RES Committee North West - Greater Manchester West Annual ... · Mr Mark Garrod Project Consultant...
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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 Page 2
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]
RES Committee North West - Greater Manchester West Annual Report Page 3
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 Annual Report Page 4
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 Annual Report Page 5
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
RES Committee North West - Greater Manchester West Annual Report Page 6
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.
Month Date Number of Members Present at Meeting
April 04/04/2014 3
May 02/05/2014 4
July 04/07/2014 3
August 01/08/2014 3
September 05/09/2014 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.
Month Date Number of Members Present at Meeting
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
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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
September 10/09/2014 2
September 10/09/2014 2
September 25/09/2014 2
September 26/09/2014 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
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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
Name Number of Meetings Attended
Mr Ian Beaumont (Vice Chair) 5
Mrs Seonaid Beddows 1
Dr Janice Christie 1
Dr Peter Donnelly 1
Mrs Jayne Hardicre 1
Mr Michael Harnor 1
Dr Lorraine Lighton (Chair) 9
Dr Peter Owen 10
Dr Gideon Smith 4
Name Number of Meetings Attended
Mr Ian Beaumont (Vice Chair) 10
Mr Jonathan Deans 3
Dr Peter Donnelly 4
Dr Lorraine Lighton (Chair) 36
Dr Peter Owen 10
Dr Gideon Smith 11
RES Committee North West - Greater Manchester West Annual Report Page 9
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
RES Committee North West - Greater Manchester West Annual Report Page 10
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
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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
Favourable Opinion with Standard Conditions 2 4.08
Favourable Opinion with Additional Conditions 21 42.86
Unfavourable Opinion 2 4.08
Provisional Opinion 1 2.04
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
RES Committee North West - Greater Manchester West Annual Report Page 12
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 %
Favourable Opinion with Standard Conditions 9 33.33
Favourable Opinion with Additional Conditions 8 29.63
No Opinion transfer to full committee for review 5 18.52
Provisional Opinion 5 18.52
Unfavourable Opinion 0 0.00
Total 27 100
RES Committee North West - Greater Manchester West Annual Report Page 13
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 Page 14
Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period
Further Information Favourable Opinion with Standard Conditions
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 Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 15
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
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
REC Reference Title Number of Days on Clock
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
REC Reference Title Number of Days on Clock
14/NW/1313 WHEAT: WithHolding Enteral feeds Around packed red cell Transfusion 20
15/NW/0144 Drug use and austerity 21
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 16
Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period
Provisional Opinion
REC Reference Title Number of Days on Clock
15/NW/0071 ARTFORCE Head & Neck (2-arm study) n/a
Provisional Opinion Pending Consultation with Referee
REC Reference Title Number of Days on Clock
Further information response not complete
REC Reference Title Number of Days on Clock
Withdrawn after the meeting
REC Reference Title Number of Days on Clock
Further Information Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
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 Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 17
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
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
REC Reference Title Number of Days on Clock
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
REC Reference Title Number of Days on Clock
Provisional Opinion
REC Reference Title Number of Days on Clock
Further information response not complete
REC Reference Title Number of Days on Clock
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 18
Withdrawn after the meeting
REC Reference Title Number of Days on Clock
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 19
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
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 20
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
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 21
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
Amendment REC Reference
Title Version Date Number of Days on Clock
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
Amendment REC Reference
Title Version Date Number of Days on Clock
11/NW/0421/AM07/1
Evaluating new genetic techniques for diagnosing retinal dystrophies
Four (Modified) 11/12/2014 3
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 22
Unfavourable opinion timeline
Amendment REC Reference
Title Version Date Number of Days on Clock
RES Committee North West - Greater Manchester West Research Ethics Committee Annual Report Page 23
Table 11: Items exceeding timelines
Full applications for ethical review over 60 day timeline
REC Reference Title Number of Days on Clock
Proportionate review applications for ethical review over 14 day timeline
REC Reference Title Number of Days on Clock
14/NW/1171 Participants' Experience of Experimental Research (PEER) 18
SSAs (non Phase 1) over 25 day timeline
REC Reference Title Number of Days on Clock
SSAs (Phase 1) over 14 day timeline
REC Reference Title Number of Days on Clock
Substantial Amendments over 35 day timeline
Amendment REC Reference
Title Version Date Number of Days on Clock
Modified Amendments over 14 day timeline
Amendment REC Reference
Title Version Date Number of Days on Clock