hsc rec a annual report 01 april 2014 31 march 2015€¦ · annual report 01 april 2014 – 31...

National Research Ethics Service

HSC REC A

Annual Report

01 April 2014 – 31 March 2015

HSC REC A Annual Report

Part 1 – Committee Membership and Training

Name of REC: HSC REC A

Type of REC: Recognised, Type 1 and 3

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

Chair: Dr Catherine Hack

Vice-Chair: Dr Alastair Walker

Alternate Vice-Chair: Mrs Celia Diver-Hall

REC Manager: Miss Kathryn Taylor, Ms Jan Daley (Proportionate Review studies)

REC Assistant: Not Applicable

Committee Address: Office Suite 3 Lisburn Square House, Haslems Lane Lisburn Northern Ireland BT28 1TW

Telephone: 028 92603107

Email: [email protected]


Chair’s overview of the past year:

HSC REC A continues to deliver a professional ethical review service to the research community in Ulster and across the UK. The past 12 months have witnessed significant changes to the workload for HSC REC A. We are receiving a greater proportion of CTIMP submissions from across the UK, which I believe is in recognition of our efficient and effective review processes. The majority of committee members now complete and submit their review notes in advance of the meeting, which facilitates timely and robust review. The review proforma has also been extremely helpful in directing members to focus on the key ethical issues within submissions. The membership has also accommodated the growth in the Proportionate Review service, demonstrating both their adaptability and expertise. I would like to express particular thanks to the proportionate review REC Manager, Ms Jan Daley for supporting this service. The members of HSC REC A are dedicated, informed and reflective, and with the support of our REC Manager and the other office staff, I am confident that we will continue to provide a valued and efficient service.


HSC REC A Membership

HSC REC A: Deputy Members

Name Profession Expert or

Lay

Dates

Appointed Left

Ms Stephanie Annett PhD Researcher Expert 01/04/2015

Ms Margaret Brady Deputy Chief Education Welfare Officer Operations

Lay Plus 17/02/2014

Miss Rachel Church Postgraduate Research Student/Registered Pharmacist

Expert 17/02/2014 03/03/2015

Dr Avril Craig Project Manager Lay 01/04/2015

Dr Gordon Cran Medical Statistician (Retired)

Expert 17/02/2014

Mrs Celia Diver-Hall Oncology Research Manager

Expert 17/02/2014

Dr Catherine Hack Biomedical Sciences and Psychology Partnership Manager

Lay Plus 17/02/2014

Dr Helen Harty Lay Plus 17/02/2014

Dr Felicity Hasson Senior Lecturer Lay 17/02/2014

Dr Aine Lockhart Retired GP Expert 17/02/2014

Mrs Toni McAloon Nurse Lecturer Expert 17/02/2014

Mr Niall McSperrin Solicitor Lay Plus 17/02/2014

Dr Charles Mullan Consultant Radiologist Expert 17/02/2014

Mrs Mary Murphy Registered Nurse Expert 17/02/2014

Mr Niall O'Kane Registered Pharmacist Expert 17/02/2014

Dr Orla Quigley General Practitioner (Retired)

Expert 17/02/2014

Dr Hilary Russell Former Reader in Oncology

Expert 17/02/2014 19/06/2014

Professor Mahendra Varma

Consultant Physician in charge of Cardiology and Diabetic Services

Expert 17/02/2014

Dr Alastair Walker Retired Head of Education Services, CCEA

Lay Plus 17/02/2014

Dr Paula Walls Clinical Education Consultant

Expert 17/02/2014

Name Profession Status Meeting date attended








Dr Suzanne Martin Reader in Health Sciences Expert 29/07/2014


HSC REC A: Co-opted Members



Ms Maria McCann (resigned 01/01/2015)

Director, Public Relations Lay Plus 26/08/2014

Mr Canice Ward Pharmacist Expert None – resigned 30/06/2014

Name Profession Status Meeting date attended


HSC REC A: Members’ Declarations of Interest:

Name Declaration of Interest Date

Ms Margaret Brady Member of Amnesty International 28/08/2014

Ms Maria McCann Owner of McCann Public Relations 28/08/2014


Meetings for Full Ethical Review 01 April 2014 – 31 March 2015:

Proportionate Review Sub-Committee Meetings held during 01 April 2014 – 31 March 2015:

Sub-Committee Meetings held during 01 April 2014 – 31 March 2015:

Month Date Number of Members Present

at Meeting

April 29/04/2014 13

May 27/05/2014 10

June 24/06/2014 10

July 29/07/2014 10

August 26/08/2014 10

September 30/09/2014 11

October 28/10/2014 13

November 25/11/2014 9

December 16/12/2014 11

February 24/02/2015 11

March 31/03/2015 10

11 full committee meetings were held during the reporting period.


at Meeting

April 02/04/2014 3

May 07/05/2014 3

June 04/06/2014 3

July 02/07/2014 3

August 06/08/2014 3

September 03/09/2014 3

October 08/10/2014 3

November 05/11/2014 3

December 03/12/2014 3

January 14/01/2015 3

February 04/02/2015 3

March 04/03/2015 3

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


at Meeting

April 09/04/2014 2

April 29/04/2014 3

May 14/05/2014 2

June 11/06/2014 2

July 07/07/2014 2

July 29/07/2014 2

August 13/08/2014 2



Details of inquorate meeting held:01 April 2014 – 31 March 2015



October 15/10/2014 2

October 28/10/2014 2

November 12/11/2014 2

December 10/12/2014 2

January 14/01/2015 2

January 26/01/2015 4

February 11/02/2015 2

February 16/02/2015 2

March 11/03/2015 2

March 31/03/2015 2

20 sub-committee meetings were held during the reporting period. No inquorate meetings held


Attendance of Members at full committee meetings:01 April 2014 – 31 March 2015

Attendance of Members at proportionate review sub-committee meetings: 01 April 2014 –

31 March 2015

Name Number of

Meetings

Attended

Ms Margaret Brady 3

Miss Rachel Church 1

Dr Avril Craig 7

Dr Gordon Cran 9

Mrs Celia Diver-Hall 8

Dr Catherine Hack 7

Dr Helen Harty 5

Dr Felicity Hasson – maternity leave 0

Dr Aine Lockhart 6

Dr Suzanne Martin 1

Mrs Toni McAloon 6

Mr Niall McSperrin 8

Dr Charles Mullan 8

Mrs Mary Murphy 7

Mr Niall O'Kane 5

Dr Orla Quigley 8

Dr Hilary Russell 1

Professor Mahendra Varma 8

Dr Alastair Walker 10

Dr Paula Walls 10

Name Number of

Meetings

Attended

Ms Margaret Brady 1

Dr Gordon Cran 4


Dr Catherine Hack 6

Dr Helen Harty 1

Dr Felicity Hasson 1

Dr Aine Lockhart 1

Mrs Toni McAloon 2


Dr Charles Mullan 2

Mrs Mary Murphy 2

Dr Orla Quigley 2



Dr Paula Walls 3


Attendance of Members at sub-committee meetings: 01 April 2014 – 31 March 2015

Name Number of

Meetings

Attended

Dr Gordon Cran 1


Dr Catherine Hack 9

Dr Helen Harty 2

Dr Aine Lockhart 1

Mrs Toni McAloon 2


Dr Charles Mullan 2

Dr Orla Quigley 2



Dr Paula Walls 2


Training 01 April 2014 – 31 March 2015

Name of Member Date Event(s) attended

Ms Margaret Brady 06/10/2014 Research Involving the Disadvantaged and Vulnerable:

a Workshop for Researchers and Reviewers

Ms Margaret Brady 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Gordon Cran 23/05/2014 Translational Medicine Symposium

Dr Gordon Cran 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Gordon Cran 28/10/2014 Training Overview - Use of Personal Data in Research

Dr Gordon Cran 17/02/2015 2015 HSC REC Members' Training Day

Dr Gordon Cran 17/02/2015 Equality and Diversity Training Session

Mrs Celia Diver-Hall 23/05/2014 Translational Medicine Symposium

Mrs Celia Diver-Hall 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Mrs Celia Diver-Hall 28/10/2014 Training Overview - Use of Personal Data in Research

Mrs Celia Diver-Hall 17/02/2015 2015 HSC REC Members' Training Day

Mrs Celia Diver-Hall 17/02/2015 Equality and Diversity Training Session

Dr Catherine Hack 21/07/2014 The Ethical Issues of Research Involving Children

Dr Catherine Hack 01/10/2014 Training for New REC Chairs

Dr Catherine Hack 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Catherine Hack 28/10/2014 Training Overview on Use of Personal Data in Research

Dr Catherine Hack 10/12/2014 National Training Day for NRES Committee Chairs

Dr Catherine Hack 17/02/2015 2015 HSC REC Members' Training Day

Dr Catherine Hack 17/02/2015 Equality and Diversity Training Session

Dr Helen Harty 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Helen Harty 28/10/2014 Training Overview - Use of Personal Data in Research

Dr Aine Lockhart 17/02/2015 2015 HSC REC Members' Training Day

Mrs Toni McAloon 23/09/2014 Reading: Reports on HRA Training Events

Mrs Toni McAloon 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study


Mrs Toni McAloon 28/10/2014 Training Overview - Use of Personal Data in Research

Mrs Toni McAloon 02/02/2015 Equality and Diversity

Mr Niall McSperrin 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Mr Niall McSperrin 28/10/2014 Training Overview - Use of Personal Data in Research

Mr Niall McSperrin 17/02/2015 2015 HSC REC Members' Training Day

Mr Niall McSperrin 17/02/2015 Equality and DIversity Training Session

Dr Charles Mullan 09/10/2014 Medical Devices Training Day

Dr Charles Mullan 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Charles Mullan 28/10/2014 Training Overview - Use of Personal Data in Research

Dr Charles Mullan 17/02/2015 2015 HSC REC Members' Training Day

Dr Charles Mullan 17/02/2015 Equality and Diversity Training Session

Mrs Mary Murphy 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Mrs Mary Murphy 28/10/2014 Training Overview - Use of Personal Data in Research

Mrs Mary Murphy 17/02/2015 2015 HSC REC Members' Training Day

Mrs Mary Murphy 17/02/2015 Equality and DIversity Training Session

Mr Niall O'Kane 01/07/2014 REC Member Induction Training

Mr Niall O'Kane 10/03/2015 Equality and Diversity Training

Dr Orla Quigley 23/05/2014 Translational Medicine Symposium

Dr Orla Quigley 17/02/2015 2015 HSC REC Members' Training Day

Dr Orla Quigley 17/02/2015 Equality and Diversity Training Session

Professor Mahendra Varma 01/07/2014 REC Members Induction (Refresher)

Professor Mahendra Varma 22/09/2014 Reading: HSC REC Member Reports on HRA Training

Events

Professor Mahendra Varma 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Professor Mahendra Varma 28/10/2014 Training Overview - Use of Personal Data in Research

Professor Mahendra Varma 17/02/2015 2015 HSC REC Members' Training Day

Professor Mahendra Varma 17/02/2015 Equality and Diversity Training Session

Dr Alastair Walker 12/09/2014 Discovering Diversity Training

Dr Alastair Walker 01/10/2014 Training for New REC Chairs

Dr Alastair Walker 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study


Dr Alastair Walker 28/10/2014 Training Overview on Use of Personal Data in Research

Dr Alastair Walker 17/02/2015 2015 HSC REC Members' Training Day

Dr Alastair Walker 17/02/2015 Equality and Diversity Training Session

Dr Paula Walls 01/07/2014 REC Members Induction (Refresher)

Dr Paula Walls 19/09/2014 Reading: HSC REC Member Reports on HRA Training

Events

Dr Paula Walls 28/10/2014 Shared Ethical Debate 17 - A Qualitative Study

Dr Paula Walls 28/10/2014 Training Overview - Use of Personal Data in Research

Dr Paula Walls 17/02/2015 2015 HSC REC Members' Training Day

Dr Paula Walls 17/02/2015 Equality and Diversity Training Session


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 8 13.33

Phase 1 17 28.33

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 0 0.00

Research Database (including renewals) 0 0.00

Others 35 58.33

Total Applications Reviewed 60 100

Number of applications made invalid by the REC Manager 0

Number of applications withdrawn prior to the meeting 0

Number of student applications reviewed 19

Number of paediatric applications reviewed 7

Number of device applications reviewed 2

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 2

Number of applications reviewed that are funded by the US DHHS 0

Number of qualitative applications reviewed 4

Decisions taken at meetings following review of

applications

Number %

Favourable Opinion with Standard Conditions 4 6.67

Favourable Opinion with Additional Conditions 3 5.00

Unfavourable Opinion 4 6.67

Provisional Opinion 49 81.67

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 60 100

Number 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

42 70.00

Further Information Favourable Opinion with Additional Conditions

7 11.67

Further Information Unfavourable Opinion 0 0.00





Provisional Opinion Pending Consultation with Referee 0 0.00

Further Information response not complete 0 0.00

No decision entered on system 0 0.00

Number of studies withdrawn after the meeting 0 0.00

Total 60 100


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:

Number of applications made invalid by the REC Manager 13

Number of studies withdrawn prior to the meeting 0

Number of student applications reviewed 11

Number of paediatric applications reviewed 4

Number of device applications reviewed 0

Number of qualitative applications reviewed 4

Total Applications Reviewed 32

Decisions taken at proportionate review sub-

committee meetings

Number %



No Opinion transfer to full committee for review 0 0.00



Total 32 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 5.45

Number of applications for full ethical review 60

Number of applications for full ethical review over 60 days 0

Number of applications over 60 days as a % of total 0.00%

Number of applications for full ethical review over 40 days 4

Number of applications over 40 days as a % of total 6.67%

Number of days taken to final decision – average (mean) 27

Number of proportionate review applications for ethical

review

32

Number of proportionate review applications for ethical

review over 14 days

4

Number of proportionate review applications over 14 days as

a % of total

12.50%

Number of SSAs (non-Phase 1) reviewed 4

Number of applications for SSA review over 25 days 0

Number of applications for SSA review over 25 days as % of

all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 16

Number of applications for SSA review over 14 days 0

Number of applications for SSA review over 14 days as % of

all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 59

Number of substantial amendments over 35 days 0

Number of substantial amendments over 35 days as a % of

total substantial amendments

0.00%

Number of substantial amendments over 28 days 1

Number of substantial amendments over 28 days as a % of

total substantial amendments

1.69%

Number of modified amendments reviewed 1

Number of modified amendments over 14 days 0

Number of modified amendments over 14 days as a % of

total modified amendments

0.00%

Number of minor amendments received 80

Number of substantial amendments received for information 0

Number of substantial amendments received for new

sites/PIs

7

Number of annual progress reports received 83

Number of safety reports received 10

Number of Serious Adverse Events received 1

Number of final reports received 42

HSC REC A Research Ethics Committee Annual Report

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


REC Reference Title Number of Days on Clock

14/NI/0055 EPIOC Performance of Primary School Aged Children 35

14/NI/0056 Studies on airway epithelial cell virus interactions in children 45

14/NI/0057 PAlliative Care in chronic Kidney diSease study (PACKS study) 43

14/NI/0058 Safety, efficacy, PK, PD of dosing QBW251 in cystic fibrosis patients 23

14/NI/0069 AFFECT Trial 32

14/NI/0072 Three dimensional indices of vascularity in the detection of placental 32

14/NI/0076 “Retinal ischaemia in diabetic retinopathy" 38

14/NI/0083 Bioequivalence Study of two nasal Fluticasone Dosage Forms. 31

14/NI/1014 A Physical Activity intervention in pregnant women. 25

14/NI/1016 Oral contraceptive with GSK1265744 interaction study in healthy women 26

14/NI/1034 End of life care for patients with Motor Neurone Disease (MND) 26

14/NI/1039 Crossover Study to Evaluate SD-809 and Tetrabenazine on QT Interval 25

14/NI/1044 A study comparing two inhalers in healthy volunteers (QBR117213) 28

14/NI/1050 Changes in Histology following Ulipristal Therapy in Endometriosis 1.1 28

14/NI/1068 Predicting the risk of pre-eclampsia (PREDICT). 28

14/NI/1070 A bioequivalence paracetamol and codeine comparison study 19

14/NI/1075 Study in infants and toddlers with Respiratory Syncytial Virus 19

14/NI/1079 DENTAL HEALTH IN LOOKED AFTER CHILDREN 24

14/NI/1093 ASpirin as Treatment for ARDS (STAR) 35

14/NI/1095 Post-doctoral research project with BPD patients in music therapy 39

14/NI/1096 Clinical impact of MI on inhaled antibiotic adherence in CF 28

14/NI/1098 PK Study of GSK1278863 26

14/NI/1101 Self-Concept Clarity and Experience of Care v2 24

14/NI/1110 Access and experiences of palliative care services. Version 1. 40

14/NI/1113 CONSISTENT CTO 29

14/NI/1114 CELTIC 17

14/NI/1130 Walk With Me Study 37

14/NI/1131 Attitudes of Health Care Professionals towards people living with HIV 30

14/NI/1132 Cardiovascular risk in diabetes v1 27

14/NI/1134 Cancer and Serious Mental Illness: A Qualitative Exploration 27

14/NI/1139 The effect of lifestyle and dietary factors on disease activity in SLE 17

14/NI/1140 MYK-461-002 SAD in healthy volunteers 30


14/NI/1145 Safety and Pharmacokinetics of JZP-386 in Healthy Subjects (QCL117528) 18

14/NI/1149 Mirror box therapy with stroke patients 23

14/NI/1151 Evaluating the Impact of PPI in Northern Ireland 27

15/NI/0017 Study to evaluate the safety of QR-010 in Cystic fibrosis patients 19

15/NI/0026 IVIVR assessing PK parameters used to establish Bioequivalence(116986) 22

15/NI/0027 Associations between types of abuse and theory of mind impairments 16

15/NI/0048 Group B Streptococcus Vaccine Study in Healthy Female Volunteers 26

15/NI/0049 Preference and Ease of Use Inhaler Study 23

15/NI/0055 Approaches to dementia care in Ireland, North and South (version 1) 23

15/NI/0058 Understanding the experiences of fathers who are living with HIV 22



14/NI/0082 Promoting informed decision making through advance care planning 37

14/NI/1005 Comparative PK study of RGB-10 and Forsteo. 28

14/NI/1015 A DDI Study of CTX-4430 and midazolam in Healthy Subjects 21

14/NI/1048 'EXACT' - The EXercise And Colo-rectal cancer Trial 21

14/NI/1133 Use of mycophenolate mofetil in children with kidney transplant V 1.0 26

15/NI/0018 FIN1002 PK of AFOLIA and US Gonal-f® RFF Redi-ject SC 27

15/NI/0059 Stigma, wellbeing and medication adherence in gay men living with HIV 29

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/NI/0053 Retinal vascular calibre as a predictor of diabetic complications 41

14/NI/1049 Mass balance study of 14C-ALS-008176 in healthy subjects (QBR117356) 22

14/NI/1071 Absolute bioavailability of selumetinib (QCL117383) 21

14/NI/1097 Absolute bioavailability of ertugliflozin 25


Favourable Opinion with Additional Conditions


14/NI/0054 Exploring adolescents' lived experience of using methotrexate for JIA 41

14/NI/0081 A Charcoal Block Method Validation for Oral Tiotropium Absorption 23

14/NI/1150 PK of Modified Release Anatabine Citrate Formulations (QCL117443) 20

Unfavourable Opinion


14/NI/0071 The effectiveness of the Community Assessment of Risk Screening Tool 38

14/NI/1018 Attitudes of Health Care Professionals towards people living with HIV 21

14/NI/1069 Portglenone gets fit 24

15/NI/0056 Measuring Financial Exploitation in Northern Ireland. 28

Provisional Opinion


Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting



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



14/NI/0048 Evaluation of chest wall motion to assess respiration in PICU 11

14/NI/1008 TMS markers of plasticity in acute stroke 9

14/NI/1028 Research evaluation of the FRAILsafe intervention v1 15

14/NI/1029 The Liver App (MYLIVER.App) project 13

14/NI/1063 Investigating Inflammation and Pain in Achilles Tendinopathy (ImPAcT) 16

14/NI/1092 SMART 12

14/NI/1107 Chewing gum microbiome 11

14/NI/1109 “Stratifying treatment for diabetic macular oedema using iPS cells" 12

14/NI/1111 Development of a disease specific ureteric stone PROM 12

14/NI/1122 Inhibition Of VAP-1 by Caffeine In Healthy Human Volunteers (NOCTUA) 7

14/NI/1123 Stratified medicine for diabetes 9

14/NI/1127 Point-of-care HbA1c 11

14/NI/1146 Diversity in blood flow control to the brain. 9

14/NI/1148 Investigation of heart rate responses in cardiologists performing PCI 9

15/NI/0021 Parental experiences and views of neonatal trials (PARENT)v1 9

15/NI/0042 SWiNd-MS Small Worlds in Neurodegeneration - Multiple Sclerosis Ver. 1 10

15/NI/0043 Bone metabolism and microcirculation in type 2 diabetes and Charcot 11



14/NI/0052 An evaluation of MBT outcomes for ex-offenders with a PD diagnosis. 8

14/NI/1061 Palatability of sedative medicines in children 25

Further Information Unfavourable Opinion



Favourable Opinion with Standard Conditions


14/NI/0050 MTOC 10

15/NI/0009 Quality of life in head and neck cancer survivors V2.1 9

15/NI/0020 Breastfeeding support for women following caesarean birth 7

Favourable Opinion with Additional Conditions


14/NI/0074 Experiences of diabetic amputation 7

14/NI/0075 Factors affecting detection of systolic blood pressure 8

14/NI/0080 Family environment, community support and paediatric resilience (v1) 8

14/NI/1006 Emotion and Episodic Memories in Parkinson’s disease 9

14/NI/1057 Immediate vs standard imaging for myocardial perfusion scintigraphy 16

14/NI/1085 Evaluation of bioelectrical impedance testing in hospital inpatients. 8

14/NI/1089 Evaluation of Triggering Receptor Expressed on Myeloid cells -1 7

14/NI/1143 Measuring chemosensory changes during cancer treatment version 3 7

Unfavourable Opinion


14/NI/1027 Generation of Human Induced Pluripotent Stem Cells 7

14/NI/1059 Review of adolescent sexual health services 8

Provisional Opinion


Further information response not complete


Withdrawn after the meeting



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

Favourable opinion

Amendment REC

Reference

Title Version Date Number of Days on

Clock

06/NIR01/141/AM05 Genetic variation in biological pathways & oesophageal adenocarcinoma

Substantial Amendment 5 -

Octo

17/10/2014 10

07/NIR01/90+5/AM03

Renewal of Ethical Approval for NILS Database 078 24/04/2014 29/04/2014 16

07/NIR01/90+5/AM04

Renewal of Ethical Approval for NILS Database 082 - 25/06/2014 25/06/2014 13

07/NIR01/90+5/AM06

Renewal of Ethical Approval for NILS Database 083 14/08/2014 18/08/2014 8

07/NIR01/90+5/AM07

Renewal of Ethical Approval for NILS Database 093 - 16/02/2015 17/02/2015 22

09/NIR01/24/AM08 Predictive role of HER ligands version 6 Substantial Amendment 4 - 11

J

30/07/2014 16

10/NIR01/30/AM03 Attentional Bias in OCD Amendment 3 - 26/06/2014

28/08/2014 13

10/NIR01/56/AM05 EPOR in Human Tumours Substantial Amendment 3 -

Nov

25/11/2014 15

11/NI/0127/AM02 A pharmacist-led medicines management outpatient service. V.1

Substantial Amendment v4 22-

09

26/09/2014 17

11/NI/0188/AM04 Biomarkers & Response to Therapy in Rheumatoid Arthritis Substantial Amendment 2 -

14/1

20/10/2014 10

12/NI/0057/AM02 BUStIn version 2.0 Substantial Amendment 2 - 11

S

22/09/2014 7


13/NI/0058/AM03 Safety, PK and Efficacy of PPI-383 In HVs & HepC patients Substantial Amendment 03 -

27/

27/08/2014 14

13/NI/0072/AM02 C25006 Ph4 of Brentuximab Vedotin in Patients with Large Cell Lymphoma

Substantial Amendment - CRO

an

09/07/2014 20

13/NI/0073/AM01 Assessing the impact of MGUS: AiMS Study (Version 1.1) 1 19/05/2014 21

13/NI/0084/AM01 Gait in patients with leg length difference after hip replacement Substantial Amendment 1

18/07/2014 28

13/NI/0084/AM02 Gait in patients with leg length difference after hip replacement Substantial Amendment 2

18/07/2014 28

13/NI/0093/AM03 Italfarmaco DSC/12/2357/45 Polycythemia Vera Substantial Amendment #2 -

Upd

02/12/2014 9

13/NI/0106/AM08 A Study of CTX-4430 in Patients with Cystic Fibrosis Substantial Amendment 3 -

Prot

10/07/2014 18

13/NI/0106/AM10 A Study of CTX-4430 in Patients with Cystic Fibrosis Substantial Amendment - Early

29/10/2014 15

13/NI/0107/AM01 DDRD in Breast Cancer Study 2 21/11/2014 17

13/NI/0149/AM01 Molecular Biomarkers in Oesophageal Adenocarcinoma Amendment 3 11/03/2015 22

13/NI/0151/AM04 Evaluation of Different Formulations of PRX167700 (QBR115561)

Protocol Substantial Amendment

25/04/2014 19

13/NI/0152/AM03 Trial to Encourage Adoption and Maintenance of Mediterranean Diet

Amendment 3: 28/04/2014

28/04/2014 13

13/NI/0160/AM04 MANAGE Trial Substantial Amendment 1.0 -

De

02/12/2014 8

13/NI/0193/AM02 A direct observation study of acute knee injury assessment V1 Amendment 2 - 19/08/2014

09/09/2014 24

13/NI/0208/AM03 Individually Ventilated Cages and prevention of lab animal allergy

Substantial Amendment 1 - 26-

0

28/08/2014 13

13/NI/0208/AM04 Individually Ventilated Cages and prevention of lab animal allergy

Substantial Amendment 2;

20/01/2015 21


20/01

14/NI/0013/AM01 Pain assessment and management in advanced dementia at end of life Ph1

Substantial Amendment 1.0; 18

18/03/2014 16

14/NI/0013/AM03 Pain assessment and management in advanced dementia at end of life Ph1

Substantial Amendment 2.0; 20

27/10/2014 17

14/NI/0014/AM01 ESCAPE Endovascular Stroke Trial Substantial Amendment 1.0

17/0

17/07/2014 12

14/NI/0014/AM02 ESCAPE Endovascular Stroke Trial Substantial Amendment 2.0 -

03

03/11/2014 9

14/NI/0017/AM01 MRI in diagnosis of SAH - evaluating a non-invasive alternative to LP


16/0

20/02/2015 23

14/NI/0031/AM01 Sexual Competence (version 1) IRAS 3.5 26/09/2014 20

14/NI/0054/AM01 Exploring adolescents' lived experience of using methotrexate for JIA

Amendment 1 - 12/10/2014

16/10/2014 13

14/NI/0058/AM04 Safety, efficacy, PK, PD of dosing QBW251 in cystic fibrosis patients

SA#1 Protocol amendments #8 an

11/03/2015 23

14/NI/0081/AM02 A Charcoal Block Method Validation for Oral Tiotropium Absorption


01/0

01/09/2014 11

14/NI/0082/AM01 Promoting informed decision making through advance care planning


27/1

27/11/2014 14

14/NI/0083/AM02 Bioequivalence Study of two nasal Fluticasone Dosage Forms. Substantial Amendment 1

03/09/2014 9

14/NI/0083/AM04 Bioequivalence Study of two nasal Fluticasone Dosage Forms. Substantial Amendment 2 - 19

J

19/01/2015 24

14/NI/1005/AM02 Comparative PK study of RGB-10 and Forsteo. RGB-10-001 amendment 1,

dated

18/07/2014 11

14/NI/1005/AM04 Comparative PK study of RGB-10 and Forsteo. RGB-10-001, Amendment 2, 11

Se

17/09/2014 16


14/NI/1005/AM06 Comparative PK study of RGB-10 and Forsteo. Substantial Amendment 3,

dated

02/12/2014 9

14/NI/1005/AM07 Comparative PK study of RGB-10 and Forsteo. 2012-08-SP-13, Substantial Ame

08/01/2015 6

14/NI/1008/AM01 TMS markers of plasticity in acute stroke Amendment Number 1 - January 2

12/01/2015 13

14/NI/1014/AM01 A Physical Activity intervention in pregnant women. Substantial Amendment 1 -

10/1

16/12/2014 29

14/NI/1044/AM01 A study comparing two inhalers in healthy volunteers (QBR117213)

Final with Amendment 1 and

2:

18/11/2014 22

14/NI/1048/AM02 'EXACT' - The EXercise And Colo-rectal cancer Trial Amendment No 2 02/02/2015 10

14/NI/1048/AM03 'EXACT' - The EXercise And Colo-rectal cancer Trial Amendment 3: 3rd March 2015

03/03/2015 8

14/NI/1050/AM02 Changes in Histology following Ulipristal Therapy in Endometriosis 1.1


08/1

16/10/2014 13

14/NI/1050/AM03 Changes in Histology following Ulipristal Therapy in Endometriosis 1.1


30/1

12/01/2015 28

14/NI/1063/AM01 Investigating Inflammation and Pain in Achilles Tendinopathy (ImPAcT)

Amendment 1 - 05/02/2015

13/02/2015 23

14/NI/1075/AM03 Study in infants and toddlers with Respiratory Syncytial Virus Substantial Amendment 3 -

Upda

05/12/2014 6

14/NI/1075/AM04 Study in infants and toddlers with Respiratory Syncytial Virus Substantial Amendment 4 -

Prot

05/01/2015 9

14/NI/1098/AM01 PK Study of GSK1278863 SA 01: Protocol Amendment 04 d

26/01/2015 17

14/NI/1127/AM01 Point-of-care HbA1c Amendment 1 - 10 February 2015

11/02/2015 5

14/NI/1143/AM03 Measuring chemosensory changes during cancer treatment version 3

Substantial Amendment 1 - 16/

18/02/2015 21


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

Unfavourable opinion

Amendment REC

Reference


Clock

12/NI/0172/AM01 Assessing the cardiovascular effects of hereditary haemochromatosis

Substantial Amendment 1

03/09/2014 9

13/NI/0195/AM02 Beliefs about medicines administration from MCAs - Version 1.0

Amendment 1 - February 2015

03/02/2015 9

14/NI/0057/AM01 PAlliative Care in chronic Kidney diSease study (PACKS study) Substantial Amendment 1 -

30/0

03/10/2014 27

Favourable opinion timeline

Amendment REC

Reference


Clock

12/NI/0172/AM01/1 Assessing the cardiovascular effects of hereditary haemochromatosis

Modified Amendment 1 -

19/09/1

22/09/2014 11

Unfavourable opinion timeline

Amendment REC

Reference


Clock


Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline


Proportionate review applications for ethical review over 14 day timeline


14/NI/1028 Research evaluation of the FRAILsafe intervention v1 15

14/NI/1057 Immediate vs standard imaging for myocardial perfusion scintigraphy 16

14/NI/1061 Palatability of sedative medicines in children 25

14/NI/1063 Investigating Inflammation and Pain in Achilles Tendinopathy (ImPAcT) 16

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline

Amendment REC

Reference


Clock

Modified Amendments over 14 day timeline

Amendment REC

Reference


Clock

hsc rec a annual report 01 april 2014 31 march 2015€¦ · annual report 01 april 2014 – 31...

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