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Research Ethics Service

RES Committee North West - Greater Manchester West

Annual Report

01 April 2014 - 31 March 2015

RES Committee North West - Greater Manchester West Annual Report

Part 1 – Committee Membership and Training

Name of REC: RES Committee North West - Greater Manchester West Type of REC: Authorised Type of Flag: Qualitative Chair: Dr Lorraine Lighton (Chair) Vice-Chair: Mr Ian Beaumont – Until March 2015 Alternate Vice-Chair: Mr Jonathan Deans REC Manager: Miss Anna Bannister REC Assistant: Miss Katie Southeard – from September 2014 Committee Address: Barlow House

3rd Floor 4 Minshull Street Manchester M1 3DZ

Telephone: 0161 625 7434 Email: [email protected]


Chair’s overview of the past year:

During the last year we have lost several members. Dr Adedokun’s term of membership came to an end, Mark Garrod and Patricia Morgan have resigned for health reasons, Jayne Hardicre has had a change of work commitments and Iestyn Shapey is no longer able to commit to REC meetings owing to his surgical training rotation. Ian Beaumont, vice chair, has moved to another REC which meets on a day which is more convenient now that he has retired from his post as pharmacist. All these colleagues have provided invaluable input into the REC discussions and Ian has been a superb Vice-chair. I wish them all well for the future and hope that Iestyn has a successful career as a transplant surgeon. We have been pleased to welcome two new members during 2014/15; Janice Christie and Julie Grindey. The loss of six members and recruitment of only two has meant that the REC is down to ten members and we have therefore been reliant on the goodwill of members of other RECs to ensure that meetings are quorate. We are very grateful to those REC members who have supported Greater Manchester West by attending our meetings. Since March we have moved the REC meetings from Eccles Gateway to Barlow House for an extended trial period. The change of venue is more convenient for some members but may mean longer journeys for others. We will evaluate the change later in the year. I would like to take this opportunity to thank the members who give of their time to prepare thoroughly for meetings and for the high quality of the ethical debate. The REC has undertaken a large number of proportionate reviews which have, at times, been burdensome for volunteers who have busy lives, but the members have participated without complaint and provided an excellent service to researchers. Particular thanks go to Anna Bannister, REC Manager, and Katie Southeard, REC Assistant, for their administrative support, ensuring that the REC runs efficiently. They are to be commended for the REC achieving all timescales, with only 8% opinions being outside the stretch target of 40 days.


RES Committee North West - Greater Manchester West Membership

RES Committee North West - Greater Manchester West: Co-opted Members

Name Profession Expert or Lay

Dates

Appointed Left

Dr Joshua Adedokun Consultant In Anaesthesia and Pain Medicine

Expert 01/10/2009 01/10/2014

Mr Ian Beaumont (Vice Chair)

Retired Pharmacist Lay 01/09/2009 01/03/2015 (Transferred to GM East)

Mrs Seonaid Beddows Research Governance and Administration Manager

Lay 01/12/2013

Dr Janice Christie Senior lecturer nursing Expert 08/01/2015

Mr Jonathan Deans Consultant in Head & Neck Surgery

Expert 01/05/2013

Dr Peter Donnelly Semi-Retired Industrial Chemical Risk Assessor

Lay Plus 10/09/2009

Mr Mark Garrod Project Consultant and Pension Fund Trustee

Lay 01/09/2011 26/03/2015

Mrs Julie Grindey Research Midwife Expert 14/04/2015

Mrs Jayne Hardicre R&D Practice Development & Support Lead

Expert 27/06/2013 04/08/2014

Mr Michael Harnor Retired Lay Member Lay Plus 01/09/2009

Dr Lorraine Lighton (Chair)

Consultant in Communicable Diseases

Expert 01/09/2009

Dr Barry Miller Consultant Anaesthetist Expert 01/09/2009

Mrs Patricia Morgan Non-Exec Director Lay 01/09/2009 25/01/2015

Dr Peter Owen Retired Mathematics Lecturer

Lay Plus 01/01/2012

Mr Iestyn Shapey Transplant Surgery Registrar

Expert 18/01/2012 02/02/2015

Dr Gideon Smith Consultant in Public Health Medicine

Expert 20/08/2010

Name Profession Status Meeting date attended

Mr Jimmy Burns Co-opted Lay Member (GM East)

Lay Plus 05/09/2014 & 07/11/2014

Ms Hannah Chambers Retired Lay Member Lay Plus 04/04/2014

Mr Chris Houston Co-opted member (Lay) Lay 06/02/2015

Mr Rodney Lighton Software Engineer Expert 05/12/2014

Mrs Frances Maders Retired Clinical Trials Co-ordinator for Radiology

Expert 05/09/2014 & 05/12/2014


RES Committee North West - Greater Manchester West: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Joshua Adedokun None 14/05/2014

Mr Ian Beaumont (Vice Chair) None 04/12/2014

Mrs Seonaid Beddows Research Governance and administration Manager with NIHR Clinical Research network Greater Manchester

09/01/2015

Dr Janice Christie As part of my role as a lecturer at the university of Manchester I am expected to apply for research funding and undertake research. I also review research grants proposals for NIHR on a voluntary basis.

09/01/2015

Mr Jonathan Deans None 06/02/2015

Dr Peter Donnelly None 05/12/2014

Mr Mark Garrod Part-time employee of Redx Pharma, a pharmaceutical R&D (biotech) company. Shares held in GlaxoSmithkline. Registered volunteer with “Genesis Breast Cancer Prevention” charity. Partner is an active breast cancer researcher into diet, lifestyle and other factors. Her wider peer research team includes the Christie / Univ Hospital of South Manchester / Manchester University, and her direct professors are Tony Howell and Gareth Evans.

26/11/2014

Mr Michael Harnor Small shareholdings, Astra Zeneca, Smith and Nephew, GSK. Trustee and company director, British Epilepsy Association (working name Epilepsy Action) (Former national Chairman.) Vice-Chair of Research Committee. Trustee and Executive member, Greater Manchester Neurological Alliance. (Former Chair).The lay member for the ‘Neurology, Pain and Psychiatry Expert Advisory Group,’ Commission on Human Medicines. (Hosted by MHRA)Member of the Lay members Forum, MHRA Former public Governor, Salford Royal NHS Foundation Trust. Current public Governor, North West Ambulance NHS Trust.

01/01/2015

Dr Lorraine Lighton (Chair) Involvement in studies as a researcher. No other activities related to the conduct of research.

27/11/2014

Dr Barry Miller Member of board (and Chair of training Committee) at faculty of pain medicine. Peer reviewer for British Journal Anaesthesia

09/01/2015

Dr Peter Owen None 25/11/2014

Dr Gideon Smith Chair of Programme Steering Group for Research study at University of Liverpool. Appraisal of Clinical Academics

06/02/2015


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 04/04/2014 8

May 02/05/2014 11

August 01/08/2014 7

September 05/09/2014 8

October 03/10/2014 8

November 07/11/2014 8

December 05/12/2014 8

January 09/01/2015 10

February 06/02/2015 8

March 06/03/2015 8

10 full committee meetings were held during the reporting period.


April 04/04/2014 3

May 02/05/2014 4

July 04/07/2014 3

August 01/08/2014 3


October 03/10/2014 4

December 05/12/2014 4

January 09/01/2015 3

February 06/02/2015 3

March 06/03/2015 3

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


April 04/04/2014 2

April 11/04/2014 2

April 24/04/2014 2

April 25/04/2014 2

May 09/05/2014 2

May 14/05/2014 2

May 16/05/2014 2

May 23/05/2014 2

June 05/06/2014 2

June 06/06/2014 2

June 13/06/2014 2

June 19/06/2014 2


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

July 03/07/2014 2

July 23/07/2014 2

August 01/08/2014 2

August 08/08/2014 2

August 15/08/2014 2

August 18/08/2014 2





October 09/10/2014 2

October 28/10/2014 2

November 03/11/2014 2

November 10/11/2014 2

December 05/12/2014 2

December 10/12/2014 2

December 10/12/2014 2

December 17/12/2014 2

December 19/12/2014 2

December 19/12/2014 2

January 09/01/2015 2

January 15/01/2015 2

February 20/02/2015 2

March 18/03/2015 2

March 23/03/2015 2

37 sub-committee meetings were held during the reporting period. 0


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 Ian Beaumont (Vice Chair) 6

Mrs Seonaid Beddows 8

Dr Janice Christie 3

Mr Jonathan Deans 4

Dr Peter Donnelly 10

Mr Mark Garrod 1

Mrs Jayne Hardicre 2

Mr Michael Harnor 7

Dr Lorraine Lighton (Chair) 9

Dr Barry Miller 6

Mrs Patricia Morgan 1

Dr Peter Owen 10

Mr Iestyn Shapey 3

Dr Gideon Smith 7

Dr Joshua Adedokun 0



Mrs Seonaid Beddows 1

Dr Janice Christie 1

Dr Peter Donnelly 1

Mrs Jayne Hardicre 1

Mr Michael Harnor 1


Dr Peter Owen 10

Dr Gideon Smith 4



Mr Jonathan Deans 3

Dr Peter Donnelly 4


Dr Peter Owen 10

Dr Gideon Smith 11


Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Mr Ian Beaumont (Vice Chair) 06/10/2014 Research involving the disadvantaged and vulnerable

Mrs Seonaid Beddows 30/10/2014 Equality & Diversity Training

Mrs Seonaid Beddows 24/03/2015 National Members Training Day

Dr Janice Christie 23/01/2015 Diversity Training

Dr Janice Christie 03/02/2015 Good Clinical Practice

Mr Jonathan Deans 19/02/2015 Equality, Diversity and Human Rights - Promoting

Understanding

Mr Jonathan Deans 19/02/2015 Equality, Diversity and Human Rights - General Awareness

Dr Peter Donnelly 19/06/2014 Training - Assessing the Consequences (benefits and harms) of Research: a Health Research Authority workshop

Dr Peter Donnelly 03/12/2014 Personal Data in Research - A workshop

Dr Peter Donnelly 19/02/2015 Complex Cases

Dr Peter Donnelly 24/03/2015 National Members Training Day

Mr Mark Garrod 15/12/2014 Quantitative Research Methods and Statistics

Mr Michael Harnor 19/02/2015 Complex Cases

Dr Lorraine Lighton (Chair) 17/06/2014 Researcher Day

Dr Lorraine Lighton (Chair) 22/09/2014 Practicalities of running a REC

Dr Lorraine Lighton (Chair) 10/11/2014 NREAP meeting

Dr Lorraine Lighton (Chair) 16/01/2015 On-line information governance

Dr Barry Miller 14/11/2014 E-Learning Modules Information Governance,

Conflict Resolution, Anti-Fraud Awareness, Safeguarding Vulnerable Children and

Dementia

Dr Peter Owen 09/10/2014 Medical Devices Training Day

Dr Gideon Smith 19/02/2015 Complex Cases

Dr Gideon Smith 24/03/2015 National Members Training Day


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 0 0.00

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 49 100.00

Total Applications Reviewed 49 100

Number of applications made invalid by the REC Manager 4

Number of applications withdrawn prior to the meeting 0

Number of student applications reviewed 27

Number of paediatric applications reviewed 3

Number of device applications reviewed 0

Number of prisoner applications reviewed 1

Number of applications involving adults unable consent reviewed 0

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

Number of qualitative applications reviewed 12

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 2 4.08

Favourable Opinion with Additional Conditions 21 42.86

Unfavourable Opinion 2 4.08

Provisional Opinion 24 48.98

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 49 100

Number of studies sent back to full committee meeting for final opinion

1


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

23 46.94

Further Information Favourable Opinion with Additional Conditions

0 0.00

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 49 100


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 6

Number of studies withdrawn prior to the meeting 0

Number of student applications reviewed 14

Number of paediatric applications reviewed 2

Number of device applications reviewed 0

Number of qualitative applications reviewed 5

Total Applications Reviewed 27

Decisions taken at proportionate review sub-committee meetings

Number %



No Opinion transfer to full committee for review 5 18.52



Total 27 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 4.90

Number of applications for full ethical review 49

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 8.16%

Number of days taken to final decision – average (mean) 26

Number of proportionate review applications for ethical review

22

Number of proportionate review applications for ethical review over 14 days

1

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

4.55%

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 64

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

1.56%

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 47

Number of substantial amendments received for information 0

Number of substantial amendments received for new sites/PIs

0

Number of annual progress reports received 45

Number of safety reports received 0

Number of Serious Adverse Events received 4

Number of final reports received 42

RES Committee North West - Greater Manchester West 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/NW/0179 Exploring working alliance in aphasia rehabilitation 58

14/NW/0188 The health of compost workers 41

14/NW/0191 Impact of GH replacement post SAH in GHD 23

14/NW/0195 Longitudinal placental MRI changes in complicated pregnancies 24

14/NW/0235 Women's Experiences of Sexual Intimacy Following a Tear or Episiotomy 43

14/NW/0253 A study comparing conventional brain cooling with trans-nasal cooling. 34

14/NW/0267 R-SENSAR feasibility study: Role of SLNB in patients with anal cancer 26

14/NW/1154 Parents' experiences of support following their child's self-harm 28

14/NW/1255 PK11195 and metastatic disease in the brain 24

14/NW/1396 B-AHEAD 3; Breast - Activity and Healthy Eating After Diagnosis - 3 34

14/NW/1413 An exploration of the pregnancy experiences of women with a BMI>40 V1. 27

14/NW/1414 An IPA study of women's experiences of CBT for bulimia nervosa (V1) 21

14/NW/1471 ExPRESS 2 - longitudinal feasibility study 45

14/NW/1475 Experiences of EMDR in Paediatrics: Version 2 22

15/NW/0016 Analysis of neck muscle structure and activation in cervical dystonia 18

15/NW/0018 Combining PES with carbonation swallowing: a TMS Study. 22

15/NW/0046 BPD perceptions of interventions to prevent self-harm 30

15/NW/0086 Social networks in African Caribbean & Black Africans with psychosis 22

15/NW/0091 Relationships with mental health professionals: Service users' views 1 23

15/NW/0133 Hidden hearing loss in unexplained listening difficulties and tinnitus 22

15/NW/0157 Dysphagia in Huntington’s disease: a multimodal imaging study / v1.0 26

15/NW/0186 Evaluation of the Green Badge System 38

15/NW/0199 Can cognitive analytic therapy treat hoarding disorder? 21



Further Information Unfavourable Opinion



Favourable Opinion with Standard Conditions


14/NW/1311 Hospital discharge in advanced disease: supporting family carers V1 20

15/NW/0048 NQ01 expression in endoscopically resected human colorectal tumours 17

Favourable Opinion with Additional Conditions


14/NW/0258 Sleep and day to day fatigue in chronic fatigue syndrome 21

14/NW/0268 Patient experiences of a major trauma centre 25

14/NW/1130 The lived experience of dementia in a couple relationship 21

14/NW/1149 Undiagnosed Lupus-Like Autoimmunity and unexplained stillbirth 29

14/NW/1158 IntHemo 21

14/NW/1165 The UHSM CMR Study 23

14/NW/1190 Feasibility of a novel approach to sensory mapping in angina pectoris 21

14/NW/1196 Epigenetic factors associated with Type 2 Diabetes. 29

14/NW/1217 Evaluation of a new self-administered visual field screening tool 21

14/NW/1233 Characterisation of immune and inflammatory reactions in dandruff 21

14/NW/1262 Evaluating Specific Plans to Increase Smoking Quit Attempts 21

14/NW/1316 The influence of childbirth on pelvic sensory innervation 20

14/NW/1326 Comparison of bleeding after ACS between ticagrelor and clopidogrel 20

14/NW/1388 VAN 21

14/NW/1446 Research on the impact of NSCLC on caregivers' quality of life 21

14/NW/1469 Adolescent experiences of Eating Disorder Interventions 18

15/NW/0006 EXPRES: Exploring Processes of Recovery in Self-harm 17

15/NW/0012 The experience of Binge Eating Disorder. 17

15/NW/0029 What do service users hear when staff talk about sex and relationships 40

15/NW/0043 Towards a mobile health device for Parkinson's disease 39

15/NW/0084 Blood caffeine levels prior to rubidium-82 MPS 21

Unfavourable Opinion


14/NW/1313 WHEAT: WithHolding Enteral feeds Around packed red cell Transfusion 20

15/NW/0144 Drug use and austerity 21


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

Provisional Opinion


15/NW/0071 ARTFORCE Head & Neck (2-arm study) n/a

Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting




14/NW/1275 Predictors of resilience in adolescents with a cleft (version 1) 14

14/NW/1277 The balance and gait characteristics of fallers 9

14/NW/1279 Customers' perspectives on Healthy Living Pharmacies 13

15/NW/0137 Professional podiatry practice: An Ethnographic Study (version 1) 11

15/NW/0215 Prevalence of Cam-types lesions in Asymptomatic adults 9



Further Information Unfavourable Opinion



Favourable Opinion with Standard Conditions


14/NW/0212 Statin SSI study 12

14/NW/0213 What are long term consequences of CNS Vasculitis and mimic disorders 8

14/NW/0214 Comparison of radiotherapy treatment time Vs appointment time 11

14/NW/1101 Interplay of perivascular nerves and retinal vessels in diabetes 9

14/NW/1111 Socioeconomic position and organ donation after death in England 7

14/NW/1171 Participants' Experience of Experimental Research (PEER) 18

14/NW/1494 Audit of the use of Omalizumab in Tayside 8

14/NW/1495 Studying the retina in brittle cornea syndrome 8

15/NW/0042 Measurement of chlamydia antibodies using residual GUM specimens 8

Favourable Opinion with Additional Conditions


14/NW/1100 Dermatology patients and Dept. of Health recommendations 9

14/NW/1109 Exploring experiences and issues of Young Adults with CF 7

14/NW/1172 The profile of ITP in children and predictors of well-being 11

14/NW/1193 IBD Transition study 7

14/NW/1341 Cognitive and Emotional Factors in Illness and Health 01 8

14/NW/1346 Social outcomes of mental health service interventions Version 1 12

14/NW/1496 HECTOR Evaluation 8

15/NW/0136 Low FODMAP diet group vs. individual education: pilot study 11

Unfavourable Opinion


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

08/H1006/66/AM02 Assessment of circulating biomarkers in gynaecological cancers

1.3 05/03/2014 3

09/H1006/38/AM09 OPHTHALMIC MARKERS OF DIABETIC NEUROPATHY 11/11/2014 8

09/H1006/38/AM09 OPHTHALMIC MARKERS OF DIABETIC NEUROPATHY 30/10/2014 8

09/H1011/42/AM02 The effect of personality traits on pain control in healthy volunteers

2 07/05/2014 6

09/H1011/55/AM03 RADAR Version 1 Three 01/10/2014 7

10/H1011/26/AM05 CAEPs in infants with and without Hearing Loss 4 01/08/2014 21

10/H1014/29/AM10 Observational study of early diffuse SSc 6 30/04/2014 10

10/H1014/32/AM18 Management of breast cancer for women aged 70+ in Greater Manchester

10 28/07/2014 9

10/H1014/33/AM13 Management of breast cancer for women aged 65+ in Northwest England

5 28/07/2014 9

11/NW/0206/AM01 Inflammatory signalling pathways 1 24/06/2014 7

11/NW/0232/AM06 Immune Suppression and Cortisol 4 21/02/2014 6

11/NW/0624/AM09 Strategies to increase cervical screening uptake (STRATEGIC) version 1

9 24/04/2014 7

11/NW/0624/AM10 Strategies to increase cervical screening uptake (STRATEGIC) version 1

10 18/02/2015 6

11/NW/0723/AM05 Saccadic Eye Movements in Alzheimer’s disease 5.3 01/01/2015 1

11/NW/0743/AM12 Trajectories of Outcome in Neurological Conditions V1 5 02/09/2014 22

11/NW/0743/AM13 Trajectories of Outcome in Neurological Conditions V1 Six 04/12/2014 5

12/NW/0086/AM02 Corneal nerve fibres for detecting small fibe neuropathy Two 18/06/2014 14

12/NW/0170/AM08 BASIC-HHD study v2 8 01/04/2014 15

12/NW/0204/AM07 Evaluation of cytology and HPV testing for anal pre-cancer 6 01/04/2014 8

12/NW/0204/AM08 Evaluation of cytology and HPV testing for anal pre-cancer 7 21/07/2014 6

12/NW/0230/AM06 Breast activity and healthy eating after diagnosis - 2 6 31/03/2014 8

12/NW/0230/AM07 Breast activity and healthy eating after diagnosis - 2 7 21/05/2014 13

12/NW/0243/AM04 Feasibility evaluation of FLT PET in advanced pancreatic cancer

1 01/05/2014 17

12/NW/0267/AM02 The validation of a PROM for breathlessness and fatigue in CHF - 02

1 01/05/2014 2


12/NW/0269/AM01 Risk factors for SSI in metastatic spinal tumour patients 1 14/03/2014 13

12/NW/0414/AM03 Trismus RfPB trial 3 29/05/2014 15

12/NW/0525/AM03 HYST 2 10/09/2014 19

12/NW/0619/AM06 Investigating Medication Adherence in Psoriasis (iMAP) Four 14/11/2014 2

12/NW/0724/AM04 Shoulder Hemi-or Reverse Polarity Athroplasty for Trauma(SHeRPA) v1

4 24/04/2014 11

12/NW/0867/AM05 PREVeNT RA Two 17/11/2014 1

13/NW/0105/AM01 Optimising islet engraftment for long term function in Type 1 diabetes

1 10/07/2014 7

13/NW/0148/AM01 AuDyIt: Autonomic function in cough 2 28/05/2014 8

13/NW/0148/AM03 AuDyIt: Autonomic function in cough Three 18/09/2014 7

13/NW/0298/AM01 Electrical remodelling of the sinus node in athletes 1 23/06/2014 7

13/NW/0310/AM04 AMEND-IT (version-1) Three 23/02/2015 2

13/NW/0468/AM01 Assessment of abdominal aortic aneurysm wall distensibility and stress

1 29/04/2014 11

13/NW/0468/AM02 Assessment of abdominal aortic aneurysm wall distensibility and stress

Two 29/01/2015 1

13/NW/0580/AM02 NIPSIGEN - Clinical translation of NIPD for single gene disorders.

2 23/04/2014 20

13/NW/0580/AM03 NIPSIGEN - Clinical translation of NIPD for single gene disorders.

3 07/07/2014 12

13/NW/0758/AM04 Experience Led Commissioning for specialist maternity services

2 01/06/2014 13

13/NW/0759/AM02 Delivering dignity for older people during chemotherapy 3.5 17/03/2014 11

13/NW/0827/AM01 Biological effects of CMR 1 01/07/2014 5

13/NW/0867/AM02 Langerhans' Cells in Normal and Psoriasis Skin 1 21/11/2014 2

13/NW/0871/AM01 Experiences of the therapeutic relationship 1 29/05/2014 8

13/NW/0878/AM02 Diet and lifestyle after prostate cancer diagnosis (Version 1) 2 11/07/2014 13

13/NW/0888/AM01 Evaluating a planner to aid a community weight management programme

1 03/06/2014 3

14/NW/0082/AM01 Understanding IUGR & SGA from the pregnant woman's perspective V1.0

1 22/05/2014 4

14/NW/0126/AM01 Self Directed Triple P for Psychosis: Symptoms, Parenting and Schemas

1 28/07/2014 2

14/NW/0127/AM01 How mothers in a Mother and Baby Unit construe nursing staff. 1 08/08/2014 21

14/NW/0235/AM01 Women's Experiences of Sexual Intimacy Following a Tear or 1 19/10/2014 6


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

Episiotomy

14/NW/0235/AM02 Women's Experiences of Sexual Intimacy Following a Tear or Episiotomy

Two 22/11/2014 16

14/NW/0258/AM01 Sleep and day to day fatigue in chronic fatigue syndrome 1 18/07/2014 5

14/NW/0267/AM01 R-SENSAR feasibility study: Role of SLNB in patients with anal cancer

1 13/06/2014 7

14/NW/0268/AM01 Patient experiences of a major trauma centre One 14/11/2014 1

14/NW/1165/AM02 The UHSM CMR Study Two 07/11/2014 30

14/NW/1190/AM01 Feasibility of a novel approach to sensory mapping in angina pectoris

One 15/12/2014 20

14/NW/1255/AM01 PK11195 and metastatic disease in the brain One 25/11/2014 15

14/NW/1275/AM01 Predictors of resilience in adolescents with a cleft (version 1) One 21/10/2014 7

14/NW/1275/AM02 Predictors of resilience in adolescents with a cleft (version 1) Two 13/01/2015 3

14/NW/1316/AM01 The influence of childbirth on pelvic sensory innervation 27/02/2015 25

14/NW/1341/AM01 Cognitive and Emotional Factors in Illness and Health 01 One 25/11/2014 7

14/NW/1388/AM01 VAN 12/12/2014 7

14/NW/1471/AM01 ExPRESS 2 - longitudinal feasibility study One 13/01/2015 1

Unfavourable opinion



11/NW/0421/AM07 Evaluating new genetic techniques for diagnosing retinal dystrophies

Four 30/09/2014 7

11/NW/0802/AM03 Clinical study of the PyroTITAN shoulder resurfacing prosthesis V1

Two 02/12/2014 12

Favourable opinion timeline



11/NW/0421/AM07/1

Evaluating new genetic techniques for diagnosing retinal dystrophies

Four (Modified) 11/12/2014 3


Unfavourable opinion timeline




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/NW/1171 Participants' Experience of Experimental Research (PEER) 18

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline



Modified Amendments over 14 day timeline



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