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HYWEL DDA UNIVERSITY HEALTH BOARD

Research and Development Strategy (2016 – 2020)

Policy Number: 027 Supersedes:

Hywel Dda

University

Health

Board R&D

Strategy

2014-2017

Standards For Healthcare

Services No/s

21. Research,

Development and

Innovation

Version

No: Date Of Review:

Reviewer Name:

Completed Action:

Approved by: Date

Approved: New Review

Date:

1 2017

2.1 June 2015

Updated June 2015 - Commercial Research Strategy and R&D Costing

Process incorporated as Appendices 3 and 4 (Version 2.1 approved by Chair‟s

action)

June 2015 2017

3 2016 Lisa Seale Revised Board 4.04.2016 04.04.2020

Brief Summary of Document:

Sets out the way in which clinical Research and Development (R&D) activities will

be prioritised, supported and integrated into everyday clinical practice, and

describes how the clinical research infrastructure will be developed and

maintained to ensure capacity and capability to deliver R&D across Hywel Dda

University Health Board (HDUHB).

To be read in conjunction with:

HDUHB Research Governance Policy

HDUHB Good Clinical Practice Policy

HDUHB R&D Standard Operating Procedures (SOPs)

Research Governance Framework for Health and Social Care in Wales (2nd

Edition, 2009)

Community Nursing Research Strategy for Wales (2013)

HDUHB Research Strategy for Nurses and Allied Health Professionals (pending)

Health and Care Research Wales Strategic Plan (2015-2020)

Classification: Non Clinical Category: Strategy

Freedom Of Information Status

Open

Authorised by: Phil Kloer Job Title

Medical Director & Director of Clinical Strategy

Signature:

A signed copy of this document is stored within Corporate Services


Database No: 027 of 25 Version 3

Research and Development Strategy 2016 - 2020

Responsible Officer/Author:

Dr Lisa Seale Job

Title: Senior R&D Manager

Contact Details:

Dept R&D Base Prince Philip Hospital

Tel No 01554 779308 E-mail: [email protected]

Scope ORGANISATION

WIDE DIRECTORATE

DEPARTMENT ONLY

COUNTY ONLY

Staff Group

Administrative/ Estates

Allied Health Professionals Ancillary Maintenance

Medical & Dental Nursing Scientific & Professional Other

CONSULTATION

Please indicate the name of the individual(s)/group(s) or committee(s) involved in the consultation process and state date agreement obtained.

Individual(s)

R&D Director

Senior R&D Manager

Assistant Director,

Medical Directorate

Date(s)

Group(s)

R&D Team

Sponsor Review

Panel

Health and Care

Research Wales

Workforce

Hywel Dda UHB

Research Nurse

Group

Date(s)

Committee(s) R&D Sub-Committee Date(s) 22/02/16

RATIFYING AUTHORITY (in accordance with the Schedule of Delegation)

KEY

COMMENTS/ POINTS TO NOTE

NAME OF COMMITTEE

A = Approval Required Date Approval

Obtained FR = Final Ratification

University Partnership Board A 4.4.2016 Updated June 2015 - Commercial

Research Strategy and R&D Costing

Process incorporated as Appendices

3 and 4 (Version 2.1 approved by

Chair’s action)

Date Equality Impact Assessment Undertaken

Updated

16/03/2016

Group completing

Equality impact assessment

Equality and Diversity Advisor

Senior R&D Manager

Please enter any keywords to be used in the policy search system to

enable staff to locate this policy

Research, development, R&D, research governance, clinical trials,

intellectual property rights, patents, Research Ethics Committee




Document Implementation Plan

How Will This Policy Be Implemented?

The R&D Strategy will be implemented by the R&D Department as part of the R&D Work Plan. Progress will be monitored at monthly R&D Team meetings. Where appropriate, reports will be presented to the R&D Sub-Committee which meets quarterly.

Who Should Use The Document?

Hywel Dda UHB R&D Department, research active staff working in or with the HDUHB (including academic and commercial partners), staff providing clinical support services for R&D activities (including Pathology, Pharmacy and Radiology), Service Transformation Programme Manager.

What (if any) Training/Financial Implications are Associated with this document?

It is anticipated that release for training will be agreed within the R&D Department according to standard Workforce & Organisational Development policy. There will be no additional financial implications for courses etc as these will be covered by the ring-fenced budget allocated directly to R&D through Health and Care Research Wales, Welsh Government. However, some staff requiring research-related training will need Study Leave approval, and cover may also be required to enable staff to be released to attend such training.

What are the Action Plan/Timescales for implementing this policy?

Action By Whom By When

Review and update Policies, Standard Operating Procedures (SOPs), Workplace Instructions (WIs) and Guidance.

R&D Department

Encourage collaborative research with the HDUHB‟s academic partners (Swansea University, Aberystwyth University, University of Wales Trinity Saint David).

R&D Director, Senior R&D Manager

DONE

Promote links with industry by liaising with the Health and Care Research Wales Industry Manager for South West Wales and via networking at conferences and through discussion with MediWales, the Association of British Pharmaceutical Industry (ABPI), etc.

Research Nurse (Commercial and Internal)

DONE

Develop and implement a Cost Recovery Plan to reclaim costs incurred for undertaking commercial research at the HDUHB.

R&D Manager DONE

Introduce routine risk-based monitoring of HDUHB-Sponsored CTIMPs and random monitoring of externally-Sponsored (Hosted) CTIMPs.

Senior R&D Manager DONE

Introduce an audit programme to assess compliance with the Research Governance Framework.

R&D Manager DONE

Explore options to enhance the involvement of patients, service users and carers in the design, conduct and reporting of research.

R&D Manager October 2014




CONTENTS

1. INTRODUCTION ............................................................................................................... 5

2. POLICY STATEMENT ....................................................................................................... 5

3. SCOPE .............................................................................................................................. 6

4. AIMS .................................................................................................................................. 6

5. OBJECTIVES .................................................................................................................... 7

6. STRATEGIC DIRECTION FOR RESEARCH AND DEVELOPMENT ................................ 8

6.1 NATIONAL REQUIREMENTS ....................................................................................................................

......................................................................................................................................................................... 8

6.2 LOCAL REQUIREMENTS .................................................................................................... 9

6.3. LOCAL IMPLEMENTATION ................................................................................................................... 12

7. RESPONSIBILITIES ........................................................................................................ 13

7.1 CHIEF EXECUTIVE ................................................................................................................................... 13

7.2 CLINICAL EXECUTIVE DIRECTORS .................................................................................................. 13

7.3 ASSISTANT DIRECTOR, MEDICAL DIRECTOR ............................................................................ 13

7.4 RESEARCH AND DEVELOPMENT DEPARTMENT ...................................................................... 13

7.5 HEALTH PROFESSIONALS AND SERVICE MANAGERS .......................................................... 13

8. TRAINING ........................................................................................................................ 13

9. INTELLECTUAL PROPERTY RIGHTS ........................................................................... 14

10. IMPLEMENTATION ......................................................................................................... 14

11. MONITORING ................................................................................................................. 15

12. REVIEW ........................................................................................................................... 15

13. REFERENCES ................................................................................................................ 15

14. APPENDICES .................................................................................................................. 16

14. APPENDIX 1: SPONSORSHIP REVIEW PANEL PROCESS ........................................ 17

15. APPENDIX 2: COMMERCIAL RESEARCH STRATEGY ................................................ 19

16. APPENDIX 3: RESEARCH AND DEVELOPMENT SUB-COMMITTEE TERMS OF

REFERENCE ........................................................................................................................... 20




1. INTRODUCTION This Strategy sets out how all Research and Development (R&D) activities will be prioritised and supported within Hywel Dda University Health Board (HDUHB) and when the UHB deals with other agencies. It will help R&D activities become integrated into everyday practice, promote a quality research culture and safeguard the HDUHB‟s NHS R&D Activity Based Funding (ABF) received from the Division of Social Care and Health Research (DSCHR), Welsh Government (WG).

This Strategy provides the HDUHB with a strategic direction for R&D within the context of the Annual Quality Statement, Quality Improvement Plan and the Integrated Medium Term Plan.

The following documents should be read for further detail on the application of various aspects of R&D in practice:

HDUHB Research Governance Policy

HDUHB Good Clinical Practice Policy

HDUHB R&D Standard Operating Procedures (SOPs)

Research Governance Framework for Health and Social Care in Wales (Welsh Government, 2009)

Community Nursing Research Strategy for Wales (2013)

HDUHB Research Strategy for Nurses, Midwives and Allied Health Professionals (pending)

The Health and Care Research Wales Strategic Plan 2015-2020 (Welsh Government, 2015)

2. POLICY STATEMENT The activities described in this Strategy will create a clear strategic direction for healthcare R&D within the Welsh policy context. Both policy and practice must be evidence-based, and ring-fenced NHS R&D funding from Health and Care Research Wales, Welsh Government (WG) has enabled the HDUHB to better develop its own R&D infrastructure to help achieve this. By realigning the All-Wales NHS R&D funding (2011-2014), WG ensured that all Health Boards and Trusts across Wales could increase capacity to support and undertake high quality R&D. The changes enabled by the increase in R&D funding must be sustainable in the long term and the HDUHB will need to ensure that R&D activities are supported, facilitate grant capture and allow timely appointments. The HDUHB will also need to ensure that available evidence is reviewed for effectiveness, new evidence sought where there is a need and research findings do become implemented into practice (translational research) where they would benefit the local population in a cost-effective way.

Hywel Dda University Health Board is committed to ensuring that clinical R&D activities undertaken using its resources (e.g. premises, equipment, patients, data, staff) meet all the applicable research governance guidelines and legislation, are scientifically and financially sound, are designed to generate robust and generalisable data and, above all, protect the safety, dignity, rights and wellbeing of patients or research subjects. The HDUHB also encourages the dissemination of research findings and the implementation of change in practice where this has been proven as safe and effective, and agreed via the appropriate HDUHB mechanisms.

In order to achieve this, Hywel Dda University Health Board provides research active staff with support in relation to:

participation in Research and Development (R&D);




implementation of Good Clinical Practice (GCP) guidelines, and other guidelines for support services, such as Good Manufacturing Practice (GMP) and Good Clinical Laboratory Practice (GCLP);

organisational approval and monitoring of R&D activities to ensure compliance with the Research Governance Framework and applicable Statutory requirements;

undertaking training in relation to research design, conduct and analysis (research methodology, informed consent, statistics, etc);

facilitating and coordinating the various permissions, approvals, favourable opinions and notices of no objection which may be required to undertake healthcare research involving human subjects, their samples and data;

participation in research governance audits and monitoring of clinical trial activities, including the Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice Inspections;

collecting, storing and recording details of human tissue samples in compliance with the HDUHB‟s Human Tissue Authority (HTA) licence for Research, and participation in HTA Inspections of licensable activities;

evaluation and implementation of research findings (translational research) to promote evidence based healthcare;

collaboration with the Health and Care Research Wales, Welsh Government and with academic and commercial partners to deliver both local and national R&D Strategies, and to meet standard targets (Standards for Healthcare in Wales (Standard 21), Health and Care Research Wales Key Performance Indicators, All Wales Cancer Delivery Plan, etc).

Within Hywel Dda University Health Board, the term „Research and Development (R&D)‟ is used to encompass the areas described above. The R&D Department sits within the Medical Directorate and is designed to support the delivery of safe, high quality clinical research by providing organisational review and approval for research before it begins, ensuring that staff comply with the Research Governance Framework and any other applicable Statutory requirements. By ensuring that all R&D activities have received both R&D and NHS Research Ethics Committee (REC) approvals, the HDUHB and its research community can be assured that the research activities undertaken are fundamentally safe and ethical, and are indemnified by the Welsh Risk Pool.

3. SCOPE This Strategy and the support services that it describes are of relevance to all research active clinical and non-clinical staff and to service managers involved in delivering support for research activities within Hywel Dda University Health Board (Pathology, Pharmacy, Radiology, Physiotherapy, Audiology, Cardiology, etc). It applies to research carried out in both Primary and Secondary Care. It is also relevant to external partner organisations such as Health and Care Research Wales, Research Centres and Units, the Swansea Trials Unit (STU), the Research Design and Support Unit (RDSU), other NHS Health Boards and Trusts, Higher Education Institutions (HEIs) and Industry partners in the South West Wales region, nationally and internationally.

4. AIMS This Strategy aims to provide details of how R&D activities will be supported, promoted and implemented within Hywel Dda University Health Board in order to promote a quality research culture and evidence based health care, and to meet with national and local priorities. Current Welsh Government priority areas are job creation, economic growth and tackling poverty; Health and Care Research Wales, WG‟s research funding streams prioritise R&D in disease prevention and early intervention.




This Strategy closely reflects the aims of the Health and care Research Wales Strategic Plan (2015-2020) which demonstrates Wales‟ commitment to creating a dynamic research environment for the health and wealth of Wales. DSCHR‟s mission statement is, “to facilitate the collaboration between Health Boards, Trusts and Universities in Wales in order to combine research, both basic and translational research, clinical care and education to create world-leading improvements in healthcare”. This Strategy also supports the aims of A Regional Collaboration for Health (ARCH) partnership between HDUHB, Abertawe Bro Morgannwg UHB and Swansea University. It also complements the HDUHB‟s Clinical Services Strategy, through the work of the Population Health Groups, in particular by doing more robust economic evaluations, and in the more timely dissemination and implementation of research findings. 5. OBJECTIVES The HDUHB‟s objective is to provide an innovation-friendly environment which will encourage and assist individuals with an interest in research, focused on the needs of people within Hywel Dda.

Hywel Dda University Health Board is committed to: a) Its role in supporting the Welsh Government‟s research agenda and in establishing the

HDUHB as a recognised centre for research across Wales, UK-wide and internationally. b) Ensuring that the HDUHB has the capacity and infrastructure to enable delivery of safe,

effective R&D activities as required across all staff levels, disciplines and clinical support services.

c) Increasing the number of Chief Investigators (HDUHB-led research studies) and Principal Investigators (hosted studies), and maintaining any increases.

d) Increasing the number of research studies which are registered on the Health and Care Research Wales Clinical Research Portfolio, and increasing the number of subjects recruited into Portfolio studies.

e) Providing advice, guidance and training for the research community (including clinical support services) in research governance systems and processes to obtain organisational approval and indemnity for R&D activities which use HDUHB resources.

f) Compliance with the Good Clinical Practice guidelines, Human Tissue Authority codes of practice and other national legislation, within available resources, where appropriate.

g) Ensuring that research within the organisation is assessed by the Sponsor Review Panel (see Appendix 2) to improve scientific validity, ensure safety, capacity and practicality and compliance with national legislation.

h) Ensuring that all proposed R&D activities are risk assessed and risk management plan developed where appropriate.

i) Ensuring that HDUHB -Sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs), and other research studies which are classified as „high risk‟, are appropriately monitored.

j) Ensuring that HDUHB hosted studies are appropriately monitored and supported. k) Adopting and registering more high quality, externally peer reviewed and funded clinical

trials on the National Institute for Health Research (NIHR) Clinical Research Portfolio, via Health and Care Research Wales Workforce.

l) Managing clinical research accounts and charitable funds via the R&D Accountant, and ensuring that the HDUHB‟s Standing Financial Instructions are complied with in the use of such funds to support R&D activities.

m) Facilitating external grant capture by highlighting funding opportunities to the research community, and providing assistance with applications.




n) Increasing the number of commercially sponsored studies, increasing the number of patients recruited into such studies and ensuring all costs incurred by the HDUHB are recovered from the commercial sponsor.

o) Providing a positive organisational environment for R&D, giving all healthcare professionals the opportunity to undertake research and facilitating mentoring where needed.

p) Promoting education and training in R&D for all staff, especially to expand the number of Health and Care Research Wales Clinical Research Fellows, Bevan Fellows, Clinical Research Time awards, and research degrees (MSc, MPhil, PhD and MD).

q) Establishing Research Governance audits (up to 10% projects per year), addressing audit findings and sharing anonymised outcomes with the research community.

r) Promoting the dissemination and implementation of research findings into practice, and working with the HDUHB‟s Innovations Lead to safeguard any Intellectual Property Rights arising from the R&D undertaken.

s) Ensuring specific arrangements are in place for participating in routine MHRA Good Clinical Practice and HTA Statutory Inspections, and for producing and implementing the resulting Corrective and Preventative Action Plans (CAPAs).

6. STRATEGIC DIRECTION FOR RESEARCH AND DEVELOPMENT 6.1 National Requirements Together for Health (2011) states that the vital contribution of the NHS to research and development will continue to be supported by the Welsh Government: „Besides their potential for saving and improving lives, research and development have additional value in terms of creating economic development and in attracting the best expertise into the Welsh health service.‟

The Quality Delivery Plan (2010) reinforces this message:

‘The Welsh Government via its National Institute for Social Care and Health Research (NISCHR) is committed to supporting high quality health and social care research to improve the health, well-being and wealth of the people in Wales.’

The Welsh Government‟s Community Nursing Research Strategy for Wales was launched in 2013. In order to obtain the best patient outcomes in community nursing, practice needs to be underpinned by robust research-based evidence. The Community Nursing Research Strategy for Wales was developed and implemented in Wales to provide the nursing profession with the evidence to support future organisational and professional change in achieving excellence in the community.

The aims of the Community Nursing Research Strategy are to: - Prioritise research ideas to provide the evidence for the future health and healthcare of

the people in Wales; - Establish the existing support infrastructure and training available to researchers; - Develop an All Wales Framework for community nurses/midwives to undertake

research to the required international standards within a supported environment.

Many HDUHB Nurses and Midwives are involved in R&D in their post registration development (e.g. Master of Science, MSc degree) and generally qualitative research is undertaken. HDUHB recognises the value of both qualitative and quantitative research, and the former is a particularly useful methodology to explore and evaluate patients‟ experiences.

The National Institute for Social Care and Health Research (NISCHR)‟s Industry Engagement in Wales (2012) also outlines the Welsh Government‟s commitment to increasing commercial




research activity across NHS Wales. The HDUHB R&D Department has produced a Commercial Research Strategy and Cost Recovery Plan as part of its Work Plan.

Maximising the HDUHB‟s use of the NHS R&D budget to support research excellence to increase patient participation in non-commercial and commercial trials and other well-designed studies is seen as key to future progress.

Health and Care Research Wales expects NHS organisations to place a greater emphasis on innovation, knowledge transfer, commercial trials, new technologies and the use of patient data for research. In doing so, DSCHR is actively working with the NHS to develop a culture where research and innovation is a core organisational activity. Health Boards and Trusts are required to comply with the NISCHR Delivery Programme (2011), and to meet targets outlined in the NISCHR Delivery Framework for the performance management of NHS R&D (2014).

The HDUHB‟s Commercial Research Strategy (Appendix 3) and R&D Costing Process (HDUHB R&D Costing Process) define the Cost Recovery Plan, to ensure that the HDUHB is appropriately reimbursed for conducting and supporting commercial research, and will outline how commercial income will be used to continue to build the HDUHB‟s research infrastructure and capacity.

The R&D Department continues to develop links with GP practices, coordinating all Primary Care Research Incentive Scheme (PiCRIS) applications to Welsh Government and now listing Patient Identification Centres (PICs) within Primary Care in Hywel Dda HDUHB for current and future research including Clinical Trials of Investigational Medicinal Products (CTIMPs).

The Standards for Healthcare in Wales (Standard 21: Research, Development and Innovation, 2011) require organisations and services to:

a) ensure that the principles and requirements of the Research Governance Framework for

Health and Social Care are consistently applied; b) have an outcome focussed research and development strategy that benefits patients and

improves service delivery; and c) promote research, development and innovation.

This Strategy, along with the Commercial Research Strategy (Appendix 3), describes how Hywel Dda University Health Board already meets and/or intends meeting the above standards.

The Welsh Government Cancer Delivery Plan (2010) states that research is critical to effective cancer care and sets clear targets in relation to recruitment of cancer patients to clinical trials: ‘At least 10% of new cancer patients each year agree to participate in high quality studies on the NISCHR portfolio or commercial research register, with at least 7.5% of these research participants taking part in more complex studies which involve an intervention. Research activity should include rarer cancers, with patient referral routes in place where studies are not available locally.’

6.2 Local Requirements The care provided to patients within Hywel Dda University Health Board should be based on the best available research evidence to ensure that care is up-to-date, effective, safe and appropriate. Such evidence may come in the form of primary research but can be more useful when distilled into systematic reviews, meta-analyses, clinical guidelines or summaries of best evidence.




The R&D Department encourages and promotes the dissemination of research findings through its annual monitoring process and end of study close-down visits (HDUHB -Sponsored CTIMPs only). Researchers are encouraged to register their research studies on national databases such as the International Standard Randomised Controlled Trial Number (ISRCTN) and the Health and Care Research Wales‟ Commercial Clinical Trials database, and to post protocol summaries and outcomes on the National Research Ethics Service (NRES) website.

To ensure that HDUHB patients and staff are afforded the same opportunities as other patients across Wales, commitment and sustained investment in R&D infrastructure, including staff, premises, equipment and clinical service support, are essential across all main hospital sites.

HDUHB staff will be given equal opportunity to conduct research and development Irrespective of any protected characteristic and assistance will be given where necessary to facilitate this where individuals with any particular characteristic(s) may otherwise be disadvantaged or underrepresented in R&D activities.

Issues around patient capacity and consent to take part in R&D activities and issues relating to particular protected characteristics will be addressed in the Research Governance Policy and Good Clinical Practice Policy.

Consideration will be given to ensuring that membership of the HDUHB R&D Committee reflects the demographic staff profile of the HDUHB.

The R&D Team has established an area on the R&D intranet pages for the dissemination of research findings and will continue to promote International Clinical Trials Day every May, in conjunction with Health and Care Research Wales Workforce and the local research community, at each of the four main hospital sites.

Hywel Dda University Health Board will support the following aspects of R&D: a) Research Governance

Good Clinical Practice (GCP) training/certification for appropriate staff Research Passports/Letters of Access Data Protection Act, Mental Capacity Act, Human Tissue Act, etc Safety reporting and Pharmacovigilance Record keeping and data management Monitoring and auditing research Reporting to Sponsor and external bodies Archiving Intellectual Property Rights (IPR) Dealing with allegations of research fraud and misconduct Dealing with complaints relating to R&D activities Freedom Of Information Act (FOIA) requests

b) Sponsor Review Panel (SRP) will meet regularly (usually monthly) for Scientific/Peer review Risk Assessment Portfolio/Pathway to Portfolio status Project costing and adoption template (to facilitate a decision to support/reject) Clinical support services requirements and performance Feasibility assessments and addressing reasons for failure Contract approvals (internal and external) Service Level Agreement approvals




From January 2016, Hywel Dda UHB SRP members also attend the Abertawe Bro Morgannwg University Health Board/Swansea University (ABMUHB/SU) Joint Study Review Committee (JSRC)

c) Competency and training R&D Department staff Researchers Clinical support services staff

d) Appropriate physical environment The Clinical Research Centre (CRC) at Prince Philip Hospital (PPH) has

appropriate security, power, IT, phone/internet access, appropriate storage space, work benches

There is R&D office space and IT access in Withybush General Hospital (WGH), facilities for storing samples and transfer in a timely way for analysis or permanent storage (e.g. Wales Cancer Bank)

Ensuring that there is appropriate Research Nurse office space available in Bronglais General Hospital (BGH), Glangwili General Hospital (GGH), PPH and WGH

Purchase and maintain appropriate research equipment according to R&D Standard Operating Procedures (SOPs)

Appropriate IT and databases (ReDA, EDGE, FACE, Macro4, QPULSE) e) Developing Stronger Partnerships

Health and Care Research Wales Workforce, Support Centre, Research Units and Centres, Permissions Coordinating Unit (PCU)

National Research Ethics Service (NRES) Welsh Regional Research Hubs (South East Wales and North Wales) Other NHS Health Boards/Trusts in Wales and across the UK A Regional Collaboration for Health (ARCH) The Forum of NHS Wales R&D Management in Health and Social Care

(FORWARD) The Swansea Trials Unit (STU) and Research Design and Conduct Service

(RDCS) at Swansea University Higher Education Institutions (HEIs) Industry (Pharmaceutical, medical device, bioscience companies) Third Sector companies Other research groups across the UK and Internationally

f) Reporting Health and Care Research Wales (Spending Plan, Mid-Year and Annual

Financial Returns) Quarterly Research Activity Data Reports to DSCHR (to determine HDUHB‟s

annual R&D Activity Based Funding allocation from WG) Performance Monitoring of individual studies (including time to issue approval,

time to recruit first subject, recruitment to time and to target, study closure) Meeting the criteria to maintain University Health Board status (Welsh

Government) Cancer Delivery Plan Standards for Healthcare in Wales (Standard 21) Annual Quality Statement and Quality Improvement Plan Integrated Medium Term Plan Business Planning and Performance Assurance Committee

g) Forward/succession planning and change management Ensure the R&D Department is appropriately staffed to meet developing needs Impact of future funding on delivery of the R&D Strategy




R&D Director is part of a small task force including the Chief Executive Officer, Medical Director, Strategic Lead and Workforce Planning to prioritise posts

Managing change imposed by external factors on the R&D Department such as the Division for Social Care and Health Research and Health Research Authority.

6.3. Local Implementation

Hywel Dda University Health Board is committed to its role, not only in supporting the above requirements, but also in establishing the HDUHB as a recognised centre for research across Wales. The R&D Director and Assistant Director, Medical Directorate will provide assurance to the Board that the HDUHB has: a) a robust R&D Department which supports and encourages increased participation in high

quality research and works to increase the numbers of Chief and Principal Investigators and studies registered on the Health and Care Research Wales Clinical Research Portfolio;

b) a mechanism to monitor progress of all research studies, particularly those with „Pathway to Portfolio‟ status to promote their inclusion onto the Portfolio, and to ensure that subject recruitment into Portfolio studies is on time and to target;

c) an effective multi-agency R&D Sub-Committee which monitors the research agenda within the HDUHB (see Appendix 3);

d) a clear R&D Strategy which outlines the organisation‟s strategic direction for research and facilitates collaboration with Universities and Industry;

e) appropriate partnership agreements/memoranda of understanding with research partners e.g. Health and Care Research Wales Workforce, STU, RDCS, HEIs, ARCH;

f) a Commercial Strategy, including a Cost Recovery Plan, which promotes the use of commercial funding to further enhance the HDUHB research infrastructure and capacity;

g) a Research Governance Policy and departmental Standard Operating Procedures that are fit for purpose and are complied with;

h) facilities to undertake high quality research; i) a HDUHB -wide Research Governance Audit programme; j) a clear financial R&D strategy to ensure R&D funding is prioritised appropriately and used

fairly and effectively, in line with DSCHR Welsh Government guidelines and the HDUHB‟s Standing Financial Instructions;

k) systems in place to reimburse the HDUHB‟s support services (Pharmacy, Pathology, Radiology, etc) for the contribution that they make to support research;

l) adequate numbers of appropriately trained staff to support and undertake research; m) systems to meet national research targets (e.g. cancer trial recruitment); n) systems to performance manage the effective use of NHS R&D funding and grant funding

awarded in both primary and secondary care; o) a plan to address knowledge transfer in the NHS, in collaboration with other relevant

agencies, in order to implement the recommendations of the NISCHR Knowledge Transfer Task and Finish Group Report (September 2014) and HDUHB Chairman;

p) systems in place to allow forward planning to deal with the impact of further restructuring of Health and Care Research Wales;

q) systems to manage potential changes in the HDUHB‟s NHS R&D Activity Based Funding allocations (contingency plans should the HDUHB‟s funding allocation be reduced).




7. RESPONSIBILITIES 7.1 Chief Executive The Chief Executive and Board hold ultimate responsibility for Research and Development (R&D) within the University Health Board.

7.2 Clinical Executive Directors Accountability for organisation-wide R&D sits with the Medical Director, Director of Nursing and Midwifery and the Director of Therapies and Health Science. The Medical Director has overall management responsibility for the Research and Development Department.

7.3 Assistant Director, Medical Director Led by the Medical Director, the Assistant Director to the Medical Director facilitates a coordinated approach to Research and Development within the organisation and will support the implementation of the R&D Strategy.

7.4 Research and Development Department Led by the R&D Director and Senior R&D Manager, the R&D Team will help research active clinical and non-clinical staff to meet their own responsibilities to ensure that they conduct healthcare R&D in compliance with the Research Governance Framework, Good Clinical Practice guidelines and any other applicable legislative requirements.

7.5 Health Professionals and Service Managers Health professionals and clinical support service managers have a duty to apply the principles contained within this Strategy and its associated Policies. 8. TRAINING Good Clinical Practice (GCP) training is mandatory for some staff (including clinical support services staff) involved in Clinical Trials of Investigational Medicinal Products (CTIMPs), where training will be commensurate with the individual‟s role in the trial. It will also be required for other higher-risk studies (such as medical device studies or surgical trials) where GCP training has been identified as a requirement by the Sponsor Review Panel or JSRC. Those involved with CTIMPs will also undergo study specific training, usually provided by the study sponsor. If no study specific training is provided by the sponsor, the Chief/Principal Investigator should organise or provide training to all individuals listed on the Study Delegation Log, in order to demonstrate that sufficient training has been undertaken on the requirement of the study protocol to fulfil their role. GCP training is encouraged but not yet mandatory for researchers involved in other research.

The R&D Department maintains a database of the GCP certifications for staff and research partners (e.g. those employed by HEIs) researching within the HDUHB. Following receipt of foundation GCP training (usually a full day course), individuals are expected to attend GCP refresher/update training (typically 2-3 hours) every 2 years. The training provider (e.g. externally commissioned trainer or Health and Care Research Wales Support Centre) will undertake a competency assessment of each individual trained, and a summary of the areas of GCP covered will form part of the certification.

GCP and other general research-related training is provided by Health and Care Research Wales Support Centre, with opportunities posted on their website and circulated to the Wales research community. These emails are cascaded through the R&D Sub-Committee and HDUHB staff are encouraged to attend any research-related training applicable for them. Health and Care Research Wales Support Centre sends the R&D Department lists of attendees.




STU and RDCS at Swansea University provide additional research training on methodology and statistics. Researchers enrolled or employed in HEIs will have additional training by their institution where needed. All research related training certificates will be kept alongside the CVs in any research files held within Hywel Dda University Health Board. Research staff will be expected to keep a record of all their research related training.

Informal training (e.g. study design, statistics, centrifuging, sample storage and labelling, etc) is supplied by Research Nurses and R&D Officers on an ad hoc basis per project (cascade training, agreed via the R&D Department). A presentation by the R&D Team (usually a Grand Round) will occur in each main hospital at least once a year on a rolling basis, to inform the research community of any issues affecting research activities.

9. INTELLECTUAL PROPERTY RIGHTS Health and Care Research Wales works with partners to develop a detailed knowledge of the characteristics and strengths of the Welsh life science sector. Opportunities include developing medical technologies and diagnostic products and often involve work conducted by small or medium sized companies. Such companies may require expert guidance in order to work with the NHS, and Health and Care Research Wales is ideally placed to provide this support within the HDUHB. This work will also provide opportunities for collaborative product development and the commercialisation of NHS derived research and Intellectual Property Rights (IPR).

The R&D Department supports the HDUHB research community to access various WG IPR support schemes such as INVENT and Invention for Innovation (i4i) and to discuss with HEIs researching within the HDUHB. The HDUHB R&D Team does not currently have the experience or capacity to develop an IPR service purely within the HDUHB.

10. IMPLEMENTATION The R&D Department staff are responsible for assisting the Senior R&D Manager and R&D Director in implementing the R&D Strategy. All research support staff, Research Nurses and the active research community have a responsibility to deliver the HDUHB R&D Strategy. This Strategy will be delivered in line with the Health and Care Research Wales Strategic Plan (2015-2020) by application of the R&D Department Work Plan. In order to facilitate implementation of the R&D Strategy: a) The R&D Department will continuously maintain awareness and evaluate potential new

research opportunities, by proactive collaboration and „horizon scanning‟; b) The R&D Department will endeavour to increase the number of Chief and Principal

Investigators and the quality and quantity of R&D undertaken at HDUHB; c) The R&D Department organisational structure will be continuously evaluated and

reviewed where appropriate in order to ensure it is fit for purpose; d) The R&D Director and Assistant Director, Medical Director, will ensure that the University

Partnership Board is regularly updated in relation to R&D issues and progress against the R&D Work Plan;

e) The R&D Department will ensure that the Operational Performance Board and the Executive Board are aware of the benefits to HDUHB of participating in clinical research;

f) The R&D Director will liaise with the Medical Director to ensure that specific R&D activities are included in clinical job descriptions and job plans;

g) Where possible, an academic representative will be present at Consultant interviews, and the inclusion of research questions which explore the candidate‟s future research plans in addition to their past research experience;




h) The R&D Department will monitor its performance against the research criteria for University Health Board status, and will endeavour to ensure that these criteria are met or exceeded when reporting to Welsh Government;

i) The R&D Director will advise the University Partnership Board and the Mid Wales Healthcare Collaborative on developing a rural health research portfolio across HDUHB.

11. MONITORING This Strategy will be applied through the R&D Department Work Plan recording the following Key Performance Indicators (KPIs) to measure progress: a) Increase in the number of National Institute for Health Research/Health and Care

Research Wales Clinical Research Portfolio projects per year, and sustained number of projects that are adopted onto the Portfolio (either HDUHB led or HDUHB hosted) (target 10% increase per year)

b) Increase in the number of Chief Investigators year on year c) Increase in the number of Commercially sponsored trials per year (target 5% increase per

year) d) Increase in the number of patients recruited into Portfolio research studies and clinical

trials (target 10% increase per year) e) Increase in the number of patients recruited into commercial research studies and clinical

trials (target 5% increase per year) f) Increased NHS R&D infrastructure (specifically more research space, equipment in BGH

and WGH) g) Increase in the number of Academic appointments within the HDUHB (Professors /

Senior Lecturers) by 2017. h) Increased external grant capture (above 2015 levels) i) Increased number of staff registered for higher degrees with a research component

(above 2015 levels) j) Obtain HTA license for Biobanking 2016

The target increases are defined in the NISCHR Delivery Framework for the performance management of NHS R&D (2014).

Leading to:

Improved care for patients

Improved health and wealth of the population of Wales

Enhancement of a research oriented culture in the NHS

The R&D Director will provide annual summaries of the Key Performance Indicators to Health and Care Research Wales and the HDUHB through the University Partnership Board. Any examples of how R&D activities have influenced clinical care will also be showcased.

12. REVIEW The Strategy will be reviewed in 2020, or sooner as the need arises after discussion through the quarterly R&D Sub-Committee or more urgently on the discretion of the R&D Director.

13. REFERENCES 1. HDUHB Research Governance Policy (pending). 2. HDUHB Good Clinical Practice Policy (pending). 3. HDUHB R&D Standard Operating Procedures (SOPs) – see R&D website for details. 4. Research Governance Framework for Health and Social Care in Wales (2nd Edition,

2009). 5. Community Nursing Research Strategy for Wales (Welsh Government, 2013).




6. HDUHB Research Strategy for Nurses, Midwives and Allied Health Professionals (pending).

7. HDUHB Annual Quality Statement (2012/13). 8. HDUHB Quality Improvement Plan. 9. Health and Care Research Wales Strategic Plan (2015-2020). (Welsh Government,

2015). 10. Standards for Healthcare in Wales (Standard 21). Healthcare Standards for Wales:

Making the Connections, Designed for Life (Welsh Assembly Government, 2005). 11. NISCHR Key Performance Indicators (2012). 12. NISCHR Welsh Government Delivery Framework for the performance management of

NHS R&D (2014). 13. Together for Health - Cancer Delivery Plan (Welsh Government, 2012). 14. HDHB Clinical Services Strategy (2013-2017). 15. Model Standing Financial Instructions for Local Health Boards (Welsh Government,

2012). 16. Together for Health – A Five Year Vision for the NHS in Wales (Welsh Government,

2011). 17. Achieving Excellence - The Quality Delivery Plan for the NHS in Wales (Welsh

Government, 2012). 18. NISCHR Industry Engagement in Wales (2012). 19. National Assembly for Wales, Improving Health in Wales: A Plan for the NHS and its

Partners, 2001. 20. R&D Costing Process (version 5, February 2015). 21. Health and Care Research Wales Strategic Plan (2015-2020).

14. APPENDICES

Appendix 1: Sponsorship Review Panel Process. Appendix 2: Commercial Research Strategy. Appendix 3: Research and Development Sub-Committee Terms of Reference.




14. APPENDIX 1: SPONSORSHIP REVIEW PANEL PROCESS

Sponsorship Review Panel Purpose

1) To provide a consistent and transparent process for in-house research proposals. 2) To ensure that all such proposals are fully considered before they are sponsored and

are hence fully worked up before being submitted for ethics approval. 3) To assist the R&D managers in the management of research proposals. 4) To assist researchers in getting worthwhile proposals through the system as quickly as

possible. 5) To assist the Research Ethics Committee by preventing poor quality proposals using up

their resources. The overall purpose of the Sponsorship Review Panel (SRP) is to consider whether, for in-house research proposals, the Health Board can/is willing to fulfil its responsibilities as Sponsor as laid out in the Research Governance Framework (RGF) for Health and Social Care in Wales 2nd Edition (Welsh Government 2009) To that extent the SRP will consider research proposals in terms of

Scientific quality and validity

Information use and dissemination/value of findings

Health and safety of researchers and participants

Finance, resource use and Intellectual Property The ultimate purpose of the panel is to decide whether or not to grant sponsorship as without a sponsor the proposal cannot progress. Membership The core panel should consist of the following core members:

Core Members Responsibilities

R&D Director / Deputy Director

Chair and ultimate approval of proposals

Senior R&D Manager Managerially responsible for R&D activities

R&D Manager

Lead R&D manager for new study governance and costings

University Link

General Research advice, specialist methodology advice, external scrutiny

Trials Unit Statistician Statistical review / link to other trials unit advice.

Lay member (via Involving People)

To give an independent view on any aspect of any research proposal

Portfolio Research Coordinator Responsible for portfolio studies, grant funding, assisting with protocol/application submissions




In addition there are a number of specialist members who would not be required to attend the panel but may be asked to submit a brief written response to a request for consideration of concerns relating to their specialist area:

Specialist Members Responsibilities

Support Service Managers

To provide opinion on impacts on service support areas in question

Service Managers

To provide managerial support for the application

Information Governance Manager

To provide opinion relating to matters of data protection

Finance

To provide opinion relating to matters of finance

Science / Clinical (internal peer)

To provide specialist opinion.

External Peer review

At least one external review will be received before proceeding.

The core members will meet once a month in person with the availability of video and audio conferencing to minimise travel and time loss. It is anticipated that with the front-loading of the work in getting proposals into an appropriate standard for the panel, it should not take long to make a decision on each one. To that extent it is hoped that the meeting itself should not take more than a couple of hours. Panel members will need to set aside some time to read the proposals in advance of the meeting. There will be a standard review form („Research Review‟) in use for the members to use / comment. If unable to attend, this form should be returned to the R&D Manager in time for the SRP meeting. The R&D Manager will seek any internal or external reviews prior to the meeting. The application The deadline for proposals is the last day of the month with the panel meeting on the second Thursday of the following month. The minimum requirements for the SRP to consider a proposal are:

IRAS application (R&D form) in draft

SSI Form (if different to the R&D form) in draft

Participant Information Sheet

Informed Consent Form

Protocol

Data Collection forms

Any other relevant documents (e.g. non-validated questionnaires) The R&D Manager will respond to the applicant with any queries or comments collated from the meeting / members and await a response or discussion. If all queries are answered appropriately the R&D Manager can sign the sponsor‟s section of the IRAS form. In some instances the proposal may have to return to the next available SRP for discussion.




15. APPENDIX 2: COMMERCIAL RESEARCH STRATEGY Commercial Research Strategy In order to achieve better healthcare locally, nationally and internationally it is a fundamental aspect of research within the NHS that commercial companies have potential access to our patients, not only to improve care for future patients but also to allow current patients access to the latest treatments. Geographically, HDUHB is also in a position to offer unique population groups to commercial companies due to the local demographic, who historically have missed out on such options. For these reasons, there is an important role within R&D to promote and encourage commercial research to take place within the Hywel Dda area. Whilst encouraging commercial research to take place it is vital that all legislative, legal and ethical aspects of research work are adhered to without creating any unnecessary barriers and causing delays. It is important therefore that there is a robust and streamlined governance process in place which will take into account of, and have a good working knowledge of, the following (although not comprehensive):

Finance procedures

Service Support arrangements

Contract negotiations

Strong links with the relevant DSCHR departments (Permissions Coordinating Unit, Health Research Wales, etc)

Legislative considerations (MHRA, HTA, etc)

Data Protection

Human Resources

Research Ethics Committee The Health Board via the R&D department will, as well as ensuring appropriate governance procedures, assist in the employment of specialist staff such as research nurses in order to create a proactive environment for commercial research to be undertaken. These staff will not only undertake research activities but also be able to assist in the initial set-up of studies (Expressions of Interest, Feasibility questionnaires) and study management (invoicing, point of contact, Principal Investigator support, etc). Following initial priming of these posts it is intended that they will become self-funding via commercial research income. One aspect of commercial research which differentiates it from other types of research is in the financial aspects of hosting such studies. Whilst the Health Board is encouraging of such research it is important that all costs above standard care are identified, accounted for and reimbursed to the right department. For more information see HDUHB R&D Costing Process document (latest version available from the R&D office), which includes cost recovery and income distribution models.




16. APPENDIX 3: RESEARCH AND DEVELOPMENT SUB-COMMITTEE TERMS OF

REFERENCE

RESEARCH & DEVELOPMENT SUB-COMMITTEE

TERMS OF REFERENCE

Version Issued to: Date Comments

V0.2 Research & Development Committee

07.10.2013 Approved

V0.3 Research & Development Committee 24.10.2014 Approved

V0.4 University Partnership Board 16.11.2015 Approved

V0.5 Research & Development Sub-Committee

27.11.2015 Changes requested

V0.6 Research & Development Sub-Committee

22.02.2016 Approved

V0.6 University Partnership Board 04.04.2016


UNIVERSITY PARTNERSHIP

BOARD

QUALITY, SAFETY &

EXPERIENCE ASSURANCE COMMITTEE

PRIMARY CARE

APPLICATIONS COMMITTEE

MENTAL HEALTH

LEGISLATION ASSURANCE COMMITTEE

CHARITABLE FUNDS

COMMITTEE

BUSINESS PLANNING &

PERFORMANCE ASSURANCE COMMITTEE

AUDIT & RISK ASSURANCE COMMITTEE

REMUNERATION & TERMS OF

SERVICE COMMITTEE

Research & Development

Sub-Committee




1.1 The Research & Development Sub-Committee has been established as a Sub-

Committee of the University Partnership Board and constituted from 1st June 2015.

2.1 The membership of the Sub-Committee may comprise core membership and other co-

opted members as required. Core membership shall comprise:

2.2 Membership of the Sub-Committee will be reviewed on an annual basis.

3.1 A quorum shall consist of no less than half of the membership, and must include as a

minimum the Chair or Vice-Chair of the Sub-Committee.

3.2 An Independent Member shall attend the meeting in a scrutiny capacity.

RESEARCH & DEVELOPMENT SUB-COMMITTEE

1. Constitution

2. Membership

Title

R&D Director (Chair)

Deputy R&D Director (Vice Chair)

Independent Member

Quality Assurance Officer

R&D Manager/s

Portfolio Research Coordinator

Head of Consent & Mental Capacity

Assistant Director of Nursing (with a responsibility for research)

Assistant Director of Therapies and Health Science (with a responsibility for research)

Lay representative

Research active representatives

Associate Medical Director (with responsibility for R&D)

Representatives from Service Support areas (Pathology, Pharmacy and Radiology)

A representative from Aberystwyth University

A representative from Swansea University

A representative from The University of Wales Trinity Saint David

Finance Manager

Clinical Trials Nurse

Head of Medical Education and Knowledge

Workforce and Organisational Development representative

Representatives from the Division for Social Care and Health Research (DSCHR) Welsh Government - Health and Care Research Wales Workforce

3. Quorum and Attendance




3.3 Any senior officer of the HDUHB or partner organisation may, where appropriate, be invited to attend, for either all or part of a meeting, to assist with discussions on a particular matter.

3.4 The Sub-Committee may also co-opt additional independent external “experts” from

outside the organisation to provide specialist skills. 3.5 Should any member be unavailable to attend, they may nominate a deputy with full

voting rights to attend in their place, subject to the agreement of the Chair.

3.6 The Chair of the Research & Development Sub-Committee shall have reasonable access to Executive Directors and other relevant senior staff.

3.7 The Sub-Committee may ask any or all of those who normally attend but who are not

members to withdraw to facilitate open and frank discussion of particular matters.

4.1 The purpose of the Research & Development Sub-Committee will be to assure the

Board, via the University Partnership Board, that it is discharging its functions and meeting its responsibilities with regards to the quality and safety of research activity carried out within the organisation.

4.2 The Research & Development Sub-Committee will promote and support involvement in high quality healthcare research, promote evidence-based healthcare, build research capacity and foster a research culture.

4.3 The Research & Development Sub-Committee aims to facilitate collaboration with the

Research and Academic community to maximise outcome and impact for the Health Board and the patients it serves.

5.1 Assure the Board in relation to arrangements for ensuring compliance with all relevant

frameworks, UK Clinical Trials and other Regulations (transposed into UK law from European Union Directives) and reporting requirements.

5.2 Consider the implications for the Board of the outcomes arising from relevant review, audit or inspection carried out by external regulatory authorities, review progress with resulting Corrective And Preventative Action plans (CAPAs) and authorising their completion.

5.3 Oversee the development of the Board‟s Research and Development (R&D) Strategy,

R&D Policies, Standard Operating Procedures and other relevant documents in line with local and national priorities and guidance, for sign off by the Board after scrutiny from the University Partnership Board.

5.4 The Research & Development Sub-Committee will ensure the HDUHB maintains its

University status by monitoring and driving improvement in those metrics associated with University status against which it will be judged by Welsh Government:

University Links

4. Purpose

5. Key Responsibilities




Health Education and Training Contribution

Contribution to Quality Care

Contribution to Health Research

Contribution to other Health Related activities 5.5 Ensure strong relationships and effective communication with associated Higher

Education Institutions and other external organisations. 5.6 Promote the dissemination of research findings in order to contribute to clinical

effectiveness and evidence-based healthcare delivery. 5.7 Agree issues to be escalated to the University Partnership Board with recommendations

for action. 5.8 The Research & Development Sub-Committee will provide assurance to the Board that

the ring fenced R&D Activity Based Funding is being spent according to Welsh Government requirements.

5.9 The principal duties of the Research & Development Sub-Committee are to:

5.9.1 Ensure R&D is appropriately resourced and that resources are channelled to local and national R&D priorities in the health community.

5.9.2 Report to relevant agencies such as the Division for Social Care and Health

Research (DSCHR), Welsh Government, through the approval of the R&D Annual Return, Mid Year Return and Annual Spending Plan.

5.9.3 Receive and comment on financial, performance management and data reports

submitted to DSCHR or Health and Care Research Wales.

5.9.4 To review new research applications pertaining to a member‟s specialist field / management responsibilities when requested by the R&D Manager.

5.9.5 Promote increased staff involvement in research activity, including facilitating

access to relevant training to enhance research capacity and capability.

5.9.6 Encourage multi-disciplinary and multi-agency R&D, including patient/public involvement where appropriate.

5.9.7 Report on R&D activity to relevant health community Committees and Health

Board via the R&D Director or their nominated person. 5.10 The Sub-Committee will, in respect of its provision of assurance and advice to the

University Partnership Board, ensure the implementation and adherence to relevant research legislation and any requests for reports to DSCHR.

6.1 The Sub-Committee Secretary is to hold an agenda setting meeting with the Chair

and/or the Vice Chair and the R&D Director, at least four weeks before the meeting date.

6. Agenda and Papers




6.2 The agenda will be based around the Sub-Committee work plan, identified risks, matters arising from previous meetings, issues emerging throughout the year and requests from Sub-Committee members. Following approval, the agenda and timetable for papers will be circulated to all Sub-Committee members.

6.3 All papers must be approved by the relevant R&D Manager. 6.4 The agenda and papers for meetings will be distributed seven days in advance of the

meeting. 6.5 The minutes and action log will be circulated to members within ten days to check the

accuracy. 6.6 Members must forward amendments to the Sub-Committee Secretary within the next

seven days. The Sub-Committee Secretary will then forward the final version to the Sub-Committee Chair for approval.

7.1 The Sub-Committee will meet four times a year and shall agree an annual schedule of

meetings. Any additional meetings will be arranged as determined by the Chair of the Sub-Committee in discussion with the R&D Director.

7.2 The Chair of the Sub-Committee, in discussion with the Sub-Committee Secretary,

shall determine the time and the place of meetings of the Sub-Committee and procedures of such meetings.

8.1 The Sub-Committee will be accountable to the University Partnership Board for its

performance in exercising the functions set out in these Terms of Reference. 8.2 The Sub-Committee shall embed the HDUHB‟s vision, corporate standards, priorities

and requirements, e.g. equality and human rights, through the conduct of its business. 8.3 The requirements for the conduct of business as set out in the HDUHB‟s Standing

Orders are equally applicable to the operation of the Sub-Committee.

9.1 The Sub-Committee, through its Chair and members, shall work closely with the

Board‟s other committees, including joint /sub committees and groups to provide advice and assurance to the Board through the: 9.1.1 joint planning and co-ordination of Board and Committee business; 9.1.2 sharing of information.

9.2 In doing so, the Sub-Committee shall contribute to the integration of good governance

across the organisation, ensuing that all sources of assurance are incorporated into the Board‟s overall risk and assurance framework.

7. Frequency of Meetings

8. Accountability, Responsibility and Authority

9. Reporting




9.3 The Sub-Committee may establish sub-groups or task and finish groups to carry out on its behalf specific aspects of Sub-Committee business. The Sub-Committee will receive an update following each Group‟s meetings detailing the business undertaken on its behalf. The following Groups have been or will be established: 9.3.1 R&D Core Team; 9.3.2 Sponsor Review Panel; 9.3.3 Medicines and Healthcare Products Regulatory Agency (MHRA) Task &

Finish Group (to be established as required); 9.3.4 Human Tissue Authority Task & Finish Group (to be established as required).

9.4 The Sub-Committee Chair, supported by the Sub-Committee Secretary, shall:

9.4.1 Report formally, regularly and on a timely basis to the University Partnership Board on the Sub-Committee‟s activities. This includes the submission of a Sub-Committee update report as well as the presentation of an annual report within 6 weeks of the end of the financial year;

9.4.2 Bring to the University Partnership Board‟s specific attention any significant matters under consideration by the Sub-Committee;

9.4.3 Ensure appropriate escalation arrangements are in place to alert the HDUHB Chair, Chief Executive, or Chair of other relevant Committees, of any urgent/critical matters that may compromise patient care and affect the operation and/or reputation of the HDUHB.

10.1 The Sub-Committee Secretary shall be determined by the R&D Director.

11.1 These Terms of Reference and operating arrangements shall be reviewed on at least

an annual basis by the Sub-Committee for approval by the University Partnership Board.

10. Secretarial Support

11. Review Date

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