RESEARCH & DEVELOPMENT ANNUAL REPORT … · Oncology, Dr Judith Carser, in late 2013 has been very...

July 2014

RESEARCH & DEVELOPMENT

ANNUAL REPORT

2013/2014

Research and Development Annual Report 2013/2014 Page 3 of 103

CONTENTS Page

1. INTRODUCTION 7

2. HEAD OF NURSING, MIDWIFERY AND ALLIED HEALTH PROFESSIONS RESEARCH AND DEVELOPMENT / HONORARY RESEARCH FELLOW

10

2.1 WORKAGE: ACTIVE AGEING THROUGH WORK ABILITY 10

2.2 RESEARCH AND DEVELOPMENT STRATEGY FOR NURSES, MIDWIVES AND ALLIED HEALTH PROFESSIONALS – WORKSHOP

11

2.3 PRACTICE DEVELOPMENT 11

2.4 DEVELOPING PRACTICE IN HEALTHCARE (DHPC) PROGRAMME 11

2.5 PRACTICE DEVELOPMENT COLLABORATIVE GROUP (PDCG) 11

3. RESEARCH GOVERNANCE 12

3.1 RESEARCH GOVERNANCE COMMITTEE – MEMBERSHIP – MARCH 2014 12

3.2 RESEARCH GOVERNANCE COMMITTEE – TERMS OF REFERENCE 12

3.3 RESEARCH GOVERNANCE LEAFLET – MAY 2014 12

3.4 RESEARCH AND DEVELOPMENT ON TRUST’S WEBSITE 12

3.5 RESEARCH GOVERNANCE APPROVALS 12

3.6 RESEARCH APPLICATIONS 13

3.6.1 RESEARCH APPLICATIONS – RECEIPT OF MULTI-CENTRE APPLICATIONS FOR NI TRUSTS

14

3.7 AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH STUDIES 14

3.8 RESEARCH ENQUIRIES 14

4. RESEARCH ACHIEVEMENTS 15

5. RESEARCH GOVERNANCE – CONTROLS ASSURANCE STANDARDS 26

5.1 BUSINESS SERVICES ORGANISATION, INTERNAL AUDIT – RESEARCH GOVERNANCE

26

5.2 BUSINESS SERVICES ORGANISATION, INTERNAL AUDIT – INFORMATION GOVERNANCE 2012/2013

27

6. RESEARCH STAFF 27

7. PERSONAL AND PUBLIC INVOLVEMENT (PPI) REPRESENTATIVES 27

7.1 MAPPING COMMUNITY DEVELOPMENT APPROACHES ACROSS THE TRUST 28

7.2 PPI INFECTION CONTROL FORUM 28

8. RESEARCH & DEVELOPMENT STRATEGY 28

9. POLICY FOR THE MANAGEMENT OF RESEARCH AND DEVELOPMENT 29


CONTENTS Page

10. RESEARCH AND DEVELOPMENT ACTION PLAN 2013-2015 29

11. KEY PRIORITIES FOR 2013/2014 29

11.1 KEY PRIORITIES FOR 2014/2015 30

12. RESEARCH AND DEVELOPMENT WORKSHOP TO SHOWCASE RESEARCH UNDERTAKEN BY TRUST STAFF

30

13. DOCTORAL FELLOWSHIP APPLICATIONS 31

14. RESEARCH GOVERNANCE PRESENTATIONS 31

15. RESEARCH EPS ELECTRONIC DATABASE 31

15.1 EDGE DATABASE 31

16. HSC RESEARCH FUNDING 32

17. HSC RESEARCH AND DEVELOPMENT DIVISION 33

17.1 RETIREMENT – ASSISTANT DIRECTOR HSC R&D DIVISION 33

17.2 APPOINTMENT – ASSISTANT DIRECTOR HSC R&D DIVISION 33

18. COLLABORATIVE RESEARCH STUDIES WITH INDUSTRY 33

18.1 MODEL TEMPLATE AGREEMENT FOR COLLABORATIVE INVESTIGATIONS INVOLVING MEDICAL DEVICE COMPANIES AND HSC TRUSTS

33

19. HSC INNOVATIONS 34

19.1 GLAXO SMITH KLINE MEETING 34

20. NI CLINICAL RESEARCH NETWORK (NICRN) 34

20.1 NICRN SPECIFIC INTEREST GROUPS 35

21. GOOD CLINICAL PRACTICE (GCP) TRAINING 35

22. NORTHERN IRELAND CLINICAL TRIALS UNIT (NICTU) FORMERLY CLINICAL RESEARCH SUPPORT CENTRE (CRSC)

35

23. NORTHERN IRELAND CLINICAL RESEARCH FACILITY 36

24. OFFICE FOR RESEARCH ETHICS COMMITTEES NORTHERN IRELAND (ORECNI)

36

24.1 GAFREC IMPLICATIONS FOR RESEARCH GOVERNANCE COMMITTEES 36

24.2 PROPORTIONATE REVIEW SERVICE 36

25. NI CANCER CLINICAL TRIALS CENTRE 37

25.1 APPOINTMENT OF CANCER RESEARCH NURSE 37

25.2 TRAINING OPPORTUNITY AT THE NATIONAL CANCER INSTITUTE, USA 37


CONTENTS Page

26. LIFE SCIENCES LINK WITH CRAIGAVON BOROUGH COUNCIL 37

26.1 DELEGATION VISITS 37

26.1.1 MASSACHUSETTS DELEGATION 37

26.1.2 ASIA PACIFIC DELEGATION 37

26.2 WORKSHOP – AUTUMN 2014 38

26.3 NI LOCAL GOVERNMENT ASSOCIATION AWARDS – BEST JOINT INITIATIVE FOR CRAIGAVON AS A CENTRE OF EXCELLENCE FOR LIFE SCIENCES

38

27. REGIONAL RESEARCH GROUPS 38

28. RESEARCH AND DEVELOPMENT INPUT TO TRUST 39

28.1 TRUST BOARD WORKSHOP 39

28.1.1 PERCENTAGE OF CHARITABLE FUNDS FOR RESEARCH 39

28.1.2 RESEARCH COLLABORATION WITH UNIVERSITIES 39

28.1.3 RESEARCH IN THE AREA OF DEMENTIA 39

28.2 OTHER RESEARCH & DEVELOPMENT CONTRIBUTIONS WITHIN THE TRUST 39

28.3 PROMOTION OF SOCIAL CARE RESEARCH 40

29. COLLABORATIVE RESEARCH WITH UNIVERSITY OF ULSTER AND QUEEN’S UNIVERSITY BELFAST

40

29.1 UNIVERSITY OF ULSTER 40

29.2 QUEEN’S UNIVERSITY BELFAST 40

30. FUNDING OPPORTUNITIES 41

30.1 EUROPEAN FUNDING 41

30.1.1 EUROPEAN FUNDING – SOCIAL POLICY EXPERIMENTATIONS – “PROGRAMME FOR EMPLOYMENT AND SOCIAL SOLIDARITY PROGRESS”

41

30.1.2 EUROPEAN REGIONAL DEVELOPMENT FUNDING (ERDF) 41

30.1.3 DHSSPS SLIPPAGE CAPITAL FUNDS 42

31. BUSINESS SERVICE ORGANISATION – AUDIT OF RESEARCH GOVERNANCE 2012/2013

42

32. HONEST BROKER GOVERNANCE BOARD 44


APPENDICIES Page

APPENDIX 1 Research Governance Committee Membership 47

APPENDIX 2 Research Governance Committee Terms of Reference 48

APPENDIX 3 Research Governance Leaflet 49

APPENDIX 4 Research Applications 2013 / 2014 51

APPENDIX 5 Amendments to Research Applications 2013 / 2014 56

APPENDIX 6 Enquiries 2013 / 2014 61

APPENDIX 7 Research & Development Action Plan 2013 - 2015 67

APPENDIX 8 Workshop Programme Showcase of Research undertaken by Trust Staff 75

APPENDIX 9 Collaborative Research Studies with Industry 78

APPENDIX 10 Model Collaborative Research Agreement 80

APPENDIX 11 HSC Trust Research Fund 2013/2014 81

APPENDIX 12 Good Clinical Practice – Arrangements for web based e-learning 83

APPENDIX 13 Medical Staff Induction e-learning – Patients Enrolled in Clinical Trials 85

APPENDIX 14 Research Projects – Research Invoice Request Form 91

APPENDIX 15 Research Nurse Finance Training Session 92

APPENDIX 16 Publications – Dr D McEneaney/Dr Andrew Howe 93

APPENDIX 17 Publications – Dr I Menown 95

APPENDIX 18 Key Performance Indicators 98


1. INTRODUCTION

The year 2013/2014 has concluded with several important developments in Research and Development.

Following the successful Cardiology, Commerce and Collaboration Conference on 8 February 2013 two visits which involved the Cardiolovascular Research Department, Craigavon Area Hospital were hosted by Craigavon Borough Council and Invest NI on 17 May 2013 and 5 December 2013. On the first occasion a delegation from Massachusetts visited Craigavon Area Hospital where they viewed a stent procedure undertaken by Dr Ian Menown, Consultant Cardiologist. The second visit comprised delegates from Asia Pacific countries (Australia, China, India, Japan, Malaysia, New Zealand, Singapore, Taiwan, Pakistan, South Korea, Thailand and Vietnam) when Dr David McEneaney, Consultant Cardiologist and Dr Ian Menown gave presentations on the innovative research collaborations already in place in Cardiology at Craigavon Area Hospital and outlined opportunities for extension of that research. See Paragraph 26.1 for further details. Liaison between Craigavon Borough Council and the Trust continued throughout the year and it is planned to have a follow up Workshop to the 2013 Conference during the next year with the involvement of small to medium sized local businesses.

Craigavon Cardiovascular Research Unit, Craigavon Area Hospital was again selected by Invest NI as one of the key players in Northern Ireland in Life Sciences for promotion at the Bio International Convention (the Global event for Biotechnology), held in Chicago from 22 to 25 April 2013.

The number of research applications received in 2013/2014 was 80 compared to 56 in 2012/2013. The number of enquiries received in 2013/2014 was 102 compared to 65 in the previous year.

The approval of research applications within 30 calendar days was 100% for all quarters during the year 2013/2014.

The Trust’s research governance process met Research Governance Controls Assurance Standards and achieved substantive compliance with a score of 96.76%. The score for 2012/2013 was 96.7%.

For the sixth successive year the HSC Trust Research Fund received £50,000 from the HSC Research & Development Division to support small research projects. Ten applications were received: all of which were awarded a level of funding albeit not the total amount requested (Appendix 11).

Business Services Organisation, Internal Audit of Research Governance was undertaken in July 2013 and reported on in October 2013 with the final version of the Report issued in December 2013. See Paragraph 31 for further details.

In April 2013 a Clinical Research Nurse for Diabetes (0.5 WTE) funded by the NI Clinical Research Network took up post.


In May 2013, Mrs Leanne McCourt, Clinical Research Nurse for Cancer (Full time) took up post.

NI Clinical Research Network (NICRN) adopted Studies continued in the specialities of Children, Stroke, Cardiovascular, Critical Care and Renal as well as Diabetes. The Trust has representation on those Networks as well as on the Dementia and Respiratory Networks.

The Director of the NI Children’s Network is Dr Mike Smith, Consultant Paediatrician, Craigavon Area Hospital who also represents Northern Ireland on the Board of Medicines for Childrens Research Network. Dr Neal Morgan, Consultant Nephrologist, Daisy Hill Hospital fulfils the role of the NI Co-Lead for the Renal Network and represents Northern Ireland on the United Kingdom Kidney Research Consortium.

Close links have been maintained with the NI Cancer Clinical Trials Centre in relation to the Cancer Studies taken forward in Craigavon Area Hospital where a Clinical Research Nurse for Cancer is based. The appointment of a Consultant in Medical Oncology, Dr Judith Carser, in late 2013 has been very beneficial for research studies being taken forward in the Trust.

The continued support of the Chair, Chief Executive, Executive and Non-Executive Directors of Trust Board has been greatly appreciated. The Medical Director has responsibility for Research and Development and meets monthly with the Associate Medical Director Research and Development. The Annual Report for Research and Development has been presented to the Trust Board on an annual basis by the Associate Medical Director for Research and Development, most recently on 12 December 2013 at a Trust Board Workshop when accompanied by Dr Ian Menown, Consultant Cardiologist. Meetings with Executive Directors have been held on an as and when required basis. The commitment and interest of the Research Governance Committee members (Appendix 1) in taking forward the responsibilities of the Committee (Appendix 2) has been appreciated and must also be acknowledged. Craigavon Area Hospital and Daisy Hill Hospital have been sites for several important national and international Studies and Clinical Trials. Collaborative research has been on-going throughout the Trust with local Industry and Universities both locally and nationally. As well as the direct benefits of providing new treatments or interventions and increasing the quality of care provided for patients and clients, research motivates staff to identify service improvements. It has been encouraging that there has been evidence of research being carried out by Social Work, Nursing and Allied Health Professional staff during the year. All staff have been supported in undertaking research as part of their academic studies.


The annual Workshop at which Trust staff showcased the research they had undertaken was held on 12 March 2014 when Dr Siobhan McGrath, Head of the Office for Research Ethics Committees was guest speaker. The Trust strives to ensure that research undertaken contributes to:

The Trust’s corporate objectives

The recommendations of the Compton Review – Transforming your Care

Improving patient safety

Driving improvements in care

Improving quality and efficiency

Preventing Hospital admissions and reducing lengths of stay

Enabling rapid and clinical decision making

Facilitating and evaluating the shift from secondary care to community care

Evaluating and accommodating new technologies

Developing future clinical pathways

Ensuring local access to services

Having stakeholder support

Providing opportunity for patients and clients to access the latest treatments/devices

Identifying unmet needs

The priority which the Trust accords to research should continue to assist with the recruitment and retention of high quality staff. The Trust has the benefit of having talented research staff with endless innovative ideas although –

Staff require protected time to undertake research; and

Assistance to develop innovations from the business/engineering/academic sectors

____________________ ________________ Dr Peter Sharpe Miss Irene Knox Consultant Chemical Pathologist Research Manager Associate Medical Director Research & Development

Research & Development Office Ramone Building

Craigavon Area Hospital 68 Lurgan Road

PORTADOWN BT63 5QQ E-mail: [email protected]

Telephone: 028 3861 4274

mailto:[email protected]


2. HEAD OF NURSING, MIDWIFERY AND ALLIED HEALTH PROFESSIONS RESEARCH AND DEVELOPMENT/HONORARY RESEARCH FELLOW

Dr Patricia Gillen, Head of Nursing, Midwifery and Allied Health Professions Research and Development/Honorary Research Fellow has been in post from February 2012 and since then has provided invaluable support and guidance to researchers in all those disciplines and also to staff in other professions.

Dr Gillen has worked with Nurses, Midwives and Allied Health Professionals in promoting a culture of research and evidence-based practice within the Trust and has led the implementation of the Healthcare Professions Strategy for Research and Development. Dr Gillen has been a key member of the Research Governance Committee. As an Honorary Research Fellow with the University of Ulster, Dr Gillen has collaborated with the Institute of Nursing and Health Research in undertaking research and practice development to effect health and social care gain for patients and their families within the Trust. 2.1 WORKAGE: ACTIVE AGEING THROUGH WORK ABILITY Dr Gillen represented the Trust in the development of a project funded by the European Union’s ‘Programme for Employment and Social Solidarity – Progress’ linked with Nottingham Trent University and Stoke Council. The funding awarded was £1.1m with 83,913 Euros allocated to the Trust for the employment of a Change Coordinator in Midwifery Services where the project will take place over a period of eighteen months. The project also involves the Age and Employment Network, Nottinghamshire Employer First, Nottinghamshire Fit for Work Service, the TUC, the European Foundation for the Improvement of Living and Working Conditions, the Department for Work and Pensions, the Royal College of Midwives, as well as experts from Kingston University, Lancaster University, and Tilburg University. The project entitled Workage: Active Ageing Through Work Ability will be carried out with the UK Work Organisation Network (UK WON). The first project of its kind will involve working with a mix of public and private sector organisations to look at workers’ attitudes, their levels of engagement and plans for retirement.

It is hoped the project will significantly improve employee wellbeing, engagement and ‘work ability’ across the workforce, through smarter, more productive working and also lead to savings for organisations in terms of recruitment and retraining costs. At the end of the project a toolkit will be produced and information on good practice will be collated and made available to national policymakers throughout Europe. It will also be made available to employers so they can identify and pilot the most appropriate policies and programmes to make it possible for workers to stay in work longer.


2.2 RESEARCH AND DEVELOPMENT STRATEGY FOR NURSES, MIDWIVES AND

ALLIED HEALTH PROFESSIONALS – WORKSHOP The Workshop held on 18 November 2013 provided an opportunity for Nurses, Midwives and Allied Health Professional staff to contribute to a draft Strategy for Research and Development in their professions which when fully drafted would be issued for further consultation before adoption. 2.3 PRACTICE DEVELOPMENT

Practice Development is an activity which is a key component of the ‘D’ of R& D and has the potential to help patients and staff to translate complex organisational and strategic agendas into a practical reality. The Francis Reports (2013) have highlighted the importance of paying attention to the workplace culture within Health Care organisations and its impact on patient care and outcomes. Practice Development is a key mechanism through which person centred processes, systems and ways of working are embedded in the workplace.

2.4 DEVELOPING PRACTICE IN HEALTHCARE (DPHC) PROGRAMME

The Trust has signed a Memorandum of Understanding with the University of Ulster which recognises the Trust as a partner in the delivery of the Developing Practice in Healthcare Programme. The DPHC offers registered practitioners the opportunity to obtain academic credit for their practice based learning that is clearly linked to personal, professional and organisational needs. It offers an alternative way for practitioners to work towards an academic award, including BSc Hons Developing Practice in Healthcare or PG Diploma / MSc Developing Practice in Healthcare. Nurses and Allied Health Professionals from the Trust are currently enrolled on this programme with more commissioned places available from September 2014.

2.5 PRACTICE DEVELOPMENT COLLABORATIVE GROUP (PDCG)

This group is a Trust based initiative which was set up to assist with the implementation of the Northern Ireland Practice Development Strategic Framework and Operational Plan within the Trust. It has a multidisciplinary membership which includes Nurses, Midwives, Allied Health Professionals and Social Workers. It is an important forum which brings together both those who can influence the practice development agenda in the Trust and those who have such skills and experience. Additional members will be sought as practice development in the Trust develops momentum.


3. RESEARCH GOVERNANCE

Since the establishment of Research and Development in the Trust there has been a single research governance process for all research applications.

3.1 RESEARCH GOVERNANCE COMMITTEE - MEMBERSHIP

The membership of the Research Governance Committee which was established in January 2008 has been reviewed annually. The current membership as at March 2014 has been included in Appendix 1. The Committee meets on a six weekly basis.

3.2 RESEARCH GOVERNANCE COMMITTEE – TERMS OF REFERENCE

The Terms of Reference have been attached in Appendix 2.

3.3 RESEARCH GOVERNANCE LEAFLET

The Research Governance Leaflet was reviewed in May 2014 - Appendix 3.

3.4 RESEARCH AND DEVELOPMENT ON TRUST’S WEBSITE

Research and Development was included as a link on the front page of the Trust’s website which became live on 15 June 2011.

3.5 RESEARCH GOVERNANCE APPROVALS

A metrics was developed by the Research Manager’s Forum for recording activity on the approval of research applications on a quarterly basis. The percentage for the approval of research applications within 30 calendar days in this Trust was 100% for all four quarters during 2013/2014. Median approval times for all Trusts were provided for the quarters during 2013/2014 as follows, Trust median figures for the same quarters given in brackets: Quarter 1 – 28 days (8 days) Quarter 2 – 17 days (9 days) Quarter 3 – 27 days (13 days) Quarter 4 – 28 days (16.5 days)


3.6 RESEARCH APPLICATIONS

Research applications for 2013/2014 totalled 80 whereas 56 research applications were received in 2012/2013. Appendix 4 provides the titles of the research applications received from various researchers within the Trust and includes Clinical Trials, research studies being undertaken for academic purposes and by University researchers.

The following table shows the numbers of research applications received since Research and Development was established in the Trust in April 2008.


3.6.1 RESEARCH APPLICATIONS – RECEIPT OF MULTI-CENTRE APPLICATIONS FOR NI TRUSTS

With effect from 1 May 2013 the Research Gateway was established in the Western HSC Trust at the Research & Development Office, C-TRIC Building, Altnagelvin Hospital to receive and distribute all multi-centre research applications for participating Trusts in Northern Ireland. Applications from Devolved Nations as well as multi-centre Studies within Northern Ireland are included in this application process.

Research governance approval can only be issued by individual Trusts before Studies can commence in that Trust.

3.7 AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH STUDIES

Amendments to 70 previously approved Studies were reviewed and acknowledged during the year (Appendix 5). In 2012/2013 amendments were received for 58 Studies.

3.8 RESEARCH ENQUIRIES

The number of enquiries received in 2013/2014 was 102 (Appendix 6). Many of those enquiries required the review of detailed project proposals and the provision of written confirmation, mainly for Universities, as to whether the proposal was deemed a service evaluation, survey or audit.

The following table shows the number of enquiries received since the establishment of Research and Development in the Trust in April 2008.


4. RESEARCH ACHIEVEMENTS

Research studies carried out within the Trust have driven improvements in care, allowing patients access to new treatments and interventions as a result of staff involvement in a range of on-going National and International Studies. Patients have had access to next-generation Cardiology stents; Clinical Trials have contributed to Clinical Guidelines being issued by the National Institute for Health and Clinical Excellence (NICE); and researchers have published papers in Peer Reviewed Journals; presented posters and papers at a variety of Conferences locally, nationally and further afield. Those achievements have been outlined in the table below and show that many disciplines of staff, including Nursing, Allied Health Professionals and Social Work, have undertaken successful and important research.


Name Study Activity

Craigavon Cardiovascular Research Unit

Cardiovascular Research Unit selected by Invest NI as one of the key players in Life Sciences in NI

Craigavon Cardiovascular Research Unit included in the Invest NI brochure for presentation at the Bio International Convention (The Global Event for Biotechnology) 22 to 25 April 2013, Chicago, U.S.A.

Dr David McEneaney, Consultant Cardiologist, Director of Cardiovascular Research

(1) NGAL (Neutrophil Gelatinase Associated Lipocalin) as a predictor of Acute Kidney Injury post coronary angiogram; and

(2) H-FABP (Heart Fatty Acid

Binding Protein) as a potential biomarker for coronary artery disease in an exercise stress test population

Randox Laboratories funded a Research Fellow post for a period of 2 years (Dr Michael Connolly, Research Fellow, Cardiology)

(1) A multi-functional algorithm using ECG and impedance cardiography to enhance AED usability and performance for lay operators

(2) Investigation of the Impedance Cardiogram (ICG) measured via defibrillator pads during Electrophysiology Studies and implantable Cardiovertor-Defibrillator (ICD) Implantation

HeartSine funded Research Fellow post for a period of 2 years (Dr Andrew Howe) which led to multiple publications (See Appendix 16) and award of MD. Appendix 16 also includes other publications for Dr David McEneaney.

Part time PhD Student Philip Walsh, Waterford Institute of Technology/University of Ulster Jointly supervised by Dr David McEneaney and Professor Omar Escalona, University of Ulster

Part time PhD Student David Lynn, University of Ulster Jointly supervised by Dr David McEneaney and Professor Omar Escalona, University of Ulster


Name Study Activity

Dr David McEneaney, Consultant Cardiologist, Director of Cardiovascular Research

Product evaluation of heart monitor by Intelesens undertaken in Cardiology Department, Craigavon Area Hospital

Appointed as Co-Director of the Centre of Advanced Cardiology Research and honored with a Visiting Professorship, University of Ulster

Cardiovascular Research

Dr Ian Menown, Consultant Cardiologist, Director of Interventional Cardiology Cardiovascular Research Nurses: Mrs Kate Vernon-Kelly, Mrs Michelle Kinnin, Mrs Alison McMullan

2013-2014 Publications (See Appendix 17)

Data Safety Monitoring Board: Intracoronary Adenosine vs Sodium Nitroprusside in Primary PCI

BIOTRONIK III Registry, drug eluting stent with biodegradable polymer and thromboresistant coating

Chief Investigator / National Lead Investigator (Continuing long term follow up)

eBiomatrix Registry, drug eluting stent with biodegradable polymer

Highest global recruiter (Continuing long term follow up)

Capella Sideguard Registry – Sidebranch stent

Third highest UK recruiter (Now in follow up)

ENERGY: Long term safety profile of the PRO-Kinetic ENERGY bare metal coronary stent system in daily clinical practice

Chief Investigator / National Lead Investigator and highest UK recruiter (Final follow up)

eNobori Registry: Drug eluting stent with biodegradable polymer

Enrolment completed (In follow up)

Leaders Free – randomised study of a polymer free drug eluting stent versus non-coated bare metal stent

Second highest recruiter


Name Study Activity

Dr Ian Menown, Consultant Cardiologist, Director of Interventional Cardiology Cardiovascular Research Nurses: Mrs Kate Vernon-Kelly, Mrs Michelle Kinnin, Mrs Alison McMullen

Magical Registry: Quick healing stent on drug eluting balloon

Lead Site for European Study

NOBLE Randomised Study of Coronary Artery Bypass Grafting versus PCI in left main coronary disease.

Third highest UK recruiter

Platinum plus – randomised study of Promus Element versus Xience drug eluting stents

Completed enrolment (In follow up)

TE-PROVE: TaxisTM ElementTM Paciltaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study

Chief Investigator / National Lead Investigator (In follow up)

TRIAS: A Randomised Study of the Genous pro healing stent versus the conventional bare metal stent

Second highest recruiter (On-going enrolment)

Renal Denervation for treatment of resistant hypertension

Chief Investigator Poster presentation at NICON (NI Confederation for Health and Social Services) Conference – 5 and 6 March 2014. Mrs Nikki Cinnamond, Cardiology Secondary Prevention Specialist Nurse presented poster at event.

Multi-centre, Prospective, Clinical outcomes after deployment of the Abluminal Sirolimus Coated Bio-Engineering Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry – REMEDEE

Craigavon Area Hospital only site in UK


Name Study Activity

Dr Ian Menown, Consultant Cardiologist, Director of Interventional Cardiology

A Post Marketing multi-centre, single arm Observational Clinical Registry to evaluate safety and efficacy of BioMime Sirolimus Eluting Stent System in all corners real world population with Coronary Artery Stenosis in the United Kingdom – MILES Registry

Chief Investigator for the world-wide Registry

EnligHTN European Observational Study

Chief Investigator for a National study

Dr Andrew Moriarty Research Cardiologist Cardiovascular Research Nurses: Sister Anne Mackin, Mrs Michelle Kinnin, Mrs Alison McMullan

Dr Moriarty is a Member of Advisory Boards of Pharmaceutical Companies and also a member of the Trust’s Research Governance Committee

IMPROVE-IT A multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (Ezetimibe/simvastatin tablet) vs simvastatin monotherapy in high risk subjects presenting with ACS

Principal Investigator Second highest recruiter in Northern Ireland

TIGRIS A registry of long-term risk, management and resource utilization of stable coronary artery disease in post-MI patients.

Principal Investigator Highest recruiter in UK

PREFER VTE Registry Prevention of thromboembolic events – European Registry in Venous Thromboembolism

Principal Investigator Highest recruiter in UK

LIVELIFE Phase IV prospective observational cohort study in older heart failure patients initiated on Ivabradine

Principal Investigator Dr Moriarty a member of the National Steering Committee for this Study.


Name Study Activity

Dr Andrew Moriarty Research Cardiologist Cardiovascular Research Nurses: Sister Anne Mackin, Mrs Michelle Kinnin, Mrs Alison McMullan

Also Principal Investigator for the following studies: GLORIA AF PREFER AF Registry PARADIGM RELAX 2 CAD PEGASUS ISCHAEMIA COMPASS ODYSSEY SIGNIFY TAO

Dr Neal Morgan, Consultant Nephrologist Renal Research Nurse: Mrs Dympna Sands

Frail and Elderly Patient Outcomes on Dialysis (FEPOD): Part 1 Quality of life, physical functioning and symptoms of frail older patients on dialysis: comparison of haemodialysis and assisted peritoneal dialysis

Highest recruitment in Northern Ireland

Frail and Elderly Patient Outcomes on Dialysis (FEPOD): Part 2 Prospective longitudinal study of assisted peritoneal dialysis compared to haemodialysis for frail older patients with end-stage kidney disease


A study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis (PD-CRAFT)

Recruited 10% more than the participant sample size allocated for Trust and had highest recruitment in Northern Ireland


Name Study Activity

Dr Mike Smith, Consultant Paediatrician Children’s Research Nurses: Mrs Sara Gilpin / Mrs Judith Ratcliffe

Identification of Major Susceptibility Genes for Eczema and Food Allergy

Highest recruitment in Northern Ireland. Study now closed.

Dr Johnny Body, Consultant Paediatrician Children’s Research Nurses: Mrs Sara Gilpin / Mrs Judith Ratcliffe

A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs (SANAD II)


Dr Patricia McCaffrey, Consultant Geriatrician Stroke Research Nurse: Mrs Kate Douglas

DARS – Dopamine Augmented Rehabilitation in Stroke: Does Co-careldopa treatment in combination with routine NHS occupational and physical therapy, delivered early after stroke within a stroke rehabilitation service, improve functional recovery including walking ability and arm function?

Joint highest recruitment in Northern Ireland

Dr Michael McCormick, Consultant Geriatrician Stroke Research Nurse: Mrs Kate Douglas

CROMIS-2 Microbleeds and genetic risk factors to predict the risk of intracranial haemorrhage in patients treated with anticoagulation following stroke



Name Study Activity

Dr Geoff McCracken, Consultant Obstetrician and Gynaecologist Cancer Research Nurse: Mrs Leanne McCourt

International Cancer Benchmarking Partnership: Root causes of diagnosis and treatment delays in breast, lung, colorectal and ovarian cancer

116 participants recruited up to March 2014

Dr Mae McConnell, Consultant Diabetologist Diabetes Research Nurse: Mrs Sharon Carr

Declining Structured Education in Type 1 Diabetes

Recruited 15. Study now closed.

Declining Structured Education in Type 2 Diabetes

Recruited 7. Study on-going

Postnatal Lifestyle Intervention in women with Gestational Diabetes (PAIGE study)

Recruited 15. Study on-going

Trialnet – Patient Identification Centre for study

Information given to 115 patients. Study on-going.

Diabetes Care in UK Universities

Recruited 10. Study closed.

Dr Patricia Gillen, Head of Nursing, Midwifery and Allied Health Professions Research & Development/ Honorary Research Fellow

Presentation for Student Midwives on PhD Research

University of Applied Sciences, Innsbruck, Austria

Evidence Based Midwifery Early Pregnancy Loss

Paper published: Perceptions of Healthcare Professionals 12(1): 29-34

Royal College of Midwives Midwifery Education for the 21 Century: Educating for a compassionate workforce

Chaired Inaugural Education Conference, Institute of Education, London. 31 March 2014

Guidelines and Audit Implementation Network (GAIN) “Guidelines for Admission to and Transfer from Midwife-led Care”.

Development of Activity Funding - £15,901. Due for completion June 2015.

Mr John Boyle A syncretic approach to the role of pathological organisations in violence

Article published in the British Journal of Psychotherapy, July 2013


Name Study Activity

Mr Daniel Harte, Lead Occupational Therapist, Trauma and Orthopaedics

A comparative study – A template to improve the Jebsen-Taylor Hand Function Test

Poster presentation at NICON (NI Confederation for Health and Social Services) Conference – 5 and 6 March 2014. Miss Denise Curran, Occupational Therapist and Mr Daniel Harte presented the poster at the event.

2013 Lean Healthcare National Award in the category “Best Impact on Patient Experience”

The Trauma and Orthopaedics Therapy Team in Craigavon Area Hospital won the award in Leeds on 7 February 2013. The presentation focused on an initiative in relation to a pre-operative education group for patients awaiting total hip replacement whereby all relevant professional staff had input into that session. The initiative meant that several hundred hours of professional time was being saved on an annual basis and patients also benefitted. Computer software used had been purchased with some of the monies donated to Occupational Therapy by Mrs Eileen Wright (PPI representative).

Article published in the Daily Mail on 1 February 2014

Just like that! Heal damaged hands the Tommy Cooper way: Doctors use magic tricks on patients after surgery, strokes – even arthritis.

Mrs Tina Hughes, Occupational Therapist

KINECT-ABILITY: The use of ‘Kinect’ gaming console within Occupational Therapy Stroke Rehabilitation

Coverage of rehabilitation initiative on BBC NI TV News – December 2013 Presentation at NIMAST Conference – March 2014

Mrs Leanne McCourt

Cancer Clinical Research Nurse

Awarded a place on the summer 2014 course ‘Principles and Practice of Cancer Prevention and Control’ at the National Cancer Institute, Rockville, Maryland, USA

Dr Esther Reid, Alcohol Liaison Midwife and Postdoctoral researcher

A prospective study exploring risk factors associated with fetal macrosomnia and women’s experiences of delivering a large for gestational age infant – Physical Activity, Nutrition and Development Antenatally (PANDA)

Awarded PhD


Name Study Activity

Mrs Maggie Bennett, Practice Education Facilitator

Focus Groups to explore nurse mentors experience of assessing pre-registration nursing students in practice

Research findings included in the Willis Commission’s Review of Nurse Education

Appointed University Teaching Fellow – June 2013

Ms Sharon Burnside

Practice Education Facilitator

Burdett Trust for MSc Studies - competed and was successful in being awarded £2,500

Ms Donna McLaughlin

Heart Failure Nurse Specialist

Burdett Trust for MSc Studies – competed and was successful in being awarded £1,200

Dr Carmel Rooney, Assistant Director of Corporate Parenting

Care Leavers experience of transition: their understanding of their life experiences of negotiating life’s events

Awarded PhD – December 2013

Research presented at: International Collaboration and Debate on Transitions and Turning Points, University of Hildesheim, Germany – 16 and 17 May 2013

International Research Symposium on Care Leavers’ Transitions: Challenges and Opportunities, Trinity College, Dublin – 30 July 2013

Research in Social Work and Social Care – A Way forward? Organised by HSC Research & Development and PHA, 6 February 2014

Report published in the Journal of Social Work and Society, Vol 12 (No 1) 20

Dr Michael Hoy, Head of Short Term Residential Care Services

The participation promise of Family Group Conferencing – Theory or Practice? A qualitative comparison study within the Southern HSC Trust

Queen’s University sought permission from the researcher and the Research & Development Office to adopt the proforma designed to respond to the Peer Review comments and the Trust’s Peer Review proforma for use by the University.

Awarded PhD – December 2013


Name Study Activity

Mr Mark Irwin, Training & Development Consultant, Social Services Workforce Development and Training Team

An examination of effective practice assessment within the direct observation of Social Work Students in the Southern Health and Social Care Trust

Contributed to the training of prospective Practice Teachers in Northern Ireland.

Used to encourage best practice in the Practice Teachers in Northern Ireland.

Contributed to Level I Social Work Students training at the South West College as part of the University of Ulster teaching for Social Work degree.

Presented at the NI Practice at its Best Workshops for Social Work Students, Practice Teachers and those involved in the education of Social Workers

Article published in the Journal of Practice Teaching and Learning for Social Work, Health and Nursing – June 2013.

Recognition Award ABPI and Public Health Agency, Institute of Healthcare Management Awards – November 2013

Mr Fergal O’Brien, Promoting Well Being Manager

MSc – Dying Fifteen Years Too Soon – What can Traveller Men and Society do?

Poster presentation at Conference – Policy to Practice; Profiling the Impact of Ireland’s National Men’s Health Policy – Dublin – 13 June 2013

Highly commended ABPI and Public Health Agency, Institute of Healthcare Management Awards – November 2013

Mrs Patricia Trainor, Adult Safeguarding Manager

Review of Adult Safeguarding Alerts. What factors influence Designated Officers in progressing safeguarding alerts/referrals through the investigation process

As a result of the Study there was a major review of the Trust’s Adult Protection form. The outcomes also impacted the delivery of adult safeguarding training programme. The summary and recommendations have been shared with DHSS&PS Social Care Department, Health and Social Care Board and the NI Adult Safeguarding Partnership.


5. RESEARCH GOVERNANCE – CONTROLS ASSURANCE STANDARDS

The research governance process achieved substantive compliance in the Controls Assurance Standard with a score of 96.76% for 2013/2014. The score for 2012/2013 was also 96.7% when revised in accordance with the recommendations of the Business Services Organisation Internal Audit – see Paragraph 31 for further details. The percentage achievement for research governance has achieved substantive compliance for the past number of years as detailed in the following table.

5.1 Business Services Organisation, Internal Audit – Research Governance

A Business Services Organisation audit was carried out in July 2013 on the self-assessed Research Governance Controls Assurance Standard for 2012/2013. The Audit Report recommended that specific Controls Assurance Standard criteria for 2012/2013 be reviewed and scores adjusted accordingly. The Controls Assurance documentation was reviewed in liaison with Financial Management staff. The revised Self-assessment template and Action Plan was submitted to the Trust on 10 January 2014 with a 1.5 per cent reduction in the level of substantive compliance. See Paragraph 31 for further details.


5.2 Business Services Organisation, Internal Audit – Information Governance 2012/2013

Internal Audit reviewed the Research Governance permissions process as one of eight Departments included in the audit of Information Governance. There was one recommendation for Research and Development to which staff were already in adherence.

6. RESEARCH STAFF

Research staff funded by the HSC Research and Development Division included:

Research and Development Office Associate Medical Director Research and Development Dr Peter Sharpe from 1 July 2008, 2 PAs Research Manager Miss Irene Knox from 1 April 2008 Research Administrator Mrs Valerie Hamilton from 5 January 2009 Administrative Assistant Mrs Mairead McAreavey from 7 June 2010

Pharmacy, Finance and Clinical Research Nurses

Clinical Trials Pharmacist (O.5 WTE) Mrs Roisin McNulty

Finance (0.5 WTE)

Ms Sorcha O’Dowd

Clinical Research Nurses Mrs Michelle Kinnen and Mrs Kate Vernon-Kelly 2 x 0.5 WTE - Cardiovascular Mrs Sara Gilpin and Mrs Judith Ratcliffe 2 x 0.5 WTE - Children’s Mrs Laura Espie 0.5 WTE – Critical Care Mrs Catherine Douglas, Full time – Stroke Mrs Dympna Sands 0.53 WTE – Nephrology Mrs Sharon Carr - 0.5 WTE - Diabetes – Commenced 3 April 2013 Mrs Leanne McCourt, Full time - Cancer – Commenced 27 May 2013

7. PERSONAL AND PUBLIC INVOLVEMENT (PPI) REPRESENTATIVES

The two Personal and Public Involvement (PPI) representatives, Mrs Eileen Wright and Mr Lee Wilson, who became members of the Research Governance Committee in January 2011, continue to make a very valuable contribution to the work of the Committee. These members were recruited by the HSC Research and Development


Division through the Patient Client Council, having expressed an interest in being involved in Research and Development in the Southern Health and Social Care Trust.

7.1 MAPPING COMMUNITY DEVELOPMENT APPROACHES ACROSS THE TRUST

Research and Development contributed to the baseline audit of mapping community development approaches across the Trust. It was highlighted that in recent years there was a requirement for all research applications to have user involvement input from PPI representatives therefore in that respect the PPI membership of the Trust’s Research Governance Committee had been timely. User involvement was an important element of research applications and researchers were required to obtain PPI views.

The input of the PPI members has been very beneficial and brought an added dimension from the user involvement perspective to the Committee which previously comprised of multi-professional members only. The benefits have been enormous through the PPI contribution to the assessment of research applications. In relation to specific research applications, comments and observations made by PPI representatives were conveyed to researchers on behalf of the Research Governance Committee for consideration in their final research documentation. PPI members were involved in all aspects of the Research Governance Committee’s role and function which included membership of a Sub Group to review Research Fund applications and award funding provided by the PHA HSC Research and Development Division. 7.2 PPI INFECTION CONTROL FORUM On 11 December 2013 one of the PPI members of the Research Governance Committee agreed to meet with the PPI representatives on the Infection Control Forum to share their experience of the PPI role.

8. RESEARCH & DEVELOPMENT STRATEGY

The Trust’s Research & Development Strategy, available on the Intranet was based on the regional Strategy for 2007-2012 of the HSC Research and Development Division “Research for Health and Wellbeing”. The aim of the Trust’s Strategy was to build on the existing record of research involvement and to support staff who wished to undertake clinical and social care research to improve the health and wellbeing of patients and clients by increasing the understanding of diagnosis, treatment and prevention of disease. The Trust also wished to support staff undertaking research as part of their academic studies. The Research and Development Strategy was planned to be reviewed when the new Regional Strategy for HSC Research and Development was anticipated to be issued last year. However the Business Services Organisation Internal Audit of Research Governance recommended that the Strategy be revised if only to change the date and contact address. See Paragraph 31 for further details. The Strategy was revised, the


contact address having been correct but other elements of the research governance process which no longer existed were removed because of being replaced by the web-based Integrated Research Application System.

9. POLICY FOR THE MANAGEMENT OF RESEARCH AND DEVELOPMENT

The Policy was reviewed and approved by the Trust’s Scrutiny Committee in June 2011 and can be viewed on the Trust’s intranet. The Policy has been reviewed and will be considered by the Trust’s Scrutiny Committee within the next few months.

10. RESEARCH & DEVELOPMENT ACTION PLAN 2013-2015

The Action Plan (Appendix 7) outlines the main areas of work to be taken forward and the target dates for completion.

Allied Health Professions, Nursing and Social Work continued to be the priority areas in which research has been promoted and encouraged. Presentations were made to specific groups within those disciplines particularly the Senior Nurse Governance Forum and the Allied Health Professions Governance Forum. The appointment of the Head of Nursing, Midwifery and Allied Health Professions Research and Development/Honorary Research Fellow has provided valuable support to those staff groupings and also to other disciplines.

11. KEY PRIORITIES FOR 2013/2014

The key priorities for 2013/2014 included:

Establishing Research & Development as a core function of the Trust.

Supporting and encouraging research in Nursing, Allied Health Professions and Social Work.

Ensuring that Agreements in relation to Collaborative Studies with Industry are agreed and signed-off before Research Governance approval can be issued or Studies commence.

Refining the financial management and reporting arrangements for research income and expenditure to ensure adherence to the requirements of Research Governance Controls Assurance Standards.


Ensuring that activities/issues relating to Research & Development have been brought to the attention of the Medical Director, the Senior Management Team and Trust Board.

Liaising with the Universities in relation to collaborative research studies with the Trust.

Progressing the Trust proposal that a percentage of Charitable Funds received for no specific purpose in the preceeding year be allocated to research.

Encouraging research applications in the area of dementia.

Raising the profile of Research & Development as a means of income generation for the Trust and working with Finance in that respect.

Ensuring all Research & Development staff funded by the HSC Research & Development Division, NI Clinical Research Network have been appointed.

See Appendix 7 – Action Plan 2013-2015 for further details.

11.1 KEY PRIORITIES FOR 2014/2015

The aspiration for 2014/2015 would be for Research and Development to strive to contribute to the Trust being one of excellence with the additional priorities to those for the year 2013/2014 above:-

Improving the quality of research.

Developing collaborative research with the University of Ulster and Queen’s University, Belfast.

Promoting European Funding opportunities and ensuring applications developed and submitted.

Working with Craigavon Borough Council to enhance the research facilities available for Cardiology research at Craigavon Area Hospital and accessing funding opportunities.

12. RESEARCH AND DEVELOPMENT WORKSHOP TO SHOWCASE RESEARCH UNDERTAKEN BY TRUST STAFF

The Annual Workshop to showcase research undertaken by Trust staff in the areas of Adult Safeguarding, Midwifery, Social Care, Short Term Residential Care and District Nursing was held on 12 March 2014 and attended by 34 staff (Appendix 8). The guest speaker was Dr Siobhan McGrath, Office for Research Ethics Committees, Northern Ireland. Dr David Brownlee, HSC Innovations also gave a short presentation.


13. DOCTORAL FELLOWSHIP APPLICATIONS

One member of staff submitted an application for the Doctoral Fellowship funding opportunity available through the HSC Research and Development Division but was not successful.

14. RESEARCH GOVERNANCE PRESENTATIONS

Presentations on the background to Research & Development, the principles of research, the research governance application and permission process were provided for the following groups:-

University of Ulster students (20 June 2013)

Staff Grade Medical staff (6 March 2014)

Glaxo Smith Kline arranged by HSC Innovations (3 October 2013) and

other Trust staff on an as and when required basis

On 21 June 2013 the Medical Director arranged for Associate Medical Directors to make presentations on their respective roles for the Trust Chair and Non-Executive Directors and that included the role of the Associate Medical Director Research and Development.

15. RESEARCH EPS ELECTRONIC DATABASE

All research activity from April 2007 has been entered on the EPS database, the research system provided by HSC Research and Development Division for Trusts in Northern Ireland. A review of the functionality and capability of the EPS system was undertaken by a Working Group of representatives from Trust Research and Development Offices and whilst some refinement has been possible, the system has limitations. 15.1 EDGE DATABASE The EDGE research database, currently in use in some Trusts in England, has been reviewed by the HSC Research and Development Division and some of the Research Managers and agreed as appropriate for use in Northern Ireland. An implementation programme has been developed, introducing the system on a Trust by Trust basis. The system could become operational in the Trust during 2014/2015.


16. HSC TRUST RESEARCH FUNDING

For the sixth consecutive year, HSC Research and Development Division provided the HSC Trust Research Fund of £50,000. The availability of the funding has been invaluable and enabled many research projects to commence with some developing into larger Studies. Ten applications were received for the HSC Trust Research Fund 2013/2014, all of which were awarded funding. The applications were received from Breast Surgery, Clinical Specialist Physiotherapy, Geriatric Medicine/Cardiology, Memory Service, Intensive Care Medicine and Anaesthetics, Occupational Therapy, Nursing, Social Care, Nephrology and Neurology. The Trust’s Report on the HSC Trust Research Fund 2013-2014 prepared for the HSC Research and Development Division has been included in Appendix 11.

In future the focus of the HSC Trust Research funding will be on high quality research studies.


17. HSC RESEARCH AND DEVELOPMENT DIVISION

Trust Research and Development staff work closely with the staff of the HSC Research and Development Division of the Public Health Agency who:

Provide a regional advisory service and strategic direction for Research and Development

Provide advice and guidance on specific programme areas

Fund the Research and Development staff within the Trust

Fund the HSC Trust Research Fund

Fund the Doctoral Fellowship Awards

Provide information on research funding opportunities available throughout Northern Ireland, All Ireland and the United Kingdom - National Institute for Health Research, Medical Research Council etc

Provide information on research related Conferences, Seminars, Workshops

Highlight consultation documents open for comment

Facilitate Regional Research Meetings

Provide assistance with the identification of PPI Representatives

17.1 RETIREMENT – ASSISTANT DIRECTOR HSC RESEARCH AND DEVELOPMENT DIVISION

Dr Michael Neely who established the HSC Research and Development Division retired in June 2013.

17.2 APPOINTMENT – ASSISTANT DIRECTOR HSC RESEARCH AND

DEVELOPMENT DIVISION

Dr Janice Bailie was appointed Assistant Director HSC Research and Development Division and took up post prior to Dr Neely’s retirement.

18. COLLABORATIVE RESEARCH STUDIES WITH INDUSTRY

In order to ensure a process was in place to address the financial and intellectual property issues relating to Collaborative Research Studies with Industry a proforma (Appendix 9) was developed for completion by the Chief Investigator/Principal Investigator signed off by the Company, Management Accountant and Heads of Service for the Departments involved. The information provided would enable the Agreement to be prepared and signed-off by the Trust and the Company as a pre-requisite to Research Governance approval being issued for the research to commence. 18.1 MODEL TEMPLATE AGREEMENT FOR COLLABORATIVE INVESTIGATIONS

INVOLVING MEDICAL DEVICE COMPANIES AND HSC TRUSTS A model Agreement (Appendix 10) was developed by the Trust and a Company with whom collaborative research was being undertaken. The Agreement was drafted in


liaison with the Legal Advisors for the Company and the Trust. On 31 July 2013 the Agreement was issued by PHA HSC Research and Development Division as a model template for use by all Trusts.

19. HSC INNOVATIONS

HSC Innovations provide the innovation management and Intellectual Property (IP) support service to Trusts on a regional basis.

Meetings with Dr David Brownlee, HSC Innovations Advisor took place during the year to review projects and requests from staff in relation to intellectual property/innovation, patents, copyrights, confidentiality disclosure or collaborative agreements. 19.1 GLAXO SMITH KLINE MEETING On 3 October 2013 Glaxo Smith Kline staff met with representatives of Research & Development to obtain information on the research areas of interest within Northern Ireland. At that event Dr Peter Sharpe gave a presentation on the Trust’s research activity.

20. NI CLINICAL RESEARCH NETWORK (NICRN)

The NI Clinical Research Network was established to support the contribution of the clinical research community in Northern Ireland to the work of the UK Clinical Research Collaboration and the associated National Institute for Health Research Clinical Research Network. NICRN aims to increase access to and participation in high quality clinical studies in Health and Social Care in Northern Ireland. Research Managers meet with Dr Paul Biagioni, Senior Manager, NICRN on a regular basis to discuss relevant issues.

The NICRN has funded the following research posts in the Trust to support specific Network adopted Studies:

Cardiovascular Research Nurse Band 6 Mrs M Kinnen 0.5 WTE Mrs K Vernon-Kelly 0.5 WTE

Children Research Nurses Band 6 Mrs S Gilpin 0.5 WTE

Mrs J Ratcliffe 0.5 WTE

Critical Care Research Nurse Band 6 Mrs L Espie 0.5 WTE


Diabetes Research Nurse Band 6 Mrs S Carr 0.5 WTE from 3 April 2013

Renal Research Nurse Band 6 Mrs D Sands 0.53 WTE

Stroke Research Nurse Band 6 Mrs K Douglas 1.0 WTE

20.1 NICRN SPECIFIC INTEREST GROUPS

The Trust has the following representation on the NICRN Specific Interest Groups:

Cardiovascular Dr I Menown

Children Dr M Smith, Director NI Clinical Research Network for Children

Critical Care Dr C Clarke

Dementia Dr S Best

Diabetes Dr M McConnell

Renal Dr N Morgan NI Co-Lead

Respiratory Dr R Convery

Stroke Dr P McCaffrey, Dr M McCormick

21. GOOD CLINICAL PRACTICE (GCP) TRAINING

Since 1 January 2013, e-learning Good Clinical Practice Training has only been available through the National Institute of Health Research, Learning Management System. Access to the e-learning has been funded by the regional HSC Research and Development Division. Information regarding the GCP e-learning (Appendix 12) has been placed on the Trust’s intranet. Whilst GCP Training has been mandatory for staff involved in Clinical Trials research, all staff undertaking research studies have been required to undertake the training.

22. NORTHERN IRELAND CLINICAL TRIALS UNIT (NICTU) FORMERLY CLINICAL RESEARCH SUPPORT CENTRE (CRSC)

The NI Clinical Trials Unit (NICTU) formerly known as the Clinical Research Support Centre is a UK Clinical Research Collaboration (UKCRC) fully registered Clinical Trials Unit with a specific remit to provide support for the design, conduct, analysis and publication of Clinical Trials and other well designed studies.


The NICTU can provide specialist advice, support and training for investigators undertaking research within or of value to Health and Social Care. NICTU has a broad range of research expertise including Trial management, statistics, data management, monitoring and health economics across clinical research in clinical, community and general practice settings.

23. NORTHERN IRELAND CLINICAL RESEARCH FACILITY

The NI Clinical Research Facility (NICRF) was established in 2013 as a joint venture with Belfast Health and Social Care Trust, Queen’s University and the University of Ulster. Funding was provided by the Wellcome Trust and Wolfson Foundation for the state-of-the art facilities which includes ten clinical rooms to support clinical research and is based at Belfast City Hospital.

24. OFFICE FOR RESEARCH ETHICS COMMITTEES NORTHERN IRELAND (ORECNI)

Meetings with Dr Siobhan McGrath, Head of the ORECNI, continue on a yearly basis to discuss general issues relating to research applications and forthcoming changes in relation to ethics. 24.1 GAFREC IMPLICATIONS FOR RESEARCH ETHICS COMMITTEES

Since the introduction of the harmonised edition of the Governance Arrangements for

Research Ethics Committees (GAFREC) issued by the UK Health Departments in

September 2011, certain categories of research studies are exempt from HSC/NHS

Research Ethics Review as follows: those only involving staff as research participants

(by virtue of their professional role) e.g. focus groups; those using HSC premises only;

those involving use of anonymised data previously collected in the course of normal

care; those using anonymised acellular material (e.g. plasma, serum, DNA,) extracted

from tissue previously collected in the course of normal care; those using previously

collected tissue or cellular material within the terms of research consent (provided a

Research Licence from the Human Tissue Authority was in place).

24.2 PROPORTIONATE REVIEW SERVICE The Proportionate Review Service introduced by the Research Ethics Service allows for the expedited proportionate review of research studies which raise no material ethical issues i.e. minimal risk, burden or intrusion for research participants. Such studies would include anonymous tissue studies and non-sensitive questionnaire and interview studies. Applications meeting those criteria would be reviewed by a Sub Committee rather than a full Research Ethics Committee with the aim of notifying the final decision to the applicant within 14 calendar days of receipt of a valid application.


25. NI CANCER CLINICAL TRIALS NETWORK

Trust staff met with Senior Managers from the NI Cancer Trials Network on 14 May 2013 and 12 November 2013 to update on on-going and planned Clinical Trials, research governance approvals, local challenges and manpower issues. 25.1 APPOINTMENT OF CANCER RESEARCH NURSE On 27 May 2013, Mrs Leanne McCourt took up post as the full time Band 6 Cancer Research Nurse funded through NICTN by the HSC Research & Development Division and Cancer Research UK. 25.2 TRAINING OPPORTUNITY AT THE NATIONAL CANCER INSTITUTE, USA Mrs Leanne McCourt was advised on 19 March 2014 that she was successful in being selected to attend the four week training “Principles and Practice of Cancer Prevention and Control” funded by the Health Research Board and the PHA Health and Social Care Research & Development Division. The training will take place in July 2014 and will provide specialised instruction on the principles and practice of cancer prevention control.

26. LIFE SCIENCES LINK WITH CRAIGAVON BOROUGH COUNCIL

Craigavon Borough Council had identified the Life Sciences as a key growth sector for the Borough Council area and invited the Trust and other relevant organisations to meet and discuss potential opportunities. As a result the Cardiology, Commerce and Collaboration Conference was held on 8 February 2013. 26.1 DELEGATION VISITS Since the Conference two delegation visits have been hosted by Invest NI and Craigavon Borough Council which incorporated Cardiology Research, Craigavon Area Hospital in their visits:-

26.1.1 MASSACHUSETTS DELEGATION On 17 May 2013 the delegation met at Craigavon Area Hospital and had a session chaired by Dr David McEneaney, Director of Cardiovascular Research and a ‘Live Link’ to the Cardiology Cath Lab where Dr Ian Menown, Director of Interventional Cardiology performed a live case on the insertion of a stent.

26.1.2 ASIA PACIFIC DELEGATION The delegation was comprised of representatives from the Life Sciences sector in Asia Pacific countries such as Australia, China, India, Japan, Malaysia, New Zealand, Singapore, Taiwan, Pakistan, South Korea, Thailand and Vietnam. Dr


Peter Sharpe, Associate Medical Director Research and Development provided background to the on-going research in the Trust. Dr David McEneaney, Consultant Cardiologist and Dr Ian Menown gave presentations on the innovative research collaborations already in place in Cardiology at Craigavon Area Hospital and outlined opportunities available for extension of those collaborations.

26.2 WORKSHOP – AUTUMN 2014 The link with Craigavon Borough Council has been maintained and opportunities for working together developed. Plans were being developed for a Workshop in the Autumn of 2014 as a follow up to the Cardiology, Commerce and Collaboration Conference involving small to medium sized enterprises.

26.3 NI LOCAL GOVERNMENT ASSOCIATION AWARDS – BEST JOINT INITIATIVE FOR CRIAGAVON AS A CENTRE OF EXCELLENCE FOR LIFE SCIENCES

Craigavon Borough Council was one of 22 entrants for the award for the best joint initiative as a Centre of Excellence for Life Sciences based on their involvement with the Trust. Despite the high level of competition the Council was shortlisted to the final three with the winner being Fermanagh District Council in relation to the G8 Summit.

27. REGIONAL RESEARCH GROUPS

The Associate Medical Director Research & Development represented the Trust on the following Regional Groups:

Research Strategic Advisory Group

Research Directors Group

Honest Broker Governance Board – From December 2013 (Research Manager as Deputy)

The Research Manager represented the Trust on the Regional Groups:

Research Governance Operational Sub Group

Research Managers Forum The Associate Medical Director Research & Development and Research Manager are both members of the Trust’s Information Governance Forum. The Research Manager has been a member of the Trust’s Capital Allocations Group since December 2013.


28. RESEARCH AND DEVELOPMENT INPUT TO TRUST

28.1 TRUST BOARD WORKSHOP

On 12 December 2013 the presentation of the Research and Development Annual Report for 2012/2013 was made by Dr Peter Sharpe, Associate Medical Director Research & Development. Dr Ian Menown, Consultant Cardiologist also made a presentation on his proposed research on renal denervation. The following were the outcomes of the Workshop.

28.1.1 PERCENTAGE OF CHARITABLE FUNDS FOR RESEARCH

The Chief Executive advised that the Senior Management Team proposed to allocate a percentage of Charitable Funds for the preceeding year not identified for any particular service area to research. The proposal would be considered by the Endowments and Gifts Committee.

28.1.2 RESEARCH COLLABORATION WITH UNIVERSITIES

The Chief Executive said she had meetings with Queen’s University and the University of Ulster and both Universities were interested in research collaboration with the Trust; geographical proximity was not a barrier. The Medical Director and Associate Medical Director Research & Development were asked to meet with both Universities to follow up. See Paragraphs 29.1 and 29.2 for details of those meetings.

28.1.3 RESEARCH IN THE AREA OF DEMENTIA

It was suggested that research in the area of Dementia should be encouraged given the increase in prevalence. Since that Workshop the PHA Research and Development Division and Atlantic Philanthropies issued a call for commissioned research applications in the area of Dementia which was promoted throughout the Trust. It was hoped that there would be joint applications between the Trust and the Universities.

28.2 OTHER RESEARCH & DEVELOPMENT CONTRIBUTIONS WITHIN THE TRUST During the year Research and Development contributed to the following:-

Monthly input to Medical Director’s Report for Trust Board meetings

Section 75 Annual Progress Report for Research and Development


Web-based Medical Induction Programme for Junior Doctors in the Emergency Management arrangements of patients enrolled in Clinical Trials being admitted to Hospital (Appendix 13)

Continuous Improvement Newsletter – Improving the Trust’s response to Adult Safeguarding situations – Article on research undertaken by Mrs Patricia Trainor, Head of Adult Safeguarding

28.3 PROMOTION OF SOCIAL CARE RESEARCH The Associate Medical Director and Research Manager in wishing to promote Social Care Research in the Trust met with –

Ms Anne McGlade, Social Care Lead, Health and Social Care Board, Social Care and Children’s Directorate on 12 November 2013 along with Ms Francesca Leyden, Assistant Director Social Work.

Dr Ruth Carroll, Programme Manager (Social Care Lead), PHA Research and Development Division on 9 December 2013.

29. COLLABORATIVE RESEARCH WITH UNIVERSITY OF ULSTER AND QUEEN’S UNIVERSITY BELFAST The Medical Director, Associate Medical Director Research & Development and Research Manager, at the suggestion of Trust Board had the following meetings when presentations were made on the research background within the Trust.

29.1 UNIVERSITY OF ULSTER A meeting with Professor Hugh McKenna, Pro Vice-Chancellor took place on 4 February 2014 who confirmed the University of Ulster was interested in being involved in such research and provided a number of contacts of Professors in Schools within the University. There had been a follow up with the Professors and a meeting with Professor Gerard Leavey, Director Bamford Centre for Mental Health & Wellbeing took place on 3 March 2014 involving the Associate Medical Director for Mental Health and Learning Disability (Dr Neta Chada) and Consultants in Mental Health (Dr Michelle Gilmour and Dr Jo Minay). 29.2 QUEEN’S UNIVERSITY BELFAST A meeting with Dr Dermot Leonard, Head of Business Alliance and Mrs Louise Dunlop, Head of Research Governance took place on 31 March 2014. Opportunities for collaborative research were discussed and it was suggested that the possibility of a Joint Appointment with the Trust may be considered within the University.


30. FUNDING OPPORTUNITIES

30.1 EUROPEAN FUNDING

In accordance with the regional priority accorded to European Union Funding all opportunities to become involved in applications and partnerships continued to be promoted throughout the Trust. Support was provided to interested staff groups to become involved in EU funding application proposals. The Associate Medical Director Research & Development and Research Manager met with the following in relation to EU Funding:

Dr Gillian Rankin on behalf of the Health and Social Care Board on 3 June 2013.

Dr Shirley Davey who had been appointed to assist Trusts and Universities in relation to EU applications on 17 September 2013.

30.1.1 EU FUNDING – SOCIAL POLICY EXPERMINENTATIONS –‘PROGRAMME FOR EMPLOYMENT AND SOCIAL SOLIDARITY – PROGRESS’

A successful application for EU Funding was submitted by Nottingham Trent University, Stoke Council and the Trust which was awarded 1.1 million Euros. The Trust received 83,913 Euros for the employment of a Change Coordinator for a period of eighteen months. The associated research planned to commence later in 2014 would examine the retention of midwifery staff in the final years of working to prevent the loss of crucial knowledge, skills and experience.

30.1.2 EUROPEAN REGIONAL DEVELOPMENT FUNDING(ERDF)

European Regional Development funding, although not normally available for research, had some slippage funding for which Trusts were asked to submit applications. Three applications were submitted and funded awarded for the following:-

A Minus 80C freezer for use in relation to renal research studies - £10,668 (Dr Neal Morgan, Consultant Nephrologist)

A Gold Standard Electrical Impedance Spectroscopy (EIS) System for Advanced Cardiac Tissue Characterisation Research – 72,000 Euros (Dr David McEneaney, Consultant Cardiologist)

Renal Denervation Catheters - £256,000


(Dr Ian Menown, Consultant Cardiologist)

30.1.3 DHSSPS SLIPPAGE CAPITAL FUNDS

Opportunity was given to Trusts to submit applications for funding for research related bids from Department Capital Funds. On 7 October 2013 confirmation was received that all applications had been funded which included the following:

Testing and recording equipment related to electrical impedance spectroscopy (Cardiovascular research) - £112,132

(Dr David McEneaney, Consultant Cardiologist)

Optical coherence imaging (Cardiovascular research) - £42,000 (Dr Ian Menown, Consultant Cardiologist)

ORDEALS – Organ Dysfunction in Emergency Abdominal Surgery (Anaesthetics and Intensive Care Medicine Research) - £10,000 (Dr Andrew Ferguson, Consultant in Anaesthetics and Intensive Care Medicine)

RT4 Novacor Monitors – Comparison of non-invasive algorithm recognition monitoring with conventional investigations (Atrial Fibrillation Research) - £10,000 (Dr Michael McCormick, Consultant Geriatrician)

Bar code scanner to examine the novel use of scanning to assist with data collection (Stroke Care Research) - £9,700 (Dr Michael McCormick, Consultant Geriatrician)

31. BUSINESS SERVICES ORGANISATION – AUDIT OF RESEARCH

GOVERNANCE 2012/2013

In June 2013 Research & Development were advised that an Audit of Research Governance would be carried out in July 2013. The audit process commenced on 2 July 2013 undertaken by two Auditors for a period of eight days. Each Auditor reviewed ten files. Closed Records store research files were reviewed as were the Controls Assurance Standards files for 2012/2013. Auditors also met with a number of staff involved in research. A verbal report of the Audit was provided on 28 August 2013 with the first draft Report issued on 3 October 2013 and the final revised version received on 10 December 2013.

The Audit Report provided satisfactory assurance on the system of internal control over

Research Governance on the basis that the majority of controls tested had operated satisfactorily during the period under review. There were no issues arising in the testing carried out on sponsorship, research misconduct, intellectual property and public


involvement. However a number of issues were highlighted which have been addressed and included the following with the action taken detailed after each:

The absence of signed Agreements for three collaborative research studies involving Industry. It was acknowledged that there had been protracted negotiations about these particular Agreements involving the Trust’s Legal Advisors and also the Legal Advisors of the Companies.

Action: Two of the three Agreements have been signed off with the third in the final stages of completion. Also arrangements have been in place since July 2013 to ensure that in future Agreements will be finalised and signed-off before Studies commence. Issues regarding study design, Protocol/Clinical Investigation Plan, Intellectual Property Clauses and Costings having been discussed and agreed by the Chief Investigator/Principal Investigator, HSC Innovations, the Company, Management Accounts and the Head of Services of each Department involved in the Study. See Appendix 9 for the associated Collaborative Studies with Industry proforma.

A number of issues were raised in relation to the raising of invoices and the receipt of income for research activity also Principal Investigators must be responsible for invoicing in accordance with Study Agreements.

Action: A revised Invoice Request Form specifically for Research was developed and agreed with Financial Management and issued to all staff involved in the invoicing process for research Studies. A copy is included in Appendix 14. On 12 April 2013 an Awareness Session for Clinical Research Nurses was facilitated by Financial Management and included the Invoicing Process etc. See Appendix 15.

The Trust Research and Development Strategy required updating although it was acknowledged that the new Regional Strategy which would influence the content was awaited.

ACTION: The Trust Research and Development Strategy has been updated.

Although research incidents were notified to Research & Development by the Principal Investigator and reported to the Research Governance Committee there was a risk of under reporting. The DATIX system was not currently utilised to produce a Research Incident Report and a central record was not maintained by the Research & Development Office; incidents were recorded in specific Study files.

ACTION: The DATIX IR2 within the Coding Section of the DATIX system now included the question “Is this a Research incident” and “If so, please contact Dr Peter Sharpe or Irene Knox, Research Office, Telephone 3861 2657 or 3861 4274”. Also all research related incidents have been included in an Incidents Register for Research which has been established and will be maintained by Research & Development.


In relation to the Controls Assurance Standard for Research Governance there was a need to develop, formalise and report on Key Performance Indicators in relation to Research Governance.

ACTION: In the absence of Key Performance Indicators being accessible for Research Governance, Key Performance Indicators were developed for the Trust and approved by the Research Governance Committee on 11 December 2013 (Appendix 18). The Key Performance Indicators were based on the criteria within the Controls Assurance Standard for Research Governance. Key Performance Indicators have been prepared for each Research Governance Committee meeting since then and will be a standing item on the agenda for all future meetings. The content of the Key Performance Indicators will be reviewed on an annual basis.

Research & Development should have a Risk Register.

ACTION: A Risk Register for Research has been established and will be maintained by Research & Development.

Research Governance Controls Assurance Standards for 2012/2013 should be updated to reflect the issues contained in the Audit Report.

ACTION: A meeting was held with Financial Management staff on 10 January 2014 to review and agree the revision of the Controls Assurance Standard for Research Governance documentation for 2012/2013 based on the issues which had been raised in the Audit Report. The revised Self-assessment template and Action Plan was submitted to the Trust on 10 January 2014 with a 1.5 per cent reduction in the level of substantive compliance.

32. HONEST BROKER GOVERNANCE BOARD The Honest Broker Governance Board was established late in 2013 comprised of representatives Trusts (Dr Peter Sharpe being the Trust’s representative), Business Services Organisation who delivered the Honest Broker Service, the Department’s Information Analysis Department, Health and Social Care Board, Public Health Agency, Patient Client Council, Office from Research Ethics Committees NI. The Honest Broker Governance Board have responsibility for considering the appropriateness of Health and Social Care related research applications for access to pre-existing anonymised data held within the Regional Data Warehouse at the Business Services Organisation. These arrangements should facilitate access to anonymised data for ethically approved Health and Social Care related research purposes.



APPENDICES


APPENDIX 1

RESEARCH GOVERNANCE COMMITTEE MEMBERSHIP

Membership revised 14 March 2014 Chairman:

Dr Peter Sharpe (Chairman) Consultant Chemical Pathologist, Associate Medical Director Research and Development

Committee Members:

Mrs Debbie Burns, Interim Director of Acute Services

Mr Barry Conway, Acting Assistant Director of Acute Services, Medicine and Unscheduled Care

Dr Ivor Crothers, Consultant Clinical Psychologist, Area Brain Injury Team

Mr Dean Faloon, Financial Management Accountant

Dr Patricia Gillen, Head of Nursing and Allied Health Professions Research and Development/Honorary Research Fellow

Dr Stephen Hall, Associate Medical Director Cancer and Clinical Services

Mrs Carmel Harney, Assistant Director AHP Governance

Miss Irene Knox, Research Manager

Ms Francesca Leyden, Assistant Director Social Work

Dr David McEneaney, Consultant Cardiologist

Dr Roisin McNulty, Clinical Trials Pharmacist

Mrs Margaret Marshall, Acting Assistant Director Governance

Dr Neal Morgan, Consultant Nephrologist

Dr Andrew Moriarty, Research Cardiologist

Mr Gerard Rocks, Acting Assistant Director Promoting Well-Being

Dr John Simpson, Medical Director

Mr Lee Wilson, Personal and Public Involvement Representative

Mrs Eileen Wright, Personal and Public Involvement Representative

Mrs Fiona Wright, Assistant Director Nurse Governance

Information to:

Dr Tracey Boyce, Director of Pharmacy Services


APPENDIX 2

RESEARCH GOVERNANCE COMMITTEE TERMS OF REFERENCE

The Terms of Reference of the Research Governance Committee are to: 1. Promote, encourage and support research with all staff in the Trust 2. Consider all research proposals received (following initial screening against the

Research Management System by the Medical Directorate), and make appropriate decisions with regard to approval

3. Agree a process to consider appeals made by researchers/chief investigators for

research proposals which have been declined by the Committee 4. Quality assure and sign-off research governance monitoring outputs prior to

consideration by the Trust Governance Committee 5. Promote and encourage a multidisciplinary research culture in the Trust and with

other agencies, which will secure implementation of policies and procedures for effective research management and enable the creation of new knowledge and implantation of existing knowledge for the good of current and future patients/clients

6. Support the identification of research training needs of staff in the Trust and

seek to ensure that these are met 7. Liaise with outside bodies that have a statutory or advisory role in research

matters including the Research & Development structures within the HPSS in Northern Ireland

8. Monitor funding from commercial and non-commercial funders and ensure that

all research funding within the Trust is managed to a high standard of cost-effectiveness and accountability to the public.


APPENDIX 3

Advice to Researchers

Contact the Research & Development Office for assistance and guidance regarding your research application.

Become familiar with the on-line Integrated Research Application System for all permissions and approvals by registering on the IRAS website and undertaking the e-learning module.

www.myresearchproject.org.uk

For research involving more than one

Trust:

Contact a Trust to undertake the role of Lead Trust

Forward complete application to Research Gateway for issue to all participating Trusts. Contact email address is:

[email protected]

Telephone 028 7161 1126

Contact Details Southern Health & Social Care Trust Research & Development Office The Ramone Building Craigavon Area Hospital 68 Lurgan Road Portadown BT63 5QQ

Director Research & Development Dr Peter Sharpe Tel: 028 3861 2657 [email protected]

Research Manager Miss Irene Knox Tel: 028 3861 4274 [email protected]

Head of Nursing and Allied Health Professions Research and Development/Honorary Research Fellow Dr Patricia Gillen Tel: 028 3883 3252 [email protected]

Other Trust Research Managers: [email protected] [email protected] [email protected]

[email protected]

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http://www.myresearchproject.org.uk/










Research is defined as a systematic

activity which:

Attempts to answer a clearly

defined question

Employs systematic and rigorous

methods including quantitative

and/or qualitative paradigms

Leads to generalisable and new

knowledge

Advantages of Research

Improves clinical outcomes/quality

of care

Majority of new devices have

emanated from healthcare

research

Raises standards of practice by

participation in

national/international studies

Enhances an enquiring, analytical,

evidence based approach to all

clinical and social care

interventions/treatments

Enhances the recruitment and

retention of high quality staff

Research Governance Framework for Health and Social Care February 2007 www.dhsspsni.gov.uk/research_ governance_ framework.pdf

Framework for the governance of

research conducted by or on behalf of Health & Social Care Trusts

Health and Social Care Trusts must have systems in place to ensure principles and requirements of framework are consistently applied

Framework

- brings together general principles of good practice

- is of direct relevance to all those who host, conduct, participate in, fund and manage Health and Social Care research

- seeks to promote improvements in research quality

- aims to prevent poor performance, adverse incidents, research misconduct and fraud and to ensure lessons are learned and shared.

Research Governance focuses on five main areas:

Ethics

Science

Information

Health & Safety and Employment

Finance and Intellectual Property


APPENDIX 4

RESEARCH APPLICATIONS 2013/2014

Ref Number

Study Title

ST1314/01 The role of Emotional Intelligence on disordered eating attitudes and behaviours, low self-esteem and health literacy

ST1314/02 An evaluation of self-efficacy and fear avoidance and its impact upon pain management programme participants: Can we predict attrition rates?

ST1314/03 OneShot Registry ST1314/04 Caring for patients with Multiple Sclerosis in the Community: the

perceptions of District Nurses ST1314/05 A pragmatic randomised controlled trial comparing the effectiveness and

cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs

ST1314/06 A randomised phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast

ST1314/07 The Experiences of HSC Services of People with Long-Term (Chronic) Pain

ST1314/08 UK Childhood ITP (Immune Thrombocytopenic Purpura) Registry ST1314/09 Light therapy to reduce fatigue in adolescent survivors of traumatic brain

injury (TBI) ST1314/10 Validation of biomarkers in the diagnosis of early kidney transplant

complications and the prediction of chronic kidney transplant dysfunction ST1314/11 Defining normal bone turnover by mortality risk: a new look at bone

alkaline phosphatase in haemodialysis patients ST1314/12 Epilepsy Pharmacogenomics (EpiPGX): Genome-based biomarker

discovery for valproate teratogenesis ST1314/13 Assessment of an Education and Guidance programme for Eliquis

Adherence in Non-Valvular Atrial Fibrillation ST1314/14 PAndemic INfluenza Triage in the Emergency Department ST1314/15 XANTUS: Xarelto on prevention of stroke and non-central nervous

system systemic embolism in patients with non-valvular atrial fibrillation: A non-interverntional study

ST1314/16 A Post Marketing Multicentre, Single Arm, Observational Clinical Registry to Evaluate Safety and Efficacy of BioMime Sirolimus Eluting Stent System in All Corners Real World Population With Coronary Artery Stenosis in the United Kingdom

ST1314/17 Restart or Stop Antithrombotic Randomised Trial ST1314/18 Can a template improve the Jensen Hand Function Test?


Ref Number

Study Title

ST1314/19 James Lind Alliance Intensive Care Research Priority Setting Partnership Project

ST1314/20 Natural History Study of the Development of Type 1 Diabetes ST1314/21 Multi-centre, Prospective, Clinical Outcomes after Deployment of the

Alumina Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) Post Market Registry

ST1314/22 European Transfusion Practice and Outcome Survey. An observational outcome study of transfusion practice in surgical patients (excluding cardiothoracic surgery) throughout Europe

ST1314/23 A randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in women with early breast cancer

ST1314/24 A study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis

ST1314/25 A registry of high risk patients with coronary or peripheral artery disease ST1314/26 Northern Ireland Human Rights Commission: Provision of an evidence

base regarding how the right to family life of children on the edge of care, or cared for within the Care System is protected and promoted within Northern Ireland

ST1314/27 An evaluation of home-based rehabilitation for older persons in comparison with rehabilitation in other settings

ST1314/28 FOCUS4 - Molecular selection of therapy in colorectal cancer: a molecularly stratified randomised controlled trials programme

ST1314/29 Prospective observational study of the long term hazards of anti-TNF therapy in Rheumatoid Arthritis

ST1314/30 An examination of the person-centeredness of current workplace culture in clinical settings in Northern Ireland

ST1314/31 The musculoskeletal consequences of breast reconstruction using the latissimus dorsi muscle

ST1314/32 Transitions and outcomes for care leavers with mental health needs and/or intellectual disabilities.

ST1314/33 Normal Birth Research - Focus Groups ST1314/34 Identification of Molecular Biomarkers to Neo-adjuvant chemotherapy in

early stage Oesophageal Adenocarcinoma ST1314/35 Barriers to good transitional Diabetes Care in UK Universities ST1314/36 Examining the differences in how residential facilities support people with

intellectual disabilities with challenging behaviour and/or mental health problems

ST1314/37 EQUAL: The European Quality Study on treatment in advanced chronic kidney disease

ST1314/38 Enlighten European Observational Study


Ref Number

Study Title

ST1314/39 Organ Dysfunction and Endothelial Glycocalyx Shedding after Emergency Abdominal Surgery

ST1314/40 A randomized controlled trial of Rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS outcomes for people using Anticoagulation)

ST1314/41 Role of Active Deresuscitation After Resuscitation (RADAR) in Intensive Care Unit Patients

ST1314/42 Improving mental health pathways and care for adolescents in transition to adult services in Northern Ireland (IMPACT)

ST1314/43 Building reflective practice in Social Work through Action Learning ST1314/44 Fluid Strategies and Outcomes in Critically Ill Patients: a Systematic

Review and Meta-Analysis ST1314/45 Prevention of Thromboembolic Events - European Registry in Venous

Thromboembolism. ST1314/46

Serelaxin when added to standard therapy in acute heart failure ST1314/47 Tackling early Morbidity and Mortality in myeloma: assessing the benefit

of antibiotic prophylaxis and its effect on healthcare associated infections

ST1314/48 Quality of life in older heart failure patients initiated on Ivabradine in the UK

ST1314/49 A First In Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF5633 (Synthetic Surfactant) in Preterm Neonates with Respiratory Distress Syndrome

ST1314/50 TIGRIS: LongTerm rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post myocardial infarction patients

ST1314/51 An Epidemiological ASD Study and establishing a Research Database ST1314/52 Midwives experiences of caring for the critically ill mother in delivery

suite ST1314/53 Domestic violence and women with learning disabilities ST1314/54 Febuxostat versus Allopurinol Streamlined Trial (FAST): A prospective,

randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating the long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia

ST1314/55 Examining the use of a nursing quality indicators (NQIs) framework in evidencing the impact of nursing on patient safety outcomes and the patient experience in adult in-patient wards of a Health and Social Care (HSC) Trust in Northern Ireland

ST1314/56 Effectiveness of compression clothing to enhance sensory Input and improve task performance in adults with Learning Disability

ST1314/57 Learning Disability


Ref Number

Study Title

ST1314/58 Safety and tolerability of clopidogrel when added to aspirin and dipyridamole in high risk patients with recent ischaemic stroke: a randomised controlled trial

ST1314/59 Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

ST1314/60 Conceptualising the experiences of family members who support young intellectually disabled individuals into ‘adulthood’

ST1314/61 Transition to adult services by young people with life-limiting conditions in Belfast and Dublin: a realist evaluation using mixed methods

ST1314/62 Inpatient suicide whilst under non-routine observation

ST1314/63 Stories from people with Fibromyalgia: insights from narrative analysis ST1314/64 An Evaluation of a pilot contact service for families, who are subject to

Court and Child Protection proceedings in a Trust area in Northern Ireland; through exploration of the perceptions of the stakeholders.

ST1314/65 SEM on Qualitative Data ST1314/66 Epigenetics and outcomes in Kidney transplantation ST1314/67 Factors that enhance the quality of professional social work supervision

within integrated care teams within the DMHD and OPPC in Southern Health and Social Services Trust

ST1314/68 Assessment of Interventricular Mechanical Dyssynchrony measured by Echocardiography as a quantitative tool in the stratification in Heart Failure patients undergoing Cardiac Resynchronisation Therapy

ST1314/69 Decision-making around medication use in patients with dementia at the end of life: the physician’s perspective

ST1314/70 Pain assessment and management for patients with advanced dementia nearing the end of life: PHASE ONE

ST1314/71 A Nationwide Register of first degree relatives of patients with Rheumatoid Arthritis to evaluate predictors of the development of Rheumatoid Arthritis

ST1314/72 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

ST1314/73 Northern Ireland Baby Hearts Study: a case control study of risk and protective factors for congenital heart disease

ST1314/74 Midwives’ Views On Interprofessional Working Within The Intrapartum Setting

ST1314/75 Feeding and Autoimmunity in Down's Syndrome Evaluation Study ST1314/76 Analysis of AF Cardioversion Waveforms for Optimised Treatment

Protocols. ST1314/77 Development of a diagnostic assay to predict response to a drug

approved for the treatment of ulcerative colitis


Ref Number

Study Title

ST1314/78 Training follow up of the CAWT Leadership Development Programme for Social Work Team Leaders and the Regional Professional Supervision Programme

ST1314/79 Adolescent Health Care & Transition ST1314/80 Intensive Care Over Nations


APPENDIX 5

AMENDMENTS TO RESEARCH APPLICATIONS 2013/2014

Ref Number

Study Title

ST0910/44 A study of adjuvant chemotherapy in colorectal cancer by the CaCTUS and OCTO groups (SCOT)

ST0809/25 UK Genetics Prostate Cancer Study: Epidemiology and Molecular Genetics Studies

ST0910/08 Trial of Perioperative Endocrine Therapy - Individualising Care (POETIC)

ST0910/44 A study of adjuvant chemotherapy in colorectal cancer by the CaCTUS and OCTO groups (SCOT)

ST0910/58 A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction (PARADIGM)

ST1011/09 FRAGMATIC: A randomised phase III clinical trial investigating the effect of Fragmin added to standard therapy in patients with lung cancer

ST1011/10 SOS: The Stroke Oxygen Study

ST1011/11 I2S2 A Randomised Trial of Iodine Supplementation in Preterm Infants with Follow-up at 2 Year

ST1011/43 Syndromic epilepsy and learning disability: characterisation of phenotype and detection of pathogenic genomic copy number.

ST1112/03 REMODL-B: A Randomised Evaluation of Molecular guided therapy for Diffuse Large B-cell Lymphoma with Bortezomib

ST1112/05 Identification of Major Susceptibility Genes for Eczema and Food Allergy

ST1112/25 NGAL (Neutrophil Gelatinase Associated Lipocalin) as a predictor of Acute Kidney Injury post coronary angiogram

ST1112/33 International Cancer Benchmarking Partnership: Root Causes of diagnosis and treatment delays in breast, lung, colorectal and ovarian cancer

ST1112/39 A Prospective Exploration of the Experience of Continence Services in People with Multiple Sclerosis With a Primary Focus on the Factors Affecting the Continuity of Use of Intermittent Self-Catheterisation

ST1112/50 A Randomised Controlled Trial Evaluation of the Effectiveness of the Letterbox Club in Improving Educational Outcomes among Children Aged 7 – 11 Years in Foster Care in Northern Ireland


Ref Number

Study Title

ST1112/54 DARS - Dopamine Augmented Rehabilitation in Stroke: Does Co-careldopa treatment in combination with routine NHS occupational and physical therapy, delivered early after stroke within a stroke rehabilitation service, improve functional recovery including walking ability and arm function?

ST1213/16 National Study of Hodgkin's Lymphoma Genetics

ST0809/07 IMPROVE IT: A multicentre, double-blind, randomised study to establish the clinical benefit and safety of Vytorin ((No Suggestions) Tablet) vs Simvastatin Monotherapy in high-risk subjects presenting with Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial)

ST0910/08 POETIC: Trial of Perioperative Endocrine Therapy - Individualising Care

ST1011/07 RAD001: A randomized double-blind placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC or Sporadic Lymphangioleiomyomatosis (LAM).

ST1112/03 REMODL-B: A Randomised Evaluation of Molecular guided therapy for Diffuse Large B-cell Lymphoma with Bortezomib

ST1112/33 International Cancer Benchmarking Partnership: Root Causes of diagnosis and treatment delays in breast, lung, colorectal and ovarian cancer

ST1112/35 BIOTRONIK - Safety and Performance Registry for an allcomers patient population with the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III

ST1112/48 A Qualitative exploration of the experience of Parents whose child has availed of Frontline Fostering Service in the SHSCT

ST1213/08 Living with and beyond Prostate cancer - A study of the impact on men of increased and variable investigation and treatment of prostate cancer in the Island of Ireland - Prostate investigations study

ST1213/11 Development of a bronchiectasis-specific intervention focusing on adherence to treatment in bronchiectasis

ST0910/58 PARADIGM: A multicentre, randomized double-blind, parallel group. Active-controlled study to evaluate the efficacy and safety of LCZ696 compared to Enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction

ST1011/05 FH02: Mammographic Surveillance in Women Aged 35-39 Years and Enhanced Familial Risk of Breast Cancer

ST1011/11 I2S2: A Randomised Trial of Iodine Supplementation in Preterm Infants with follow-up at 2 Years


Ref Number

Study Title

ST1011/61 TRANSCRIPT: A Study to assess the incidence of mutations in the tyrosine kinase domain of the epidermal growth factor receptor in UK patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer and to investigate the quality of life of these patients undergoing first-line monotherapy with Erlotinib (Tarceva®).

ST1112/23 CAD: Efficacy Of Ranolazine In Patients With Coronary Artery Disease.

ST1213/08 Living with and beyond prostate cancer: A study of the impact on men of increased and variable investigation and treatment of prostate cancer in the Island of Ireland – Prostate Investigations Study

ST0809/07 IMPROVE IT: A multicentre, double-blind, randomised study to establish the clinical benefit and safety of Vytorin ((No Suggestions) Tablet) vs Simvastatin Monotherapy in high-risk subjects presenting with Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial)

ST0809/48 PANDA: A prospective study exploring risk factors associated with fetal macrosomia and women's experiences of delivering a large for gestational age infant - "Physical Activity Nutrition and Development Antenatally".

ST0910/56 SIGNIFY: Effects of Ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised Double-Blind Placebo-Controlled International Multicentre Study. Study assessing the morbi-mortality benefits of the If inhibitor Ivabradine in patients with coronary artery disease.

ST1011/11 I2S2: A Randomised Trial of Iodine Supplementation in Preterm Infants with Follow-up at 2 Years

ST1011/50 PEGASUS: A Randomised, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

ST1213/08 Living with and beyond prostate cancer: A study of the impact on men of increased and variable investigation and treatment of prostate cancer in the Island of Ireland.

ST1213/47 Looking at retirement options for adults with intellectual disabilities

ST1314/24 PD-CRAFT A study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis

ST0910/04 BADBIR: British Association of Dermatologists Biological Intervention Register


Ref Number

Study Title

ST1011/50 PEGASUS: A Randomised, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

ST1112/35 BIOTRONIK - SaFety and Performance Registry for an allcomers patient population with the Limus Eluting Orsiro Stent System Within daily clinical practice – III

ST1213/11 Development of a bronchiectasis-specific intervention focusing on adherence to treatment in bronchiectasis

ST1213/48 GLORIA: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients with Atrial Fibrillation

ST1314/03 OneShot Registry

ST0910/56 SIGNIFY: Effects of Ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised Double-Blind Placebo-Controlled International Multicentre Study. Study assessing the morbi-mortality benefits of the If inhibitor Ivabradine in patients with coronary artery disease.

ST0910/58 PARADIGM: A multicentre, randomized double-blind, parallel group. Active-controlled study to evaluate the efficacy and safety of LCZ696 compared to Enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction

ST1011/09 FRAGMATIC: A randomised phase III clinical trial investigating the effect of Fragmin added to standard therapy in patients with lung cancer

ST1011/11 I2S2 A Randomised Trial of Iodine Supplementation in Preterm Infants with Follow-up at 2 Years

ST1112/44 PREDNOS: Long-term tapering versus standard prednisolone (steroid) therapy for the treatment of the initial episode of childhood nephrotic syndrome: national multicentre randomised double blind trial.

ST1213/18 The Impact of Caring for Animals on Adults with a Learning Disability

ST1213/44 PAIGE: A Postnatal lifestyle intervention programme for overweight women with previous gestational diabetes mellitus (PAIGE)

ST1314/19 JLA: James Lind Alliance Intensive Care Research Priority Setting Partnership Project.

ST1314/24 PD Craft: A study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis.

ST1314/59 Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

ST1314/17 Restart or Stop Antithrombotics Randomised Trial


Ref Number

Study Title

ST0809/57 PC-1: Primary Thrombocythaemia 1 - ‘A randomised trial to compare Aspirin versus Hydroxyurea / Aspirin in Intermediate Risk Primary Thrombocythaemia and Aspirin only with observation in Low Risk Primary Thrombocythaemia

ST0910/40 NOBLE: Coronary Artery Bypass Grafting versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis

ST0910/44 SCOT: A study of adjuvant chemotherapy in colorectal cancer by the Cactus and Octo Groups

ST1011/61 TRANSCRIPT: A Study to assess the incidence of mutations in the tyrosine kinase domain of the epidermal growth factor receptor in UK patients with newly diagnosed locally advanced or metastatic non-small cell lung cancer and to investigate the quality of life of these patients undergoing first-line monotherapy with Erlotinib (Tarceva®).

ST1112/54 DARS - Dopamine Augmented Rehabilitation in Stroke: Does Co-careldopa treatment in combination with routine NHS occupational and physical therapy, delivered early after stroke within a stroke rehabilitation service, improve functional recovery including walking ability and arm function?

ST1213/19 ISCHAEMIA: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches

ST1314/37 EQUAL: The European Quality Study on treatment in advanced chronic kidney disease

ST1314/46 RELAX 2: Serelaxin when added to standard therapy in acute heart failure.

ST1213/53 Speed of Increasing Milk Feeds Trial




ST1314/62 Inpatient suicide whilst under non routine observation


APPENDIX 6

ENQUIRIES 2013/2014

Enquiry Ref Proposal

Ÿ ENQ1314-01 Advice provided in relation to MSc dissertation

Ÿ ENQ1314-02 Enquiry regarding participation in the Mimpomersen Study. Review of database showed insufficient numbers of patients and the recent European Medicines Agency marketing authorisation refusal had also increased concerns about Mimpomersen so the Trust cannot proceed to participate in the Study

Ÿ ENQ1314-03 Enquiry regarding funding to undertake further research

Ÿ ENQ1314-04 Enquiry regarding audit registration

Ÿ ENQ1314-05 Enquiry regarding trialling of a product

Ÿ ENQ1314-06 Enquiry regarding Synthetic Surfactant Study.

ENQ1314-07 Enquiry regarding trialling of a chair with a hoist

Ÿ ENQ1314-08 Enquiry from a member of staff interested in becoming involved in research

Ÿ ENQ1314-09 Enquiry regarding funding for Congenital Diaphragmatic Hernia with a view to identifying prevention strategies and better treatment of the condition

Ÿ ENQ1314-10 Assembly question regarding research carried out in NI on Fetal (sic) Anticonvulsant Syndrome

Ÿ ENQ1314-11 Enquiry regarding research issues

Ÿ ENQ1314-12 Enquiry which led to a meeting regarding Spirit Healthcare diabetes devices including glucometers and a novel needle free insulin injection device

Ÿ ENQ1314-13 Study proposal reviewed and deemed a service evaluation

Ÿ ENQ1314-14 Enquiry regarding Trust interest in participating in HIHR/FIAT Trial

Ÿ ENQ1314-15 Enquiry regarding research within the Trust

Ÿ ENQ1314-16 Enquiry regarding research governance approval for a small scale service evaluation

Ÿ ENQ1314-17 Enquiry regarding an all in one dignity garment provided with advice regarding early versions of the garment by Continence staff. Referred to another Trust because there was not a requirement for such a garment in any in-patient setting in the Southern HSC Trust.

Ÿ ENQ1314-18 Enquiry which led to a meeting with the Managing Director and staff member of a Company interested in designing new computer systems to enhance patient care



Ÿ ENQ1314-19 Enquiry relating to a Data Access Agreement in relation to a National Confidential Enquiry

Ÿ ENQ1314-20 Enquiry regarding a Service Review proposal deemed an evaluation

Ÿ ENQ1314-21 Enquiry requesting up to date contact details for mothers who participated in a specific Study when receiving regional services in Belfast Trust some years ago

ENQ1314-22 Enquiry regarding a study "The experiences of HSC Services of People with Long-Term Chronic Pain" - Deemed an Audit by ORECNI

Ÿ ENQ1314-23 Enquiry regarding a proposal to introduce a new procedure deemed a service evaluation which required the decision of Line Management

Ÿ ENQ1314-24 Enquiry from an MSc student wishing to carry out an audit of haemodialysis patients with a Vitamin D deficiency

Ÿ ENQ1314-25 Enquiry from a PhD Student wishing to undertake research investigating service user experiences of intervention programmes for the perpetrators of Intimate Partner Violence. Programme not used in this Trust

Ÿ ENQ1314-26 Enquiry which resulted in a meeting with an individual interested in undertaking voluntary work.

ENQ1314-27 Enquiry regarding Good Clinical Practice training

Ÿ ENQ1314-28 Enquiry regarding an audit advised to contact Effectiveness and Evaluation Department

Ÿ ENQ1314-29 Enquiry regarding request to have a Specialist Nurse print and distribute questionnaires to patients to ascertain their understanding of how they perceive their therapy and the need to adhere. Advised the Trust could not participate due to the time involved.

Ÿ ENQ1314-30 Enquiry regarding the graphic preparation and printing of a poster which has been selected for presentation at an all-Ireland Conference

Ÿ ENQ1314-31 Enquiry from a member of staff in another Trust undertaking a Doctoral thesis wishing to extend the research to the Southern HSC Trust

Ÿ ENQ1314-32 Enquiry from a Specialist Practitioner undertaking a PhD wishing to extend Study to Daisy Hill Hospital

Ÿ ENQ1314-33 Enquiry from ST4 General Adult Psychiatry Trainees regarding a Local Collaborator for their proposed Study

Ÿ ENQ1314-34 Enquiry from a Consultant regarding the creation of a database linking histologically identified cases with the Child Health Register

Ÿ ENQ1314-35 Enquiry from a member of Midwifery staff regarding research required for Master’s degree

Ÿ ENQ1314-36 Enquiry from University researchers regarding an Autism Study to be undertaken in all Trusts

Ÿ ENQ1314-37 Enquiry regarding two Studies (i) involving healthcare professionals and (ii) patients in Belfast and Southern HSC Trusts



Ÿ ENQ1314-38 Enquiry regarding a prospective observational study of fluid balance and outcomes in patients in the Intensive Care Unit

Ÿ ENQ1314-39 Enquiry about the possibility of extending an on-going research study in Belfast HSC Trust to Southern HSC Trust

Ÿ ENQ1314-40 Enquiry from Royal Devon and Exeter NHS Foundation Trust regarding interest in IBD Research Studies

Ÿ ENQ1314-41 Enquiry regarding the development of a framework for Enhancing Reflective Social Work Practice and request for the involvement of staff to participate in a Consultation Group

Ÿ ENQ1314-42 Enquiry regarding proposal for MSc

Ÿ ENQ1314-43 Enquiry regarding interest in undertaking research

Ÿ ENQ1314-44 Enquiry from a researcher undertaking a PhD developing a research proposal on the Investigation of the relationship between physical fitness, sedentary behaviour and falls risk.

Ÿ ENQ1314-45 Enquiry regarding the development of an MSc proposal

Ÿ ENQ1314-46 Enquiry regarding MSc research study and research governance approval process.

Ÿ ENQ1314-47 Enquiry regarding Research Governance approval and Good Clinical Practice Training

Ÿ ENQ1314-48 Enquiry regarding an evaluation proposal for Research Methods Course reviewed and comments provided.

Ÿ ENQ1314-49 Enquiry regarding interest in participating in a Stroke Trial collaboration

Ÿ ENQ1314-50 Request from Lecturers, University of Ulster to have Commissioned Research Dementia Care application signed off on behalf of the Trust

Ÿ ENQ1314-51 Enquiry regarding this Trust acting as Lead site for a proposed Study where imaging would be carried out by a Medical Photographer in another Trust

Ÿ ENQ1314-52 Enquiry regarding regarding Sure Start service users/clients

Ÿ ENQ1314-53 Enquiry regarding a proposal to evaluate a parenting programme in the Trust

Ÿ ENQ1314-54 Enquiry from Staff Grade Psychiatrists wishing to participate in a National Audit

Ÿ ENQ1314-55 Enquiry from a member of staff who wished to introduce a new treatment and publish the results of their findings

Ÿ ENQ1314-56 Enquiry regarding the possible testing of a urinary catheter.

Ÿ ENQ1314-57 Enquiry from a Consultant Physician regarding Primary Care involvement in research studies



Ÿ ENQ1314-58 Enquiry from a Principle Practitioner about Trust participation in a study organised by one of the voluntary organisations

Ÿ ENQ1314-59 Enquiry from a Consultant regarding statistical input for a research study and GCP training.

Ÿ ENQ1314-60 Enquiry from a Registrar as to how they and their colleagues could undertake a number of research studies

Ÿ ENQ1314-61 Enquiry from a Consultant seeking advice as to how events were reported for a patient given a drug for compassionate use and who was involved in a clinical trial for that drug

Ÿ ENQ1314-62 Enquiry from an MSc Student wishing to develop a questionnaire to determine best method to deliver training to their students

Ÿ ENQ1314-63 Enquiry from a member of staff regarding options for research required for an MSc Course

Ÿ ENQ1314-64 Details provided of a Carer’s Assessment Satisfaction Survey proposed

Ÿ ENQ1314-65 Enquiry regarding a proposed study which would take place within the Trust but the research activity which would only take place in the family home

Ÿ ENQ1314-66 Enquiry from a researcher requesting the identification of staff to participate in a survey for an MSc Study regarding case studies of those whose presentation is not consistent with their diagnosis

Ÿ ENQ1314-67 Enquiry regarding a request for the provision of information on all Social Work/Social Care studies carried out in the Trust since the establishment of the R&D Office.

Ÿ ENQ1314-68 Enquiry regarding the provision of a Placement Agreement for an Audit Facilitator from Belfast HSC Trust assigned to assist with an audit in this Trust relating to a specific disease

Ÿ ENQ1314-69 Enquiry requesting information in relation to research, systematic reviews, literature reviews and evidence based practice

Ÿ ENQ1314-70 Enquiry regarding a University member of staff requesting a Placement Agreement in relation Data Access Agreement with the Trust

Ÿ ENQ1314-71 Enquiry from an applicant for a post in Southern HSC Trust requesting information on research which had been given as one of the topic areas for interview

Ÿ ENQ1314-72 Enquiry regarding a proposal paper regarding in relation to an evaluation reviewed and determined as a service evaluation with comments provided on the requirements in terms of liaising with other Departments, obtaining costings etc.

Ÿ ENQ1314-73 Enquiry regarding information in relation to research and ethical approval requirements



Ÿ ENQ1314-74 Enquiry from a member of staff undertaking MSc research. Proposal sent to Queen’s University for review and would then be shared with the Trust

Ÿ ENQ1314-75 Enquiry regarding proposal papers for an audit, advice sought from Ethics

Ÿ ENQ1314-76 Enquiry regarding information about conducting an audit within the Trust

Ÿ ENQ1314-77 Enquiry regarding interest in participating in a Stroke Trial

Ÿ ENQ1314-78 Assembly Question

ENQ1314-79 Enquiry seeking advice regarding completion of research or undertaking a service evaluation in relation to services in learning disability.

Ÿ ENQ1314-80 Comprehensive proposal reviewed for a Doctorate

Ÿ ENQ1314-81 Enquiry from a member of staff undertaking an MSc in Inter-professional Health and Social Care Management for the review of the dissertation proposal

Ÿ ENQ1314-82 Request for the review of a proposal for Study in relation to Application of Research Methods in Social Work Course

Ÿ ENQ1314-83 Request for the review of a protocol for an Observational Study

Ÿ ENQ1314-84 Request for the review of a protocol

Ÿ ENQ1314-85 Enquiry seeking interest in a Study; Expression of interest submitted on behalf of the Trust; then advised the Study was only opening In Primary Care.

Ÿ ENQ1314-86 Student requesting a placement in a Hospital or Health Research Laboratory

Ÿ ENQ1314-87 Request for the review of a Protocol

Ÿ ENQ1314-88 Request for the review of a Proposal

Ÿ ENQ1314-89 Details of proposed MSc Questionnaire reviewed

Ÿ ENQ1314-90 Member of staff planning to undertake an MSc in Advanced Practice wishing to discuss two research proposals

Ÿ ENQ1314-91 Request regarding an audit of treatment and outcomes in children with a specific condition

Ÿ ENQ1314-92 Enquiry regarding a Study which had been carried out on quality of life and mental health in people with chronic illness and the proposal to extend the Study to cancer patients

Ÿ ENQ1314-93 Advice and guidance provided in relation to interest in undertaking research

Ÿ ENQ1314-94 Proposal submitted reviewed and deemed an evaluation or survey

Ÿ ENQ1314-95 Request for details of SPSS Information Analyst



Ÿ ENQ1314-96 Enquiry regarding the development of a Patient Information Sheet for service users to read prior to attending the Psychology Service in Adult Mental Health

Ÿ ENQ1314-97 Enquiry regarding information relating to a placement agreement

Ÿ ENQ1314-98 Advice provided in relation to a proposed novel project

Ÿ ENQ1314-99 Enquiry from a member of staff interested in opening a Study with which they were involved in another Trust.

Ÿ ENQ1314-100 Enquiry from a member of staff interested in becoming involved in research

Ÿ ENQ1314-101 Enquiry from a member of staff interested in research provided with relevant information on research governance, Queen’s Medical Library etc

Ÿ ENQ1314-102 Review of proposal to carry out an evaluation


APPENDIX 7

Research & Development Action Plan 2013 – 2015

Area of Work

Action Plan Target Date Completed

Research Governance Committee

Review and update membership

March 2013 January 2014 January 2015

Involve and develop role for Personal and Public Representatives (PPI) on the Research Governance Committee

On-going

Arrange yearly schedule of meetings on a six-weekly basis

January 2013 January 2013 January 2014 January 2015

Research and Development Annual Report

Prepare 2012/2013 Annual Report for Research Governance Committee approval Present 2012/2013 Annual Report to Trust Board with input on Interventional Cardiology research Prepare 2013/2014 Annual Report for Research Governance Committee approval Present 2013/2014 Annual Report to Trust Board

June 2013 12 December 2013 June 2014 December 2014


Area of Work


Research Governance Ensuring financial and intellectual property input has been provided for Agreements in relation to Collaborative Studies with Industry to facilitate sign off and issue of Research Governance approval before commencement of research.

On-going

Prepare Research Governance Controls Assurance Standards

December 2013 December 2014 December 2015

Review Standard Operating Procedures June 2015

Revised Standard Operating Procedures uploaded to Intranet

June 2013

Raise the profile of Research & Development as a means of income generation for the Trust

On-going

Support and encourage research in Nursing, Midwifery, Allied Health Professions and Social Work

On-going

Seek Annual/End of Study Reports 2012/2013 2013/2014 2014/2015

August 2013 August 2014 August 2015

Review Research Governance Leaflet

On-going

Review Trust Research and Development Strategy when Regional HSC Research and Development Strategy becomes available

2014

Review Trust Policy for the Management of Research and Development and submit to Scrutiny Committee

2014

Research Governance Workshops

Arrange and deliver Workshops as and when required including HSC Innovations/Intellectual Property

On-going


Area of Work


Research Governance Strategy Review the Trust’s Strategy for Research and Development when the Regional Strategy for Research and Development becomes available

2013/2014 Ongoing

Encourage and Promote Research Organise a Workshop to showcase research undertaken by Trust staff

13 December 2013

Organise a Workshop to showcase research undertaken by Trust staff

12 March 2014 March 2015

Joint Appointment between Trust and University

Meet regularly with the Head of Nursing, Midwifery and Allied Health Professions Research and Development/ Honorary Research Fellow

On-going

Web-based Induction for Junior Doctors – Emergency management arrangements of patients enrolled in Clinical Trials

Develop and review web-based Induction for Junior Doctors on the Emergency management arrangements of patients enrolled in Clinical Trials

On-going

Trust Research Profile Establish Research and Development as a core function of the Trust

On-going

Ensuring Research and Development issues/activities are brought to the attention of the Medical Director, Senior Management Team and Trust Board through input to the Medical Director’s Monthly Reports to Trust Board

On-going

Presentation to specific staff groupings

Offer presentations to all staff groups and respond to specific requests

As and when required

Good Clinical Practice Training Develop arrangements for researchers to access GCP Training via e-learning

1 January 2013


Area of Work


Research Governance Permissions Prepare quarterly returns on approval of research applications within 30 days

March 2013 June 2013 September 2013 December 2013 March 2014 June 2014 September 2014 December 2014 March 2015 June 2015 September 2015 December 2015 March 2016

Research Governance Permissions Process Encouraging research applications in the area of dementia

Multi-centre studies to be received and disseminated to Trusts by Research Gateway based in Western HSC Trust with effect from 1 May 2013 Contribute to the revision of the regional:-

Guidance for Applicants

Guidance for Trust Research Office

Seek and promote opportunities for staff to become involved in research calls in the area of dementia.

PHA Research & Development Division and Atlantic Philanthropies call for Dementia Care closing date – 8 May 2014

On-going July 2013 July 2013 8 May 2014


Area of Work


Maintain Research Software Maintain database of Research Applications from 01 April 2007 (establishment of SHSCT) Trust implementation of the EDGE Research Software system purchased by the HSC Research & Development Division

On-going To be implemented on a Trust by Trust basis

Financial Management Refining the financial management and reporting arrangements for research income and expenditure to ensure adherence to the requirements of Research Governance Controls Assurance Standards

On-going

Raising the profile of Research and Development as a means of income generation for the Trust

On-going

Ensuring financial and intellectual property issues relating to Collaborative Research Studies have been addressed and signed-off in the proforma developed for Collaborative Studies with Industry as a pre-requisite to Research Governance approval being issued for the research to commence.

On-going

Ensuring Principal Investigators and Clinical Research Nurses submit Invoice Request Forms for Research in a timely manner and in accordance with the requirements of the Agreement for the Clinical Trial/Study.

On-going

Research Funding Publicise funding/partnership opportunities and support the development of applications for:

European Union Funding

National Institute for Health Research

On-going On-going

Progress the Trust proposal that a percentage of Charitable Funds received for no specific purpose in the preceeding year be allocated to research.

On-going


Area of Work


NICRN Funded Posts Appoint Clinical Research Nurse – Renal 0.53 WTE March 2012

Appoint replacement Clinical Research Nurse – Critical Care 0.5 WTE

August 2012

Appoint replacement Clinical Research Pharmacist – 0.5 WTE

January 2013

Appoint Clinical Research Nurse – Diabetes 0.50 WTE

April 2013

Appoint additional Clinical Research Nurse – Children 0.5 WTE

June 2013

Appoint replacement Clinical Research Nurse Cancer – Full Time

May 2013

HSC Trust Research Fund Seek applications for HSC Trust Research Fund June 2013 June 2014

Establish Sub Group of Research Governance Committee to review applications and agree funding allocations

August 2013 September 2014

Report on funding to HSC Research & Development Office

May 2013 May 2014

Maintain links with the Public Sector

Craigavon Borough Council – Life Sciences initiative focusing in Cardiology

On-going

Establish links with the Universities in relation to collaborative research studies with the Trust

University of Ulster Queen’s University, Belfast

4 February 2014 31 March 2014

Standard Operating Procedures (SOPs)

Review and have SOPs uploaded to Trust Intranet April 2013 April 2015


Area of Work


Input to Regional Groups Strategic Advisory Group – Dr Sharpe

On-going

Directors Group – Dr Sharpe

On-going

Honest Broker Governance Board – Dr Sharpe with Miss Knox deputy

On-going

Research Governance Operational Sub-Group – Miss Knox

On-going

Research Managers Forum – Miss Knox

On-going

Promote and seek representation from Trust on all NI Clinical Research Networks

Cardiovascular – Dr I Menown On-going

Children – Dr M Smith – Director NI Clinical Research Network for Children (also represents NI on the Board of Medicines for Childrens Research Network)

On-going

Critical Care – Dr C Clarke On-going

Dementia – Dr S Best On-going

Diabetes – Dr M McConnell On-going

Primary Care Not Applicable -

Renal – Dr N Morgan – NI Co-Lead (also represents NI on the UK Kidney Research Consortium)

On-going

Respiratory – Dr R Convery On-going

Stroke – Dr P McCaffrey, Dr M McCormick On-going

Vision Not Applicable -


Area of Work


Memorandum of Understanding for effective Research Governance between Universities and NI Health and Social Care Trust

Revise Memorandum of Understanding developed and discussed at meeting with Universities

October 2013

Comments on revised Memorandum of Understanding

September 2013

Memorandum of Understanding to be signed off by Trust Directors of Research and Development

2014

Maintain links with HSC Research and Development Organisations

HSC Research and Development Division PHA

NI Clinical Research Network

HSC Innovations

Office for Research Ethics Committees NI

NI Cancer Trials Network

On-going


APPENDIX 8

RESEARCH AND DEVELOPMENT WORKSHOP

To showcase research undertaken by Trust Staff in Adult Safeguarding, Midwifery, Social Care, Short Term Residential Care

and District Nursing

Guest Speaker: Dr Siobhan McGrath, Office for Research Ethics

Committees NI “Role and function of ORECNI and research requirements for ethical

review”

All staff interested in research can attend Places must be booked in advance not later than Friday, 7 March 2014

Please contact – Mairead McAreavey

Email: [email protected] Telephone: 028 3861 4277

Date: Wednesday, 12 March 2014 Time: 2.00 pm to 4.00 pm Venue: Lecture Theatre, Medical Education Centre, Craigavon Area Hospital



Workshop to showcase research undertaken by Trust Staff

Lecture Theatre, Medical Education Centre, Craigavon Area Hospital Wednesday, 12 March 2014 - 2 pm to 4 pm

Welcome and Introduction: 2 pm Dr Peter Sharpe, Associate Medical Director Research and Development Guest speaker:

Dr Siobhan McGrath, Office for Research Ethics Committees NI – “Role and function of ORECNI and research requirements for ethical review”

2.30 pm Dr Patricia Gillen, Head of Nursing and Allied Health Professions

Research & Development/Honorary Research Fellow Building capacity and capability for Research and Development in practice

2.45 pm Mrs Patricia Trainor, Lead Professional Adult Safeguarding

Review of Adult Safeguarding Alerts. What factors influence Designated Officers in progressing safeguarding alerts/referrals through the investigation process

2.55 pm Mrs Teresa McCann, Midwife

An assessment of women’s views and experiences on Induction of Labour

3.05 pm Dr Esther Reid, Alcohol Liaison Midwife and Postdoctoral

researcher QUB – PhD awarded June 2012 A prospective study exploring risk factors associated with fetal macrosomia and women’s experiences of delivering a large for gestational age infant – Physical Activity, Nutrition and Development Antenatally

3.15 pm Dr Carmel Rooney, Assistant Director of Corporate Parenting – PhD awarded 12.12.13 Care Leavers experiences of transition: their understanding of their life experiences of negotiating life’s events

3.25 pm Dr Michael Hoy, Head of Short Term Residential Care Services –

PhD awarded 12.12.13


The participation promise of Family Group Conferencing – Theory or Practice? A qualitative comparison study within the SHSCT.

3.35 pm Ms Karen Templeton, Staff Nurse, District Nursing

Caring for patients with multiple sclerosis in the Community: the perceptions of District Nurses

3.45 pm Dr David Brownlee, HSC Innovations Advisor Support for Ideas to Improve Patient Care 4 pm CLOSE: Dr Peter Sharpe


APPENDIX 9

Collaborative Studies With Industry

To be completed by the Chief Investigator/Principal Investigator for all Collaborative Studies with Industry and submitted to the Research Office at the address below.

Research Governance approval will not be issued for a Study to commence until the Agreement has been developed, agreed and signed by the Company and the Trust.

Study Title:

Study Type eg Diagnostic, Medical Device:

Chief Investigator:

Principal Investigator / Researcher – Include Contact Details:

Company – Include Contact Name and Details:

Study Design, Protocol/Clinical Investigation Plan Developed By:

Intellectual Property Clauses Discussed With


HSC Innovations and Company – Provide Details of Clause Agreed:

Costings: Met by Company – Provide full details of costs

Company Finance Department Contact details Name: Email: Telephone No:

Met by Trust – Provide full details of costs as agreed by Management Accountant, Finance Department

Services provided by all Support Departments involved in the study eg Laboratory – provide full details of procedures/tests discussed and costings as agreed by Head of Service and Management Accountant

Signatures: Company

Date:

Trust Management Accountant

Date:

Head of Service of each Support Department involved in the Study

Date:


APPENDIX 10

Model Industry Collaborative Research Agreement, Med Tech (mICRA Tech)

(This agreement is amended from the NIHR/MRC model Industry Collaborative Research Agreement (mICRA) Version 2

MODEL AGREEMENT FOR COLLABORATIVE COMMERCIAL CLINICAL RESEARCH

CONDUCTED BY COMPANIES IN THE MEDICAL TECHNOLOGY INDUSTRIES AND NHS/HSC ORGANISATIONS

[Name of Clinical Research Collaboration] This Agreement dated [insert date]

is between [insert name of NHS/HSC Organisation] of [insert address]

(Hereinafter known as the “NHS/HSC Organisation”) AND

[….insert name of the company….], of [….insert address….] (Hereinafter known as the “Company”)

NOW WHEREAS the Company is a company involved in the research, development, manufacture and sale of technologies / devices for use in humans WHEREAS the Company is developing new treatments or therapies in the field of [….insert field….] WHEREAS the NHS/HSC Organisation is concerned with the diagnosis, treatment and prevention of disease and clinical research for the improvement of healthcare WHEREAS the NHS/HSC Organisation has a particular interest and expertise in [….insert area of expertise….] WHEREAS the Company and NHS/HSC Organisation wish to engage in the Clinical Research Collaboration entitled: “ [ …… insert title of research collaboration ……] ” It is agreed that the NHS/HSC Organisation and Company wish to participate in the aforementioned Clinical Research Collaboration in accordance with this Agreement


APPENDIX 11

Research & Development Office

HSC TRUST RESEARCH FUND 2013-2014

The Trust is grateful to the HSC Research & Development Division for providing £50,000 for the HSC Trust Research Fund for 2013-2014, the sixth year this funding has been provided. The funding has enabled research to be undertaken which otherwise would not have been developed or progressed. In excess of seventy research projects have been funded over the past six years and have been of significant benefit not only to the researchers but also to the Trust. There are examples of successful outcomes as a result of research undertaken:-

Investigating if the integration of a template to the hand function testing procedure led to a significant reduction in the time taken to administer the diagnostic test compared to the current procedure yet achieved the same result.

Presented at the 9th Triennial International Federation Society of Hand

Therapists in New Delhi, India Expo Centre, March 2013.

An examination of effective practice assessment within the direct observation of Social Work Students in the Southern Health and Social Care Trust. The outcome of the research:

Contributed to the training of prospective Practice Teachers in Northern

Ireland Used to encourage best practice in the Practice Teachers in Northern

Ireland Contributed to Level I Social Work Students training at the South West

College as part of the University of Ulster teaching for Social Work degree Presented at the NI Practice at is Best Workshops for Social Work

Students, Practice Teachers and those involved in the education of Social Workers

Article accepted for the Journal of Practice Teaching and Learning In 2013/2014 applications for the HSC Trust Research Fund were sought on the basis that proposals addressed the Trust’s corporate objectives which are as follows:

Providing safe high quality care for patients and clients


Maximising independence and choice for patients and clients

Supporting people and communities to live healthy lives and improve their health and well-being

Being a great place to work, valuing our staff

Being a good social partner within our communities

Maximising best use of resources Applicants were also advised that the assessment of applications would be on the basis of the following criteria:

Relevance to the Trust’s corporate objectives

Scientific merit

Potential to develop into larger research projects

Value for money Ten applications were received for the HSC Trust Research Fund for 2013/2014, all of which were awarded funding, as follows:

1. The benefit of Perclot on post-operative recovery for breast cancer £3,000

2. Effects of altering bodyweight using an anti-gravity treadmill on biomechanical parameter and in vivo muscle tendon behaviour during running £800

3. Comparison of Atrial Fibrillation detection rates post stroke/TIA with prolonged non-

invasive monitoring versus standard care £20,000

4. A structured education programme for carers – a before and after Study £700

5. Fluid strategies and outcomes in critically ill patients: a systematic review and meta-analysis £1,000

6. The effect of Deep Touch Pressure in adults with severe Learning Disability and Autism £3,000

7. Examining the nursing contribution to quality patient care through nursing quality indicators £8,400

8. Factors that enhance the quality of professional and operational supervision across multi-disciplinary teams within the Southern Health and Social Care Trust £10,000

9. Centrifuge for use in Renal research - Awarded funding through slippage funding for research but could not be purchased because amount was less than lower limit for capital equipment £1,062

10. Frequency, causes and outcome of thunderclap headache £1,000

TOTAL £49,962


APPENDIX 12

Arrangements for Good Clinical Practice Training via e-learning Effective from 1 January 2013

In future Good Clinical Practice (GCP) Training will only be available through e-learning supported by the regional HSC Research & Development Division. The training will be available free of charge for both Network and Non-Network Studies. Registration for GCP e-learning Training GCP e-learning can be accessed by registering on the National Institute of Health Research (NIHR) Learning Management System (LMS) either hold control (Ctrl) and click on this link . http://www.crn.nihr.ac.uk/learning-development/good-clinical-practice/

When the page opens scroll to the bottom of the screen and access the course via the link

(Access our courses via the) Learning Management System (LMS)

When registering there are two screens to be completed; on the first screen: Select – Register for an LMS Account – complete User Name, email address and

Password The second screen requires you to complete a series of boxes. Please note for the following you should make the suggested selections: Network/Organisation: Select Devolved Nations Local Network/Organisation, select one of the following –

NI Clinical Research Network (NICRN)

NI Cancer Trials Network (NICTN)

NI Non-Network NHS Trust/Other Organisation – Select ‘I am based outside England’ What is your main job – Select by level of post e.g. Consultant Name of NIHR Study – if Non-Network, it is essential to complete that box e.g.

insert “No Study” which will allow you complete the registration process and have access to the Learning Management System (LMS); if not completed this will entail you having to complete the registration process again.

http://www.crn.nihr.ac.uk/learning-development/good-clinical-practice/

http://www.crn.nihr.ac.uk/learning-development/good-clinical-practice/

https://learning.nihr.ac.uk/KIP/SignIn.aspx?ReturnUrl=%2fKIP%2fSTS%2fIssueClaims.aspx%3fwa%3dwsignin1.0%26wtrealm%3dhttps%253a%252f%252flearning.nihr.ac.uk%252flearning%252f%26wctx%3drm%253d0%2526id%253dpassive%2526ru%253d%25252flearning%25252f%26wct%3d2014-06-06T16%253a29%253a28Z&wtrealm=https%3a%2f%2flearning.nihr.ac.uk%2flearning%2f


Registrations to access the training are approved centrally by the NIHR Team and take no longer than one working day. You will receive an email to confirm your registration. When confirmation of registration is received you can access the Learning Management System. Courses are listed within the ‘My Learning Plan’ tab available on the red bar running across the screen. GCP e-learning is listed at the top of the screen and a place can be requested immediately.


APPENDIX 13







APPENDIX 14

Customer Number

Invoice Number

Batch

Invoice Total £

Directorate of Finance & Procurement Date

Prep By

Checked By

Organisation to be billed:

Contact Person:

Organisation Address:

Postcode:

Contact Tel No:

Study Name:

Study Ref No:

Details of Research Activity Undertaken:

(Staff costs, tests, consumables etc.)

Invoice Date/Period Covered:

Quantity:

Per Patient:

Total Amount (ex VAT) £

Cost Centre:

Income Sub code:

Principal Investigator:

Form Completed By:

Research Area/Department:

Telephone No:

E-mail address:

Date:

Authorised By:

Principal Investigator

For Finance Use

This form should be completed in full and emailed with any backup information to: [email protected]

Income Section, Cashiers Office, Ghana House, Finance Department

Daisy Hill Hospital, 5 Hospital Road, Newry, BT35 8DR

Please note that incomplete forms will be returned.

INVOICE REQUEST FORM FOR RESEARCH

Please return this form no later than 3rd last working day of the month

Any queries please contact Fiona Lynch 02830 835000 ext 4673

& [email protected] (both Income Team) & CC [email protected] (FM)


APPENDIX 15

Directorate of Finance & Procurement Corporate & Capital Services

Research & Development – Research Nurse Finance Training Session

Date: Friday 12th April 2013 at 11am CAH MEC Tutorial Room 2

AGENDA

Introductions

Funding of PHA Research Nurse Posts

Use of Cost Centres

Clinical Trial Agreements

Invoicing Process

Goods & Services

Budget Holder Reports

Public Funds

Discretionary Funds

Breakeven – Invoice, recover full costs and remain within budget!!

Any other business or questions


APENDIX 16

Dr David McEneaney Publications 2013- 2014

Lynn William D, Escalona Omar J, McEneaney David J. Electronics 2014, 3, 1-x, manuscripts: doi: 10.3390/electronics30x/000x

Howe A, Escalona O, Di Maio R, Massot B, Cromie N, Darragh K, Adgey J, McEneaney D. A support vector machine for predicting defibrillation outcomes from waveform metrics. Resuscitation. 2014:85(3):343-349.

Lynn William D, Escalona Omar J, McEneaney David J. Arm and wrist surface potential mapping for wearable ECG rhythm recording devices: a polkot clinical study. Jurnal of Physics: Conference Series 450 (2013)012026

Philip R Walsh, Omar J Escalona, Vivek Kodoth, Noel C Castro, David McEneaney, Ernest Lau, Ganesh Manoharan. Dynamic Changes in Intracardiac Resistance as a Predictive Marker during Internal Cardioversion of Atrial Fibrillation. Computing in Cardiology 2013; 40:611-614.

Dr A Howe - Publications

Howe A, Escalona O, Di Maio R, Massot B, Cromie N, Darragh K, Adgey J, McEneaney D. A support vector machine for predicting defibrillation outcomes from waveform metrics. Resuscitation. 2014:85(3):343-349. Abstracts Howe A, Di Maio R, Massot B, et al. AMSA and Slope Are Predictive of Shock Success and Return of Spontaneous Circulation but Not Arrest Duration Following Ventricular Fibrillation Cardiac Arrest. Circulation. 2012;126:A180 Howe A, Di Maio R, McEneaney D. Transthoracic Impedance Is Poorly Predicted by Patient Characteristics but Significantly Reduced by Placement of Defibrillator Pads in the Anteroposterior Position Circulation. 2012;126:A302 Howe A, Di Maio R, Crawford P, et al. The Impedance Cardiogram as an Indicator of Chest Compression Efficacy During Cardiopulmonary Resuscitation in a Porcine Model: Correlation with Physiological Parameters and Comparison with Compression Depth and Thrust. Circulation. 2011;124:A54


Crawford P, DiMaio R, Howe A, Clutton E. Initial study of the performance of LiDCO™ compared to thermodilution during ventricular fibrillation and cardiac compression to measure cardiac output Resuscitation, Volume 82, Supplement 1, October 2011, Page S34 Di Maio R, Howe A, McCanny P, et al. Is the impedance cardiogram a potential indicator of effective external cardiac massage in a human model? A study to establish if there is a linear correlation between the impedance cardiogram and depth in a cardiac arrest setting. Resuscitation, Volume 83, Supplement 1, 15 October 2012, Page e62 Navarro C, Di Maio R, Howe A, et al. Estimated duration of ventricular fibrillation or simply VF quality? Journal of Electrocardiology, Volume 44, Issue 6, November–December 2011, Pages 746-747 Di Maio R, Howe A, Crawford P, et al. Measurement of Depth, Thrust and Thoracic Impedance During Mechanical Cardiopulmonary Resuscitation: Is Thoracic Impedance a Potential Indicator of Effective External Cardiac Massage in a Porcine Model of Cardiac Arrest? Circulation. 2011;124:A196 Di Maio R, Howe A, McCanny P, et al. Is the Impedance Cardiogram a Potential Indicator of Effective External Cardiac Massage in a Human Model? A Study to Establish If There Is a Linear Correlation Between the Impedance Cardiogram and Depth in a Cardiac Arrest Setting. Circulation. 2012;126:A94 Di Maio R, Brody D, McAnlis J, Howe A, et al. Does Real-Time Audiovisual Feedback for Public Access Defibrillation Enhance Device Usability and Outcomes? A Simulated Pilot Study on a Disposable Home-Use Defibrillator. Circulation. 2012;126:A95 Di Maio R, Crawford P, Howe A, et al. Does Refibrillation Occur in High-Impedance Patients Who Have Received Shocks Using Biphasic Waveforms with Longer Pulse Durations? Circulation. 2012;126:A301

http://www.sciencedirect.com.honni.ezp1.qub.ac.uk/science/article/pii/S0300957211701411









APPENDIX 17

Dr Ian Menown Publications 2013 - 2014 Menown IBA, Davies S, Gupta S, Kalra P, Lang CC, Morley C, Padmanabhan S. Resting Heart Rate And Outcomes In Patients With Cardiovascular Disease. Cardiovascular Therapeutics 2013;31(4):215-23

Kalra P, Morley C, Barnes S, Menown IBA, Kassianos G, Padmanabhan S, Gupta S, Lang CC. Dosing and Persistence of Evidence Based Use of Beta-Blockers in Cardiovascular Disease: A National Study using the General Practice Research Database. International Journal of Cardiology 2013;167(6):2695-9 Sharma D, Tauro R, Menown IBA. Value of non-invasive imaging in acute chest pain. Quarterly Journal of Medicine 2013;106(5):467-9

Connolly M, Menown IBA. Key Advances in Clinical Cardiology. Advances In Therapy 2013;30(4):369-86

Armstrong PW et al for the STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.N Engl J Med 2013;368(15):1379-87

Connolly M, Menown IBA, Hussey S, Cinnamond N, Damani L. The Dronedarone Shared-Care Clinical Model and Database: A Coordinated Paradigm to Optimise Management of Evolving Clinical Recommendations. Advances In Therapy 2013;30(6):623-9

Muir AR, Menown IBA. Genetic biomarkers in cardiovascular disease. Biomarkers in Medicine 2013;7(4):497-9

Menown IBA. Very Long Stent Technology: Clinical And Practical Value. Future Cardiology 2013;9(5):641-4

Menown IBA. Low molecular weight heparin in ST elevation MI. New data and practical implications. Proceedings ICCAD 21013:69-172

Menown IBA. Bioabsorbable stent coatings and polymer free drug delivery. Proceedings ICCAD 2013:287-290

Shand JA, Sharma D, Hanratty C, McClelland A, Menown IBA, Spence MS, et al. A prospective intravascular ultrasound investigation of the necessity for and efficacy of postdilation beyond nominal diameter of 3 current generation DES platforms for the percutaneous treatment of the left main coronary artery. Catheterization and Cardiovascular Intervention. 2013 doi: 10.1002/ccd.25265. [Epub ahead of print] PMID:24167078


Hodkinson EC, Ramsewak A, Murphy JC, Shand JA, McClelland AJ, Menown IBA, et al. An Audit of Outcomes After Same-Day Discharge Post-PCI in Acute Coronary Syndrome and Elective Patients. Journal of Interventional Cardiology. 2013;26(6):570-7

Menown IBA. 2013: The Year of Renal Denervation? Advances In Therapy Adv Ther. 2013;30(12):1038-40

Papers Submitted for Publication Urban P, Valdés M, Menown IBA, et al.Stent thombosis and bleeding after implantation of Biolimus A9-eluting resorbable polymer coronary stents. A report from the international e-BioMatrix registry. J Am Coll Cardiol Intervent In Press 2014 Connolly M, McEneaney D, Morgan N, Menown IBA, Harbinson M. Novel biomarkers of acute kidney injury following contrast coronary angiography. In Press 2014 McNeice AH, McAleavey NM, Menown IBA. Advances In Clinical Cardiology. Adv Ther In Press 2014

Book Chapters

Connolly M, Menown IBA. Epidemiology and classification of myocardial infarction. In: Myocardial Infarction. London: Future Science Group, 2013 In Press

Abstracts

Menown IBA, Oldroyd K, Alhaddad I, Berland J, Eberli F, Hildick-Smith D, Iosseliani D, Kleber F, Valdés M, Roffi M, Urban P. Comparable low rates of MACE and stent thrombosis in patients undergoing PCI with the BioMatrix and BioMatrix Flex stents: a 12-month sub-study of the e-BioMatrix Post Market Registry. Complex Cardiovascular Therapeutics Japan Proceedings 2013 Tamburino C, Erglis A, Menown IBA, Horváth IG, Lecoq G, Moreno R, Gilbert T, Capodanno D, Allocco DJ, Dawkins KD. Primary Endpoint Results from the TAXUS Element Post-Approval Surveillance Study (TE-PROVE): 1-Year Outcomes in Unselected Patients Treated With a Thin-Strut, Platinum-Chromium, Paclitaxel-Eluting Stent. TCT 2013 eBiomatrix investigators. Comparable low rates of MACE between patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) patients in the 12-month follow-up of the e-BioMatrix registry. TCT 2013 Menown IBA, Oldroyd K, Alhaddad I, Berland J, Eberli F, Hildick-Smith D, Iosseliani D, Kleber F, Valdés M, Roffi M, Urban P. Comparable low rates of MACE and stent


thrombosis in patients undergoing PCI with the BioMatrix and BioMatrix Flex stents: a 12-month sub-study of the e-BioMatrix Post Market Registry. AsiaPCR Proceedings 2014

APPENDIX 18

RESEARCH GOVERNANCE

Key Performance Indicators


Research Governance Controls Assurance Standard 15 Key indicators capable of showing improvements in research governance and/or providing early warning of risk are used at all levels of the organisation, including the Board, and the efficacy and usefulness of the indicators is reviewed regularly

Standard to be attained

Performance achieved

Key Performance Indicators have been developed for all stages of the research governance management process:-

1 Substantive compliance with Research Governance Controls Assurance Standard

Greater than 75% score to be attained for substantive compliance

2.

Number of Adverse Events in research

100% of all Adverse Events to be reviewed and investigated, outcomes actioned and learning shared

APPENDIX 18

RESEARCH GOVERNANCE






3. Number of funded Research posts – filled and unfilled

Staff in post – no unfilled posts Associate Medical Director R&D Research Manager Research Administrator Research Administrative Assistant Clinical Research Pharmacist 0.5 Clinical Research Nurses: Cancer 1.0 Cardiology 0.5 x 2 Children’s 0.5 x 2 Critical Care 0.5 Diabetes 0.5 Stroke 1.0 Renal 0.5

APPENDIX 18

RESEARCH GOVERNANCE






4. Number of complaints involving research Number of complaints received

5. Number of researchers with up to date Good Clinical Practice Training

100% of researchers GCP trained

6.

Percentage of Clinical Trials subject to Monitoring by Clinical Research Organisations

100% of Clinical Trials monitored by Clinical Research Organisations

7. Approval of research applications within 30 calendar days

90% of research applications approved within 30 calendar days

8.

Enquiries requiring review of Protocols for proposed research by the Associate Medical Director Research and Development

50% within 48 hours 100% within 7 calendar days

APPENDIX 18

RESEARCH GOVERNANCE






9. Enquiries – response to other requests for information

100% within 7 calendar days

10. Amendments – Acknowledgement of Substantial Amendments


11. Amendments – Acknowledgement of Minor Amendments


APPENDIX 18

RESEARCH GOVERNANCE






12. Provision of Research and Development support and advice – Monday to Friday

90% of the working week

13.

Provision of comments on Policy and Strategy documents received by Research and Development

90% within 7 working days

14. Monitoring submission of Invoice requests for Clinical Trials involving income to the Trust

50% of Invoice requests monitored per month

15. Insertion of Emergency Management Arrangements for Clinical Trials on the Trust’s intranet

100% inserted following approval of Clinical Trials

16. Quarterly submission of the Trust’s Metrics within one week of month end: - June, September, December and March

100% submitted within 7 working days

APPENDIX 18

RESEARCH GOVERNANCE






17. Benchmarking the Trust’s Metrics against other Trusts

100% benchmarking against available Metrics

18. Facilitating eight Meetings of the Research Governance Committee during the year

100% facilitation of eight Research Governance Committee meetings per year

19.

Key Performance Indicators to be an agenda item at all Research Governance Committee meetings

100% Research Governance Committee meetings have Key Performance Indicators as an agenda item

20. Reviewing Key Performance Indicators on an annual basis

Key Performance Indicators reviewed on an annual basis

R & D July 2014

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