RES Committee Yorkshire & The Humber - Leeds West Annual ... · Lay Plus 07/01/2005 07/01/2015 Dr...

Research Ethics Service

RES Committee Yorkshire & The Humber - Leeds West

Annual Report

01 April 2014 - 31 March 2015

RES Committee Yorkshire & The Humber - Leeds West Annual Report Page 2

Part 1 – Committee Membership and Training

Name of REC: NRES Committee Yorkshire & The Humber - Leeds West

Type of REC: REC recognised to review CTIMPs in Patients - Type III

Type of Flag: Phase 1 Studies in Patients Medical Devices Research involving Adults Lacking Capacity Research involving Children Qualitative Research

Chair: Dr Sheila E. Fisher (from 1st August 2014)

Dr Rhona Bratt (until 1st August 2014)

Vice-Chair: Dr Vera Neumann (from 1st August 2014)

Dr Sheila E. Fisher (until 1st August 2014)

Alternate Vice-Chair: Mr Anthony Warnock-Smith (from 12th September 2014)

Dr Vera Neumann (until 1st August 2014)

REC Manager: Miss Sarah Grimshaw

REC Assistant: Miss Christie Ord

Committee Address: Room 001, Jarrow Business Centre Rolling Mill Road Jarrow Tyne and Wear NE32 3DT

Telephone: 0191 4283548

Email: [email protected]


Chair’s overview of the past year:

This is my first annual report as Chair of the Leeds (West) Research Ethics Committee. It is a pleasure to lead such an active, informed and hard-working group. My first pleasure is to thank our previous Chair, Dr Rhona Bratt, who led us with great skill and left us in good spirit, well prepared to meet all the demands of REC work. We were able to keep Rhona’s wisdom and insight during the transition period as she was keen to attain her full 10 years of service as a member of the REC. In view of this, although she completed her term as Chair in July, she actually attended her final meeting in December 2014, leaving with our very best wishes as she continues to serve the HRA as Chair of Leeds (East), together with a ‘gold star’ to express our thanks for her exemplary leadership. Vera Neumann and Tony Warnock-Smith were welcomed as Vice-Chair and Alternate Vice-Chair respectively. Both bring experience and complementary talents to their roles and provide a strong core team working together effectively and often beyond the ‘call of duty’. This ethos of service extends to the membership as a whole. No matter how long and complex the applications, these are carefully appraised and questions prepared with insight. It is good to hear that our efforts in this regard and our care to treat all who attend with care and courtesy have been marked by letters of thanks. We see a wide range of applications, from the straightforward to the challenging and, inevitably with that diversity, discussion can be intense and, at times, challenging. It is a credit to all members that they are open in their contributions, showing the highest standards of integrity. I would hope that all applicants who attend our meetings feel that they have had a full, helpful and constructive scrutiny of their studies, in line with the overall ethos of encouraging good research in the NHS to the benefit of all. The ‘flip side’ of this is that keeping to time can be challenging. We have undertaken an internal audit and continue to work together to focus questions without detracting from the value of individual contributions nor of the care taken in the review of potential studies. When researchers are well prepared this is readily achieved, poorly structured proposals are far more difficult to manage with care and rigour. The commitment of all to the Proportionate Review and Sub-committee work remains at a high level with all being willing to contribute time and expertise. The former can be very difficult to fit into busy lives with other pressures and we have consistently requested that the time line be extended, something which would assist all in carrying out this task with the care that is required to give the best possible opinions to researchers. The enthusiasm and commitment of members is shown by their attendance at many and diverse training events, thus maintaining the expertise which underpins our ‘flags’. It can be challenging in today’s work environment to take time for such days so their care in this regard is very welcome. Leeds (West) is always ‘up for a challenge’ and we were a pilot REC for the trial of the HARP system for the review of applications. As ever members were insightful and constructive in their feedback. After a period of change, membership has remained relatively stable this year. Membership is well balanced which adds probity and confidence to the opinions we give. Whatever the question, someone will know the answer. Reema Harrison and Jerry Masterson left us to new posts and new parts of the world and we wish them well with their ongoing careers. Jonathan Thornley and Ashley Stratton-Powell joined us bringing much expertise in emergency care (including paediatrics) and medical devices respectively. Heather Rostron has taken a year’s leave and it was a pleasure to hear of the safe arrival of baby Charlotte. We look forward to Heather’s return in the New Year. Complementary to all of this is the continued support and professionalism shown by our REC Manager and Assistant and the staff at the Jarrow Office. This year we said goodbye to Sarah Grimshaw as our REC Manager, with our congratulations to her as she takes on her new role and we welcomed Christie Ord as our new REC Manager. Christie was already well known to us as Sarah’s Assistant and the new team of Christie and REC Assistant, Kirstie Penman are settling into their duties very well. It is easy not to be fully aware of the volume of work behind the scenes that supports so many aspects of our work. The figures in this report indicate just how much is done, week on week, month on month. In summary, we have completed another successful year, working together and doing all we can to live up to Rhona’s motto – Leeds (West) is the best. Long may we continue to hold that aspiration.


RES Committee Yorkshire & The Humber - Leeds West Membership

RES Committee Yorkshire & The Humber - Leeds West: Deputy Members

RES Committee Yorkshire & The Humber - Leeds West: Co-opted Members

Name Profession Expert or

Lay

Dates

Appointed Left

Dr Rhona Bratt Retired Multimedia Project Manager

Lay Plus 07/01/2005 07/01/2015

Dr Michael Clarke Senior Dento Legal Advisor

Expert 17/06/2013

Ms Danni Collingridge Moore

Research Fellow Lay 01/11/2013

Dr Martin Elliott Consultant Paediatric Oncologist

Expert 01/04/2010

Dr Diane Farrar Research Programme Manager - Maternal and Child Health

Expert 18/06/2013

Dr Sheila E. Fisher MHRA Committee on Safety of Devices

Expert 20/07/2007

Dr Jan Geddes Retired Senior Research Fellow

Lay 12/06/2013

Ms Sarah Kirkland Research Governance Facilitator

Lay Plus 01/02/2013

Miss Emma Lundy Advanced Clinical Pharmacist (Oncology and Clinical Trials)

Expert 09/10/2013

Dr Caroline Magee Communications Consultant

Lay 15/08/2013

Dr Vera Neumann Consultant in Rehabilitation Medicine

Expert 20/07/2007

Dr Jane Orton Consultant Oncologist Expert 29/04/2008

Mrs Heather Rostron Senior Research Nurse Expert 22/10/2013

Mr Vishal Sharma Research Fellow/PhD Student

Lay 07/10/2013

Mr Ashley Stratton-Powell PhD Doctoral Training Centre for Tissue Engineering and Regenerative Medicine

Lay Plus 22/09/2014

Dr Jonathan Thornley A&E Consultant Expert 25/07/2014

Mr Anthony Warnock-Smith

Retired solicitor Lay Plus 01/12/2012

None. None.


RES Committee Yorkshire & The Humber - Leeds West: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Rhona Bratt None 11/04/2014

Dr Michael Clarke Company he works for can sometimes be asked for opinions on REC outcomes although he would ensure he was not involved in such advice.

11/04/2014

Ms Danni Collingridge Moore None 09/05/2014

Dr Martin Elliott Candlelighters and Neuroblastoma Alliance Trustee.Clinical Trials Lead for Paediatric Oncology at Leeds General Infirmary.Member of the NIHR CCL CSG.

11/04/2014

Dr Diane Farrar None. 16/01/2015

Dr Sheila E. Fisher MHRA - Chair of Committee - input to clinical investigations which support commercialisation of medical devices.Member of HTA screening and diagnostics panel which identified research topics and funds research.Peer reviewer for HTA, NIHR and CRUK and other funding streams.

11/04/2014

Dr Jan Geddes None 11/04/2014

Ms Sarah Kirkland Research Governance Facilitator at Bradford District Care Trust, however R&D Director has responsibility for signing off persmissions.

11/04/2014

Miss Emma Lundy None 16/01/2015

Dr Caroline Magee Currently works for the NIHR trainees coordinating centre who provides funding to researchers

11/04/2014

Dr Vera Neumann None 11/04/2014

Dr Jane Orton None 11/04/2014

Mr Vishal Sharma None 11/04/2014

Mr Ashley Stratton-Powell Part of University of Leeds School of Mechanical Engineering.

16/01/2015

Dr Jonathan Thornley None. 16/01/2015

Mr Anthony Warnock-Smith None 11/04/2014


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 11/04/2014 14

May 09/05/2014 10

July 11/07/2014 13

August 08/08/2014 11

September 12/09/2014 12

October 10/10/2014 13

November 14/11/2014 13

December 12/12/2014 12

January 16/01/2015 13

February 13/02/2015 12

March 13/03/2015 10

11 full committee meetings were held during the reporting period.


at Meeting

May 01/05/2014 3

June 02/06/2014 3

June 30/06/2014 3

July 29/07/2014 3

September 01/09/2014 3

October 02/10/2014 3

October 06/10/2014 3

November 03/11/2014 3

December 01/12/2014 3

January 14/01/2015 3

February 11/02/2015 3

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


at Meeting

April 02/04/2014 3

April 04/04/2014 2

April 17/04/2014 2

May 02/05/2014 2

May 16/05/2014 2

May 30/05/2014 2

June 13/06/2014 2

June 27/06/2014 2

July 11/07/2014 2


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

July 25/07/2014 2

July 29/07/2014 3

July 30/07/2014 3

August 08/08/2014 2

August 22/08/2014 2

August 28/08/2014 3







October 03/10/2014 2

October 13/10/2014 3

October 17/10/2014 2

October 20/10/2014 3

October 31/10/2014 2

October 31/10/2014 3

November 14/11/2014 2

November 24/11/2014 5

November 28/11/2014 2

December 12/12/2014 2

December 28/12/2014 2

January 05/01/2015 2

January 16/01/2015 2

January 19/01/2015 2

January 27/01/2015 3

January 30/01/2015 2

February 04/02/2015 3

February 05/02/2015 4

February 13/02/2015 2

February 27/02/2015 3

February 27/02/2015 2

March 13/03/2015 2

March 17/03/2015 3

March 23/03/2015 2

March 24/03/2015 3

March 27/03/2015 2

47 sub-committee meetings were held during the reporting period. None.


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

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

Name Number of

Meetings

Attended

Mr Anthony Warnock-Smith 11

Dr Sheila E. Fisher 10

Miss Emma Lundy 10

Dr Vera Neumann 10

Dr Jane Orton 10

Dr Michael Clarke 9

Dr Diane Farrar 9

Dr Jan Geddes 9

Mr Vishal Sharma 9

Dr Rhona Bratt 7

Dr Caroline Magee 7

Mrs Heather Rostron 7

Ms Danni Collingridge Moore 6

Ms Sarah Kirkland 6

Mr Ashley Stratton-Powell 5

Dr Martin Elliott 4

Dr Jonathan Thornley 4

Name Number of

Meetings

Attended


Dr Martin Elliott 4

Dr Rhona Bratt 3

Dr Caroline Magee 3

Dr Vera Neumann 3


Dr Michael Clarke 2


Dr Diane Farrar 2


Mr Vishal Sharma 2

Dr Jan Geddes 1

Dr Jane Orton 1

Name Number of

Meetings

Attended



Dr Vera Neumann 14


Miss Emma Lundy 7

Dr Jane Orton 7


Dr Martin Elliott 6

Dr Diane Farrar 5

Dr Caroline Magee 5

Mr Vishal Sharma 5

Dr Rhona Bratt 4

Dr Michael Clarke 4

Dr Jan Geddes 3

Ms Sarah Kirkland 3


Dr Jonathan Thornley 2


Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Dr Rhona Bratt 09/04/2014 Attendance at HRA/NREA Chairs' meeting including

update on EU clinical trials regulation, paternalism in

research and use of new review forms.

Dr Rhona Bratt 17/06/2014 Researcher Training Day

Dr Rhona Bratt 24/06/2014 Human Tissue Act (Advanced)

Dr Rhona Bratt 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Dr Rhona Bratt 03/12/2014 Personal Data in Research

Dr Michael Clarke 01/05/2014 Personal Data in Research - A Workshop.

Dr Michael Clarke 14/06/2014 Equality and Diversity

Dr Michael Clarke 17/06/2014 Local Mental Capacity Act Training Day

Dr Michael Clarke 19/02/2015 Complex Cases

Ms Danni Collingridge Moore 18/06/2014 Adults Lacking Capacity Toolkit

Ms Danni Collingridge Moore 18/06/2014 HRA Mental Capacity Act 2005

Ms Danni Collingridge Moore 29/07/2014 Members' Induction Training

Dr Martin Elliott 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Dr Diane Farrar 20/05/2014 Induction

Dr Diane Farrar 17/06/2014 Local Mental Capacity Act Training Day

Dr Sheila E. Fisher 09/10/2014 Medical Devices Training

Dr Sheila E. Fisher 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Dr Sheila E. Fisher 10/12/2014 National Training Day for RES Committee Chairs

Dr Jan Geddes 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Dr Jan Geddes 12/01/2015 CTIMP Training Day

Ms Sarah Kirkland 16/10/2014 Reviewing CTIMPs

Ms Sarah Kirkland 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Ms Sarah Kirkland 12/02/2015 Adults lacking capacity - including emergency research -

advanced


Ms Sarah Kirkland 24/03/2015 National Members Training Day

Ms Sarah Kirkland 24/03/2015 National Members' Training Day

Miss Emma Lundy 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Miss Emma Lundy 29/01/2015 Equality & Diversity (Online Training Module)

Dr Caroline Magee 09/10/2014 Medical Devices Training

Dr Vera Neumann 02/07/2014 Equality and Diversity

Dr Vera Neumann 08/08/2014 Self-Directed Learning: Online ALC Toolkit

Dr Vera Neumann 09/10/2014 Medical Devices Training

Dr Jane Orton 17/06/2014 Local Mental Capacity Act Training Day

Dr Jane Orton 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Mrs Heather Rostron 04/06/2014 Mental Capacity Act Toolkit

Mrs Heather Rostron 21/07/2014 The Ethical Issues of Research Involving Children

Mrs Heather Rostron 21/07/2014 The Ethical Issues of Research Involving Children

Mrs Heather Rostron 13/11/2014 RES Committee Members Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Mr Vishal Sharma 20/05/2014 RES Committee Members Induction

Mr Vishal Sharma 13/06/2014 Equality and Diversity

Mr Vishal Sharma 03/12/2014 Personal Data in Research - A Workshop

Mr Vishal Sharma 15/12/2014 Quantitative Research Methods and Statistics: A Health

Research Authority Workshop

Mr Vishal Sharma 21/01/2015 Internet/Web-based research

Mr Vishal Sharma 10/02/2015 Qualitative Research and Ethical Review

Mr Vishal Sharma 10/02/2015 Qualitative Research and Ethical Review

Mr Vishal Sharma 12/02/2015 Adults Lacking Capacity Including Emergency Research

- Advanced

Mr Vishal Sharma 12/02/2015 Adults lacking capacity - including emergency research -

advanced

Mr Ashley Stratton-Powell 21/01/2015 Equality & Diversity (Online Training Module)

Mr Ashley Stratton-Powell 19/02/2015 Complex Cases

Mr Ashley Stratton-Powell 09/03/2015 RES Committee Members Induction

Mr Anthony Warnock-Smith 13/11/2014 RES Committee Members


Regional Training Day [Human Tissue Act & Mental Capacity

Act]

Mr Anthony Warnock-Smith 08/01/2015 Training for New REC Chairs

Mr Anthony Warnock-Smith 29/01/2015 Equality & Diversity (Online Training Module)


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 11 18.64

Phase 1 0 0.00

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 0 0.00

Research Database (including renewals) 0 0.00

Others 48 81.36

Total Applications Reviewed 59 100

Number of applications made invalid by the REC Manager 6

Number of applications withdrawn prior to the meeting 1

Number of student applications reviewed 20

Number of paediatric applications reviewed 6

Number of device applications reviewed 4

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 10

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

Number of qualitative applications reviewed 9

Decisions taken at meetings following review of

applications

Number %

Favourable Opinion with Standard Conditions 3 5.08

Favourable Opinion with Additional Conditions 6 10.17

Unfavourable Opinion 4 6.78

Provisional Opinion 46 77.97

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 59 100

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

36 61.02

Further Information Favourable Opinion with Additional Conditions

9 15.25

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 1 1.69

Total 59 100


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 7

Number of studies withdrawn prior to the meeting 2

Number of student applications reviewed 13

Number of paediatric applications reviewed 2

Number of device applications reviewed 0

Number of qualitative applications reviewed 4

Total Applications Reviewed 27

Decisions taken at proportionate review sub-

committee meetings

Number %



No Opinion transfer to full committee for review 3 11.11



Total 27 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 5.36

Number of applications for full ethical review 59

Number of applications for full ethical review over 60 days 1

Number of applications over 60 days as a % of total 1.69%

Number of applications for full ethical review over 40 days 9

Number of applications over 40 days as a % of total 15.25%

Number of days taken to final decision – average (mean) 32

Number of proportionate review applications for ethical

review

24

Number of proportionate review applications for ethical

review over 14 days

0

Number of proportionate review applications over 14 days as

a % of total

0.00%

Number of SSAs (non-Phase 1) reviewed 1

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 0

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 118

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

0.85%

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 97

Number of substantial amendments received for information 0

Number of substantial amendments received for new

sites/PIs

36

Number of annual progress reports received 99

Number of safety reports received 24

Number of Serious Adverse Events received 3

Number of final reports received 20

RES Committee Yorkshire & The Humber - Leeds West Research Ethics Committee Annual Report Page 17

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/YH/0113 Exercise as a therapy for rehabilitation in Schizophrenic patients 20

14/YH/0126 The Athletes Heart Study 19

14/YH/0128 SaFaRI (SNS versus the FENIX MSA for adult FI) 32

14/YH/0133 Challenge EXUFIBER 27

14/YH/0138 SENTRI version 1. 22

14/YH/1025 Prodigy-I 19

14/YH/1027 Maiden Back Study 25

14/YH/1059 Measuring quality in community nursing: a mixed methods study 29

14/YH/1091 Mobilising lower limb fluid for hemodynamic stability in haemodialysis 49

14/YH/1110 Dose finding safety study of VAL201 in cancer patients 49

14/YH/1129 Environmental effects T1DM 34

14/YH/1146 A study exploring the effects of attending a pain choir on wellbeing 31

14/YH/1149 Getting vitamin D dosing right 35

14/YH/1170 Non invasive cardiac output monitoring to reduce complication in NOF 22

14/YH/1174 The Delirium Observation Screening Scale (DOSS) Study 39

14/YH/1193 Exploring the interactions between staff and patients (Version 1) 31

14/YH/1208 Recognising suffering at the end of life 59

14/YH/1259 ALPHA 31

14/YH/1260 Frontier II 30

14/YH/1278 Validation of TEG 6s in Interventional Cardiology 33

14/YH/1303 VISTAKONÂ® MULTIFOCAL CONTACT LENSES USED BY FUNCTIONAL EMMETROPES 28

14/YH/1304 Phase 2 Study of Ataluren (PTC124) as Treatment for MPS I 33

15/YH/0007 Occupational Possibilities & Quality of life with terminal cancer 49

15/YH/0010 Phase 3 Study in Ventilated Gram Positive Nosocomial Pneumonia 47

15/YH/0011 A study to evaluate GP2013 and rituximab in RA 39

15/YH/0017 Extension Paediatric stdy of Intrathecal IdursulfaseIT with ElapraseÂ® 26

15/YH/0035 Informed family planning decisions for rare genetic conditions. 45

15/YH/0037 Development of the Addiction Therapist Rating Scale (ATRS) 33

15/YH/0049 Exploration of the ESP/Patient decision making process - Version 1 40

15/YH/0050 Patient's lived experience of Occ Therapy in a hosp major trauma ward 82

15/YH/0089 Supervised Exercise and Intermittent Claudication Study (SEIC) 33

15/YH/0107 Unloading shoes for intermittent claudication 34


15/YH/0108 FUTURE 4 33

15/YH/0114 Theory of Mind and moral judgement after traumatic brain injury V1.1 30

15/YH/0117 REPAIR-Right vEntricular remodeling in Pulmonary ArterIal hypeRtension 32

15/YH/0118 Bipolar Disorder Adherence Project 31



14/YH/0107 Feasibility Study - fMRI in measuring the effect of HD on the Brain 40

14/YH/0139 Crafting a case-finder of TBI for patients and staff in CDT - v1 52

14/YH/1032 Services for Juvenile Huntington's Disease 24

14/YH/1050 HRpQCT in Osteogenesis Imperfecta 38

14/YH/1070 Developing a new EEG method for the early diagnosis of dementia. 22

14/YH/1126 Medicines Optimisation in Cancer Pain 33

14/YH/1175 Ibrutinib in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma 47

14/YH/1186 Non-interventional study to investigate patterns of use of SelincroÂ® 30

14/YH/1263 GlySure study in Acute Care Setting patients 27

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/YH/0137 CEMARC long-term outcome study 19

14/YH/1018 The role of the pharmacy team in reducing hospital readmissions v1.5 20

14/YH/1261 To perfom defibrillation threshold testing(DFT) or not to perform DFT? 24

Favourable Opinion with Additional Conditions


14/YH/0085 FLAIR version 1.0 18

14/YH/0119 Paediatric Refill (PRefill) Study 18

14/YH/1106 Relational management of risk and anxiety in mental health practice 20

14/YH/1162 SABRTOOTH v1.0 24


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

15/YH/0020 Calibre 17

15/YH/0040 Dementia Caregiver's Access of Information Resources V1 37

Unfavourable Opinion


14/YH/0096 Measuring quality in community nursing: a mixed methods study 29

14/YH/1107 Comparing Simulation to traditional teaching in Gout management 20

14/YH/1150 MicroRNAs as biomarkers for acne scarring 24

14/YH/1187 The use of softcast heel protectors for the prevention of heel ulcers 21

Provisional Opinion


Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting


14/YH/1291 A RCT To Compare TAP Block Vs Local Anaesthetic After Hernia Repair 28



14/YH/1062 Access to cervical screening among women living with HIV (v 1) 13


14/YH/1111 Health Economics of Chronic Osteomyelitis 14

14/YH/1113 The use of the internet to seek information within GP consultations 9

14/YH/1215 Kneeling ability following total knee arthroplasty (Replacement) 12

14/YH/1295 Detection of Biomarkers for Improved Prognosis of Hodgkin’s Lymphoma 11

14/YH/1296 Which type of depot do patients prefer and has less side effects? 12

14/YH/1297 EXPERT - Riociguat Registry 9



14/YH/1166 DINOSAUR Paediatric Bone and Joint Study: Qualitative component 14

14/YH/1298 RSI - Does ultrasound improve identification of conventional landmarks? 11

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/YH/1013 Evaluating the Mindful Path to Compassion. ID:156932 7

14/YH/1116 Drug Targets in IBD 8

14/YH/1207 Biochemical markers of infection in diabetic foot ulcers 6

14/YH/1210 Margherita Hut 2010: Xtreme Alps analysis of biological samples 8

14/YH/1252 Patterns and processes in audiology appointments v1 11

14/YH/1253 Accel-Heal: Gene Expression Study. 7

14/YH/1257 Exploring the journey of women diagnosed with ovarian cancer (v1) 8

15/YH/0026 MELODIC: Maintaining Exercise Long-term 6

15/YH/0076 Evaluation of counselling for tailored combined pill use 8

15/YH/0077 Does auditory cueing affect gait parameters in Cerebral Palsy children 8

Favourable Opinion with Additional Conditions


14/YH/0160 Evaluation of GP exercise referral V1 9

14/YH/1109 Testing interventions to reduce alcohol consumption use - Version 2 13


14/YH/1211 Bowel Cancer Screening Non-respondence: the Drivers and Barriers 8

14/YH/1214 Surgical Tourniquets and Cerebral Emboli 8

Unfavourable Opinion


14/YH/1063 Satisfaction with medication in older people with type 2 diabetes 7

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

01/023/AM01 Prospective study classifying rheumatoid arthritis according to cytok

Amendment #8 18/04/2013 13

04/Q1205/65/AM11 Genetic polymorphisms in HLA-B27 associated diseases. Amendment 5 27/03/2014 25

04/Q1205/69/AM13 Yorkshire and Humberside Haematology Network Register Substantial Amendment 12

18/06/2014 8

05/Q1108/28/AM13 Characterisation of Giant cell arteritis & polymyalgia rheumatica

Amendment 13 02/02/2015 10

05/Q1205/148/AM15

Safety evaluation of tacrolimus in atopic dermatitis (Version 2) Amendment 2, Change to CRO

21/10/2014 16

06/Q1205/169/AM19

Co ordinated programme to prevent arthritis Amendment 19, December 2014

11

07/H1307/180/AM14 Sorafenib Long Term Extension Program (STEP) Investigators Brochure, BAY 43

18/04/2014 16

08/H1307/106/AM09 MRI Evaluation of Transcatheter and Surgical Aortic Valve Implantation

5 17/02/2015 22

08/H1307/85/AM07 12C/13C Calcium Carbonate Breath Test for Gastric Acid Secretion.Ver:1

GA08/8635 Amendment Code

v8.1

02/04/2014 19

08/H1311/86/AM04 IMMUNOMODULATORY EFFECTS GENERATED BY EXTRACORPOREAL PHOTOPHERESIS

Amendment no.4, Change in CI

08/09/2014 7

09/H1307/105/AM04 Assessment of hip cartilage degeneration April 2014, Version 4

08/05/2014 21

09/H1307/7/AM06 Drivers of eating behaviour during a period of overconsumption Amendment 7 19/02/2015 23

09/H1307/82/AM03 Acellular allogeneic cardiac valves Amendment (30 16/06/2014 17

09/H1307/98/AM13 Disease continuum Amendment #10, Protocol and PI

09/09/2014 9

09/H1307/99/AM10 ADEOS - ADalimumab in persistent Early Oligoarthrits Study 10.1 18/06/2014 10

09/H1307/99/AM11 ADEOS - ADalimumab in persistent Early Oligoarthrits Study Amendment 11 06/01/2015 17

09/H1311/58/AM04 Driving simulator performance in obstructive sleep apnoea Amendment 1, Addition of PI, E

05/06/2014 12

10/H1307/116/AM07 ENDURES Pilot 2 02/02/2014 21


10/H1307/126/AM12 CC-10004-PSA-002 Apremilast in Active Psoriatic Arthritis Pill Reminder 19/06/2014 10

10/H1307/126/AM13 CC-10004-PSA-002 Apremilast in Active Psoriatic Arthritis CC-10004-PSA-002, IB v14, date

21/07/2014 8

10/H1307/27/AM04 ROLARR (RObotic versus LAparoscopic Resection for Rectal cancer)

Amendment 3 (24/03/2014)

26/03/2014 8

10/H1307/91/AM08 Compassionate Use Study of Mepolizumab in Hypereosinophilic Syndrome

Substantial Amendment 7, PIS

U

08/07/2014 12

10/H1307/91/AM09 Compassionate Use Study of Mepolizumab in Hypereosinophilic Syndrome

9 23/12/2014 23

11/H1307/6/AM27 SWITCH version 1.0 SA22 03/04/2014 18



11/H1307/6/AM38 SWITCH version 1.0 Amendment 31, Temporary halt

16/12/2014 14

11/H1307/9/AM13 CC-10004-PSA-003 Apremilast in Active Psoriatic Arthritis Pill Reminder Boxes

18/06/2014 10

11/H1307/9/AM14 CC-10004-PSA-003 Apremilast in Active Psoriatic Arthritis CC-10004-PSA-003, IB v14, date

21/07/2014 8

11/YH/0022/AM09 Outcome measurement for addiction interventions Substantial Amendment 4,

Recru

29/09/2014 19

11/YH/0385/AM05 B1971009 Phase 3 study to assess Meningococcal B Vaccine Substantial Amendment 03

25/03/2014 13

11/YH/0409/AM02 Minuteman Interspinous Process Implant versus Surgical Decompression

Amendment 2, Update to Protoco

16/07/2014 11

11/YH/0413/AM02 The epidemiology of viral RTIs in immunocompromised patients

Substantial Amendment 1,

Recon

16/12/2014 14

11/YH/0424/AM03 Vibration in boys with a history of fracture version 1 Amendment 3 28/05/2014 21

11/YH/0442/AM06 ENCHANTED Substantial Amendment 5

11/08/2014 9

12/YH/0011/AM11 Efficacy of Pomalidomide in Systemic Sclerosis (SSC), amend.1 08NOV11

Protocol Amendment 4

27/03/2014 11

12/YH/0011/AM12 Efficacy of Pomalidomide in Systemic Sclerosis (SSC), amend.1 08NOV11

Pomalidomide Investigators Bro

12/05/2014 15


12/YH/0020/AM08 Shire 318 - Open Label Study to Provide Continued Access to SPD503

SA02, Substantial Amendment IB

09/01/2015 13

12/YH/0020/AM09 Shire 318 - Open Label Study to Provide Continued Access to SPD503

Substantial Amendment 6, IB

Ed

26/02/2015 20

12/YH/0022/AM06 MIDSHIPS (v1.0) Amendment 6, 19/03/14

25/03/2014 10

12/YH/0169/AM01 3 Tesla ST-elevation Myocardial Infarction (3T-STEMI) Amendment One 20/12/2014 15

12/YH/0363/AM04 Detection and management of pain in patients with dementia Amendment 3, 10/03/14

19/03/2014 16

12/YH/0375/AM06 Improving neutrophil responses in pneumonia using simvastatin

AM04 01/12/2014 21

12/YH/0377/AM05 CMV modulation of the immune system in ANCA-associated vasculitis - v1

Version 1.0 21/05/2014 10

12/YH/0377/AM06 CMV modulation of the immune system in ANCA-associated vasculitis - v1

Amendment 005 15/08/2014 23

12/YH/0424/AM01 PERFECT Amendment 1 04/07/2014 20

12/YH/0438/AM05 Bone Vibration as a Novel Assessment of Bone Density in Children

4, 12/03/14 14/03/2014 18

12/YH/0467/AM08 Phase I/II Trial of RNActive derived vaccine in Prostate Cancer Protocol Amendment 6

15/07/2014 15

12/YH/0467/AM09 Phase I/II Trial of RNActive derived vaccine in Prostate Cancer 17/09/2014 20

12/YH/0492/AM06 Community occupational therapy for people with dementia Amendment 5, 07/03/14

20/03/2014 14

13/YH/0003/AM14 Ibrutinib in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma

10 17/02/2015 13

13/YH/0010/AM03 Atraumatic Restorative Treatment for caries in the elderly Amendment 2 29/01/2015 21

13/YH/0029/AM02 SonR ECHO - ICSY01 2.0 20/11/2013 21

13/YH/0029/AM03 SonR ECHO - ICSY01 Amendment 3, Change to commerc

17/10/2014 15

13/YH/0030/AM02 Shoulder PAtch for Rotator Cuff tears Amendment 2, 19/11/13 - update

02/04/2014 16

13/YH/0030/AM02 Shoulder PAtch for Rotator Cuff tears Amendment 2, 19/11/2013

28/02/2014 16

13/YH/0030/AM03 Shoulder PAtch for Rotator Cuff tears Amendment 3 13/05/2014 16


13/YH/0030/AM04 Shoulder PAtch for Rotator Cuff tears Amendment 4 10/12/2014 20

13/YH/0033/AM01 Hearing Aids, Mild Hearing Loss and Tinnitus 1 02/02/2014 13

13/YH/0059/AM02 Hydralazine/Nitrates in Heart Failure 2 24/07/2014 12

13/YH/0059/AM04 Hydralazine/Nitrates in Heart Failure Amendment 3 16/01/2015 11

13/YH/0066/AM08 PRESSURE 2 Pressure 2 Amendment 4

31/03/2014 24

13/YH/0118/AM06 QVA149 versus Seretide exacerbation study Substantial Amendment 5-

Amend

11/04/2014 21

13/YH/0118/AM07 QVA149 versus Seretide exacerbation study Substantial Amendment 06PICF V

19/05/2014 14

13/YH/0136/AM09 ELAD for Treatment of AILD (VTI-208) Amendment 6 12/04/2014 19

13/YH/0136/AM11 ELAD for Treatment of AILD (VTI-208) 6.0 12/04/2014 20

13/YH/0136/AM13 ELAD for Treatment of AILD (VTI-208) IMPD Version 3.3 01/08/2014 14

13/YH/0147/AM04 ELAD for Treatment of AAH (VTI-210) Amendment 3 - CIP Amendment 3,

06/08/2014 20

13/YH/0147/AM06 ELAD for Treatment of AAH (VTI-210) Protocol Amendment 4.0

03/12/2014 28

13/YH/0153/AM01 The impact of robotic surgery on teamwork (v1) Amendment 1 28/03/2014 21

13/YH/0163/AM02 A CBT resource for young people with dental anxiety 2 21/10/2014 27

13/YH/0201/AM10 Study of Sativex in Children (aged 8-18) with Severe Spasticity Substantial Amendment 5

13/06/2014 7

13/YH/0219/AM01 Cognition in Cystic Fibrosis patients and matched controls (Version 1)

1 19/09/2014 17

13/YH/0232/AM02 ECho: Efficacy of Inhaled GSK2339345 in Chronic Idiopathic Cough

Substantial Amendment 1

31/03/2014 25

13/YH/0246/AM02 ELectrical & Magnetic Stimulation after trauma - the ELMS Trial

3.0 16/02/2014 17

13/YH/0279/AM04 PROMOTE 2.0, 13/02/14 10/03/2014 16

13/YH/0279/AM08 PROMOTE 3.0 10/06/2014 7

13/YH/0279/AM11 PROMOTE Amendment 6 (protocol version

07/10/2014 14

13/YH/0284/AM02 Pilot trial of omeprazole in idiopathic pulmonary fibrosis 4.0 03/07/2014 21

13/YH/0309/AM03 CORAL XT – Open-label extension trial of the CORAL trial Substantial Amendment 3

06/12/2014 8


13/YH/0317/AM01 CUSTOM-DBS Protocol Version AB

30/04/2014 13

13/YH/0347/AM01 Facilitators and barriers to active recall for HIV/STI testing of MSM

Amendment 1, 22/01/14

17/03/2014 16

13/YH/0366/AM03 Efficacy and safety of 11b-HSD1 inhibitor in IIH AM01 10/11/2014 15

13/YH/0372/AM04 Patient Reporting of Safety: A Feasibility Study Amendment 2 24/09/2014 19

13/YH/0377/AM01 Computerised aphasia therapy RCT (Big CACTUS) 1.0 20/06/2014 14

13/YH/0377/AM05 Computerised aphasia therapy RCT (Big CACTUS) Amendment 2 20/02/2015 14

13/YH/0400/AM02 Delirium prevention for older people in hospital: a feasibility study

1.0 26/06/2014 8


Amendment 2, Thank You Letter

07/08/2014 14


Amendment 3 21/10/2014 12


Amendment 4 17/02/2015 19

13/YH/0401/AM03 Cross-over study with NVA237 vs tiotropium in early morning symptoms

Amendment 2, 20/03/2014

20/03/2014 17

13/YH/0401/AM04 Cross-over study with NVA237 vs tiotropium in early morning symptoms

3 26/06/2014 21

13/YH/0408/AM01 Fitness to Treat (FiTT) Amendment 1 05/06/2014 13

14/YH/0006/AM06 Open Label Extension Study of Lacosamide in Paediatric Subjects

Amendment 4, Changes of NCI Fe

17/03/2015 14

14/YH/0007/AM08 acosamide in Subjects ages 4 years and over and less than 17 with Epil

Amendment 5, Changes of NCI Fe

17/03/2015 14

14/YH/0034/AM03 IciCLLe -Assessment of the Mechanism of Action of Ibrutinib Amendment 4 08/05/2014 20

14/YH/0049/AM03 Protocol CP-01 Study of SonoLysis Headframe Version 4c Oct 18 2013

2 28/11/2014 19

14/YH/0070/AM01 Experiences of relationships in individuals with psychosis Amendment 1 14/04/2014 15

14/YH/0078/AM01 MICROSHOCK 1.0 07/07/2014 11

14/YH/0085/AM03 FLAIR version 1.0 Amendment 2.0, Update to proto

04/09/2014 11

14/YH/0085/AM04 FLAIR version 1.0 Amendment 2.0, Addition of Que

04/09/2014 24

14/YH/0107/AM01 Feasibility Study - fMRI in measuring the effect of HD on the Brain

1 18/09/2014 17


14/YH/0128/AM01 SaFaRI (SNS versus the FENIX MSA for adult FI) Amendment 1, Change to Primary

10/10/2014 22

14/YH/1032/AM01 Services for Juvenile Huntington's Disease Amendment 1, Extension of Age

20/11/2014 22

14/YH/1050/AM01 HRpQCT in Osteogenesis Imperfecta Amendment 1, Change to ionizin

08/10/2014 10

14/YH/1050/AM02 HRpQCT in Osteogenesis Imperfecta 2 26/11/2014 17

14/YH/1110/AM01 Dose finding safety study of VAL201 in cancer patients VAL201-101, F2.0 22/01/2015 20

14/YH/1149/AM01 Getting vitamin D dosing right Substantial Amendment 1,

Chang

04/12/2014 15

14/YH/1162/AM01 SABRTOOTH v1.0 MO14/11248/G/201

50216

16/02/2015 12

14/YH/1166/AM01 DINOSAUR Paediatric Bone and Joint Study: Qualitative component

Amendment 1, Topic Guides

13/10/2014 12


Amendment 1, Protocol 1.1

10/12/2014 27


Substantial Amendment 3,

Patie

04/02/2015 8

14/YH/1259/AM01 ALPHA Alpha Amend 1, v2.0

04/02/2015 12

14/YH/1260/AM01 Frontier II Amendment 1 26/02/2015 13

15/YH/0017/AM01 Extension Paediatric stdy of Intrathecal IdursulfaseIT with ElapraseÂ®

UKSpecific Protocol

Amendment

12/03/2015 7

15/YH/0020/AM01 Calibre Amendment 1 - Change to PIS an

26/01/2015 19

Unfavourable opinion

Amendment REC

Reference


Clock


Sub Amend 9, Updated IB and PI

16/10/2014 35

13/YH/0136/AM07 ELAD for Treatment of AILD (VTI-208) Script for 208E 26/03/2014 8


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

Follow Up Phon

13/YH/0147/AM02 ELAD for Treatment of AAH (VTI-210) Script for 210E Follow Up Phon

26/03/2014 8

Favourable opinion timeline

Amendment REC

Reference


Clock

13/YH/0003/AM13/1 Ibrutinib in Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma

Investigator’s Brochure v8.0 a

14/01/2015 5

Unfavourable opinion timeline

Amendment REC

Reference


Clock


Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline


15/YH/0050 Patient's lived experience of Occ Therapy in a hosp major trauma ward 82

Proportionate review applications for ethical review over 14 day timeline


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


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