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Research Ethics Service

HSC REC B

Annual Report

01 April 2016 - 31 March 2017

Part 1 – Committee Membership and Training

Name of REC: HSC REC B

Type of REC: Recognised, Type 1 and 3

Type of Flag: Phase 1, Research Databases, ALC (NI only), Medical Devices, Qualitative, Paediatrics

Chair: Professor Patrick Murphy

Vice-Chair: Dr Sarah Anne Moorhead

Alternate Vice-Chair: Ms Sue Trouton

REC Manager: Mr Matthew Mills Mrs Katrina Greer PRS Manager

REC Assistant: None

Committee Address: Business Services OrganisationUnit 4, Lissue Industrial Estate WestRathdown Walk, Moira RoadLisburnBT28 2RF

Telephone: 028 95361400

Email: [email protected]

HSC REC B Annual Report

Chair’s overview of the past year:

I think it is fair to say that it has been another successful year for HSC REC B. The reason for that success is obvious - it is down to the professionalism, dedication and team-work of all those involved, both REC members and managerial support.

REC B members have a shared sense of duty, a wonderful level of inter-personal empathy, solidarity and communication and they always face even the most challenging situations with a remarkable degree of good humour and determination. It is a privilege to work with them.

We are ably supported by the entire OREC office staff, who serve the cause of ethical research with an understated level of professionalism, expertise and insight, which makes the work of REC B so much easier.

In many ways it was also a demanding year. The volume of work requires the Committee to process six applications every month at its main meeting, which requires precise time management and the ongoing co-operation and support of all those involved in the decision-making process.

Dealing with PR applications and sub-committee work places extra demands on REC B members, but they have always responded to requests for their commitment with enthusiasm and a willingness not always associated with modern society. It may be time for their efforts to be publicly acknowledged beyond the comments in this overview.

In terms of the nature of the applications we receive, it is clear that there are a greater number of Phase 1 trials at the expense of public sector research. Seeking funding for research is obviously becoming more difficult and the problem may significantly increase following Brexit. There are many challenges ahead for health and social services research.

REC B's achievements in terms of performance show that we have performed effectively and efficiently in the past year. We will continue to strive for ethical excellence and in seeking to do so we have one remarkable strength - the ability of all those people who sit on, or support, the committee. In view of the challenges ahead, we will need to nurture that strength.


HSC REC B Membership

Name Profession Expert or Lay

DatesAppointed Left

Dr Ronald Atkinson

Retired Consultant in Medical Oncology

Expert 01/04/2015

Ms Margaret Brady

Deputy Chief Executive

Lay Plus 01/04/2011

Mrs Karen Cardwell

Community Pharmacist

Expert 01/04/2015 23/03/2017

Dr Elinor Johnston

Research Assistant (Clinical Studies Coordinator)

Expert 01/04/2015

Dr Justin Magee

Senior Lecturer in Design Education

Lay

Miss Leigh-Ann McCrum

Expert

Mrs Siobhan McCullough

Nurse / Lecturer

Expert 17/02/2014

Mrs Cliona McDowell

Statistician Expert 17/02/2014

Mr John Edward Mone

Retired (Former Executive Director of Nursing)

Lay 17/02/2014

Dr Sarah Anne Moorhead

Lecturer in Health & Interpersonal Communication

Lay 17/02/2014

Dr Nicoli Morrison

Independent Lay Plus 17/02/2014

Ms Aine Morrison

Service Manager, Community Treatment & Support Services for Learning Disability

Lay 17/02/2014

Professor Patrick Murphy

Advisor on Social & Economic Policy

Lay Plus 17/02/2014


HSC REC B: Deputy Members

HSC REC B: Co-opted Members

Dr Seamus O'Brien

Outcomes Manager, Primary Joint Unit

Expert 17/02/2014

Mr Leon O'Hagan

Pharmacist Expert 15/12/2014

Dr Mark Reid Retired Consultant Paediatrician

Expert 01/04/2015

Ms Marilyn Trimble

Lay Plus 17/02/2014

Ms Sue Trouton

Community Midwifery Sister

Expert 17/02/2014

Name Profession Status Meeting date attended Ms Rejina Mariam Verghis Junior Biostatistician Expert 07/07/2016 Ms Rejina Mariam Verghis Junior Biostatistician Expert 13/10/2016 Ms Rejina Mariam Verghis Junior Biostatistician Expert 09/06/2016 Ms Rejina Mariam Verghis Junior Biostatistician Expert 11/08/2016 Ms Mary McMahon Director Lay 16/02/2017

Name Profession Status Meeting date attended


HSC REC B: Members’ Declarations of Interest:

Name Declaration of Interest DateDr Ronald Atkinson None 10/03/2017Dr Elinor Johnston As an employee of QUB I would be an internal

reviewer for a limited number of studies related to respiratory medicine.

07/07/2016

Dr Elinor Johnston Present post: Research Assistant / Clinical Strategy Coordinator QUB, Centre for Experimental Medicine.

10/03/2017

Dr Justin Magee Ulster university academic 10/03/2017Ms Rejina Mariam Verghis Biostatistician for Northern Ireland Clinical Trials

Unit, PHS at Queen's University Belfast07/07/2016

Miss Leigh-Ann McCrum Leigh-Anne volunteers for Diabetes UK and works on occasion for the NI Chest Heart and Stroke foundation. Leigh-Anne works for the Centre for Public Health at Queens University Belfast and her supervisors are Dr Gerry Mckenna and Professor Jane Woodside. She also works for the NI Clinical Trials Unit

27/02/2017

Miss Leigh-Ann McCrum Volunteer in Diabetics UK.Carries out health checks with NI Chest Heart and Stroke.NI Clinical Trials Unit.QUB - Centre for public health.

10/03/2017

Mrs Cliona McDowell My current post is Senior Biostatistician 10/03/2017Ms Mary McMahon MMM Consultancy. Independent Monitoring Board,

Maghaberry08/02/2017

Mr John Edward Mone Non-Executive Director - Health and Social Care Board. Discontinued Nurse Registration- December 2015

10/03/2017

Dr Sarah Anne Moorhead International Association of Communication in Healthcare. Section Editor and Board member of Journal of Medical Internet Research.Member of International Association of Communication in Healthcare.Ulster University Ethics Committee and Research Committee.

10/03/2017

Dr Nicoli Morrison I work in the Northern Ireland Statistics & Research Agency (outposted to the Department for the economy).Peer reviewer for childcare in practice.

10/03/2017

Professor Patrick Murphy None 10/03/2017Mr Leon O'Hagan None 10/03/2017Dr Mark Reid Helping Hand - Charity for RBHSC (Children's

hospital)10/03/2017

Ms Marilyn Trimble None 10/03/2017


Meetings for Full Ethical Review 01 April 2016 - 31 March 2017:

Proportionate Review Sub-Committee Meetings held during 01 April 2016 - 31 March 2017:

Sub-Committee Meetings held during 01 April 2016 - 31 March 2017:

Month Date Number of Members Present at Meeting

April 14/04/2016 11

May 12/05/2016 12

June 09/06/2016 10

July 07/07/2016 12

August 11/08/2016 11

September 15/09/2016 12

October 13/10/2016 11

November 10/11/2016 12

January 12/01/2017 12

February 16/02/2017 11

10 full committee meetings were held during the reporting period.


April 11/04/2016 3May 09/05/2016 3June 06/06/2016 3July 04/07/2016 3August 01/08/2016 3August 30/08/2016 3September 26/09/2016 3October 24/10/2016 3November 21/11/2016 3December 19/12/2016 3January 30/01/2017 1February 27/02/2017 3March 27/03/2017 3

13 proportionate review sub-committee meetings were held during the reporting period.


April 06/04/2016 2April 26/04/2016 2


Details of inquorate meeting held:01 April 2016 - 31 March 2017

May 04/05/2016 2May 24/05/2016 2June 08/06/2016 3June 28/06/2016 2July 19/07/2016 2August 03/08/2016 2August 23/08/2016 3September 06/09/2016 2September 27/09/2016 3October 21/10/2016 2November 15/11/2016 2December 08/12/2016 2December 22/12/2016 2January 12/01/2017 2January 30/01/2017 3February 07/02/2017 2March 01/03/2017 2March 08/03/2017 2March 15/03/2017 2

21 sub-committee meetings were held during the reporting period.

Date Reason Action takenNone


Attendance of Members at full committee meetings:01 April 2016 - 31 March 2017

Attendance of Members at proportionate review sub-committee meetings: 01 April 2016 - 31 March 2017

Attendance of Members at sub-committee meetings: 01 April 2016 - 31 March 2017

Name Number of Meetings Attended

Dr Ronald Atkinson 7Ms Margaret Brady 1Mrs Karen Cardwell 2Dr Elinor Johnston 9Dr Justin Magee 1Ms Rejina Mariam Verghis 4Mrs Siobhan McCullough 4Mrs Cliona McDowell 7Ms Mary McMahon 1Mr John Edward Mone 7Dr Sarah Anne Moorhead 9Ms Aine Morrison 6Dr Nicoli Morrison 5Professor Patrick Murphy 10Dr Seamus O'Brien 10Mr Leon O'Hagan 7Dr Mark Reid 9Ms Marilyn Trimble 9Ms Sue Trouton 6


Mrs Karen Cardwell 1Dr Elinor Johnston 3Mrs Siobhan McCullough 3Mrs Cliona McDowell 3Mr John Edward Mone 5Dr Sarah Anne Moorhead 5Professor Patrick Murphy 7Dr Seamus O'Brien 4Mr Leon O'Hagan 2Ms Marilyn Trimble 1Ms Sue Trouton 3


Dr Ronald Atkinson 1


Mrs Karen Cardwell 1Dr Elinor Johnston 4Mrs Siobhan McCullough 2Mrs Cliona McDowell 1Mr John Edward Mone 4Dr Sarah Anne Moorhead 8Professor Patrick Murphy 5Dr Seamus O'Brien 3Mr Leon O'Hagan 8Ms Marilyn Trimble 1Ms Sue Trouton 8


Training 01 April 2016 - 31 March 2017

Name of Member Date Event(s) attendedDr Ronald Atkinson 07/03/2017 ORECNI Annual Members

Conference 2017Dr Elinor Johnston 21/07/2016 BSO Equality and Diversity e-

learningDr Elinor Johnston 29/11/2016 Attended tour of Phase 1 CRO

Facility BioKinetic BelfastDr Elinor Johnston 07/03/2017 ORECNI Annual Members

Conference 2017Dr Justin Magee 07/03/2017 ORECNI Annual Members

Conference 2017Miss Leigh-Ann McCrum 07/03/2017 ORECNI Annual Members

Conference 2017Mrs Siobhan McCullough 14/12/2016 Epistemic Injustice and the

Ethics of Healthcare Encounters: Evidence From Chronic Fatigue Syndrome

Mrs Cliona McDowell 30/11/2016 NRES- Committee members induction

Mrs Cliona McDowell 07/03/2017 ORECNI Annual Members Conference 2017

Mr John Edward Mone 07/03/2017 ORECNI Annual Members Conference 2017

Dr Sarah Anne Moorhead 07/03/2017 ORECNI Annual Members Conference 2017

Dr Nicoli Morrison 07/03/2017 ORECNI Annual Members Conference 2017

Professor Patrick Murphy 01/12/2016 NRES- National Training day for Committee Chairs

Professor Patrick Murphy 07/03/2017 ORECNI Annual Members Conference 2017

Dr Seamus O'Brien 07/03/2017 ORECNI Annual Members Conference 2017

Mr Leon O'Hagan 07/03/2017 ORECNI Annual Members Conference 2017

Dr Mark Reid 07/03/2017 ORECNI Annual Members Conference 2017

Ms Marilyn Trimble 07/03/2017 ORECNI Annual Members Conference 2017

Ms Sue Trouton 17/11/2016 Northern Ireland Ethcis Forum- why-there-can-be-no-moral-

obligation-to-eradicate-disabilityMs Sue Trouton 07/03/2017 ORECNI Annual Members

Conference 2017


PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD

Table 1: Applications assigned to a full committee meeting held within the reporting period:

Table 2: Breakdown of full applications and other activity during reporting period

Table 3: Decisions given at meetings held within the reporting period

Applications for full ethical review – Study Type Number %Clinical Trial of Investigational Medicinal Product 3 5.17Phase 1 21 36.21Gene Therapy 0 0.00Research Tissue Bank (including renewals) 0 0.00Research Database (including renewals) 1 1.72Others 33 56.90Total Applications Reviewed 58 100

Number of applications made invalid by the REC Manager 1Number of applications withdrawn prior to the meeting 0Number of student applications reviewed 16Number of paediatric applications reviewed 4Number of device applications reviewed 3Number of prisoner applications reviewed 1Number of applications involving adults unable consent reviewed 0Number of applications reviewed that are funded by the US DHHS 0Number of qualitative applications reviewed 3

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 23 39.66Favourable Opinion with Additional Conditions 5 8.62Unfavourable Opinion 1 1.72Provisional Opinion 29 50.00Provisional Opinion Pending Consultation with Referee 0 0.00Total 58 100Number of studies sent back to full committee meeting for final opinion

0


Table 4: Summary of current status of applications reviewed during the reporting period

Status of applications at date of generation of report Number %Further Information Favourable Opinion with Standard Conditions

27 46.55

Further Information Favourable Opinion with Additional Conditions

2 3.45

Further Information Unfavourable Opinion 0 0.00Favourable Opinion with Standard Conditions 23 39.66Favourable Opinion with Additional Conditions 5 8.62Unfavourable Opinion 1 1.72Provisional Opinion 0 0.00Provisional Opinion Pending Consultation with Referee 0 0.00Further Information response not complete 0 0.00No decision entered on system 0 0.00Number of studies withdrawn after the meeting 0 0.00Total 58 100


Table 5: Applications assigned to a proportionate review sub-committee within the reporting period

Table 7: Decisions given at proportionate review sub-committee meetings held within the reporting period

Table 6: Breakdown of PRS applications and other activity during reporting period:

Total Applications Reviewed 37

Number of applications made invalid by the REC Manager 7Number of studies withdrawn prior to the meeting 0Number of student applications reviewed 15Number of paediatric applications reviewed 5Number of device applications reviewed 1Number of qualitative applications reviewed 5

Decisions taken at proportionate review sub-committee meetings

Number %

Favourable Opinion with Standard Conditions 12 32.43Favourable Opinion with Additional Conditions 6 16.22No Opinion transfer to full committee for review 1 2.70Provisional Opinion 18 48.65Unfavourable Opinion 0 0.00Total 37 100


Table 8: Other Management Information based on the number of completed applications for the reporting period:Average number of applications reviewed per full meeting 5.80Number of completed applications for full ethical review 58Number of completed applications for full ethical review over 60 days

0

Number of completed applications over 60 days as a % of total

0.00%

Number of completed applications for full ethical review over 40 days

0

Number of completed applications over 40 days as a % of total

0.00%

Number of days taken to final decision – average (mean) 22

Number of completed proportionate review applications for ethical review

35

Number of completed proportionate review applications for ethical review over 14 days

1

Number of completed proportionate review applications over 14 days as a % of total

2.86%

Number of SSAs (non-Phase 1) reviewed 2Number of completed applications for SSA review over 25 days

0

Number of completed applications for SSA review over 25 days as % of all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 22Number of completed applications for SSA review over 14 days

0

Number of completed applications for SSA review over 14 days as % of all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 103Number of completed substantial amendments over 35 days 0Number of completed substantial amendments over 35 days as a % of total substantial amendments

0.00%

Number of completed substantial amendments over 28 days 0Number of completed substantial amendments over 28 days as a % of total substantial amendments

0.00%

Number of modified amendments reviewed 0Number of completed modified amendments over 14 days 0Number of completed modified amendments over 14 days as a % of total modified amendments

0.00%

Number of non substantial amendments received 117Number of substantial amendments received for information 2Number of substantial amendments received for new sites/PIs

1

Number of annual progress reports received 84Number of safety reports received 26Number of Serious Adverse Events received 2Number of final reports received 53


Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period

Further Information Favourable Opinion with Standard ConditionsREC Reference Title Number of Days on Clock 16/NI/0054 Retinal Evaluation in AD and MCI 21 16/NI/0058 Music therapy for palliative care patients 32 16/NI/0070 A drug interaction study of AL-794, v1 23 16/NI/0076 MAGE 25 16/NI/0097 AIDE (Project Phase Two) 35 16/NI/0110 Exploring the lived experience of adolescent boys with Haemophilia 20 16/NI/0121 Thorough QT study of imeglimin, version 1 18 16/NI/0130 Care Pathways and Outcomes Study 26 16/NI/0133 Antidepressant Response: Biological and Clinical Markers (ABC Study) 27 16/NI/0135 GP practice based pharmacist input to medicines optimisation 23 16/NI/0158 A Method for Recording Heart Rate and Rhythm (H2020) 24 16/NI/0185 SITless RCT 19 16/NI/0205 USG PECS vs LIA for breast cancer surgery 24 16/NI/0213 Let's talk about sex too: 22 16/NI/0214 Inhaled Oxytocin in women after birth and in nonpregnant women 27 16/NI/0226 Does birth experience moderate genetic risk for PND? Version 2 21 16/NI/0227 Transfer of Antiepileptics in Breastmilk and Infant Feeding Decisions 22 16/NI/0232 Factors associated with alcohol use in pregnancy in Northern Ireland 23 16/NI/0236 Nutrition in Nontuberculous Mycobacterial Infection 33 17/NI/0002 Vision related quality of life measured using Virtual Reality. 19 17/NI/0003 ADME study of [14C]-BIA 9-1067 in healthy male subjects (QCL117756) 19 17/NI/0007 Evaluation of the Early Intervention Support Service in NI 21 17/NI/0008 A study to assess the absolute bioavailability of AZD0284 (QCL117831) 29 17/NI/0016 GSK3036656 – first doses in humans; v1 20 17/NI/0017 A PET scan study of AVP-923 and AVP-786, version A 22 17/NI/0021 A Feasibility Study for an Intervention to Reduce Diabetes Distress 20 17/NI/0026 Quality Care For Children- Evidence Informed Inspection Practice 28

Further Information Favourable Opinion with Additional ConditionsREC Reference Title Number of Days on Clock 16/NI/0159 Proof-of-concept prototype: virtual ward for outpatient renal anaemia 25

HSC REC B Research Ethics Committee Annual Report

17/NI/0022 CrossFit4Survivors: exercise with young adult cancer survivors. 22

Further Information Unfavourable OpinionREC Reference Title Number of Days on Clock

Favourable Opinion with Standard ConditionsREC Reference Title Number of Days on Clock 16/NI/0048 Safety and blood levels of repeated doses of IX-01 in healthy men 20 16/NI/0061 Investigating the strengths and weaknesses of trauma history measures 20 16/NI/0073 Life After Prostate Cancer Diagnosis (LAPCD) Normative supplement NI 20 16/NI/0074 Comparing blood levels after taking liquid and tablet forms of AL-794 20 16/NI/0077 Planning for the future of adults with a learning disability 20 16/NI/0079 Health and Social Care Professionals' FFP 33 16/NI/0094 Bioavailability and food effect of a GDC-0276 tablet (QCL117781) 18 16/NI/0095 ADME study of Pitolisant in Healthy CYP2D6 Genotyped Males (QCL117662) 19 16/NI/0114 Use of a diagnostic assay to predict response to an anti-PD1 therapy 19 16/NI/0116 MOBIDIC Patient Study 19 16/NI/0129 GSK2646264 clinical study in healthy subjects and urticaria patients. 28 16/NI/0132 Electrical Stimulation Frequency Comparison Study 19 16/NI/0146 Drug Interaction Study between BCT197 and AzithromycinÂ® 21 16/NI/0148 Safety and blood levels of repeated doses of MR1916, version 1 19 16/NI/0166 Study Assessing Safety,Tolerability, PK & PD of 2 Drugs for Infection 19 16/NI/0176 Radiation Induced Skin Reaction Study IBRB-02 19 16/NI/0183 Comparing blood levels of Lacosamide in Japanese volunteers, v1 20 16/NI/0184 Relative bioavailability of HTL0018318 oral formulations, v1 19 16/NI/0186 CBC project 19 16/NI/0207 Blood levels of inhaled fluticasone and salmeterol; v1 18 16/NI/0230 Study to evaluate PK of PRX167700 in fed and fasting state (QCL117933) 20 17/NI/0001 AIRDP 18 17/NI/0023 Healthy Volunteer Study to Evaluate Novel Sirolimus Formulation 117958 19

Favourable Opinion with Additional ConditionsREC Reference Title Number of Days on Clock


Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period

16/NI/0055 CIBRAC 20 16/NI/0060 Adolescents' subjective experience of PNES 27 16/NI/0165 Presumed Ocular Tuberculosis 19 16/NI/0202 A study to evaluate safety, tolerability and PK of HL217 eye drops 21 16/NI/0238 PK comparison of 3 MR formulations of MIN-101 & food effect in one MR 20

Unfavourable OpinionREC Reference Title Number of Days on Clock 16/NI/0209 AIRDP 31

Provisional OpinionREC Reference Title Number of Days on Clock

Provisional Opinion Pending Consultation with RefereeREC Reference Title Number of Days on Clock

Further information response not completeREC Reference Title Number of Days on Clock

Withdrawn after the meetingREC Reference Title Number of Days on Clock

Further Information Favourable Opinion with Standard ConditionsREC Reference Title Number of Days on Clock 16/NI/0090 Speech perception in cochlear implant patients using a new microphone 5 16/NI/0119 Characterisation of primary human pancreatic tumour cells 7 16/NI/0139 A finite element model of the SCC for BPPV diagnosis 10


16/NI/0143 Impact of a collaborative liaison psychiatry approach 7 16/NI/0163 Head & Neck 5000 Follow-up Study 8 16/NI/0164 01 A pilot study validating the current Nutritional Screening Tool 11 16/NI/0170 Assessing Bronchial Hyper-reactivity in a Birth Cohort Study 10 16/NI/0212 Investigating motor control in the basal ganglia 8 16/NI/0239 MARI 8 16/NI/0240 Haemodynamics in CKD: Transition to Renal Replacement therapy 8 16/NI/0256 Cognitive-behavioural factors in persistent vestibular symptoms (V1) 8 16/NI/0260 Burden of Illness in Geographic Atrophy in the UK, Germany and Ireland 7 17/NI/0019 Together study: version 1 12 17/NI/0047 CBT for Insomnia Workshop: factor analysis and cohort studies 9 17/NI/0067 Peripheral Memory B Cells in MS 7

Further Information Favourable Opinion with Additional ConditionsREC Reference Title Number of Days on Clock 16/NI/0069 MINERVA UK Multicentre Investigation 13 16/NI/0120 Acne Delphi Study 9

Further Information Unfavourable OpinionREC Reference Title Number of Days on Clock

Favourable Opinion with Standard ConditionsREC Reference Title Number of Days on Clock 16/NI/0068 Identification of Cognitive Impairment in Longitudinal Ageing Study 8 16/NI/0088 Multimorbidity in secondary care V1 6 16/NI/0118 Iron metabolism, Anaemia and Coeliac disease. 6 16/NI/0138 Ultrasound Location of Oscillating Shear Stress in Dialysis Fistulae 6 16/NI/0188 Exploration of the expectations and experiences of significant others 9 16/NI/0189 Amygdala TDP-43 pathology in the population 9 16/NI/0211 LUSTRUM Pre-trial Development Work 7 16/NI/0258 Assessing the benefit of ranibizumab treatment for AMD - A follow-up 8 17/NI/0025 The perception of care in CT scanning. Version 1. 7 17/NI/0050 Are TNF Inhibitors associated with lower risk of alzheimers disease 7


17/NI/0060 Antidepressant prescribing in NI: an administrative data linkage study 17 17/NI/0068 IHC Dual Staining: a new depth measurement for melanoma diagnosis 6

Favourable Opinion with Additional ConditionsREC Reference Title Number of Days on Clock 16/NI/0066 Compassion in Midwifery 001 8 16/NI/0089 How the spirituality of people impacts diabetes self-manangement (V1) 5 16/NI/0187 Radomics classification of colorectal cancer V2 9 16/NI/0270 An investigation of patients’ perceptions of vestibular testing 7 17/NI/0046 Multiple Breath Washout, a clinimetrics dataset 8

Unfavourable OpinionREC Reference Title Number of Days on Clock

Provisional OpinionREC Reference Title Number of Days on Clock 17/NI/0020 The role of misidentification of own speech in childhood stuttering n/a

Further information response not completeREC Reference Title Number of Days on Clock

Withdrawn after the meetingREC Reference Title Number of Days on Clock 16/NI/0237 PPV to compare hemodynamic monitoring in ICU 7


Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period

Favourable opinionAmendment REC Reference

Title Version Date Number of Days on Clock

08/NIR03/113/AM13 The TUDA Study 23/05/2016 6 08/NIR03/113/AM14 The TUDA Study 07/11/2016 5 09/NIR02/66/AM06 Physical Activity and the Regeneration of Connswater (the

PARC Study)22/12/2016 19

10/NIR02/45/AM13 Study of Pomalidomide in Subjects with MPN-Associated Myelofibrosis

Pomalidomide IB - Edition 22.0

10/06/2016 17

10/NIR02/55/AM01 Can ultrasound predict response to carpal tunnel steroid injection?

10

12/NI/0077/AM02 Maternal Folate and Cognitive Development of the Offspring 06/07/2016 13 12/NI/0077/AM04 Maternal Folate and Cognitive Development of the Offspring 21/11/2016 9 12/NI/0077/AM06 Maternal Folate and Cognitive Development of the Offspring 19/12/2016 21 12/NI/0077/AM07 Maternal Folate and Cognitive Development of the Offspring 07/03/2017 8 12/NI/0136/AM14 Riboflavin, Genetic Related Disease & Hypertension 05/05/2016 18 12/NI/0136/AM16 Riboflavin, Genetic Related Disease & Hypertension 08/09/2016 18 12/NI/0154/AM09 Pomalidomide in Relapsed and/or Refractory Multiple Myeloma

Patients06/07/2016 13

13/NI/0129/AM02 LAL Deficiency Registry Substantial Amendment No 1 -

2

20/06/2016 7

13/NI/0129/AM03 LAL Deficiency Registry Substantial Amendment No.2_27O

24/10/2016 19

13/NI/0129/AM06 LAL Deficiency Registry 30/01/2017 7 13/NI/0138/AM04 PORTICO I STUDY 19/09/2016 7 13/NI/0148/AM22 WB28182 The effect of lebrikizumab in patients with severe

asthma14/07/2016 19

13/NI/0148/AM23 WB28182 The effect of lebrikizumab in patients with severe asthma

06/10/2016 14

13/NI/0168/AM07 Exploring the needs & QoL of people with heart failure & their carers

Substantial Amendment #3

25/04/2016 4

13/NI/0182/AM01 A trial of cognitive rehabilitation in Multiple Sclerosis V1.0 12/08/2016 7 14/NI/0068/AM07 Cardiovascular Event (CVE) Risk Study Substantial 26/01/2017 11


Amendment 4_20/01/

14/NI/1025/AM02 Retinal structure and function in Diabetic Macular Oedema Substantial Amendment 2

21/06/2016 5

14/NI/1033/AM03 Phase 1 - ALM201 in advanced ovarian cancer and other solid tumours

28/06/2016 21

14/NI/1036/AM07 Efficacy of a nutritional biscuit in malnutrition management Substantial Amendment #5

20/03/2016 13

14/NI/1037/AM09 Treatment of lymphoma by Betalutin targeted internal radiation therapy

18/08/2016 18

14/NI/1037/AM10 Treatment of lymphoma by Betalutin targeted internal radiation therapy

14/12/2016 8

14/NI/1038/AM06 The Paediatric EVICELÂ® Neuro Study 09/11/2016 5 14/NI/1120/AM05 EDNA 15/12/2016 5 14/NI/1128/AM11 A Phase I study of BCX4430 in healthy subjects (QCL117377) Substantial

Amendment #619/04/2016 3

15/NI/0001/AM02 SPRITE - A Feasibility and Pilot Study Substantial Amendment #1

04/04/2016 17

15/NI/0001/AM03 SPRITE - A Feasibility and Pilot Study 13/12/2016 4 15/NI/0064/AM10 Vertex - VX14-661-106 - Cystic Fibrosis 01/04/2016 18 15/NI/0064/AM11 Vertex - VX14-661-106 - Cystic Fibrosis Substantial

Amendment #910/06/2016 17

15/NI/0064/AM12 Vertex - VX14-661-106 - Cystic Fibrosis 15/01/2017 21 15/NI/0077/AM02 Clinimetric properties bronchiectasis v1.0 22/11/2016 14 15/NI/0113/AM03 VX14-809-109 Cystic Fibrosis 30/03/2016 5 15/NI/0113/AM04 VX14-809-109 Cystic Fibrosis 12/07/2016 6 15/NI/0137/AM06 Phase 1 Study of BLU-554 in Patients with Hepatocellular

Carcinoma Substantial

Amendment #527/04/2016 2

15/NI/0137/AM09 Phase 1 Study of BLU-554 in Patients with Hepatocellular Carcinoma

14/07/2016 19

15/NI/0139/AM02 ELAPR002 implant – safety and efficacy, v1 29/06/2016 19 15/NI/0139/AM03 ELAPR002 implant – safety and efficacy, v1 22/12/2016 19 15/NI/0160/AM04 Technology Enriched Supported Accommodation for People

with Dementia Substantial

Amendment #231/08/2016 22

15/NI/0160/AM05 Technology Enriched Supported Accommodation for People with Dementia

28/11/2016 8


15/NI/0174/AM03 An intervention programme to reduce cognitive impairment due to cancer

V2.0 13/09/2016 14

15/NI/0178/AM02 3D modelling of the breast Substantial Amendment #1

19/04/2016 3

15/NI/0180/AM02 Nitric Oxide & Human Skin - Normal and Perturbed Conditions 04/11/2016 10 15/NI/0188/AM02 Long-term Study of FerriproxÂ® in Patients with Sickle Cell

Disease03/05/2016 20

15/NI/0189/AM02 Immune Tolerance Induction with Methotrexate in Hurler Syndrome

V3.0 19/07/2016 16

15/NI/0195/AM01 Emodepside - first doses in humans, v1 25/05/2016 10 15/NI/0195/AM02 Emodepside - first doses in humans, v1 20/01/2017 17 15/NI/0210/AM01 Exploration of Men's Experiences of Prostate Cancer v1.0

21.09.1521/04/2016 3

15/NI/0232/AM02 The New Baby Programme: A Pilot Randomised Trial (Version 1)

06/05/2016 5


06/06/2016 21


12/08/2016 7

15/NI/0236/AM02 Multi-centre PMCF study of INFINITYÂ® Total Ankle System 08/11/2016 19 15/NI/0256/AM01 Comparison of two testing modalities for Troponin I 1 20/02/2017 8 15/NI/0268/AM02 Patient interviews on perceptions of quality within dentistry Substantial

Amnemdnet #223/03/2016 12

15/NI/0270/AM02 The use of social media for healthcare advice: A focus group study

15/09/2016 11

16/NI/0001/AM01 CCI15106-CFI – first doses in humans; version 1 Substantial Amendment #1

06/04/2016 16

16/NI/0003/AM01 REducing Antimicrobials in Care Homes (REACH) 29/08/2016 5 16/NI/0003/AM02 REducing Antimicrobials in Care Homes (REACH) 13/12/2016 8 16/NI/0006/AM06 Multiple Dose, Crossover Study of Oral Testosterone

Undecanoate30/05/2016 5

16/NI/0014/AM02 Bioavailability Study of BMS-626529 in Healthy Subjects (QCL117632)

Substantial Amendment #1

17/03/2016 17

16/NI/0029/AM01 OptiPREG 04/08/2016 18 16/NI/0054/AM01 Retinal Evaluation in AD and MCI Amendment 1 17/06/2016 10 16/NI/0055/AM02 CIBRAC 20/09/2016 4


16/NI/0055/AM03 CIBRAC 07/02/2017 22 16/NI/0058/AM02 Music therapy for palliative care patients 29/06/2016 13 16/NI/0058/AM03 Music therapy for palliative care patients 21/07/2016 12 16/NI/0058/AM04 Music therapy for palliative care patients 15/08/2016 7 16/NI/0058/AM05 Music therapy for palliative care patients Substantial

Amendment #426/08/2016 11

16/NI/0060/AM01 Adolescents' subjective experience of PNES 05/10/2016 6 16/NI/0060/AM02 Adolescents' subjective experience of PNES 19/10/2016 25 16/NI/0060/AM03 Adolescents' subjective experience of PNES 23/11/2016 14 16/NI/0060/AM04 Adolescents' subjective experience of PNES Substantial

Amendment #408/12/2016 11

16/NI/0069/AM02 MINERVA UK Multicentre Investigation 03/03/2017 12 16/NI/0070/AM01 A drug interaction study of AL-794, v1 24/05/2016 12 16/NI/0070/AM03 A drug interaction study of AL-794, v1 04/07/2016 15 16/NI/0070/AM04 A drug interaction study of AL-794, v1 19/08/2016 14 16/NI/0070/AM05 A drug interaction study of AL-794, v1 20/01/2017 14 16/NI/0074/AM02 Comparing blood levels after taking liquid and tablet forms of

AL-79419/08/2016 14

16/NI/0074/AM03 Comparing blood levels after taking liquid and tablet forms of AL-794

01/12/2016 6

16/NI/0094/AM01 Bioavailability and food effect of a GDC-0276 tablet (QCL117781)

24/08/2016 13


19/09/2016 8


01/11/2016 13

16/NI/0110/AM02 Exploring the lived experience of adolescent boys with Haemophilia

15/12/2016 24

16/NI/0116/AM01 MOBIDIC Patient Study 27/10/2016 13 16/NI/0116/AM02 MOBIDIC Patient Study 20/02/2017 9 16/NI/0121/AM01 Thorough QT study of imeglimin, version 1 15/08/2016 7 16/NI/0130/AM02 Care Pathways and Outcomes Study 07/10/2016 13 16/NI/0148/AM01 Safety and blood levels of repeated doses of MR1916, version

1 Substantial

Amendment #115/11/2016 22

16/NI/0148/AM02 Safety and blood levels of repeated doses of MR1916, version 1

06/12/2016 14


Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period

16/NI/0166/AM01 Study Assessing Safety,Tolerability, PK & PD of 2 Drugs for Infection

26/08/2016 11

16/NI/0166/AM03 Study Assessing Safety,Tolerability, PK & PD of 2 Drugs for Infection

29/11/2016 7

16/NI/0170/AM02 Assessing Bronchial Hyper-reactivity in a Birth Cohort Study 06/02/2017 13 16/NI/0176/AM01 Radiation Induced Skin Reaction Study IBRB-02 Substantial

Amendment #111/11/2016 20

16/NI/0183/AM01 Comparing blood levels of Lacosamide in Japanese volunteers, v1

07/12/2016 13

16/NI/0184/AM01 Relative bioavailability of HTL0018318 oral formulations, v1 30/09/2016 17 16/NI/0185/AM02 SITless RCT 28/02/2017 14 16/NI/0238/AM04 PK comparison of 3 MR formulations of MIN-101 & food effect

in one MR27/01/2017 7

16/NI/0238/AM07 PK comparison of 3 MR formulations of MIN-101 & food effect in one MR

14/02/2017 14

16/NI/0256/AM01 Cognitive-behavioural factors in persistent vestibular symptoms (V1)

14/02/2017 14

17/NI/0008/AM01 A study to assess the absolute bioavailability of AZD0284 (QCL117831)

06/03/2017 3

Unfavourable opinionAmendment REC Reference


Favourable opinion timelineAmendment REC Reference


Unfavourable opinion timelineAmendment REC Reference



Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timelineREC Reference Title Number of Days on Clock

Proportionate review applications for ethical review over 14 day timelineREC Reference Title Number of Days on Clock 17/NI/0060 Antidepressant prescribing in NI: an administrative data linkage study 17

SSAs (non Phase 1) over 25 day timelineREC Reference Title Number of Days on Clock

SSAs (Phase 1) over 14 day timelineREC Reference Title Number of Days on Clock

Substantial Amendments over 35 day timelineAmendment REC Reference


Modified Amendments over 14 day timelineAmendment REC Reference



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