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Research Ethics Service
RES Committee South Central - Oxford A
Annual Report
01 April 2014 - 31 March 2015
RES Committee South Central - Oxford A Annual Report Page 2
Part 1 – Committee Membership and Training
Name of REC: RES Committee South Central - Oxford A
Type of REC: Recognised Type I, Type III
Type of Flag: Phase 1 in Health Volunteers Phase 1 Studies in Patients Gene Therapy or Stem Cell Clinical trials, Paediatric IRB Registered
Chair: Dr Karen Melham October 2010 - October 2014 Dr John Keen November 2014 – March 2015
Vice-Chair: Dr Cynthia Graham
Alternate Vice-Chair: None
REC Manager: Miss Stephanie MacPherson: April 2014 – April 2015 Miss Lauren Allen: May 2015 – current
REC Assistant: Miss Emma Bell: April 2014 – June 2014 Miss Ruth Avery: July 2014 – September 2014 Steve Mainwairing: September 2014 – February 2015 Mark Dawson: May 2015 – current
Committee Address: Bristol Research Ethics Committee Centre Whitefriars Level 3 Block B Lewins Mead Bristol BS1 2NT
Telephone: 0117 342 1387
Email: [email protected]
RES Committee South Central - Oxford A Annual Report Page 3
Chair’s overview of the past year:
I found an efficient, erudite and effervescent committee when I acted as a stepping stone between permanent Chairs during 2014/15, undertaking consistently strong ethical review sometimes within challenging accelerated timelines. Well done Oxford A. John Keen Chair (November 2014 – March 2015)
RES Committee South Central - Oxford A Annual Report Page 4
RES Committee South Central - Oxford A Membership
RES Committee South Central - Oxford A: Deputy Members
RES Committee South Central - Oxford A: Co-opted Members
Name Profession Expert or
Lay
Dates
Appointed Left
Ms Raj Bains Pharmacovigilance Business Consultant
Lay Plus 29/05/2008
Ms Jane Cheeseman Research Nurse Expert 20/05/2013
Mr Stuart Cole Head of Communications Lay Plus 01/06/2011
Ms Ana de Veciana Clinical Trials Pharmacist Expert 05/02/2015
Ms Alison Eden Manager Patient Recruitment
Lay Plus 01/01/2008 31/12/2014
Mrs Marion Fiddes Consultant Project Manager
Lay Plus 13/02/2006
Dr Cynthia Graham Senior Lecturer in Psychology
Expert 12/12/2005
Mrs Lyndsay Hills Retired Registered Nurse Lay 01/04/2010
Dr Stephanie Jones Postdoctoral Research Scientist
Expert 01/11/2014
Mrs Alison Kealy Legal Assistant – Wills and Probate
Lay Plus 28/05/2013
Dr John Keen GP Expert 01/11/2014 31/03/2015
Ms Joanne Keenan Head of Development Lay 12/05/2014
Mrs Doreen Laity Retired Pharmacist Lay 05/08/2013
Dr Karen Melham Ethicist (Chair) Lay Plus 15/12/2005 27/10/2014
Ms Christine Montague-Johnson
Paediatric Nurse Expert 01/06/2014
Dr Yash Patel Research Project Manager
Expert 01/10/2014 09/02/2015
Dr Mohit Sharma Consultant in Public Health
Expert 29/05/2013
Mr Martin Usherwood Retired Gynaecologist Expert 05/09/2011
Name Profession Status Meeting date attended
Name Profession Status Meeting date attended
RES Committee South Central - Oxford A Annual Report Page 5
RES Committee South Central - Oxford A: Members’ Declarations of Interest:
Name Declaration of Interest Date
Ms Jane Cheeseman None 06/03/2015
Dr Kim Cheetham None 14/11/2014
Mr Stuart Cole None 05/12/2014
Ms Ana de Veciana Husband works for VERTEX Pharmaceuticals ltd Europe and has shares in the company.
21/01/2015
Mrs Marion Fiddes Creative Dementia arts network treasurer 05/12/2014
Dr Cynthia Graham None 05/12/2014
Mrs Lyndsay Hills None 05/12/2014
Dr Stephanie Jones None 05/12/2014
Mrs Alison Kealy Shareholding in GlaxosmithKline 05/12/2014
Dr John Keen None 07/11/2014
Ms Joanne Keenan None 15/05/2014
Mrs Doreen Laity None 05/12/2014
Ms Christine Montague-Johnson
Employed as a Paediatric Research Nurse in the University of Oxford's Department of Paediatrics. Attends the Oxford University Hospitals Trust Trial Safety Group Committee meetings monitoring and reporting adverse events to trials running within the Trust and University.
15/05/2014
Ms Christine Montague-Johnson
Attends the Oxford University Hospitals Trust Trial Safety Group Committee meetings monitoring and reporting adverse events to trials running within the Trust and University.
05/12/2014
Dr Mohit Sharma None 06/03/2015
Mr Martin Usherwood Trustee of Ducklings Trust 10/02/2015
RES Committee South Central - Oxford A 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 10
May 02/05/2014 8
June 06/06/2014 8
July 04/07/2014 11
August 01/08/2014 10
September 05/09/2014 10
October 03/10/2014 11
November 07/11/2014 11
December 05/12/2014 12
February 06/02/2015 11
February 23/02/2015 8
March 06/03/2015 10
12 full committee meetings were held during the reporting period.
Month Date Number of Members Present
at Meeting
April 25/04/2014 3
May 19/05/2014 3
June 18/06/2014 3
August 15/08/2014 3
September 15/09/2014 3
October 27/10/2014 3
January 26/01/2015 3
March 23/03/2015 3
8 proportionate review sub-committee meetings were held during the reporting period.
Month Date Number of Members Present
at Meeting
April 11/04/2014 2
April 23/04/2014 2
May 16/05/2014 2
May 30/05/2014 2
June 13/06/2014 2
June 16/06/2014 2
June 27/06/2014 2
July 08/07/2014 2
July 25/07/2014 2
August 01/08/2014 2
August 08/08/2014 2
RES Committee South Central - Oxford A Annual Report Page 7
Details of inquorate meeting held:01 April 2014 - 31 March 2015
August 22/08/2014 2
September 10/09/2014 2
September 26/09/2014 2
October 03/10/2014 2
October 10/10/2014 2
October 23/10/2014 2
October 24/10/2014 2
October 27/10/2014 2
November 03/11/2014 2
November 12/11/2014 2
November 25/11/2014 2
December 12/12/2014 2
December 22/12/2014 3
January 08/01/2015 2
January 20/01/2015 2
January 22/01/2015 2
January 30/01/2015 2
February 06/02/2015 2
February 20/02/2015 2
March 06/03/2015 2
March 13/03/2015 2
32 sub-committee meetings were held during the reporting period. 0
RES Committee South Central - Oxford A Annual Report Page 8
Attendance of Members at full committee meetings:01 April 2014 - 31 March 2015
Attendance of Members at proportionate review sub-committee meetings: 01 April 2014 -
31 March 2015
Name Number of
Meetings
Attended
Ms Raj Bains 5
Ms Jane Cheeseman 9
Mr Stuart Cole 7
Ms Alison Eden 7
Mrs Marion Fiddes 7
Dr Cynthia Graham 7
Mrs Lyndsay Hills 9
Dr Stephanie Jones 4
Mrs Alison Kealy 9
Dr John Keen 5
Ms Joanne Keenan 8
Mrs Doreen Laity 9
Dr Karen Melham 6
Ms Christine Montague-Johnson 7
Dr Yash Patel 3
Dr Mohit Sharma 9
Mr Martin Usherwood 9
Name Number of
Meetings
Attended
Ms Jane Cheeseman 2
Mr Stuart Cole 4
Ms Alison Eden 2
Mrs Marion Fiddes 1
Dr Cynthia Graham 3
Mrs Lyndsay Hills 3
Mrs Alison Kealy 1
Dr John Keen 2
Dr Karen Melham 1
Dr Yash Patel 1
Dr Mohit Sharma 1
Mr Martin Usherwood 3
RES Committee South Central - Oxford A Annual Report Page 9
Attendance of Members at sub-committee meetings: 01 April 2014 - 31 March 2015
Name Number of
Meetings
Attended
Ms Jane Cheeseman 6
Ms Alison Eden 5
Mrs Marion Fiddes 6
Dr Cynthia Graham 11
Mrs Lyndsay Hills 4
Mrs Alison Kealy 1
Dr John Keen 12
Mrs Doreen Laity 1
Dr Karen Melham 16
Dr Mohit Sharma 3
RES Committee South Central - Oxford A Annual Report Page 10
Training 01 April 2014 - 31 March 2015
Name of Member Date Event(s) attended
Ms Jane Cheeseman 05/09/2014 Oxford A REC Training Day
Mr Stuart Cole 05/09/2014 Oxford A REC Training Day
Ms Alison Eden 05/09/2014 Oxford A REC Training Day
Mrs Marion Fiddes 05/09/2014 Oxford A REC Training Day
Dr Cynthia Graham 05/09/2014 Oxford A REC Training Day
Mrs Lyndsay Hills 05/09/2014 Oxford A REC Training Day
Dr Stephanie Jones 09/03/2015 Induction
Mrs Alison Kealy 05/09/2014 Oxford A REC Training Day
Dr John Keen 20/11/2014 NREAP Training
Ms Joanne Keenan 12/06/2014 NRES Committee Members Induction
Ms Joanne Keenan 04/08/2014 Equality and Diversity - e-learning module
Ms Joanne Keenan 05/09/2014 Oxford A REC Training Day
Ms Joanne Keenan 12/01/2015 CTIMP Training
Mrs Doreen Laity 20/05/2014 Induction
Mrs Doreen Laity 19/08/2014 Equality and Diversity training (e-learning module)
Mrs Doreen Laity 05/09/2014 Oxford A REC Training Day
Dr Karen Melham 05/09/2014 Oxford A REC Training Day
Ms Christine Montague-Johnson
06/08/2014 Equality and Diversity
Ms Christine Montague-Johnson
05/09/2014 Oxford A REC Training Day
Ms Christine Montague-Johnson
25/09/2014 NRES Committee Members Induction
Ms Christine Montague-Johnson
12/03/2015 Assessing the Consequences (benefits and harms) of
Research
Ms Christine Montague-Johnson
16/03/2015 Training - Personal Data in Research - A Workshop
Dr Yash Patel 08/05/2014 Quantitative Research Methods and Statistics: A Health
Research Authority Workshop
Dr Yash Patel 12/09/2014 Human Tissue Act (Use of Human Samples in Research) -
An Introductory Level
Dr Yash Patel 10/11/2014 Qualitative Research and Ethical Review
Dr Mohit Sharma 20/05/2014 NRES Committee Members Induction
Dr Mohit Sharma 05/09/2014 Oxford A REC Training Day
RES Committee South Central - Oxford A Annual Report Page 11
PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD
Table 1: Applications assigned to a full committee meeting held within the reporting
period:
Table 2: Breakdown of full applications and other activity during reporting period
Table 3: Decisions given at meetings held within the reporting period
Applications for full ethical review – Study Type Number %
Clinical Trial of Investigational Medicinal Product 17 34.00
Phase 1 6 12.00
Gene Therapy 3 6.00
Research Tissue Bank (including renewals) 0 0.00
Research Database (including renewals) 0 0.00
Others 24 48.00
Total Applications Reviewed 50 100
Number of applications made invalid by the REC Manager 1
Number of applications withdrawn prior to the meeting 1
Number of student applications reviewed 11
Number of paediatric applications reviewed 8
Number of device applications reviewed 0
Number of prisoner applications reviewed 0
Number of applications involving adults unable consent reviewed 0
Number of applications reviewed that are funded by the US DHHS 1
Number of qualitative applications reviewed 0
Decisions taken at meetings following review of
applications
Number %
Favourable Opinion with Standard Conditions 2 4.00
Favourable Opinion with Additional Conditions 3 6.00
Unfavourable Opinion 1 2.00
Provisional Opinion 44 88.00
Provisional Opinion Pending Consultation with Referee 0 0.00
Total 50 100
Number of studies sent back to full committee meeting for final opinion
0
RES Committee South Central - Oxford A Annual Report Page 12
Table 4: Summary of current status of applications reviewed during the reporting period
Status of applications at date of generation of report Number %
Further Information Favourable Opinion with Standard Conditions
31 62.00
Further Information Favourable Opinion with Additional Conditions
12 24.00
Further Information Unfavourable Opinion 0 0.00
Favourable Opinion with Standard Conditions 2 4.00
Favourable Opinion with Additional Conditions 3 6.00
Unfavourable Opinion 1 2.00
Provisional 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 2.00
Total 50 100
RES Committee South Central - Oxford A Annual Report Page 13
Table 5: Applications assigned to a proportionate review sub-committee within the
reporting period
Table 7: Decisions given at proportionate review sub-committee meetings held within the
reporting period
Table 6: Breakdown of PRS applications and other activity during reporting period:
Number of applications made invalid by the REC Manager 5
Number of studies withdrawn prior to the meeting 1
Number of student applications reviewed 5
Number of paediatric applications reviewed 3
Number of device applications reviewed 1
Number of qualitative applications reviewed 1
Total Applications Reviewed 20
Decisions taken at proportionate review sub-
committee meetings
Number %
Favourable Opinion with Standard Conditions 4 20.00
Favourable Opinion with Additional Conditions 1 5.00
No Opinion transfer to full committee for review 1 5.00
Provisional Opinion 13 65.00
Unfavourable Opinion 1 5.00
Total 20 100
RES Committee South Central - Oxford A Annual Report Page 14
Table 8: Other Management Information for the reporting period:
Average number of applications reviewed per full meeting 4.17
Number of applications for full ethical review 50
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 1
Number of applications over 40 days as a % of total 2.00%
Number of days taken to final decision – average (mean) 24
Number of proportionate review applications for ethical
review
19
Number of proportionate review applications for ethical
review over 14 days
1
Number of proportionate review applications over 14 days as
a % of total
5.26
Number of SSAs (non-Phase 1) reviewed 11
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 9
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 149
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
0.67%
Number of modified amendments reviewed 4
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 101
Number of substantial amendments received for information 2
Number of substantial amendments received for new
sites/PIs
23
Number of annual progress reports received 109
Number of safety reports received 143
Number of Serious Adverse Events received 3
Number of final reports received 53
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 15
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/SC/0145 Midbrain changes due to anaesthesia during routine elective surgery 25
14/SC/0153 Effect of bronchoconstriction on airway cellular responses in asthma 25
14/SC/0168 High-resolution connectivity of the basal ganglia in health & disease 31
14/SC/0188 Predictors of outcome after mild traumatic brain injury in children 27
14/SC/0190 HCMR Study 26
14/SC/0195 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations 29
14/SC/0220 First Time in Human Study of the TRPV4 blocker GSK2798745 29
14/SC/0232 MenB vaccine for immunocompromised 20
14/SC/0269 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B 23
14/SC/0281 ExPresSO 20
14/SC/1145 Study to determine the efficacy of XF-73 in eradicating Staph aureus. 19
14/SC/1150 Red cell transfusion and QoL in myelodysplastic syndromes (REDDS) 20
14/SC/1159 CO-OP in children with hyperkinetic movement disorders following DBS 26
14/SC/1160 Molecular Mechanisms of Epidural Related Maternal Fever 20
14/SC/1204 Investigating Enteric Fever 26
14/SC/1231 Vaccination in Prostate Cancer (VANCE), version 1.0 24
14/SC/1278 CHECK AF - Atrial Fibrillation screening study 30
14/SC/1305 Netazepide (YF476) in patients with Barrett's oesophagus; version 1 25
14/SC/1309 The TEMPLATE Study 30
14/SC/1347 Astellas - 8232-CL-0004 - Chronic Kidney & Diabetes Type 2 25
14/SC/1361 Dapagliflozin as an add-on to Insulin Therapy in Type 1 Diabetes 20
14/SC/1362 IAVI LONG TERM FOLLOW-UP STUDY 22
14/SC/1372 RIVER - Research In Viral Eradication of HIV Reservoirs 36
14/SC/1379 Brincidofovir (CMX001) for Treatment of Ebola Virus Disease 5
14/SC/1416 IgNiTE: Immunoglobulin in the treatment of encephalitis 25
15/SC/0023 Catheter Vs Thoracoscopic Surgical Ablation in LSPAF - Multicentre RCT 20
15/SC/0050 Role of ERAP1 in development of cervical cancer (v1) 30
15/SC/0051 Foxweb 21
15/SC/0103 SCALOP-2 V4.0 24Apr2015 28
15/SC/0109 OxLith 28
15/SC/0115 HARMONY Outcomes Trial 28
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 16
Further Information Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/SC/0154 Drug interaction study of ONO-4641 with atenolol or diltiazem 39
14/SC/0170 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD 26
14/SC/0212 Women's daily activities during pregnancy 31
14/SC/0280 Biomarker Investigation & Study of Pathology in Neuropathy (Bio-SPIN) 22
14/SC/0295 IMPALA trial 29
14/SC/1067 PROMDEP 31
14/SC/1124 RCT of pregnancy outcomes followng PGS versus morphological assessment 48
14/SC/1163 Understanding meningococcal carriage and disease 23
14/SC/1256 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z 10
14/SC/1405 A research study involving imaging patients with rheumatoid arhtritis 27
14/SC/1408 Evaluating Vaccines against Ebola 5
15/SC/0054 CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238 21
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/SC/1333 PATH-2: Platelet Rich Plasma in Achilles Tendon Healing 18
15/SC/0055 Natsal-3: further characterisation of CT and MG specimens 19
Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/SC/0227 Co-administration of RTS,S and viral vectors expressing ME-TRAP 25
14/SC/1427 Vaccines Against Salmonella Typhi (VAST) 13
15/SC/0108 A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z 5
Unfavourable Opinion
REC Reference Title Number of Days on Clock
14/SC/1088 Educational intervention for heart failure in emergency department 21
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 17
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
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
15/SC/0118 Phase II of Pazopanib in patients with advanced soft tissue sarcoma 30
Further Information Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/SC/0252 A long-term follow-up of adult kidney and liver transplant recipients 10
14/SC/0253 Exploring the Journey to Parenthood 11
14/SC/0254 Qualitative study of attachment narratives in couples therapy 9
14/SC/0286 Validation of Hand 20 Questionnaire 11
14/SC/1062 A qualitative study exploring patients experiences of PPI in research 9
14/SC/1220 Can the Intraocular Pressure be Determined from MRI? 13
14/SC/1275 Growth Assessment of Preterm infants (GAP study) 7
14/SC/1350 CC-4047-MM-015-Pomalidomide for relapsed and refractory MM patients_Ob 16
14/SC/1352 European Paediatric Tuberculosis Database 8
15/SC/0178 MACCE after endoscopic vein harvest for CABG 13
15/SC/0184 PROOF-ABPM 13
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 18
Further Information Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/SC/1061 Prospective post-market evaluation of an echogenic catheter 9
14/SC/1272 DiMaP study - Dialysis Modality and Phosphate study 8
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/SC/1064 Candida and the inflammatory response in biopsy samples v1 8
14/SC/1348 Vertebral Fracture: Vertebral Analysis from 2D VFA Scans 11
15/SC/0064 Aflibercept in patients with exudative AMD refractory to ranibizumab 5
15/SC/0186 Proteomics analysis of malignant pleural effusion 8
Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/SC/1052 Quality of life in children with glaucoma and cataract 6
Unfavourable Opinion
REC Reference Title Number of Days on Clock
14/SC/1273 Platelet function using TEG in haematology patients Version 1 6
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 South Central - Oxford A Research Ethics Committee Annual Report Page 19
Withdrawn after the meeting
REC Reference Title Number of Days on Clock
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 20
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
04/Q1604/21/AM06 Expression pattern of C-type Lectins Substantial Amendment 10
25/07/2014 12
06/Q1604/162/AM06
Rectal Imaging Trial (RIT) Substantial Amendment 3
21/02/2014 14
07/H0604/113/AM23 National Diet and Nutrition Survey 2008 - 2012 Substantial Amendment 17
04/12/2014 7
07/H0604/122/AM38 A comparison of Insulins Detemir and Glargine in Girls with Diabetes
35 16/05/2014 17
07/Q1604/28/AM04 Immune factors in neurological diseases 2 13/10/2014 26
08/H0604/147/AM02 CHART-ED Substantial Amendment 2
31/03/2014 14
08/H0604/170/AM09 Placebo controlled study of zoledronic acid in osteoporotic children
Substantial Amendment 6
14/03/2014 16
08/H0604/170/AM14 Placebo controlled study of zoledronic acid in osteoporotic children
10 14/10/2014 11
08/H0604/170/AM16 Placebo controlled study of zoledronic acid in osteoporotic children
Substantial amendment 12
19/12/2014 18
08/H0604/170/AM17 Placebo controlled study of zoledronic acid in osteoporotic children
Substantial amendment 13
09/02/2015 15
09/H0604/20/AM03 OxBRC Prospective Cohort Study in Hepatitis C virus infection 3 17/10/2014 21
09/H0604/58/AM08 Biomarkers for endometriosis Substantial Amendment 6.0
16/04/2014 18
09/H0604/79/AM24 Myeloma XI 6.0 11/09/2014 18
09/H0604/79/AM27 Myeloma XI Substantial Amendment dated
17
17/12/2014 25
09/H0604/96/AM08 Functional Magnetic Resonance Imaging of Laboratory Dyspnoea
Substantial Amendment 8
14/02/2014 15
09/H0604/96/AM09 Functional Magnetic Resonance Imaging of Laboratory Dyspnoea
Substantial Amendment 9
16/06/2014 13
09/H0604/96/AM10 Functional Magnetic Resonance Imaging of Laboratory Substantial 08/07/2014 14
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 21
Dyspnoea Amendment 10
10/H0604/13/AM08 Preparatory work for OXTEXT: improved management of healthy volunteers
Version 13 28/05/2014 18
10/H0604/13/AM09 Preparatory work for OXTEXT: improved management of healthy volunteers
6 04/11/2014 10
10/H0604/45/AM14 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial Amendment dated
10
10/04/2014 8
10/H0604/45/AM15 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial Amendment (HCV003-
17/09/2014 25
10/H0604/45/AM19 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial amendment HCV003-1
17/02/2015 21
10/H0604/47/AM14 Phase I Study of IMCgp100 in Advanced Malignant Melanoma V1.0
15 18/08/2014 23
10/H0604/47/AM15 Phase I Study of IMCgp100 in Advanced Malignant Melanoma V1.0
Substantial amendment 16
18/12/2014 25
10/H0604/68/AM07 Safety extension study to 3760: Monthly rFXIII replacement therapy
Substantial Amendment 5
01/04/2014 11
10/H0604/7/AM27 Can We Reduce the Number of Vaccine Injections for Children?
Substantial Amendment 13
24/06/2014 5
10/H0604/85/AM16 Study of CHOP with Ofatumumab in patients with Richter's Syndrome V1.0
Substantial Amendment 11
15/07/2014 12
10/H0604/85/AM17 Study of CHOP with Ofatumumab in patients with Richter's Syndrome V1.0
12 31/10/2014 14
10/H0604/91/AM10 COASt - Clinical Outcomes in Arthroplasty Study Substantial Amendment 4
19/02/2014 26
10/H0604/99/AM06 Markers of Neurodegeneration in Multiple Sclerosis Substantial Amendment 2
14/03/2014 19
11/SC/0100/AM05 A DBS study in chronically implanted patients with PD V.1 Substantial Amendment 5
20/05/2014 14
11/SC/0100/AM06 A DBS study in chronically implanted patients with PD V.1 Substantial Amendment 6
10/07/2014 22
11/SC/0149/AM15 V212-011 Study of Safety & Efficacy of V212 in patients with ST or HTM
Substantial Amendment 13
20/08/2014 9
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 22
11/SC/0149/AM16 V212-011 Study of Safety & Efficacy of V212 in patients with ST or HTM
SA16 V212-011 05/11/2014 21
11/SC/0149/AM17 V212-011 Study of Safety & Efficacy of V212 in patients with ST or HTM
Substantial Amendment 17
15/12/2014 8
11/SC/0218/AM02 Measuring motor symptoms in clinical conditions 2 05/11/2014 15
11/SC/0307/AM05 Determinants of Staphylococcus aureus carriage Substantial amendment 2
12/02/2015 26
11/SC/0355/AM06 MBSR in the management of psychological distress in prostate cancer
Substantial amendment 2
05/02/2015 13
11/SC/0360/AM15 Magec 0.1 Substantial Amendment 8
06/06/2014 18
11/SC/0409/AM10 VanSel-1: A Phase I trial of Vandetanib and Selumetinib. 11 30/05/2014 18
11/SC/0409/AM11 VanSel-1: A Phase I trial of Vandetanib and Selumetinib. Substantial amendment 13
25/11/2014 17
11/SC/0410/AM04 VIT-0910 Substantial Amendment VIT-
0910
30/01/2014 15
11/SC/0452/AM05 Oral MK8669 in Children/Adolescents with Solid Tumours(6 - <18years)
Substantial Amendment 5 -
21/03/2014 21
11/SC/0498/AM03 Validation of biochemical methods in kidney disease Substantial Amendment 3
05/11/2014 7
12/SC/0014/AM09 Vasopressin vs Noradrenaline as Initial therapy in Septic Shock
6 08/10/2014 18
12/SC/0198/AM14 Cell Bandage (Mesenchymal Stem Cell Therapy) to Treat Meniscal Tears
Substantial Amendment 9
01/04/2014 16
12/SC/0328/AM10 CANDID 5.0 05/06/2014 24
12/SC/0328/AM11 CANDID Substantial Amendment 6
26/09/2014 13
12/SC/0339/AM06 STUDY OF FOLLOW-UP AND OUTCOMES FOLLOWING ADOLESCENT SEXUAL ASSAULT
Substantial amendment 3
16/11/2014 8
12/SC/0339/AM06 STUDY OF FOLLOW-UP AND OUTCOMES FOLLOWING ADOLESCENT SEXUAL ASSAULT
Substantial Amendment 3
18/11/2014 8
12/SC/0416/AM01 Surveillance of neonatal surgical morbidities 13 08/10/2014 14
12/SC/0429/AM04 Paclitaxel with or without LCL161 in patients with breast cancer 4 13/05/2014 18
12/SC/0527/AM03 215ON201: Study of BIIB033 in subjects with acute optic neuritis
Substantial Amendment 4
10/04/2014 10
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 23
12/SC/0556/AM02 Boosting the therapeutic benefits of prism adaptation using tDCS
1 30/07/2014 25
12/SC/0556/AM03 Boosting the therapeutic benefits of prism adaptation using tDCS
Substantial amendment 2
12/02/2015 25
12/SC/0557/AM04 Prism and tDCS Treatment of Complex Regional Pain Syndrome (CRPS)
Substantial Amendment 4
25/03/2014 14
12/SC/0557/AM05 Prism and tDCS Treatment of Complex Regional Pain Syndrome (CRPS)
Substantial Amendment 5
01/07/2014 14
12/SC/0559/AM06 Anti-PD-1/Everolimus in Advanced or Metastatic ClearCell Renal Cancer
Substantial Amendment 4
16/09/2014 12
12/SC/0566/AM05 Rivaroxaban in Antiphospholipid Syndrome (RAPS) Substantial Amendment 3
22/09/2014 13
12/SC/0566/AM06 Rivaroxaban in Antiphospholipid Syndrome (RAPS) Substantial Amendment 4
22/09/2014 20
12/SC/0579/AM06 GreenGeneTM F_P3 (A study in patients with severe Haemophilia A)
Substantial Amendment 5
01/05/2014 19
12/SC/0616/AM03 ROCOCO: Radiotherapy & olaparib for oesophageal carcinoma
Substantial Amendment 3
26/08/2014 21
12/SC/0639/AM08 A Phase Ib trial of MVA-EBNA1/LMP2 vaccine in nasopharyngeal carcinoma
Substantial amendment 08
17/02/2015 14
12/SC/0650/AM04 The neural basis of temporal expectations in Parkinson's Disease v1.0
Substantial Amendment 1.1
17/07/2014 14
12/SC/0650/AM05 The neural basis of temporal expectations in Parkinson's Disease v1.0
1.3 31/10/2014 14
12/SC/0660/AM04 AdNRGM; VDEPT + GMCSF in locally recurrent prostate cancer
Substantial amendment 4
24/10/2014 20
12/SC/0694/AM03 Interferon and proton MRS at 7T Substantial Amendment 3
01/04/2014 14
13/SC/0004/AM04 A phase I study to assess two new influenza vaccine candidates
SA005 20/05/2014 21
13/SC/0098/AM04 TB034:ChAdOx1 85A and MVA85A in BCG vaccinated adults Substantial Amendment 7
17/12/2014 24
13/SC/0173/AM04 Phase III Study in Metastatic Castration Resistant Prostate Cancer
3.0 03/06/2014 10
13/SC/0267/AM04 Pilot Study of Deep Brain Stimulation for Severe Anorexia nervosa
Substantial amendment 3
19/01/2015 21
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 24
13/SC/0283/AM02 Ovarian Cancer Biomarkers: A Preliminary Study 1 09/09/2014 28
13/SC/0291/AM02 GO28053 Ph1 Vemurafenib in BRAF V600 mutation positive cancer patients
3 13/05/2014 20
13/SC/0317/AM05 IELSG 37 Substantial Amendment 1
01/05/2014 13
13/SC/0322/AM04 Immunotherapy with CD25/71 Allodepleted T-cells (ICAT) Substantial amendment 3
08/12/2014 12
13/SC/0329/AM02 TB035: MVA85A- Homologous boosting by heterologous route Substantial Amendment 4
21/10/2014 24
13/SC/0329/AM03 TB035: MVA85A- Homologous boosting by heterologous route Substantial amendment 05
10/02/2015 13
13/SC/0374/AM02 Phase I, AZD8186 in Patients with CRPC, sqNSCLC, TNBc, PTEN malignancy
2 04/11/2014 10
13/SC/0376/AM02 Cardiac MRI at higher magnetic field strength to assess heart function
Substantial Amendment 2
14/04/2014 9
13/SC/0383/AM08 MK-8237-009 House Dust Mite Biomarker Study Substantial Amendment 3
21/05/2014 13
13/SC/0383/AM11 MK-8237-009 House Dust Mite Biomarker Study 5 14/10/2014 11
13/SC/0383/AM16 MK-8237-009 House Dust Mite Biomarker Study Substantial amendment 6
05/02/2015 20
13/SC/0387/AM01 Treatment trial of chronic central serous chorioretinopathy Substantial amendment 1
06/02/2015 16
13/SC/0421/AM01 A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults
Substantial Amendment 002
23/07/2014 20
13/SC/0421/AM02 A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults
Substantial Amendment 3
23/10/2014 22
13/SC/0470/AM03 Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
Substantial Amendment 2
19/03/2014 17
13/SC/0470/AM08 Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
Substantial amendment 4
24/10/2014 21
13/SC/0470/AM09 Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
Substantial amendment 5
15/01/2015 7
13/SC/0470/AM10 Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
Substantial amendment 6
06/02/2015 19
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 25
13/SC/0510/AM01 RADAR ICU Substantial Amendment 2
10/07/2014 14
13/SC/0544/AM02 PREPARE - Preconceptional diet and embryo quality: an RCT. Substantial Amendment 2
18/06/2014 15
13/SC/0544/AM03 PREPARE - Preconceptional diet and embryo quality: an RCT. 3 23/10/2014 20
13/SC/0544/AM04 PREPARE - Preconceptional diet and embryo quality: an RCT. Substantial amendment 4
19/12/2014 16
13/SC/0558/AM08 Secukinumab in treatment of chronic palmoplantar pustular psoriasis
Substantial Amendment 7
13/10/2014 8
13/SC/0568/AM06 The ONE Study Cell Therapy Trial Substantial Amendment 2
06/01/2014 2
13/SC/0568/AM09 The ONE Study Cell Therapy Trial 3 21/07/2014 1
13/SC/0568/AM14 The ONE Study Cell Therapy Trial Substantial amendment 4
24/02/2015 14
13/SC/0599/AM05 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1
SA2 05/08/2014 14
13/SC/0604/AM01 Treg Liver Trial Substantial Amendment 4.0
24/02/2014 17
13/SC/0604/AM06 Treg Liver Trial Substantial Amendment 2
21/08/2014 7
13/SC/0604/AM07 Treg Liver Trial Substantial amendment 3
24/11/2014 18
13/SC/0604/AM08 Treg Liver Trial Substantial amendment 4
24/02/2015 19
13/SC/0609/AM01 Measuring synaptic function using EEG and MEG 1 07/11/2014 19
14/SC/0004/AM03 Understanding Paratyphoid Infection Substantial Amendment 1
18/03/2014 14
14/SC/0004/AM06 Understanding Paratyphoid Infection Substantial Amendment 2
11/06/2014 14
14/SC/0004/AM07 Understanding Paratyphoid Infection 3 21/08/2014 20
14/SC/0065/AM01 28431754DIA4003 (CANVAS-R) Substantial Amendment 1
05/05/2014 11
14/SC/0065/AM02 28431754DIA4003 (CANVAS-R) Substantial Amendment 2
27/08/2014 13
14/SC/0077/AM01 Investigating the immune response to 4CMenB in infants(EUCLIDS)2+1
Substantial Amendment 1
23/04/2014 26
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 26
14/SC/0120/AM01 A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)
Substantial Amendment 1
04/07/2014 24
14/SC/0120/AM02 A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)
Substantial Amendment 2
11/08/2014 14
14/SC/0120/AM03 A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)
3 10/10/2014 17
14/SC/0120/AM05 A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)
Substantial amendment 004
25/11/2014 17
14/SC/0170/AM02 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD
2 27/02/2014 24
14/SC/0170/AM03 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD
3 03/11/2014 23
14/SC/0170/AM05 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD
Substantial Amendment 4
28/01/2015 12
14/SC/0190/AM03 HCMR Study 1 29/07/2014 24
14/SC/0190/AM05 HCMR Study 2 06/11/2014 19
14/SC/0195/AM01 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations
1 21/08/2014 20
14/SC/0195/AM02 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations
Substantial Amendment 2
23/10/2014 22
14/SC/0195/AM03 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations
Substantial amendment 4
09/02/2015 15
14/SC/0220/AM01 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial Amendment 03
18/09/2014 20
14/SC/0220/AM02 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial Amendment 4
24/10/2014 18
14/SC/0220/AM03 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial amendment 4
05/12/2014 31
14/SC/0227/AM01 Co-administration of RTS,S and viral vectors expressing ME-TRAP
SA001 20/08/2014 21
14/SC/0227/AM07 Co-administration of RTS,S and viral vectors expressing ME-TRAP
Substantial amendment 004
10/12/2014 12
14/SC/0232/AM01 MenB vaccine for immunocompromised Substantial Amendment 1
02/09/2014 7
14/SC/0269/AM01 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B
1 01/08/2014 25
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 27
14/SC/0269/AM02 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B
2 10/09/2014 19
14/SC/0269/AM03 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B
Substantial Amendment 3
21/10/2014 24
14/SC/0295/AM03 IMPALA trial 1 03/11/2014 11
14/SC/1052/AM01 Quality of life in children with glaucoma and cataract Substantial Amendment 1
25/06/2014 12
14/SC/1231/AM01 Vaccination in Prostate Cancer (VANCE), version 1.0 Substantial Amendment 1
28/01/2015 11
14/SC/1256/AM01 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment SA002
02/10/2014 0
14/SC/1256/AM02 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z SA003 22/10/2014 3
14/SC/1256/AM03 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment 4
31/10/2014 0
14/SC/1256/AM05 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment 005
24/11/2014 1
14/SC/1256/AM06 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial amendment 6
16/01/2015 2
14/SC/1256/AM08 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment 7
28/01/2015 1
14/SC/1347/AM01 Astellas - 8232-CL-0004 - Chronic Kidney & Diabetes Type 2 Substantial amendment 1
16/01/2015 24
14/SC/1408/AM01 Evaluating Vaccines against Ebola Substantial Amendment 1
18/12/2014 4
14/SC/1408/AM03 Evaluating Vaccines against Ebola Substantial amendment 2
20/01/2015 2
14/SC/1408/AM05 Evaluating Vaccines against Ebola Substantial Amendment 3
21/01/2015 7
14/SC/1408/AM06 Evaluating Vaccines against Ebola 4 03/03/2015 0
15/SC/0108/AM01 A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z
001 27/02/2015 5
Unfavourable opinion
Amendment REC
Reference
Title Version Date Number of Days on
Clock
11/SC/0307/AM03 Determinants of Staphylococcus aureus carriage Substantial 08/01/2015 15
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 28
Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period
amendment 1, 25 Se
13/SC/0173/AM08 Phase III Study in Metastatic Castration Resistant Prostate Cancer
Substantial amendment 5
02/12/2014 21
13/SC/0374/AM01 Phase I, AZD8186 in Patients with CRPC, sqNSCLC, TNBc, PTEN malignancy
1 29/10/2014 16
13/SC/0421/AM03 A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults
SA004 05/03/2015 16
13/SC/0599/AM04 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1
Substantial Amendment 1
15/04/2013 26
Favourable opinion timeline
Amendment REC
Reference
Title Version Date Number of Days on
Clock
12/SC/0051/AM01/2 PRESCRIBE Modified Amendment AM01
01/05/2014 2
13/SC/0173/AM08/1 Phase III Study in Metastatic Castration Resistant Prostate Cancer
Modified Amendment 5
08/01/2015 4
13/SC/0199/AM02/1 Protection against Pneumococcal infection in children with T1DM
Modified Amendment 1
26/03/2014 2
13/SC/0599/AM04/1 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1
Modified Amendment 1
17/06/2014 1
Unfavourable opinion timeline
Amendment REC
Reference
Title Version Date Number of Days on
Clock
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 29
RES Committee South Central - Oxford A Research Ethics Committee Annual Report Page 30
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/SC/1350 CC-4047-MM-015-Pomalidomide for relapsed and refractory MM patients_Ob 16
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