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ACCORD-2 master protocol

Description: CONFIDENTIAL ACCORD-2-001 – Master Protocol TITLE PAGE Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study
Url: /Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-master-protocol.pdf

Sex assignment in newborn babies - patient information

Description: This factsheet explains what sex assignment is and what happens when a baby's sex cannot be assigned as soon as they
Url: /Media/UHS-website-2019/Patientinformation/Childhealth/Sex-assignment-in-newborn-babies-3505-PIL.pdf

CRF Assistant Project Manager_Study Manager JD 15 11 2023

Description: Post Title: Agenda for Change: Job Description BRC Assistant Project Manager/Study Manager Directorate/Department: Trust Headquarters NIHR Biomedical Research Centre
Url: /Media/Southampton-Clinical-Research/Downloads/CRF-Assistant-Project-Manager-Study-Manager-JD-15-11-2023.pdf

PRIVACY NOTICE_Synergy between PCI with TAXUS and Cardiac SurgeryREV - FINAL

Description: Synergy between PCI with TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES) This is a privacy notice for patients who took
Url: /Media/Southampton-Clinical-Research/News-stories/PRIVACY-NOTICE-Synergy-between-PCI-with-TAXUS-and-Cardiac-SurgeryREV-FINAL.docx

Papers Trust Board - 29 November 2022

Description: Date Time Location Chair Agenda Trust Board – Open Session 29/11/2022 9:00 - 13:20 Conference Room, Heartbeat/Microsoft Teams
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2022-Trust-documents/Papers-Trust-Board-29-November-2022.pdf

Papers Trust Board 27 May 2021

Description: Date Time Location Chair Agenda Trust Board – Open Session 27/05/2021 9:00 - 13:00 Microsoft Teams Peter Hollins 1
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2021-Trust-document/TB-papers/Papers-Trust-Board-27-May-2021.pdf

Guidance on completing COVID 19 Restart Recover on EDGE

Description: Guidance on completing ‘COVID 19 Restart & Recover’ on EDGE Introduction Below are instructions on how to go about completing the information needed to reopen studies at UHS. We hope this makes it easier for you to get this information to us quickly. There are screen shots in the appendix to help you. We know this will be somewhat tedious – we wish there was another way! With over 600 studies to consider for restart, it will help us get through things quicker if you help out. We appreciate your support in advance. Logging in and Finding your studies 1. Go to www.EDGE.nhs.uk 2. Enter your email address into the username field (unless you have changed this) and your password and click login. NB if you have forgotten your password you can reset it by clicking on ‘Forgotten your password?’ and following the instructions. If you are unable to log in then please email Edge2Admin@uhs.nhs.uk and it will be sent to you. 3. Click on ‘Projects’ at the top of the screen 4. Ensure ‘Assigned Projects’ is highlighted and click search. A list of all of the studies you have been assigned to will appear in the results. 5. If a large list of studies appears click on ‘More Options’ in the grey box and then click on ‘Pick’ next to project site status and choose ‘Recruitment on hold - COVID-19’. Then click close and then search. This can be repeated for the statuses below. 6. On the list under the ‘Sites’ column there the site status for your studies is displayed. You only need to complete the information for those marked ‘Recruitment on hold - COVID-19’ ‘Follow up on hold - COVID-19’ and ‘Project site setup suspended - COVID-19’. 7. Click on the short title of the study. Completing Information needed 8. Below the green banner click on ‘Attributes’ 9. Locate the ‘COVID 19 Restart & Recover’ Attribute in the list and click on it (they are in alphabetical order). 10. A list of fields will appear and on the Right hand side will be ‘Edit Delete Audit’, click on Edit. Page 1 of 4 Guidance on completing ‘COVID 19 Restart & Recover’ on EDGE V1.1 02/06/2020 11. You can now answer the question or complete the information. This is via radio buttons, dropdowns, checklists, dates, numbers and text fields. 12. Once answered, tick the ‘Public’ box and click save. You can now move to the next and so on. We know this is NOT as slick as surveymonkey – but it will help us start studies faster to have the information. Problems and Issues If you have any problems at all then please contact Edge2Admin@uhs.nhs.uk and one of our EDGE champions will be able to help. Please bear with us as we are down on numbers but endeavour to get back to you as soon as possible. Alternatively there are support pages found by clicking on ‘Support’ and then on ‘Need some Help?’ Page 2 of 4 Guidance on completing ‘COVID 19 Restart & Recover’ on EDGE V1.1 02/06/2020 Page 3 of 4 Guidance on completing ‘COVID 19 Restart & Recover’ on EDGE V1.1 02/06/2020 Page 4 of 4 Guidance on completing ‘COVID 19 Restart & Recover’ on EDGE V1.1 02/06/2020
Url: /Media/Southampton-Clinical-Research/COVID-19/Guidance-on-completing-COVID-19-Restart-Recover-on-EDGE.pdf

Papers Trust Board - 13 January 2026

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 13/01/2026 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd Diana Eccles 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 11 November 2025 9:15 Approve the minutes of the previous meeting held on 11 November 2025 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Finance, Investment & Cash Committee 9:20 David Liverseidge, Chair 5.2 Briefing from the Chair of the People and Organisational Development 9:30 Committee Jane Harwood, Chair 5.3 Briefing from the Chair of the Quality Committee 9:40 including Maternity and Neonatal Safety 2025-26 Quarter 2 Report Tim Peachey, Chair 5.4 Chief Executive Officer's Report 9:50 Receive and note the report Sponsor: David French, Chief Executive Officer 5.5 Performance KPI Report for Month 8 10:20 Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer 5.6 11:00 5.7 11:15 5.8 11:25 5.9 11:30 5.10 11:45 5.11 11:55 5.12 12:05 5.13 12:15 6 6.1 12:25 7 12:35 8 Break Finance Report for Month 8 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer ICB System Report for Month 8 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer People Report for Month 8 Review and discuss the report Sponsor: Steve Harris, Chief People Officer Learning from Deaths 2025-26 Quarter 2 Report Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Jenny Milner, Associate Director of Patient Experience Infection Prevention and Control 2025-26 Quarter 2 Report Review and discuss the report Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Julian Sutton, Clinical Lead, Department of Infection/Julie Brooks, Deputy Director of Infection Prevention and Control Medicines Management Annual Report 2024-25 Receive and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: James Allen, Chief Pharmacist Annual Ward Staffing Nursing Establishment Review 2025 Discuss and approve the review Sponsor: Natasha Watts, Acting Chief Nursing Officer CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer Attendee: John Mcgonigle, Emergency Planning & Resilience Manager Any other business Raise any relevant or urgent matters that are not on the agenda Note the date of the next meeting: 10 March 2026 Page 2 9 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 10 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 13 January 2026 – Open Session Overview of the BAF Risk 1a: Lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. 4a: We do not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. Agenda links to the BAF No Item Linked BAF risk(s) 5.5 Performance KPI Report for Month 8 5.7 Finance Report for Month 8 5.8 ICB System Report for Month 8 5.9 People Report for Month 8 5.10 Learning from Deaths 2025-26 Quarter 2 Report 5.11 Infection Prevention and Control 2025-26 Quarter 2 Report 5.12 Medicines Management Annual Report 2024-25 5.13 Annual Ward Staffing Nursing Establishment Review 2025 6.1 Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) 1a, 1b, 1c 5a 5a 3a, 3b, 3c 1b 1c 1b 1b, 3a 1b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x x x Minutes Trust Board – Open Session Date 11/11/2025 Time 9:00 – 13:00 Location Conference Room, Heartbeat Education Centre Chair Jenni Douglas-Todd (JD-T) Present Diana Eccles, NED (DE) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Andy Hyett, Chief Operating Officer (AH) David Liverseidge, NED (DL) Tim Peachey, NED (TP) Alison Tattersall, NED (AT) Natasha Watts, Acting Chief Nursing Officer (NW) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.2) Martin de Sousa, Director of Strategy and Partnerships (MdS) (item 6.1) Lucinda Hood, Head of Medical Directorate (LH) (item 5.13) Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant (DH) (item 5.12) Vickie Purdie, Head of Patient Safety (VP) (item 7.3) Kate Pryde, Clinical Director for Improvement and Clinical Effectiveness (KP) (item 5.13) Scott Spencer, Health and Safety Advisor (SS) (item 7.3) 4 governors (observing) 2 members of staff (observing) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that no apologies had been received. The Chair provided an overview of meetings she had held and events that she had attended since the previous Board meeting. 2. Patient Story Item deferred to the next meeting. 3. Minutes of the Previous Meeting held on 9 September 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 9 September 2025, subject to a minor correction at 5.10. Page 1 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. • Actions 1281, 1283 and 1284 were closed. • Action 1282 was to be addressed through item 5.6 below. • In respect of action 1285, the Quality Committee would monitor progress on complaints response times. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee Keith Evans was invited to present the Committee Chair’s Report in respect of the meeting held on 13 October 2025, the content of which was noted. It was further noted that: • In terms of the internal audit reports, which had been received by the committee, whilst there were a number of points for the Trust to address, no areas of significant concern had been identified. • There was a focus on ‘imposter fraud’ whereby individuals who had turned up to carry out a shift were not who they claimed to be. Whilst there had been no reported incidents at the Trust, the Trust had implemented controls at the ward level, which would be subject to testing during 2025/26. 5.2 Briefing from the Chair of the Finance, Investment & Cash Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 22 September and 3 November 2025, the contents of which were noted. It was further noted that: • In September 2025, the Trust had reported that it was in line with its Financial Recovery Plan. Of the £110m Cost Improvement Programme (CIP) target, 76% had been fully developed. • The committee had reviewed the Finance Report for Month 6 (item 5.8), noting that the Trust had reported an in-month deficit of £5.4m, which was in line with the Financial Recovery Plan. • The committee had expressed concern that 17% of the CIP target was not fully developed and that the Trust was £2.5m off-track in terms of delivery of the target at Month 6. • Whilst progress had been made in terms of addressing patients with no criteria to reside and mental health patients, this remained an area of concern. • The committee considered the NHS England Medium Term Planning Framework, noting that the first submission by the Trust was due prior to Christmas 2025. 5.3 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Reports in respect of the meetings held on 22 September and 3 November 2025, the contents of which were noted. It was further noted that: • There continued to be little improvement in terms of the number of patients with no criteria to reside or mental health patients, which impacted staffing numbers. • The Trust was adopting a harder line in respect of its approach to violence and aggression, which included a greater willingness to exclude individuals. • The current participation rate in the Staff Survey was lower than the national average, which was likely indicative of staff morale and engagement. Page 2 • The Trust’s workforce numbers remained above plan, with limited options available to address this issue, especially in the absence of funding for restructuring costs. 5.4 Briefing from the Chair of the Quality Committee Tim Peachey was invited to present the Committee Chair’s Report in respect of the meeting held on 13 October 2025, the content of which was noted. It was further noted that: • The committee received an update in respect of mental health patients, noting that although there were significant issues in the Emergency Department, the whole pathway for these patients remained a problem. • The committee carried out a six-monthly review of the Trust’s progress against its Quality Priorities, noting that good progress had been made on four of the six priorities and two were slightly behind. 5.5 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • NHS England had published the Medium Term Planning Framework, which was intended to encourage organisations to think beyond a 12-month time horizon and to progress the NHS 10-Year Plan. The Trust was expected to provide its first submission prior to Christmas 2025, but the detailed planning assumptions had yet to be received from NHS England. It was noted that a more detailed report on the Medium Term Planning Framework was to be received as part of the closed session of the meeting. • The Strategic Commissioning Framework had been published by NHS England, which provided welcome clarifications about the future role of integrated care boards. • The Trust had been placed into Tier 1 for both Urgent and Emergency Care and for Elective performance. There was a national expectation that trusts would have no patients waiting over 65 weeks for elective care by 21 December 2025. Where organisations had more than 100 such patients at the end of October 2025, they had been placed into Tier 1. The Trust was taking steps, including mutual aid, to attempt to address the number of long waiters, but there was insufficient capacity in the system. • Resident doctors were due to strike for a further five-day period commencing on 14 November 2025, having rejected the Government’s latest offer to resolve the ongoing dispute with the British Medical Association. • The Hampshire and Isle of Wight Integrated Care Board and NHS England South East Region had carried out a visit to the Trust’s paediatric hearing services in May 2025. The report, received in October 2025, had been positive about the service. • The Trust and the University of Southampton had been awarded £16.3m by the National Institute for Health and Care Research. The Trust was one of only four organisations out of 15 applications to receive an award. • The NHS Business Services Authority had announced the award of a £1.2bn contract to Infosys to deliver a new and enhanced workforce management system for the NHS to replace the existing Electronic Staff Record system. The 2030 target date for implementation was considered ambitious. Further details would be considered by the People and Organisational Development Committee when available. Page 3 5.6 Performance KPI Report for Month 6 Andy Hyett was invited to present the ‘spotlight’ report in respect of Diagnostics, the content of which was noted. It was further noted that: • Diagnostics performance was a key element of the pathway, as delays in diagnosis had a consequential impact on the overall length of pathways such as those for cancer and patients on a Referral To Treatment pathway. • Although there were some concerns with Diagnostics in the Trust, the Trust, generally, performed better than other organisations. The Board discussed the matters raised in the Diagnostics ‘spotlight’. This discussion is summarised below: • There had been a long-standing issue with waiting times for cystoscopy due to insufficient capacity. However, a plan was being developed to improve the situation, although it was considered appropriate that the plan should also address broader issues with urology as a whole. • There was concern regarding the availability of magnetic resonance imaging (MRI) scanners, particularly as two scanners were out-of-action. It was noted that the current set-up in terms of MRI scanners was not fit for the longer term and a strategy for the future needed to be developed. • There was a disparity between capacity and demand in respect of the neurophysiology service, as this service had previously relied on outsourcing. • Generally, activity was increasing, but overall performance appeared to be declining. There was also the additional financial challenge that Diagnostics was funded under a ‘block’ contract arrangement which did not fully take into account the demand for these services. • There were concerns about the electrical supply capacity at the Southampton General Hospital site and the ability of the Trust to expand its Diagnostic capacity with this limitation. It was considered that a better longer-term model would be for scanners at local community diagnostics centres. Actions Andy Hyett agreed to work on and present at either a future Board meeting or Trust Board Study Session the Trust’s longer-term strategy with respect to MRI scanners and imaging. Andy Hyett agreed to develop a longer-term plan for cystoscopy/urology and to report back to the Board during Quarter 4. Andy Hyett agreed to develop a long-term solution to the neurophysiology service. Andy Hyett was invited to present the Performance KPI Report for Month 6, the content of which was noted. It was further noted that: • The Trust’s Emergency Department had recorded performance of 67.6% against the four-hour standard during September 2025. The department remained busy with c.450 patients and 120 ambulance attendances per day. • There had been some initial performance impacts with the roll out of the MIYA system in the Emergency Department, but this appeared to have now been addressed with performance up to previous levels. • A number of initiatives were being introduced into the Emergency Department in order to improve performance. These included the layout of the service, pathway re-designs, having General Practitioners in the department, and arranging with non-urgent patients to attend at a scheduled time rather than waiting in the department. Page 4 • In October 2025, the Trust had recorded 363 patients waiting over 65 weeks on a Referral To Treatment pathway against a national target of no such patients by the end of December 2025. • The Trust was making use of the independent sector, weekend working, and was requesting capacity from other providers to address the number of patients waiting over 65 weeks. • The planned industrial action by resident doctors posed a challenge, noting that the national expectation was that trusts maintain 95% of their capacity during this period. It was noted that, in contrast to previous instances of industrial action, resident doctors were apparently less forthcoming in terms of whether they intended to participate in the industrial action. • The Trust continued to report one of the lowest Hospital Standardised Mortality Rates in England. • The Trust’s cancer performance, based on a BBC article, was 21 out of 121 trusts. It was noted that whilst the number of patients being referred on a cancer pathway had increased significantly, the number of patients diagnosed with cancer had not materially changed. • There appeared to have been an increase in the number of pressure ulcers and ‘red flag’ incidents. Work was ongoing to address the findings of the pressure ulcer audit which had been presented to the Quality Committee on 2 June 2025. • The number of patients having no criteria to reside and mental health patients remained high. Actions Andy Hyett agreed to clarify the basis of the calculation of the ‘Watch & Reserve antibiotics usage per 1,000 adms’ metric. 5.7 Break 5.8 Finance Report for Month 6 Ian Howard was invited to present the Finance Report for Month 6, the content of which was noted. It was further noted that: • The Trust had submitted its Financial Recovery Plan to NHS England in August 2025, which committed to an additional £23m improvement in the Trust’s financial position to deliver a full-year position of a £54.9m deficit. In the absence of these additional improvements, the Trust had been forecasting a year-end position of a £78m deficit. The revised target was subject to a number of assumptions, including the need for demand management and improvements in non-criteria to reside and mental health patient numbers. • There were a number of risks to the achievement of the Financial Recovery Plan, including whether there would be improvements in mental health and non-criteria to reside and/or steps taken to manage demand, high levels of activity, and whether it would be possible to reduce the workforce and close theatres. The need for the Trust to focus on achieving the 65-week wait target in particular could impact the Trust’s ability to close capacity. • The Trust had reported an in-month deficit of £5.4m (£30.8m year-to-date), which was in line with the trajectory set out in the Financial Recovery Plan. The Trust’s underlying deficit had seen some marginal improvement during the period. • The Trust’s cash position remains an area of significant concern. Cash requests had been made to NHS England, but the latest request for November 2025 had been rejected. It was therefore likely that the Trust would need to manage its supplier payments in accordance with its available cash. Page 5 5.9 ICS System Report for Month 6 Ian Howard was invited to present the ICS System Report for Month 6, the content of which was noted. It was further noted that: • The Hampshire and Isle of Wight Integrated Care System had reported a year- to-date deficit of £48m. • A significant improvement in the run-rate would be required for the system to be able to deliver its 2025/26 plan. • The system was one of the worst in England in terms of the number of beds occupied by patients having no criteria to reside with approximately 23% of beds being occupied by such patients compared with a national average of 12%. • The system was also below plan in terms of its targets for access to General Practitioners and targets relating to mental health patients. It was noted that the performance in these areas had a consequential impact on the Trust’s performance in areas such as urgent and emergency care performance. 5.10 People Report for Month 6 Steve Harris was invited to present the People Report for Month 6, the content of which was noted. It was further noted that: • The overall workforce fell by 73 whole-time-equivalents (WTE) during September 2025 and was reported as being 54 WTE above the Trust’s 2025/26 plan. The reduction in workforce had been driven through a combination of the impact of the recruitment controls, mutually agreed resignation scheme (MARS) leavers, and a significant drop in use of temporary staff during the month. • On 15 October 2025, the Trust had heard the collective grievance brought by the Royal College of Nursing in respect of the removal of enhanced NHS Professionals rates. It was decided not to reverse the decision in order to maintain equity with the rest of the workforce and consistency across other local providers. A number of actions had been agreed following the hearing. • Sickness rates had increased to 3.8%, although the Trust still benchmarked well against peers. • There were concerns about the potential impact of influenza during the winter period and therefore the Trust was taking a number of actions to promote vaccination of staff. The Trust was currently third in terms of uptake in the Region. • The level of participation in the national Staff Survey remained a challenge with only 32% of staff having completed the survey compared with a national average of 38%. It was considered likely that the recent difficult decisions taken and the impact on staff was impacting staff experience and engagement. • The People and Organisational Development Committee would be examining statutory and mandatory training levels together with the latest proposed national changes. Page 6 5.11 NHSE Audit and review of 'Developing Workforce Safeguards' including UHS Self-Assessment Return Natasha Watts was invited to present the NHS England audit and review of ‘Developing Workforce Safeguards’ (2018), including the Trust’s Self-Assessment Return, the content of which was noted. It was further noted that: • ‘Developing Workforce Safeguards’ was published in October 2018 and included a range of standards to assure safe staffing across the workforce. NHS England had initiated an audit, review and improvement plan amidst concern about a national reduction in compliance. • The Trust had submitted a self-assessment as part of this NHS England review. This assessment showed that the Trust continued to comply with the majority of the standards. • The audit exercise has been used as an opportunity to identify opportunities for improvement. Twelve recommendations have been developed, of which nine were assessed as ‘green’ and three as ‘amber’. 5.12 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan Diana Hulbert was invited to present the Guardian of Safe Working Hours Quarterly Report and Update on the 10-Point Plan, the content of which was noted. It was further noted that: • Resident doctors were due to strike for five days from 14 November 2025. This would be the thirteenth strike in recent years. It was noted that, in addition to pay, the dispute also concerned working conditions and the shortage of posts and consequent risk to resident doctors of unemployment. • The Trust had performed a self-assessment against the 10-Point Plan and it was noted that the majority of the plan’s contents had been considered by the Trust for some time. There were also a number of dependencies on the part of NHS England in areas such as lead employer models. • A national review of statutory and mandatory training was expected to enable portability of training records to facilitate staff moving between NHS organisations. • There had been significant improvements in respect of gaps in rotas. 5.13 Annual Clinical Outcomes Summary Luci Hood and Kate Pryde were invited to present the Annual Clinical Outcomes Summary Report, the content of which was noted. It was further noted that: • The paper provided an overview of the clinical outcomes reviewed by the Clinical Assurance Meeting for Effectiveness and Outcomes (CAMEO) over the 12-month period to September 2025. • The majority of specialities provide reports to CAMEO, although outcome data can be more difficult in some areas to capture than in others. • The outcomes reviewed by the CAMEO and outputs from this body were also influencing the development of the Trust’s clinical strategy. • The strains on the capacity of services posed a risk to clinical outcomes. Page 7 • There was potential that a ‘quality’ override could form part of the NHS Oversight Framework in the future, operating in a similar manner to the ‘financial’ override by limiting the segmentations available to an organisation. 6. STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 2 Review Martin De Sousa was invited to present the review of Corporate Objectives 2025/26 for the second quarter, the content of which was noted. It was further noted that: • Of the 12 objectives agreed for 2025/26, six were rated ‘green’, four were ‘amber’ and two were ‘red’. • The ‘red’ rated risks were that relating to the Trust’s financial performance and that relating to the Trust’s achievement of its workforce plan for 2025/26. 6.2 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework update, the content of which was noted. It was further noted that: • BDO had completed its audit of the Trust’s risk maturity and had presented its report to the Audit and Risk Committee on 13 October 2025. The audit had highlighted a number of strengths including the Board Assurance Framework, risk definition, and use of risk in decision-making. In terms of opportunities for improvement, the audit report suggested some improvements in articulation of operational risks and use of ‘SMART’ methodology for actions. • The Board Assurance Framework had been reviewed by relevant executive directors and committees since it was last presented to the Board. There had been no changes to the ratings or target dates. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (COG) Meeting 28 October 2025 The Chair presented a summary of the Council of Governors’ meeting held on 28 October 2025. It was noted that the meeting had considered the following matters: • Chief Executive Officer’s Performance Report • Governor attendance at Council of Governors’ meetings • Review of the Council of Governors’ Expenses Reimbursement Protocol • Appointment of Jane Harwood as Deputy Chair with effect from 1 October 2025 • Membership engagement • Feedback from the Governors’ Nomination Committee It was noted that the Trust’s work on violence and aggression received particular attention from the Governors. 7.2 Register of Seals and Chair’s Action Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Page 8 It was further noted that one further item had been sealed on 7 November: Deed of Guarantee between University Hospital Southampton NHS Foundation Trust (Guarantor) and CHG-Meridian UK Limited (Beneficiary) regarding the payment and due performance obligations of UHS Estates Limited (UEL) under the Guaranteed Contract and specifically the Stryker Power Tools delivered to UEL under the pre-contract open build period with CHG. Seal number 307 on 7 November 2025. Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’ and to the additional document referred to above. 7.3 Health and Safety Services Annual Report 2024-25 Spencer Scott was invited to present the Health and Safety Services Annual Report 2024/25, the content of which was noted. It was further noted that: • The number of incidents reportable pursuant to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) had increased substantially to 68 such incidents compared to 39 in 2023/24. The majority of these incidents related to moving and handling or exposure to infectious diseases. • There was a concern that there had been a reduction in the number of health and safety related reports and escalations whilst at the same time the number of RIDDORs had increased. • Four areas of concern were highlighted: Entonox surveillance of maternity staff, display screen equipment compliance, the Southampton General Hospital loading bay, and workplace temperatures during the summer. 8. Any other business There was no other business. 9. Note the date of the next meeting: 13 January 2026 10. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. 11. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 9 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine 10/03/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Trust Board – Open Session 09/09/2025 - 8 Any other business 1286. Organ donation Machell, Craig 03/02/2026 Pending Explanation action item Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. Update: Scheduled for TBSS on 03/02/26. Trust Board – Open Session 11/11/2025 - 5.6 Performance KPI Report for Month 6 1293. MRI scanners and imaging Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to work on and present at either a future Board meeting or Trust Board Study Session the Trust’s longer-term strategy with respect to MRI scanners and imaging. 1294. Cystopscopy/urology Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to develop a longer-term plan for cystoscopy/urology and to report back to the Board during Quarter 4. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 11/11/2025 - 5.6 Performance KPI Report for Month 6 1295. Neurophysiology Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to develop a long-term solution to the neurophysiology service. 1296. Watch & Reserve antibiotics usage Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to clarify the basis of the calculation of the ‘Watch & Reserve antibiotics usage per 1,000 adms’ metric. Page 2 of 2 Agenda Item 5.1 i) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 24 November 2025 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The committee received an update in respect of the Trust’s commercial activities, noting that the Trust had robust systems in place to maximise cost recovery for private patient and overseas visitor income. The Trust’s private patient unit project continued to progress. The Trust was also seeking a partner to manage its parking provision. • The committee received the Finance Report for Month 7. The Trust had reported a £5.1m in-month deficit (£35.9m year-to-date), which was in line with the trajectory contained in the Financial Recovery Plan. The underlying deficit remained flat at £6.4m. Whilst there had been a slight reduction in the number of mental health patients, there were c.240 patients having no criteria to reside at any point during the period. There was an increased level of scrutiny in respect of non-pay expenditure. • The committee reviewed an update on the Trust’s measures for financial improvement, noting that the Trust was forecasting achievement of £85-95m against its target of £110m Cost Improvement Programme delivery for 2025/26. • The committee noted the Trust’s approach and the timelines associated with the Medium Term Planning submission. It was noted that the framework set ambitious financial and performance targets. • The committee received an update in respect of the Trust’s Theatre Experience Programme, noting that there had been a 3% increase in utilisation and a 3% reduction in cancellations. • The committee reviewed the Trust’s productivity, noting that the Trust’s productivity had fallen by 3.3% compared to the prior year due to high-cost growth. • The committee received an update in respect of the Trust’s cash position and forecast and supported a proposal to request further cash support for January 2026. • The committee received an update on Capital Planning for 2026/272029/30. It was noted that it was expected that the Trust would be allocated c.£40m per annum, although there were concerns about the impact of the Trust’s cash position and the ability of the Trust to meet this level of expenditure. N/A N/A Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.1 ii) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 15 December 2025 Key Messages: • • • • • • The committee received the Finance Report for Month 8 (see below). The committee discussed the Trust’s future transformation programmes, noting that the areas of focus would be: urgent and emergency care, elective care, and automation of administrative processes. The committee was assured that the programmes were felt to be suitably ‘bold and ambitious’ and were grounded in realistic opportunities, rather than ‘blue sky’ ideas. The committee reviewed the draft capital plan for 2026/27 – 2029/30, noting that the Trust had been allocated c.£40m of capital departmental expenditure limit (CDEL) per year. It was noted that the Trust’s cash position could place constraints on the Trust’s capital programme. The opportunity to secure funding from national programmes outside of CDEL should be pursued vigorously. The plan was to be discussed in a Trust Board Study Session prior to submission in February 2026. The committee reviewed, challenged and discussed the Trust’s medium-term plan ahead of the first submission to NHS England on 17 December 2025. The committee provided feedback in respect of the proposed submission noting that some of the assumptions within the 2025/26 plan had not materialised with regard to matters such as reductions in non-criteria to reside numbers and the committee sought assurance that learnings had been applied to the development of the medium-term plan submission. The committee was assured that such assumed reductions within the 2026/27 plan were based purely on actions which were deemed to be within the Trust’s control. The committee suggested some changes with regard to the plan, particularly around growth assumptions in the cost base, and agreed to recommend the revised plan to the Board for approval. It was noted that more detail and reviews would be required prior to the final submission date in February 2026. The committee received an update in respect of the Trust’s cash position and supported a proposal to make a further request for cash support from NHS England for January 2026. The Trust reviewed and supported a proposal for transforming the Southern Counties Pathology network. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.7 Finance Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The Trust had reported an in-month deficit of £4.9m (£40m year-todate), which was consistent with the Trust’s Financial Recovery Plan. • November 2025 had been a challenging month due to costs associated with industrial action, patients with no criteria to reside and mental health patients. • The Trust had received c.£3m of income out of £6.1m for elective over-performance. • There had been a slight improvement in the Trust’s underlying deficit. Page 1 of 2 Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: People & Organisational Development Committee Meeting Date: 21 November 2025 Key Messages: • • • • The committee reviewed the People Report for Month 7 including progress against the workforce plan. During October 2025, the overall workforce grew by 14 whole-time-equivalents (WTE). Although the substantive workforce had reduced by 15 WTE, there had been lowerthan-expected turnover and increased temporary staffing usage due in part to high sickness levels. The Trust remained on track, however, with respect to its Financial Recovery Plan trajectory. There were concerns about the response rate to the Staff Survey, which was below the national average. The Trust’s vaccination campaign for staff had started well with the uptake rate for the flu vaccine amongst staff at 43%. The committee considered the outputs of the review by NHS England of statutory and mandatory training and the implications for UHS. It was noted that a revised framework would facilitate passporting of training between NHS organisations. The Trust was aligned to the Core Skills Training Framework across six out of eleven areas and ten out of eleven areas for the Utilising E-Learning for Health material. The committee received an update in respect of the Trust’s Inclusion and Belonging strategy. It was noted that resource constraints and the impact of the current financial and operational environment on staff morale had impacted progress towards achievement of the objectives set out in the strategy. The committee reviewed the People risks contained within the Trust’s Board Assurance Framework. Assurance: N/A (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. Page 1 of 2 No Assurance Not Applicable Risk Rating: Low Medium High Not Applicable There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: People & Organisational Development Committee Meeting Date: 15 December 2025 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) • The committee reviewed the People Report for Month 8 (see below) including progress against the workforce plan and Financial Recovery Plan. • The committee considered the workforce implications of the Trust’s medium term plan submission, noting that there were a number of national expectations and targets, such as those relating to sickness rates and elimination of agency spend. In addition, the committee noted the risks associated with the plan, including those where the Trust was reliant on progress with respect to non-criteria to reside and mental health numbers. • The committee received an update regarding the Trust’s Violence and Aggression workstream, noting that the Trust had adopted a revised approach to violence, aggression and abuse directed at staff with a greater willingness to take action against violent/abusive patients and members of the public. A violence and aggression board had been established to provide executive oversight and leadership, and the Trust’s policy was being revised. This work would be accompanied by a comprehensive communication plan for both staff and members of the public. • The committee reviewed the Trust’s progress against its objectives for Year 4 of its People Strategy. 5.9 People Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The overall workforce fell during November 2025, with substantive numbers falling by 52 whole-time-equivalents (WTE). However, temporary staffing use had increased during the month due to increased sickness and operational pressures, which offset much of the reduction in substantive numbers. • The Trust was over its original plan by 214 WTE despite a decrease of nearly 400 WTE since 31 March 2025. In order to hit the Trust’s Financial Recovery Plan target, the overall workforce would need to fall by a further 137 WTE (including a 72 WTE reduction in temporary staffing) by the end of March 2026. • A forecast based on the previous year’s temporary staffing usage for the remaining months of the year indicated that the Trust would end the year approximately 500 WTE above the Trust’s 2025/26 plan. • The Trust had submitted a baseline assessment against the 10 Point Plan to improve Resident Doctors’ working lives in August 2025, which indicated that the Trust compared favourably against other organisations in the South East. The main issues concerned space available for doctors to work in and timeliness of reimbursement of course-related expenses. • The Trust was expected to meet a target of 95% of job plans having been signed off prior to 31 March 2026. At the start of December 2025, 55% of job plans had been signed off. Page 1 of 2 Any Other Matters: • Sickness absence had increased in November 2025 to 4.2% in month due to seasonal illnesses. • The staff survey closed on 28 November 2025. The completion rate for the staff survey had been lower t
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2026-Trust-documents/Papers-Trust-Board-13-January-2026.pdf

BRC Research-imaging-proposal-form_v2 2025 FINAL

Description: BRC Research Imaging Proposal form The BRC Research Imaging Proposal form should be completed by the chief/principal investigator of any new research study requiring access to imaging resources at University Hospital Southampton. The BRC Imaging Research Panel (BRC IRP) will use this information to determine the availability of resource and provide advice on costings for imaging research. This form should be completed before a full submission to this pilot scheme is made, to enable accurate timings/costings for the MR imaging to be determined. For the BRC MRI pump-priming research project award, this form will provide imaging specific background information, to help assess the feasibility of the project, alongside the full award application form. Please complete both Part 1 and Part 2 (detailed application). If detailed information is not known then please complete as much as possible (especially for Part 2), submit the form and we will be in contact to assist with this. Part 1 – Expression of interest Study title: Short title: Research question / summary of imaging requirements: Investigator: Email: Are you acting in your capacity as a UHS or UoS principal investigator? Select one only. UHS (Trust) UoS (University) Principal grant admin (n/a for BRC pump priming scheme) UHS (Trust) UoS (University) Other Part 2 – Detailed application Proposed start date: Proposed end date: Number of subjects: Statistical advice sought? Please circle Yes / No Type of study: Part of a multi-centre trial? Please circle Yes / No Approvals required? Please state Imaging required Imaging protocol (state if new or existing and who this has been discussed with) Frequency/timing/routine? Hardware/software/data storage/archiving and image processing and image analysis requirements? 1. 2. 3. 4. New imaging protocols (including MRI sequences) should be discussed with the MRI Research Radiographer, MRI Physics and relevant Consultant Radiologist (if required). Existing imaging protocols should be confirmed with the MRI Research Radiographer and relevant MRI Superintendent Radiographer (including protocol name and version date). Please indicate if each imaging event is routine (i.e. part of clinical care), additional as part of this proposal, and whether this will continue once the trial has ended. Hardware/software/data storage and post-processing requirements, including image archiving, should be discussed with radiology/medical physics/UoS. Please sign electronically to indicate that you have read and agree with the attached Joint UHS and UoS Policy for imaging research in Southampton and BRC award terms and conditions Name: Signature: Date: Please submit to the RIMG (on behalf of the BRC) by emailing: Angela.Darekar@uhs.nhs.uk Joint UHS and UoS policy for imaging research in Southampton – BRC/MRI specific Version 2, December 2019, Research Imaging Management Group This Joint Policy applies to any academic activity, hereby referred to as “Project”, which involves imaging or imaging results at UHS, whether it is research, case report, case series, audit, service evaluation or other description not specifically mentioned here. Planning and costing research 1. For research only: please inform RIMG (by emailing Angela.Darekar@uhs.nhs.uk) of the research at least one month prior to grant/award application form submission by completing the attached form 2. Please discuss protocols with the appropriate radiographer/radiologist/medical physicist assigned to the project by the Radiology Research Coordinator. This will ensure that accurate costings (or equivalent hours of scanning time) can be provided. 3. When costing grant applications, the Radiology Research team will advise on costing attribution across institutions. Ethical approval 1. The appropriate Health Research Authority and institutional (UHS or UoS) approvals need to be in place before the Project starts. Bookings 1. Please provide as much notice as possible for research bookings (at least 48 hours), and appreciate that they cannot always be accommodated at short notice. If particular procedures/personnel are required for bookings, these should be discussed with the Radiology Research team before RIMG approval is granted. 2. Liaise with the research radiographers for bookings, copying in RadiologyResearch@uhs.nhs.uk and provide: Name, DoB, Address, GP details, hospital ID (if available) and patient’s study ID. 3. Please use either the radiology research referral form or electronic requesting. Please clearly indicate the project title in the request and indicate that this is a research scan. Overlap between research and clinical imaging 1. If requesting clinical imaging that will later be used for research purposes, please clarify this to the reporting radiologist on the request form. Appropriate funding and ethical approvals must be in place. Publication 1. If manuscripts arise from Projects which make use of imaging data reported by UHS radiologists or involving UHS medical physicists, co-authorship or acknowledgement of these individuals should be discussed with them at the point of manuscript preparation. 2. Please include both UHS and UoS as affiliations, unless none of the authors have a honorary or substantive connection with UoS, and no use was made of any UoS facility. Please abide by the “Joint Partnership Policy and Guidance on Pre-clinical and Clinical Research Publications” v2.6, jointly approved by UHS and UoS. 3. Acknowledge resources (staff, space or equipment) of a particular imaging unit or department if these have been used. 4. Please remember to acknowledge any sponsorship you have received. 5. Please acknowledge BRC support using wording in section 4.5 below 6. For grants, please include the grant number and source. 7. Please inform RIMG of publications arising from imaging performed at UHS. Incidental findings 1. It is the recommendation of the RIMG that the Research Ethics Committee approved protocol defines precise instructions on how to consent for and manage incidental findings. These should specify a named clinician who will be responsible for managing incidental findings (reported by the radiologist(s) associated with the study) including informing the subject, arranging follow up tests and liaising with the GP as necessary. In the absence of clarity in the study protocol of any aspect relating to incidental findings, the Royal College of Radiologists’ guidance (https://www.rcr.ac.uk/publication/management-incidental-findings-detected-during-research-imaging), will need to be adhered to. Data management 1. Please ensure that data uploads/transfers and archiving processes have been discussed with the relevant people within PACS/Radiology Research/Medical Physics (as appropriate) and have been funded accordingly (to be confirmed for the BRC MRI pump-priming scheme). 2. Please ensure that all data management is in compliance with the General Data Protection Regulation or its UK equivalent. The award will only be made available if you meet the following conditions: BRC award terms and conditions 1. The award is subject to the terms and conditions of the BRC4 Research Contract signed by the Department for Health and Social Care and University Hospital Southampton NHS Foundation Trust on 8th November 2022. Specific applicable BRC terms are set out in Schedule 1 attached to this award letter. 2. The BRC funding is subject to the terms and conditions detailed in the BRC Collaboration Agreement signed by University Hospital Southampton NHS Foundation Trust and the University of Southampton, dated 15th September 2023. 3. Any additional grant funding secured by the postholder as a result of the BRC funding will be considered as grant income to the BRC. As the successful applicant awarded funding you will be required to: * Provide the BRC Manager with progress reports as requested by them, including a report at least 1 month prior to award end, plus information required to meet reporting requirements for NIHR, such as dates of submission of external applications * Contribute to the relevant School/Faculty conference and seminar programmes and BRC and NIHR-related training and development events in accordance with NIHR guidance. * Include an acknowledgement of NIHR Southampton BRC support on all publications, posters and other outputs resulting from this award. Schedule 1 – Specific Applicable NIHR Southampton Biomedical Research Centre Terms 1 Definitions: 1.1 "Award” means the funding applied for in this application. 1.2 BRC Manager means the member of staff at UHS employed to have overall management responsibility for the BRC. 1.3 “BRC Research Contract” means the Biomedical Research Centre grant contract signed by University Hospital Southampton NHS Foundation Trust and the Department for Health and Social Care and which is incorporate by reference, to the Award Letter. 1.4 “Background IP” means any Intellectual Property in existence at the commencement of the Research or created, devised or generated other than in the performance of the Research and which is actually used in the performance of the Research. 1.5 “Confidential Information” means all information of a commercially sensitive nature including (but not limited to) specifications, drawings, circuit diagrams, tapes, discs and other computable readable media, documents, techniques and know-how which are disclosed by one Party to the other for use in or in connection with the BRC or any Research. 1.6 “Foreground IP” means any Intellectual Property (and/or property right in Samples) that is created, generated or developed (whether in whole or in part) during the course of and for the purpose of any part of the Research. 1.7 “Parties” means Awardee and University Hospital Southampton NHS Foundation Trust. 1.8 “Research” means the project undertaken supported by the Award. 1.9 “Research Data” means information or data that is collected, collated or generated in the performance of the Research and includes (but is not limited to) information or data that is presented or stored in searchable form. For the avoidance of doubt, Research Data: a) does not include, without limitation, information or data that has been analysed as part of the Research; b) does include, but is not limited to, images. 1.10 “Samples” means material (including but not limited to biological material, organisms and chemical compounds), specimens or extracts collected, obtained or generated (whether in whole or in part) during the course of and for the purpose of any part of the Research. 1.11 “UHS” means University Hospital Southampton NHS Foundation Trust. 2 Intellectual Property 2.1 Awardee shall promptly report all Foreground IP to UHS. 2.2 Each Party shall own the Research Data and Foreground IP generated by it under the BRC or Project and the terms of clauses 11, 16 and 17 of BRC Research Contract shall apply to the use, management and exploitation of Research Data and Foreground IP. 2.3 Nothing contained in the Award Letter related to this funding shall affect the absolute and unfettered rights of each Party in all inventions, discoveries and intellectual property contained in its Background IP. 2.4 Subject to the BRC Research Contract, each Awardee shall undertake and continue at its expense the timely prosecution and maintenance of all Foreground IP which is solely owned by Awardee. In the event that the Awardee is unable or unwilling to comply with its obligation under this Clause 2.4, UHS and Funder shall consider how best to deal with such Foreground IP and shall have the option to require an assignment of such Foreground IP to the other Party to enable prosecution and maintenance of such Foreground IP by that other Party at its own cost. In the event that any Party wishes to exploit commercially any Foreground IP assigned pursuant to this Clause 2.4 that Party shall pay to the assigning Party a royalty and/or other appropriate form of remuneration which is fair and reasonable taking into consideration the factors set out under Clause 3.3. 2.5 In the event that any of the Parties are jointly responsible for generating Research Data and/or Foreground IP such Research Data and/or Foreground IP shall be jointly owned by the Parties. Ownership in Foreground IP shall be in accordance with the inventive contribution made by each Party to the generation of such Foreground IP and ownership in Research Data shall be in accordance with the relative contributions of each Party to the generation of the Research Data. 2.6 Joint owners of Foreground IP shall agree between them on who shall be responsible for the timely prosecution and maintenance of all such Foreground IP and the Party that is nominated to be so responsible shall be entitled to charge the other joint owners with a percentage of the costs of so doing as agreed between the joint owners. In the absence of any agreement to the contrary between joint owners the costs shall be equally shared. 3 Exploitation of Intellectual Property 3.1 Each Party grants to the other Party a non-exclusive, royalty-free licence (without the right to sublicence) to: 3.1.1 use its Research Data and Foreground IP for their own non-commercial research and development purposes but not for the purposes of commercial exploitation; and 3.1.2 in the case of UHS to use University of Southampton Research Data and Foreground IP in clinical activities within UHS; 3.1.3 subject to any existing third party obligations, use its Background IP for the purpose of undertaking the BRC and to enable the use of the Foreground IP pursuant to Clause 3.1.1 and 3.1.2 but not for the purposes of commercial exploitation. 3.2 The Parties will review and consider the optimum use of all Research Data and Foreground IP and agree which is the most suitable to effectively exploit or disseminate any Research Data and Foreground IP, subject to approval of the Funder. 3.3 In the event that any Party wishes to exploit commercially Foreground IP owned by the other Party, the owner of the Foreground IP shall grant to such Party a non-exclusive licence to use such Foreground IP for that purpose, subject to the agreement of appropriate terms in relation thereto, including a royalty and/or other appropriate form of remuneration which is fair and reasonable taking into consideration the respective financial and technical contributions of the Parties concerned to the development of the Foreground IP, the expenses incurred in securing intellectual property protection thereof and the costs of its commercial exploitation and any use of Background IP. 3.4 Should any of the Parties wish to exploit its own Foreground IP with a third party during the duration of the BRC, that Party must notify the other Party before approaching said third party, always provided that the disclosure of information required for such exploitation is subject to the obligations of confidentiality at least equivalent to those under Clause 11. Further any necessary notification to NIHR shall be made and their respective approval should be obtained or commercialisation agreement in place, if required, prior to exploitation. 3.5 In recognition of the Parties joint involvement with the BRC and the contribution to development of the Foreground IP a Party exploiting its own Foreground IP will provide a fair revenue share to the other Party. In the event any revenues are due to the Funder revenues shall first be distributed to the Funder prior to sharing between the Parties. 3.6 Subject to Clause 3.4 each Party agrees (where it is free and reasonably able to do so) to license on fair and reasonable terms its Foreground IP and Background IP that may be required to enable any other Party to exploit its own Foreground IP or Background IP, always subject to the obligations of confidentiality under Clause 5. 3.7 With regard to joint inventions, the Parties owning such inventions agree to co-operate fully in the protection of such joint inventions and each Party shall be entitled to make use of such joint inventions subject only to negotiating a licence in good faith from the other Party for its interest in such joint inventions on similar terms to those set out in clause 3.3. 3.8 The University shall grant to the Funder a non-exclusive, irrevocable, royalty-free, worldwide licence together with the right to grant sub-licences to health service bodies or others directly engaged in providing health care, permitting the Funder to use and publish 3.9 any information relating to the Research which is not Confidential Information of the University 3.9.1 any Foreground IP; 3.9.2 Research Data; 3.9.3 Reports; 3.9.4 arising know how; and, 3.9.5 conclusions arising from the Research 3.10 and in each case, the University acknowledges the Funder intends to exercise this right only where the Funder’s reasonable opinion the University is not appropriately managing, disseminating or using such items and in each case Funder is permitted to use or make available such items as it sees fit in support of: (i) the development, promotion or provision of health care that is not a commercial use; and/or (ii) for any other purpose that is not a commercial use. 4 Publication 4.1 Subject to the provisions of Clauses 2, 3 and 5 neither Party shall disclose or publish information or Foreground IP for the duration of the BRC and for 3 (three) years thereafter without the consent of the other Party , such consent, not to be unreasonably withheld or delayed. Further the Parties must seek to obtain all necessary consents from NIHR and any Collaborating Parties prior to publication. The obligation to seek consent of NIHR or continues after the end of the Research. 4.2 Subject to 4.1, the Parties shall be permitted to publish the Research Data of the BRC which they have undertaken in accordance with normal academic practice, subject always to the provisions of Clauses 8 and 5, and providing such disclosure does not jeopardise any application for Foreground IP protection by any Party. Request for such consent must be submitted together with the material proposed for publication to the BRC Manager. If any Party can reasonably demonstrate that such a disclosure contains material that would prejudice the value of any Background IP and/or Foreground IP, that Party shall inform the BRC Manager in writing within 28 days of that Party receiving a copy of the proposed publication and in that event the disclosure shall be amended so as to meet the objections of that Party or delayed to address their concerns. 4.3 Subject to the provisions of Clause 3 where in the opinion of UHS a proposed publication contains patentable or commercially sensitive subject matter which needs protection then the Party proposing to publish may be requested to refrain from doing so for a maximum of six 6 months in order to allow for application for patent protection in the name and at the cost of the relevant owner of the Foreground IP. The provisions of Clause 2 and 3 shall apply in respect of any licence to such Foreground IP. 4.4 Nothing contained in the Award Letter related to this funding shall prevent the submission of a thesis to examiners in accordance with the normal regulations of the Parties subject where appropriate to such examiners being bound by conditions of confidentiality in no less terms than those outlined in Clause 5 nor to the placing of such thesis in the library of the appropriate Research Party provided that access to such thesis shall only be available on conditions of confidentiality no less onerous than those contained in Clause 5 hereof. 4.5 The University shall ensure that all project investigators acknowledge in all theses, papers and other publications (including from non-BRC projects) that they receive support from the NIHR Southampton BRC, in accordance with BRC Research Contract. The form of words is: “[investigator initials] is supported by the National Institute for Health and Care Research through the NIHR Southampton Biomedical Research Centre”. 4.6 The Parties acknowledge that NIHR is entitled to publish the whole or any part of the Report. If the Parties wishes NIHR to delay such publication, it must submit a request in writing to the NIHR giving reasons for the requested delay which shall be considered in accordance with the NIHR’s Information for Authors’ Dual Publication Guidance and Embargo Policy as defined in the NIHR Contract and amended from time-to-time. 4.7 Neither Party shall use the other's name, crest, logo or registered image for any purpose without the express permission of the other Party. The Parties will agree treatment for referencing each others involvement in the BRC and joint branding for their activities subject to compliance with Clause 4.8 and the BRC Research Contract. 4.8 Neither Party shall issue any press release, public statement, or other media announcement related to the BRC or any Research Data or Foreground IP without the prior consent of the other Party and Funder, as applicable. 4.9 The Parties (in the case of the University via UHS must notify the Funder of any intention to issue a press release at least three (3) business days prior to any press release issued by it or on its behalf, directly related to the Research or Foreground IP, arising now how or Research Data or of matters arising from such Research. Awardee shall send one draft copy of the proposed press release to UHS at least five (5) business days before the date intended for release. For the avoidance of doubt this obligation shall continue in full force and effect following expiry of the Award letter 4.10 The Parties shall comply with guidance and advice from Funder on branding and publicity which may be issued from time to time including, but not limited to Funder’s guidance on the format for websites, press releases and use of social media, permitted use of the NIHR, BRC, NHS and Department of Health and Social Care brands, names and logos and ensuring all branding references to the BRC are prefixed with the term “NIHR”. 5 Confidentiality 5.1 The Parties hereto agree to use all reasonable endeavours to ensure that any Confidential Information disclosed or submitted in writing or any other tangible form to one Party (“Receiving Party”) by the other (“Disclosing Party”) shall be treated with the same care and discretion to avoid disclosure as the Receiving Party uses with its own similar information which it does not wish to disclose. Any information disclosed orally that is identified by the Disclosing Party as Confidential Information shall be treated the same as if it had been reduced to writing at the time of disclosure to the Receiving Party. 5.2 The Receiving Party shall not, during a period of seven (7) years after the termination of this Award Letter, use any such Confidential Information for any purpose other than the carrying out of its obligations under this Award funding or other than in accordance with the terms of this Award funding. 5.3 The undertaking in Clause 5.1 above shall not apply to Confidential Information: 5.3.1 which, at the time of disclosure, has already been published or is otherwise in the public domain other than through breach of the terms of this Award funding; 5.3.2 which, after disclosure to the Parties, is subsequently published or comes into the public domain by means other than an action or omission on the part of any of the Parties; 5.3.3 which a Party can demonstrate was known to him or subsequently independently developed by them; 5.3.4 lawfully acquired from third parties who had a right to disclose it with no obligations of confidentiality to any of the Parties; or 5.3.5 is required to be disclosed by applicable law or court order or by any Party's regulatory body, which is empowered by Statute or Statutory Instrument, but only to the extent of such disclosure and the Receiving Party shall notify the Disclosing Party promptly of any such request. 5.4 Staff and students and any agents, consultants or sub-contractors engaged to work on the BRC will be subject to the principles of confidentiality outlined in this Clause 5. 6 Term and Termination 6.1 The terms of this award shall come into force on the date when the Acceptance Statement is signed by the Awardee and remain in full force and effect until 31st March 2028 unless terminated earlier in accordance with the provisions of this Clause 6. 6.2 In the event that any Party shall commit any breach of or default in any terms or conditions of this Award funding, the other Party may serve written notice of such breach or default on the defaulting Party and in the event that such Party fails to remedy such default or breach within sixty (60) days after receipt of such written notice the other Party may, at their option and in addition to any other remedies which they may have at law or equity, terminate this Award funding by sending notice of termination in writing to the other Party. 6.3 If any Party (a) materially breaches any provisions of this Award funding ; or (b) passes a resolution for its winding-up; or if (c) a court of competent jurisdiction makes an order for that Party’s winding-up or dissolution; or makes an administration order in relation to that Party; or if any Party (e) appoints a receiver over, or an encumbrancer takes possession of or sells an asset of, that Party; or (f) makes an arrangement or composition with its creditors generally; or (g) makes an application to a court of competent jurisdiction for protection from its creditors generally; the other Party may terminate their involvement in the BRC. 6.4 In the event the BRC Research Contract terminates UHS may terminate this Award funding with immediate effect. 7 General 7.1 Each Party shall indemnify each of the other Parties, within the limits set out in this Clause 6, in respect of liability resulting from acts or omissions of itself, its employees or its students provided always that such indemnity shall not extend to claims for indirect or consequential loss or damages such as, but not limited to, loss of profit, revenue, contracts or the like. 7.2 Any amendments to this Award funding shall be valid only if made in writing and signed by authorised signatories of the Parties. 7.3 If any part or any provision of this Award funding shall to any extent prove invalid or unenforceable in law the remainder of such provision and all other provisions of this Award funding shall remain valid and enforceable to the fullest extent permissible by law, and such provision shall be deemed to be omitted from this Award funding to the extent of such invalidity or unenforceability. The remainder of this Award funding shall continue in full force and effect and the Parties shall negotiate in good faith to replace the invalid or unenforceable provision with a valid, legal and enforceable provision which has an effect as close as possible to the provision or terms being replaced. 7.4 No failure to exercise or delay in the exercise of any right or remedy which any Party may have under this Award funding or in connection with this Award funding shall operate as a waiver thereof, and nor shall any single or partial exercise of any such right or remedy prevent any further or other exercise thereof or of any other such right or remedy. 7.5 This Award funding including its Schedule supersedes all other agreements and understandings, whether written or oral, between the Parties about the BRC constitutes the entire agreement between the Parties regarding the BRC. 7.6 Except as otherwise expressly provided for herein, the Parties confirm that nothing in this Award funding shall confer or purport to confer on any third party any benefit or any right to enforce any term of this Award funding for the purposes of Contracts (Rights of Third Parties) Act 1999. 7.7 This Award funding shall be governed by and construed in accordance with English Law and each Party agrees to submit to the exclusive jurisdiction of the English Courts as regards any claim or matter arising under this Award funding. 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Url: /Media/Southampton-Clinical-Research/Downloads/BRC-Research-imaging-proposal-form-v2-2025-FINAL.docx

BRC Research-imaging-proposal-form_v1 FINAL 10.12.2024

Description: BRC Research Imaging Proposal form The BRC Research Imaging Proposal form should be completed by the chief/principal investigator of any new research study requiring access to imaging resources at University Hospital Southampton. The BRC Imaging Research Panel (BRC IRP) will use this information to determine the availability of resource and provide advice on costings for imaging research. Ideally, this form should be completed before a submission for this pilot scheme is made, to enable accurate costings for the MR imaging to be estimated. For the BRC MRI pump-priming research project award, this form will provide imaging specific background information, to help assess the feasibility of the project, alongside the full award application form. Please complete both Part 1 and Part 2 (detailed application). If detailed information is not known then please complete as much as possible (especially for Part 2), submit the form and we will be in contact to assist with this. Part 1 – Expression of interest Study title: Short title: Research question / summary of imaging requirements: Investigator: Email: Are you acting in your capacity as a UHS or UoS principal investigator? Select one only. UHS (Trust) UoS (University) Principal grant admin (n/a for BRC pump priming scheme) UHS (Trust) UoS (University) Other Part 2 – Detailed application Proposed start date: Proposed end date: Number of subjects: Statistical advice sought? Please circle Yes / No Type of study: Part of a multi-centre trial? Please circle Yes / No Approvals required? Please state Imaging required Imaging protocol (state if new or existing and who this has been discussed with) Frequency/timing/routine? Hardware/software/data storage/archiving and image processing and image analysis requirements? 1. 2. 3. 4. New imaging protocols (including MRI sequences) should be discussed with the MRI Research Radiographer, MRI Physics and relevant Consultant Radiologist (if required). Existing imaging protocols should be confirmed with the MRI Research Radiographer and relevant MRI Superintendent Radiographer (including protocol name and version date). Please indicate if each imaging event is routine (i.e. part of clinical care), additional as part of this proposal, and whether this will continue once the trial has ended. Hardware/software/data storage and post-processing requirements, including image archiving, should be discussed with radiology/medical physics/UoS. Please sign electronically to indicate that you have read and agree with the attached Joint UHS and UoS Policy for imaging research in Southampton and BRC award terms and conditions Name: Signature: Date: Please submit to the RIMG (on behalf of the BRC) by emailing: Angela.Darekar@uhs.nhs.uk Joint UHS and UoS policy for imaging research in Southampton – BRC/MRI specific Version 2, December 2019, Research Imaging Management Group This Joint Policy applies to any academic activity, hereby referred to as “Project”, which involves imaging or imaging results at UHS, whether it is research, case report, case series, audit, service evaluation or other description not specifically mentioned here. Planning and costing research 1. For research only: please inform RIMG (by emailing Angela.Darekar@uhs.nhs.uk) of the research at least one month prior to grant/award application form submission by completing the attached form 2. Please discuss protocols with the appropriate radiographer/radiologist/medical physicist assigned to the project by the Radiology Research Coordinator. This will ensure that accurate costings (or equivalent hours of scanning time) can be provided. 3. When costing grant applications, the Radiology Research team will advise on costing attribution across institutions. Ethical approval 1. The appropriate Health Research Authority and institutional (UHS or UoS) approvals need to be in place before the Project starts. Bookings 1. Please provide as much notice as possible for research bookings (at least 48 hours), and appreciate that they cannot always be accommodated at short notice. If particular procedures/personnel are required for bookings, these should be discussed with the Radiology Research team before RIMG approval is granted. 2. Liaise with the research radiographers for bookings, copying in RadiologyResearch@uhs.nhs.uk and provide: Name, DoB, Address, GP details, hospital ID (if available) and patient’s study ID. 3. Please use either the radiology research referral form or electronic requesting. Please clearly indicate the project title in the request and indicate that this is a research scan. Overlap between research and clinical imaging 1. If requesting clinical imaging that will later be used for research purposes, please clarify this to the reporting radiologist on the request form. Appropriate funding and ethical approvals must be in place. Publication 1. If manuscripts arise from Projects which make use of imaging data reported by UHS radiologists or involving UHS medical physicists, co-authorship or acknowledgement of these individuals should be discussed with them at the point of manuscript preparation. 2. Please include both UHS and UoS as affiliations, unless none of the authors have a honorary or substantive connection with UoS, and no use was made of any UoS facility. Please abide by the “Joint Partnership Policy and Guidance on Pre-clinical and Clinical Research Publications” v2.6, jointly approved by UHS and UoS. 3. Acknowledge resources (staff, space or equipment) of a particular imaging unit or department if these have been used. 4. Please remember to acknowledge any sponsorship you have received. 5. Please acknowledge BRC support using wording in section 4.5 below 6. For grants, please include the grant number and source. 7. Please inform RIMG of publications arising from imaging performed at UHS. Incidental findings 1. It is the recommendation of the RIMG that the Research Ethics Committee approved protocol defines precise instructions on how to consent for and manage incidental findings. These should specify a named clinician who will be responsible for managing incidental findings (reported by the radiologist(s) associated with the study) including informing the subject, arranging follow up tests and liaising with the GP as necessary. In the absence of clarity in the study protocol of any aspect relating to incidental findings, the Royal College of Radiologists’ guidance (https://www.rcr.ac.uk/publication/management-incidental-findings-detected-during-research-imaging), will need to be adhered to. Data management 1. Please ensure that data uploads/transfers and archiving processes have been discussed with the relevant people within PACS/Radiology Research/Medical Physics (as appropriate) and have been funded accordingly (to be confirmed for the BRC MRI pump-priming scheme). 2. Please ensure that all data management is in compliance with the General Data Protection Regulation or its UK equivalent. The award will only be made available if you meet the following conditions: BRC award terms and conditions 1. The award is subject to the terms and conditions of the BRC4 Research Contract signed by the Department for Health and Social Care and University Hospital Southampton NHS Foundation Trust on 8th November 2022. Specific applicable BRC terms are set out in Schedule 1 attached to this award letter. 2. The BRC funding is subject to the terms and conditions detailed in the BRC Collaboration Agreement signed by University Hospital Southampton NHS Foundation Trust and the University of Southampton, dated 15th September 2023. 3. Any additional grant funding secured by the postholder as a result of the BRC funding will be considered as grant income to the BRC. As the successful applicant awarded funding you will be required to: * Provide the BRC Manager with progress reports as requested by them, including a report at least 1 month prior to award end, plus information required to meet reporting requirements for NIHR, such as dates of submission of external applications * Contribute to the relevant School/Faculty conference and seminar programmes and BRC and NIHR-related training and development events in accordance with NIHR guidance. * Include an acknowledgement of NIHR Southampton BRC support on all publications, posters and other outputs resulting from this award. Schedule 1 – Specific Applicable NIHR Southampton Biomedical Research Centre Terms 1 Definitions: 1.1 "Award” means the funding applied for in this application. 1.2 BRC Manager means the member of staff at UHS employed to have overall management responsibility for the BRC. 1.3 “BRC Research Contract” means the Biomedical Research Centre grant contract signed by University Hospital Southampton NHS Foundation Trust and the Department for Health and Social Care and which is incorporate by reference, to the Award Letter. 1.4 “Background IP” means any Intellectual Property in existence at the commencement of the Reseacrh or created, devised or generated other than in the performance of the Research and which is actually used in the performance of the Research. 1.5 “Confidential Information” means all information of a commercially sensitive nature including (but not limited to) specifications, drawings, circuit diagrams, tapes, discs and other computable readable media, documents, techniques and know-how which are disclosed by one Party to the other for use in or in connection with the BRC or any Research. 1.6 “Foreground IP” means any Intellectual Property (and/or property right in Samples) that is created, generated or developed (whether in whole or in part) during the course of and for the purpose of any part of the Research. 1.7 “Parties” means Awardee and University Hospital Southampton NHS Foundation Trust. 1.8 “Research” means the project undertaken supported by the Award. 1.9 “Research Data” means information or data that is collected, collated or generated in the performance of the Research and includes (but is not limited to) information or data that is presented or stored in searchable form. For the avoidance of doubt, Research Data: a) does not include, without limitation, information or data that has been analysed as part of the Research; b) does include, but is not limited to, images. 1.10 “Samples” means material (including but not limited to biological material, organisms and chemical compounds), specimens or extracts collected, obtained or generated (whether in whole or in part) during the course of and for the purpose of any part of the Research. 1.11 “UHS” means University Hospital Southampton NHS Foundation Trust. 2 Intellectual Property 2.1 Awardee shall promptly report all Foreground IP to UHS. 2.2 Each Party shall own the Research Data and Foreground IP generated by it under the BRC or Project and the terms of clauses 11, 16 and 17 of BRC Research Contract shall apply to the use, management and exploitation of Research Data and Foreground IP. 2.3 Nothing contained in the Award Letter related to this funding shall affect the absolute and unfettered rights of each Party in all inventions, discoveries and intellectual property contained in its Background IP. 2.4 Subject to the BRC Research Contract, each Awardee shall undertake and continue at its expense the timely prosecution and maintenance of all Foreground IP which is solely owned by Awardee. In the event that the Awardee is unable or unwilling to comply with its obligation under this Clause 2.4, UHS and Funder shall consider how best to deal with such Foreground IP and shall have the option to require an assignment of such Foreground IP to the other Party to enable prosecution and maintenance of such Foreground IP by that other Party at its own cost. In the event that any Party wishes to exploit commercially any Foreground IP assigned pursuant to this Clause 2.4 that Party shall pay to the assigning Party a royalty and/or other appropriate form of remuneration which is fair and reasonable taking into consideration the factors set out under Clause 3.3. 2.5 In the event that any of the Parties are jointly responsible for generating Research Data and/or Foreground IP such Research Data and/or Foreground IP shall be jointly owned by the Parties. Ownership in Foreground IP shall be in accordance with the inventive contribution made by each Party to the generation of such Foreground IP and ownership in Research Data shall be in accordance with the relative contributions of each Party to the generation of the Research Data. 2.6 Joint owners of Foreground IP shall agree between them on who shall be responsible for the timely prosecution and maintenance of all such Foreground IP and the Party that is nominated to be so responsible shall be entitled to charge the other joint owners with a percentage of the costs of so doing as agreed between the joint owners. In the absence of any agreement to the contrary between joint owners the costs shall be equally shared. 3 Exploitation of Intellectual Property 3.1 Each Party grants to the other Party a non-exclusive, royalty-free licence (without the right to sublicence) to: 3.1.1 use its Research Data and Foreground IP for their own non-commercial research and development purposes but not for the purposes of commercial exploitation; and 3.1.2 in the case of UHS to use University of Southampton Research Data and Foreground IP in clinical activities within UHS; 3.1.3 subject to any existing third party obligations, use its Background IP for the purpose of undertaking the BRC and to enable the use of the Foreground IP pursuant to Clause 3.1.1 and 3.1.2 but not for the purposes of commercial exploitation. 3.2 The Parties will review and consider the optimum use of all Research Data and Foreground IP and agree which is the most suitable to effectively exploit or disseminate any Research Data and Foreground IP, subject to approval of the Funder. 3.3 In the event that any Party wishes to exploit commercially Foreground IP owned by the other Party, the owner of the Foreground IP shall grant to such Party a non-exclusive licence to use such Foreground IP for that purpose, subject to the agreement of appropriate terms in relation thereto, including a royalty and/or other appropriate form of remuneration which is fair and reasonable taking into consideration the respective financial and technical contributions of the Parties concerned to the development of the Foreground IP, the expenses incurred in securing intellectual property protection thereof and the costs of its commercial exploitation and any use of Background IP. 3.4 Should any of the Parties wish to exploit its own Foreground IP with a third party during the duration of the BRC, that Party must notify the other Party before approaching said third party, always provided that the disclosure of information required for such exploitation is subject to the obligations of confidentiality at least equivalent to those under Clause 11. Further any necessary notification to NIHR shall be made and their respective approval should be obtained or commercialisation agreement in place, if required, prior to exploitation. 3.5 In recognition of the Parties joint involvement with the BRC and the contribution to development of the Foreground IP a Party exploiting its own Foreground IP will provide a fair revenue share to the other Party. In the event any revenues are due to the Funder revenues shall first be distributed to the Funder prior to sharing between the Parties. 3.6 Subject to Clause 3.4 each Party agrees (where it is free and reasonably able to do so) to license on fair and reasonable terms its Foreground IP and Background IP that may be required to enable any other Party to exploit its own Foreground IP or Background IP, always subject to the obligations of confidentiality under Clause 5. 3.7 With regard to joint inventions, the Parties owning such inventions agree to co-operate fully in the protection of such joint inventions and each Party shall be entitled to make use of such joint inventions subject only to negotiating a licence in good faith from the other Party for its interest in such joint inventions on similar terms to those set out in clause 3.3. 3.8 The University shall grant to the Funder a non-exclusive, irrevocable, royalty-free, worldwide licence together with the right to grant sub-licences to health service bodies or others directly engaged in providing health care, permitting the Funder to use and publish 3.9 any information relating to the Research which is not Confidential Information of the University 3.9.1 any Foreground IP; 3.9.2 Research Data; 3.9.3 Reports; 3.9.4 arising know how; and, 3.9.5 conclusions arising from the Research 3.10 and in each case, the University acknowledges the Funder intends to exercise this right only where the Funder’s reasonable opinion the University is not appropriately managing, disseminating or using such items and in each case Funder is permitted to use or make available such items as it sees fit in support of: (i) the development, promotion or provision of health care that is not a commercial use; and/or (ii) for any other purpose that is not a commercial use. 4 Publication 4.1 Subject to the provisions of Clauses 2, 3 and 5 neither Party shall disclose or publish information or Foreground IP for the duration of the BRC and for 3 (three) years thereafter without the consent of the other Party , such consent, not to be unreasonably withheld or delayed. Further the Parties must seek to obtain all necessary consents from NIHR and any Collaborating Parties prior to publication. The obligation to seek consent of NIHR or continues after the end of the Research. 4.2 Subject to 4.1, the Parties shall be permitted to publish the Research Data of the BRC which they have undertaken in accordance with normal academic practice, subject always to the provisions of Clauses 8 and 5, and providing such disclosure does not jeopardise any application for Foreground IP protection by any Party. Request for such consent must be submitted together with the material proposed for publication to the BRC Manager. If any Party can reasonably demonstrate that such a disclosure contains material that would prejudice the value of any Background IP and/or Foreground IP, that Party shall inform the BRC Manager in writing within 28 days of that Party receiving a copy of the proposed publication and in that event the disclosure shall be amended so as to meet the objections of that Party or delayed to address their concerns. 4.3 Subject to the provisions of Clause 3 where in the opinion of UHS a proposed publication contains patentable or commercially sensitive subject matter which needs protection then the Party proposing to publish may be requested to refrain from doing so for a maximum of six 6 months in order to allow for application for patent protection in the name and at the cost of the relevant owner of the Foreground IP. The provisions of Clause 2 and 3 shall apply in respect of any licence to such Foreground IP. 4.4 Nothing contained in the Award Letter related to this funding shall prevent the submission of a thesis to examiners in accordance with the normal regulations of the Parties subject where appropriate to such examiners being bound by conditions of confidentiality in no less terms than those outlined in Clause 5 nor to the placing of such thesis in the library of the appropriate Research Party provided that access to such thesis shall only be available on conditions of confidentiality no less onerous than those contained in Clause 5 hereof. 4.5 The University shall ensure that all project investigators acknowledge in all theses, papers and other publications (including from non-BRC projects) that they receive support from the NIHR Southampton BRC, in accordance with BRC Research Contract. The form of words is: “[investigator initials] is supported by the National Institute for Health and Care Research through the NIHR Southampton Biomedical Research Centre”. 4.6 The Parties acknowledge that NIHR is entitled to publish the whole or any part of the Report. If the Parties wishes NIHR to delay such publication, it must submit a request in writing to the NIHR giving reasons for the requested delay which shall be considered in accordance with the NIHR’s Information for Authors’ Dual Publication Guidance and Embargo Policy as defined in the NIHR Contract and amended from time-to-time. 4.7 Neither Party shall use the other's name, crest, logo or registered image for any purpose without the express permission of the other Party. The Parties will agree treatment for referencing each others involvement in the BRC and joint branding for their activities subject to compliance with Clause 4.8 and the BRC Research Contract. 4.8 Neither Party shall issue any press release, public statement, or other media announcement related to the BRC or any Research Data or Foreground IP without the prior consent of the other Party and Funder, as applicable. 4.9 The Parties (in the case of the University via UHS must notify the Funder of any intention to issue a press release at least three (3) business days prior to any press release issued by it or on its behalf, directly related to the Research or Foreground IP, arising now how or Research Data or of matters arising from such Research. Awardee shall send one draft copy of the proposed press release to UHS at least five (5) business days before the date intended for release. For the avoidance of doubt this obligation shall continue in full force and effect following expiry of the Award letter 4.10 The Parties shall comply with guidance and advice from Funder on branding and publicity which may be issued from time to time including, but not limited to Funder’s guidance on the format for websites, press releases and use of social media, permitted use of the NIHR, BRC, NHS and Department of Health and Social Care brands, names and logos and ensuring all branding references to the BRC are prefixed with the term “NIHR”. 5 Confidentiality 5.1 The Parties hereto agree to use all reasonable endeavours to ensure that any Confidential Information disclosed or submitted in writing or any other tangible form to one Party (“Receiving Party”) by the other (“Disclosing Party”) shall be treated with the same care and discretion to avoid disclosure as the Receiving Party uses with its own similar information which it does not wish to disclose. Any information disclosed orally that is identified by the Disclosing Party as Confidential Information shall be treated the same as if it had been reduced to writing at the time of disclosure to the Receiving Party. 5.2 The Receiving Party shall not, during a period of seven (7) years after the termination of this Award Letter, use any such Confidential Information for any purpose other than the carrying out of its obligations under this Award funding or other than in accordance with the terms of this Award funding. 5.3 The undertaking in Clause 5.1 above shall not apply to Confidential Information: 5.3.1 which, at the time of disclosure, has already been published or is otherwise in the public domain other than through breach of the terms of this Award funding; 5.3.2 which, after disclosure to the Parties, is subsequently published or comes into the public domain by means other than an action or omission on the part of any of the Parties; 5.3.3 which a Party can demonstrate was known to him or subsequently independently developed by them; 5.3.4 lawfully acquired from third parties who had a right to disclose it with no obligations of confidentiality to any of the Parties; or 5.3.5 is required to be disclosed by applicable law or court order or by any Party's regulatory body, which is empowered by Statute or Statutory Instrument, but only to the extent of such disclosure and the Receiving Party shall notify the Disclosing Party promptly of any such request. 5.4 Staff and students and any agents, consultants or sub-contractors engaged to work on the BRC will be subject to the principles of confidentiality outlined in this Clause 5. 6 Term and Termination 6.1 The terms of this award shall come into force on the date when the Acceptance Statement is signed by the Awardee and remain in full force and effect until 31st March 2028 unless terminated earlier in accordance with the provisions of this Clause 6. 6.2 In the event that any Party shall commit any breach of or default in any terms or conditions of this Award funding, the other Party may serve written notice of such breach or default on the defaulting Party and in the event that such Party fails to remedy such default or breach within sixty (60) days after receipt of such written notice the other Party may, at their option and in addition to any other remedies which they may have at law or equity, terminate this Award funding by sending notice of termination in writing to the other Party. 6.3 If any Party (a) materially breaches any provisions of this Award funding ; or (b) passes a resolution for its winding-up; or if (c) a court of competent jurisdiction makes an order for that Party’s winding-up or dissolution; or makes an administration order in relation to that Party; or if any Party (e) appoints a receiver over, or an encumbrancer takes possession of or sells an asset of, that Party; or (f) makes an arrangement or composition with its creditors generally; or (g) makes an application to a court of competent jurisdiction for protection from its creditors generally; the other Party may terminate their involvement in the BRC. 6.4 In the event the BRC Research Contract terminates UHS may terminate this Award funding with immediate effect. 7 General 7.1 Each Party shall indemnify each of the other Parties, within the limits set out in this Clause 6, in respect of liability resulting from acts or omissions of itself, its employees or its students provided always that such indemnity shall not extend to claims for indirect or consequential loss or damages such as, but not limited to, loss of profit, revenue, contracts or the like. 7.2 Any amendments to this Award funding shall be valid only if made in writing and signed by authorised signatories of the Parties. 7.3 If any part or any provision of this Award funding shall to any extent prove invalid or unenforceable in law the remainder of such provision and all other provisions of this Award funding shall remain valid and enforceable to the fullest extent permissible by law, and such provision shall be deemed to be omitted from this Award funding to the extent of such invalidity or unenforceability. The remainder of this Award funding shall continue in full force and effect and the Parties shall negotiate in good faith to replace the invalid or unenforceable provision with a valid, legal and enforceable provision which has an effect as close as possible to the provision or terms being replaced. 7.4 No failure to exercise or delay in the exercise of any right or remedy which any Party may have under this Award funding or in connection with this Award funding shall operate as a waiver thereof, and nor shall any single or partial exercise of any such right or remedy prevent any further or other exercise thereof or of any other such right or remedy. 7.5 This Award funding including its Schedule supersedes all other agreements and understandings, whether written or oral, between the Parties about the BRC constitutes the entire agreement between the Parties regarding the BRC. 7.6 Except as otherwise expressly provided for herein, the Parties confirm that nothing in this Award funding shall confer or purport to confer on any third party any benefit or any right to enforce any term of this Award funding for the purposes of Contracts (Rights of Third Parties) Act 1999. 7.7 This Award funding shall be governed by and construed in accordance with English Law and each Party agrees to submit to the exclusive jurisdiction of the English Courts as regards any claim or matter arising under this Award funding. 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