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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: recb@hscni.net
HSC REC B Annual Report Page 2
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 Annual Report Page 3
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 Annual Report Page 4
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 Annual Report Page 5
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
HSC REC B Annual Report Page 6
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.
Month Date Number of Members Present at Meeting
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.
Month Date Number of Members Present at Meeting
April 06/04/2016 2April 26/04/2016 2
HSC REC B Annual Report Page 7
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
HSC REC B Annual Report Page 8
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
Name Number of Meetings Attended
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
Name Number of Meetings Attended
Dr Ronald Atkinson 1
HSC REC B Annual Report Page 9
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
HSC REC B Annual Report Page 10
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
HSC REC B Annual Report Page 11
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
HSC REC B Annual Report Page 12
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
HSC REC B Annual Report Page 13
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
HSC REC B Annual Report Page 14
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
HSC REC B Annual Report Page 15
HSC REC B Annual Report Page 16
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 Page 17
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 Azithromycin® 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
HSC REC B Research Ethics Committee Annual Report Page 18
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
HSC REC B Research Ethics Committee Annual Report Page 19
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
HSC REC B Research Ethics Committee Annual Report Page 20
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
HSC REC B Research Ethics Committee Annual Report Page 21
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
HSC REC B Research Ethics Committee Annual Report Page 22
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 EVICEL® 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
HSC REC B Research Ethics Committee Annual Report Page 23
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 Ferriprox® 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
15/NI/0232/AM03 The New Baby Programme: A Pilot Randomised Trial (Version 1)
06/06/2016 21
15/NI/0232/AM04 The New Baby Programme: A Pilot Randomised Trial (Version 1)
12/08/2016 7
15/NI/0236/AM02 Multi-centre PMCF study of INFINITY® 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
HSC REC B Research Ethics Committee Annual Report Page 24
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
16/NI/0094/AM02 Bioavailability and food effect of a GDC-0276 tablet (QCL117781)
19/09/2016 8
16/NI/0094/AM03 Bioavailability and food effect of a GDC-0276 tablet (QCL117781)
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
HSC REC B Research Ethics Committee Annual Report Page 25
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
Title Version Date Number of Days on Clock
Favourable opinion timelineAmendment REC Reference
Title Version Date Number of Days on Clock
Unfavourable opinion timelineAmendment REC Reference
Title Version Date Number of Days on Clock
HSC REC B Research Ethics Committee Annual Report Page 26
HSC REC B Research Ethics Committee Annual Report Page 27
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
Title Version Date Number of Days on Clock
Modified Amendments over 14 day timelineAmendment REC Reference
Title Version Date Number of Days on Clock
HSC REC B Research Ethics Committee Annual Report Page 28
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