to sharing the rewards with the member(s) of staff concerned.

9. Intellectual Property • What do you need to do? • Ensure staff are aware of and abide by Trust IP policy which can be accessed at http://www.leedsth.nhs.uk/sites/research_and_development/documents/LTHTIPpolicy-revisedJune11.doc • Discuss with staff possibilities for exploitation of IP • Advise staff with a potential item of IP as follows: • Do let the R&I Department know • Do keep it secret until expert advice is obtained • Don’t involve external organisations, collaborators or colleagues • Don’tsign any contracts or agreements until they have been properly scrutinised • Don’tsell or give away samples

10. Trust R&I Approval • R&I Approval • All research activity taking place in the Trust must be registered and approved. • Trust R&I Approval ensures that research studies taking place in the Trust meet research governance requirements and that there are adequate facilities, resources and capacity to undertake the research. • The R&I Department requires the Directorate R&I Lead to review the research application and authorise the Site Specific Information (SSI) form to demonstrate that issues that can only be addressed at Directorate level are considered before organisational level approval is given. • The SSI form gives information about the research study relevant to LTHT including information about funding, local investigators and patients. It forms part of the research application on the Integrated Research Application System (IRAS).

11. Trust R&I Approval • What do you need to do? • You are required to review the application and sign question 23 of the SSI form - “Authorisations required prior to R&I approval”. By signing this, you give the R&I Department reassurance that the study can go ahead in your Directorate. • You should consider the following when you are asked to sign the SSI form: • Is the investigator qualified and able to undertake this work? • Is there capacity in the Department to do this work? • Is there time in people’s schedules to do the work? • Will the study be doing/using something that is outside standard practice? • Will extra equipment be needed? • Has appropriate peer review been undertaken in compliance with Trust guidance (see http://www.leedsth.nhs.uk/sites/research_and_development/directorateguidance.php#Peer)

12. Trust R&I Approval • Finances will be reviewed separately by the relevant finance manager but you should be aware of them. • You must only sign question 23 of the SSI Form. • Do not sign as Sponsor on the R&I Form. • Do not sign anything else such as forms of indemnity, clinical trials agreements/contracts. • Do notsign the SSI form if you are the chief, principal or co-investigator of the research study. If this is the case, pass the application to your clinical director to review and sign off. If you are also the clinical director, pass the application to your Directorate Manager or Divisional Medical Manager to review and sign off. • If you are in any doubt about any aspect of signing a research project please contact the R&I Department.

13. Approval & Management of Grant Applications • Pre-Award Process • Researchers are required to discuss proposed grant applications with their Directorate Manager and Directorate Finance Manager as early as possible – and at least 3 weeks before the submission deadline. This allows time to discuss the impact, resources required and to collate costs. • Applications must be fully costed by the Directorate Finance Manager (and where University of Leeds costs will form part of the application these should be sought from the Faculty of Medicine and Health Research Team) • Once the application has been fully costed and agreed by the Directorate Manager it should be forwarded to R&I who will arrange its review and sign off by the Finance Director or Chief Executive applications up to £500k. Applications for over £500k must be agreed by the Trust Board.

14. Approval & Management of Grant Applications • What do you need to do? • Encourage researchers to apply for NIHR and other high quality grants • Advise staff on the pre-award approval process. • Advise/support the Directorate Manager and Finance Manager as required on issues including research team expertise, resource use and capacity • Post - award you should? • Inform R&I of all successful awards • Ensure the researcher obtains R&I approval via CSP

15. Audit & Monitoring • NHS Trusts are required to ensure all research is adequately monitored. • The Trust has an established programme of monitoring of both clinical trials and other clinical research studies. • You will be informed of any planned audit or monitoring visit in your directorate and the outcome of the visit. • Audit outcomes are RAG rated and the local principal investigator is responsible for undertaking any required remedial actions. R&I will work with the investigator and may require your assistance in resolving issues. • Occasionally concerns about ongoing research studies are raised with R&I and a ‘triggered’ audit will be undertaken. R&I will ensure that you are made aware of this before the audit starts. • If you have any concerns about a research study in your Directorate you should discuss these with R&I who may undertake a triggered audit.

16. SUMMARY • Directorate R&I Leads will attend the Trust R&I Forum. • Directorate R&I Leads will encourage participation in NIHR Portfolio Research • NEWDirectorate R&I Leads will work with R&I to ensure the Trust meets NIHR benchmarks for performance in initiating and delivering clinical research. NEW • Directorate R&I Leads will review, disseminate and act on R&I integrated performance reports • Directorate R&I Leads will act as the contact for intellectual property (IP) in the Directorate supported by R&I. • Directorate R&I Leads will review and approve research applications on behalf of the Directorate by sign off of the Site Specific Information form • R&I Directorate Leads will support the Directorate Manager in the approval of grant applications and delivery of successful awards • Directorate R&I Leads will be aware of audit and monitoring visits in the Directorate and will work with R&I as required on any audit outcomes and follow up actions