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Research Ethics Service

RES Committee London - Fulham

Annual Report

01 April 2014 - 31 March 2015

RES Committee London - Fulham Annual Report

Part 1 – Committee Membership and Training

Name of REC: RES Committee London - Fulham Type of REC: REC Recognised to review CTIMPS in Patients – type iii Type of Flag: Establishing Research Tissue Banks, IRB Registered Chair: Dr Charles Mackworth-Young Vice-Chair: Dr Frank Miskelly – Until October 2014 Alternate Vice-Chair: The Rev'd Nigel Griffin REC Manager: Miss Anna Bannister – From September 2014/ Miss Shehnaz Ishaq -

from April 2014 – September 2014 REC Assistant: Miss Katie Southeard – From September 2014 / Miss Diane Catterall

from April 2014 – 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:

The principal feature of this year’s activity has been the departure of three members from the Committee. Lady (Alexandra) Roche had been a founding member of the Committee 10 years ago, having previously been a member of the Riverside Committee for 10 years. She has made a major contribution to research ethics generally. Dr. Frank Miskelly, Vice Chairman, stepped down because of clinical commitments. Miss Deema Marzouq disappointingly resigned after only three months and without attending a meeting as a full member. The reduction in members, the earlier moratorium on appointing new members, and the delay in interviewing potential lay members all resulted in a significantly smaller committee, and therefore greater pressure in individual members. For the first time in the Committee’s history, there was one meeting for which a co-opted member had to be sought. We very much hope that further appointments can be made soon. In the meantime the number of full applications considered per meeting has been reduced to five. The Revd. Nigel Griffin stepped up from Alternate Vice-Chairman to Vice Chairman, and we are now seeking a volunteer for the former position. Miss Shehnaz Ishaq and Miss Diane Catterall were Manager and Assistant Manager respectively until September 2014. We thank them for excellent and skilled support. They were replaced by Miss Anna Bannister and Miss Katie Southeard, who are both providing a superb service. The mixture of applications has continued to be varied, and this has been good for maintaining members’ interest.


RES Committee London - Fulham Membership

RES Committee London - Fulham: Co-opted Members

Name Profession Expert or Lay

Dates

Appointed Left

Dr Kanagasabai Ganeshaguru

Retired Scientist Lay 01/06/2006

Dr Shaun Griffin Executive Director of External Affairs

Expert 01/11/2008

The Rev'd Nigel Griffin Parish Priest Lay Plus 01/06/2006

Ms Lesley Honeyfield Research Radiographer Expert 05/02/2015

Dr Akil Jackson Research Fellow Expert 01/10/2007

Mr David Leonard Pharmacist Expert 28/04/2005

Dr Charles Mackworth-Young

Physician (Chairman) Expert 01/01/2005

Miss Deema Marzouq Dentist - Dental Foundation Year 2

Expert 15/09/2014 12/12/2014

Dr Colin Michie Paediatrician Expert 27/03/2006

Dr Frank Miskelly Physician (Vice-Chairman) Expert 01/04/2005 01/10/2014

Dr Shirlony Morgan Psychiatrist Expert 16/11/2009

Lady Alexandra Roche Lay Member Lay Plus 23/02/2005 04/03/2015

Mrs Gillian Sichau Occupational Therapist Expert 01/07/2010

Mrs Katie Wilkinson Clinical Trials Centre Manager

Lay 09/11/2007

Mrs Marney Williams Teacher Lay Plus 11/06/2013

Name Profession Status Meeting date attended

Ms Nabila Youssouf Clinical Trials Manager Expert 21/07/2014


RES Committee London - Fulham: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Kanagasabai Ganeshaguru None 15/12/2014

The Rev'd Nigel Griffin None 15/12/2014

Dr Shaun Griffin Director of Communications and Public Affairs, Human Tissue Authority Communications and Strategy Advisor, Health Research Authority- Both positions end on 16 January 2015 -Executive Director of External Affairs, Terrence Higgins Trust, start date 20 January 2015)

29/12/2014

Ms Lesley Honeyfield Imaging Research Committee R & D Approval 16/02/2015

Dr Akil Jackson Employee of Gilead Science Ltd and stocks in Gilead Sciences. Honorary contract with SSATT research, Chelsea and Westminster Hospitals. PhD student at University of Liverpool

10/03/2015

Dr Akil Jackson Employee of Chelsea & Westminster Hospital seconded to St Stephens Aids Trust Research Charity

01/12/2014

Mr David Leonard Lead for clinical trials support services provided by pharmacy at ICHNT

28/11/2014

Dr Charles Mackworth-Young Chairman of Peer Review Committee, Imperial College.

15/12/2014

Miss Deema Marzouq None 15/09/2014

Dr Colin Michie Owner of Ealing Paediatric Courses, a teaching company, Medical Panel member for the Toxic Shock Syndrome Information Service. Trustee of the Rhodes Scholars in Britain, Trustee of the Child Accident Prevention Trust, Member of the Great Ormond Street Hospital Research Panel (award grants). Member of the London North-West NHS Trust R&D Committee, Expert Public Health Member on NICE committees relating to vitamins and nutrition in children. Conducting funded research as part of national and international networks into Kawasaki disease, Malnutrition in children, Rare disease management in children

02/12/2014

Lady Alexandra Roche Has shareholdings in GSK and Santanda 15/12/2014

Mrs Gillian Sichau None 15/12/2014

Mrs Marney Williams Patient/Carer/Public involvement and volunteer at the Stoke Association including reviewing research applications. Patient/Carer/Public involvement for NIHR CRN; Stroke Reviewer (lay) NIHR HS and DR programme and HTA programme.

31/03/2015


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

May 19/05/2014 11

June 16/06/2014 8

July 21/07/2014 9

August 11/08/2014 9

September 15/09/2014 10

October 20/10/2014 9

November 17/11/2014 10

December 15/12/2014 8

January 19/01/2015 8

February 16/02/2015 10

March 16/03/2015 10

11 full committee meetings were held during the reporting period.


May 19/05/2014 3

June 16/06/2014 3

July 18/07/2014 3

August 11/08/2014 3

September 15/09/2014 3

October 20/10/2014 3

November 17/11/2014 3

December 15/12/2014 3

January 19/01/2015 3

March 16/03/2015 3

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


April 01/04/2014 3

April 14/04/2014 2

April 28/04/2014 4

May 01/05/2014 2

May 13/05/2014 2

May 23/05/2014 2

June 12/06/2014 2

June 16/06/2014 2

June 25/06/2014 2

July 08/07/2014 2

July 15/07/2014 2


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

July 29/07/2014 2

August 20/08/2014 2

August 29/08/2014 2



October 09/10/2014 2

October 22/10/2014 3

November 05/11/2014 2

November 19/11/2014 2

December 03/12/2014 2

December 22/12/2014 2

January 07/01/2015 2

January 21/01/2015 2

February 04/02/2015 2

February 18/02/2015 2

March 18/03/2015 2

27 sub-committee meetings were held during the reporting period. There were no inquorate meetings held


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

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

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

Name Number of Meetings Attended

Dr Kanagasabai Ganeshaguru 10

The Rev'd Nigel Griffin 10

Dr Shaun Griffin 8

Ms Lesley Honeyfield 2

Dr Akil Jackson 7

Mr David Leonard 9

Dr Charles Mackworth-Young 11

Miss Deema Marzouq 1

Dr Colin Michie 4

Dr Frank Miskelly 5

Dr Shirlony Morgan 5

Lady Alexandra Roche 9

Mrs Gillian Sichau 7

Mrs Katie Wilkinson 6

Mrs Marney Williams 7




Dr Shaun Griffin 2

Dr Akil Jackson 3


Dr Frank Miskelly 2

Dr Shirlony Morgan 1







Dr Shaun Griffin 1

Dr Akil Jackson 2

Mr David Leonard 1



Dr Colin Michie 4

Dr Frank Miskelly 6





Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Dr Kanagasabai Ganeshaguru 06/11/2014 Workshop: Handling Health-Related Findings in Research

The Rev'd Nigel Griffin 05/09/2014 Joint Oxford Training Day

Dr Shaun Griffin 29/12/2014 1. Advised Genomics England on their REC application with

other REC members and Chairs. 2. Equality and Diversity

training (face-to-face) 3. Responsible for the developing

the HRA decision tool on consent and PILs http://www.hra-

decisiontools.org.uk/consent/ I also completed this tool. 4. Attendance at HRA Annual

Forum and presented a talk on biobanking with Professor

Thakkar at the HRA Annual forum and developed case studies on Research Tissue Banks for the HRA and HTA

websites 5. Developed questionnaires for the

researchers who have submitted applications to IRA and CAG

and Chairs and VCs of RECS 6. Past, Present, Future the Ethics

and Governance of Big Biobanks 7. Attendance at HRA

all staff day

Ms Lesley Honeyfield 12/03/2015 Assessing the consequences (benefits and harms) of

research: a health research authority workshop

Dr Colin Michie 21/01/2015 Internet/Web-based Research

Dr Shirlony Morgan 10/12/2014 National Training Day for NRES Committee Chairs

Dr Shirlony Morgan 12/01/2015 CTIMP Training Day

Mrs Gillian Sichau 06/11/2014 Workshop: Handling Health-Related Findings in Research

Mrs Marney Williams 05/09/2014 Oxford Training Day

Mrs Marney Williams 11/12/2014 Research in Vulnerable Groups


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 22 34.38

Phase 1 0 0.00

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 2 3.13

Research Database (including renewals) 0 0.00

Others 40 62.50

Total Applications Reviewed 64 100

Number of applications made invalid by the REC Manager 2

Number of applications withdrawn prior to the meeting 0

Number of student applications reviewed 23

Number of paediatric applications reviewed 10

Number of device applications reviewed 1

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 0

Number of qualitative applications reviewed 4

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 3 4.69

Favourable Opinion with Additional Conditions 11 17.19

Unfavourable Opinion 2 3.13

Provisional Opinion 48 75.00

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 64 100

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

47 73.44

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 1 1.56

Total 64 100


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 15

Number of studies withdrawn prior to the meeting 2

Number of student applications reviewed 8

Number of paediatric applications reviewed 4

Number of device applications reviewed 0

Number of qualitative applications reviewed 5

Total Applications Reviewed 24

Decisions taken at proportionate review sub-committee meetings

Number %



No Opinion transfer to full committee for review 2 8.33



Total 24 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 5.82

Number of applications for full ethical review 64

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 7

Number of applications over 40 days as a % of total 10.94%

Number of days taken to final decision – average (mean) 29

Number of proportionate review applications for ethical review

22

Number of proportionate review applications for ethical review over 14 days

0

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

0.00%

Number of SSAs (non-Phase 1) reviewed 4

Number of applications for SSA review over 25 days 0

Number of applications for SSA review over 25 days as % of all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 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 129

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 11

Number of substantial amendments over 28 days as a % of total substantial amendments

8.53%

Number of modified amendments reviewed 0

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 92

Number of substantial amendments received for information 1

Number of substantial amendments received for new sites/PIs

52

Number of annual progress reports received 83

Number of safety reports received 36

Number of Serious Adverse Events received 0

Number of final reports received 21

RES Committee London - Fulham 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/LO/0675 SOCRATES REDUCED 27

14/LO/0676 SOCRATES-PRESERVED 27

14/LO/0721 SIPS jr RCT 50

14/LO/0768 MRI in Channelopathies 28

14/LO/0796 Hypnosis for PNE: A Case Series 27

14/LO/0851 Open Label, Phase IIa of ALXN1007 for Antiphospholipid Syndrome 37

14/LO/0865 Phase 2 Study of Fostamatinib for Subjects with IgA Nephropathy 29

14/LO/0869 Functional assessment in bone - osteoclast markers (FAB-O study) 43

14/LO/0871 EndoBarrier TM Gastrointestinal Liner Diabetes Trial 28

14/LO/1023 The Impact of Age on Adaptive Immunity in Adults Infected with RSV 52

14/LO/1179 A PK Study of Serelaxin in Paediatric Heart Failure Patients 35

14/LO/1196 A study of LEE011 in ER+ HER2- breast cancer patients 39

14/LO/1230 Ketogenic diet treatment of epilepsy in infants 29

14/LO/1276 14863A Phase III study of Lu AE58054 in Alzheimer's Disease; Study 3 42

14/LO/1291 PALLET 23

14/LO/1318 Arrhythmias in Inherited Cardiac Conditions v1.1 21

14/LO/1368 Trimodal Prehabilitation for aneurysm surgery study (T-PASS) 20

14/LO/1370 MERIT-2 34

14/LO/1561 VITAL 25

14/LO/1600 Diffusion imaging in gliomas V1.0 25

14/LO/1629 Sleep Disordered Breathing in Children with Primary Ciliary Dyskinesia 32

14/LO/1812 PROSPECT-R 26

14/LO/1836 520-311 The FACTOR Study 35

14/LO/1837 ARPEGGIO: Laquinimod for Primary Progressive Multiple Sclerosis (PPMS) 28

14/LO/1846 An Investigation of Lumbar Spinal Nerves 40

14/LO/1851 INTRA-DIALYTIC EXERCISE IN RENAL FAILURE 42

14/LO/2021 Auricular Therapy as an adjunct to Pulmonary Rehabilitation 21

14/LO/2044 Study of the effect of cardiac nerves on heart rhythm disturbance 27

14/LO/2058 Immunological analysis of an acute HIV-1 Infection cohort 35

14/LO/2060 EFFECTIVENESS OF RIPPLE MAPPING FOR ATRIAL TACHYCARDIA ABLATION 24

14/LO/2062 COCAPP-A: Collaborative Care Planning Project-Acute 31

14/LO/2131 The Prevalence of Anorexia with Austim Spectrum Disorder 42


14/LO/2181 RIO - Rucaparib Window of Opportunity Study 22

14/LO/2219 ENZARAD Trial 39

14/LO/2220 N-Acetylcysteine in patients with Sickle Cell Disease 22

14/LO/2223 Cognitive impairment and decision making in advanced kidney disease 30

15/LO/0032 BO28984 Alectinib versus Crizotinib in advanced NSCLC 26

15/LO/0042 Thrombotic status in patients with coronary disease 21

15/LO/0071 Drama based environments as a tool to aid diagnosis in ASD 22

15/LO/0074 Royal Marsden NHS Foundation Trust Generic Biobank (v1) 24

15/LO/0080 Carer experiences of frontotemporal dementia. 22

15/LO/0181 Compression therapy following endovenous thermal ablation 30

15/LO/0275 UK SMART database and tissue bank - Version 4, 16/01/2015 38

15/LO/0289 MAGSTAR Trial 19

15/LO/0290 METformin And Longevity (METAL)-Version One 44

15/LO/0470 AF-219 on Cough Reflex Sensitivity in Healthy + Chronic Cough Patients 24

15/LO/0472 LT2762-PIV-11/13 36



Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1601 18F-FMC and MRS in gliomas 23

14/LO/2038 Tacrolimus monitoring in renal transplantation 19

15/LO/0284 Perspectives of patients commencing an Autograft in ACU 18

Favourable Opinion with Additional Conditions


14/LO/0732 Experiences of Adherence Assessment in Asthma V1 25

14/LO/0766 Investigating balance in Joint Hypermobility Syndrome 25


14/LO/1060 Dynamic Risk Factors Associated with Mentally Disordered Firesetting 23

14/LO/1252 Understanding caregiving relationships in early psychosis 28

14/LO/1267 Adolescent hip disease. Version 1 21

14/LO/1295 One Stop Vein Clinic 17

14/LO/1642 Functional imaging with 11-C-Methionine PET for pituitary adenomas 23

14/LO/2168 A study to explore the experiences of FL patients on Watch&Wait 21

15/LO/0021 RISK TAKING AMONGST LIVE PAIRED AND POOLED KIDNEY TRANSPLANT PATIENTS 22

15/LO/0458 Pneumo carriage, PIN study 23

15/LO/0465 Effect of radiotherapy on patients undergoing DIEP reconstructions 23

Unfavourable Opinion


14/LO/1628 GENPET: Targeted FCH-PET imaging based on genetic profile 23

15/LO/0471 Patients' experience and progression through the TGU and Allington 23

Provisional Opinion


Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting


15/LO/0393 Sched3 23


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



14/LO/1711 MicroRNA Expression and Function in Psoriasis II 8

15/LO/0516 Parents/carers experiences of their child having vulvovaginitis 8



Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/LO/1115 Feasibility study for NATTINA 8

14/LO/1116 Focus Group: Young Adults with Chronic Pain 9

14/LO/1473 A Study of Romiplostim Self-Administration After Use of HAT Materials. 14

14/LO/1527 Predicting drug and radiation sensitivity in thoracic cancers 5

14/LO/1528 Entrepreneurial and Criminal Tendencies Amongst Adults with ADHD 5

14/LO/1529 An evaluation of the psychosocial impact of epilepsy on marriage 4

14/LO/1916 SOBI.ANAKIN-201 study 8

14/LO/1919 Gram negative resistance and antibiotic use in ICU 8

14/LO/1921 Effects of Social Identity continuity after a major operation 8

14/LO/2106 Practice-Based Study of Bluetooth Brush and App 8

15/LO/0149 BMI, treatment modalities & outcomes in gynae-cancer patients (1.0) 8

15/LO/0504 Assessing the Impact of the First Steps Programme on Families.V1 12

15/LO/0510 Experience of infant feeding: antenatal choice v postnatal practice 11

Favourable Opinion with Additional Conditions



14/LO/0861 STAND UP - Cut-point validation study 12

14/LO/1326 The perceived accessibility and effectiveness of a selfhelp CBT CD-ROM 10

14/LO/1328 Esmya Â® Prescription Patterns in Europe_protocol version 4.0 3

14/LO/1330 Modelling retinal disease mechanisms and ocular cell development 9

14/LO/1714 Evaluating & improving a nurse led rheumatology advice line 8

14/LO/2282 Triple A Project- a pilot of an Adult ADHD Assessment Centre 9

15/LO/0155 A genomic analysis of asthma in twins 7

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

07/H0711/98/AM04 he measurement of transmural myocardial perfusion in normal subjects a

Three 01/12/2013 14

07/H0711/98/AM06 he measurement of transmural myocardial perfusion in normal subjects a

4 17/12/2014 26

07/H0712/85+5/AM02

TB Research Unit Tissue Bank (formerly TB Immunology Group Research Ti

One 24/06/2014 27

07/H0712/85+5/AM03

TB Research Unit Tissue Bank (formerly TB Immunology Group Research Ti

Three 01/11/2014 14

08/H0711/2/AM12 Vertebral artery Ischaemia Stenting Trial (VIST) Amendment 8.0 10/06/2014 15

08/H0711/45/AM40 ERCC1 Targeted Trial (ET) - Version 1.0 15/10/2014 28

09/H0711/39/AM18 The "SPRINT" trial. A phase 2 study on the efficacy of Lenalidomide.

Substantial Amendment 11,

21/5

21/05/2014 13

09/H0711/56/AM30 COU-AA-302 Abiraterone Acetate in Metastatic Prostate Cancer April-09

Abiraterone Acetate Investigat

29/10/2014 16

09/H0711/90/AM30 UKALL14 Substantial Amendment

13.03.14

13/03/2014 20

09/H0711/90/AM33 UKALL14 Substantial Amendment

20.6.201

20/06/2014 16

09/H0711/90/AM34 UKALL14 27/01/2015 18

10/H0711/36/AM07 Immune Monitoring Study Five 18/07/2014 31

10/H0711/45/AM15 MAC UCBT 5.0 15/09/2014 13

10/H0711/66/AM18 Blinatumomab(MT103)in patients with MRD+ B-precursor ALL CT Amend EC-09-UK (Prot Amend

02/04/2014 12

10/H0711/66/AM19 Blinatumomab(MT103)in patients with MRD+ B-precursor ALL 10 29/04/2014 17

10/H0711/66/AM20 Blinatumomab(MT103)in patients with MRD+ B-precursor ALL Eleven 11/07/2014 21

10/H0711/77/AM10 The LEAP-On Study Seven 22/01/2015 8

10/H0711/80/AM12 Evaluation of effect of ACE inhibitors on small aneurysm growth rate

Seven 17/10/2014 23


11/LO/0097/AM17 VIP Version: 1 Amendment 13 - Protocol V6/Apr

11/03/2014 26

11/LO/0097/AM20 VIP Version: 1 Fourteen 11/12/2014 22

11/LO/0101/AM14 Efficacy and safety of AT1001 and ERT in patients with Fabry Disease

Twelve 05/12/2015 18

11/LO/1465/AM06 MAPPING Substantial Amendment 05

07/07/2014 6

11/LO/1465/AM09 MAPPING Six 31/10/2014 19

11/LO/1498/AM09 PROTEAse inhibitor in HIV-1 patients 5.0 16/07/2014 33

11/LO/1498/AM10 PROTEAse inhibitor in HIV-1 patients Ten 30/07/2014 20

11/LO/1826/AM09 Immunity against RSV & influenza in a human challenge model Six 09/01/2015 12

11/LO/1886/AM07 Frail and Elderly Patient Outcomes on Dialysis (FEPOD): Part 2

Four 22/10/2014 26

11/LO/1908/AM15 8HA01EXT Long-Term Safety and Efficacy of rFVIIIFc Haemophilia A

13 Cooler Bag 23/02/2015 29

11/LO/1982/AM03 European Union Childhood Life-threatening Infectious Diseases Study

2 27/11/2013 23

11/LO/1996/AM05 Response and resistance to targeted therapy in renal cell carcinoma

Four 08/12/2014 12

12/LO/0071/AM04 GenomALC Trial 3 20/08/2014 21

12/LO/0262/AM27 Study in patients with high cholesterol and at risk of heart disease

Protocol Amendment 6

07/04/2014 21

12/LO/0262/AM28 Study in patients with high cholesterol and at risk of heart disease

Seven 23/05/2014 16

12/LO/0560/AM01 Longitudinal study of corneal endothelium cell density in glaucoma

1 10/04/2014 18

12/LO/0560/AM02 Longitudinal study of corneal endothelium cell density in glaucoma

Two 06/01/2015 20

12/LO/0770/AM02 A qualitative exploration of self stigma Substantial Amendment 2

18/06/2014 15

12/LO/0923/AM13 XL184-306- Phase 3 study of XL184 vs mitoxantrone & prednisone in CRPC

6.0 09/05/2014 15


09/07/2014 6


Ten 02/07/2014 20


12/LO/1078/AM10 MUK five Ten 15/12/2014 30

12/LO/1089/AM03 UCL Partners Infection DNA Bank 4 24/11/2014 17

12/LO/1236/AM05 MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin

MK1775-004-08 PISCF version 4

31/03/2014 14

12/LO/1240/AM01 London Study on the Impact of Ageing with HIV (LSIAH) - Version 1

2.0 11/03/2014 19

12/LO/1240/AM02 London Study on the Impact of Ageing with HIV (LSIAH) - Version 1

Three 30/06/2014 21

12/LO/1351/AM14 MO28231 T-DM1 Safety Study Study Protocol MO28231, versio

25/04/2014 19

12/LO/1391/AM02 PREMFOOD Version 1/010812 2 23/04/2014 15

12/LO/1402/AM04 Dietary interventions for irritable bowel syndrome Substantial Amendment

number 1

01/04/2014 23

12/LO/1402/AM05 Dietary interventions for irritable bowel syndrome Substantial Amendment 2

13/06/2014 11

12/LO/1409/AM12 POPPY Pharmacokinetic and clinical observations in people over fifty

7 04/04/2014 10

12/LO/1409/AM13 POPPY Pharmacokinetic and clinical observations in people over fifty

8 08/05/2014 19

12/LO/1768/AM05 HepFree 5.0 09/03/2014 13

12/LO/1768/AM06 HepFree Six 27/06/2014 14

12/LO/1769/AM03 Oral propionate and glucose homeostasis. - version 2 Two 07/10/2014 24

12/LO/1901/AM05 MUK four HM11/10041/CI/30

Jun2014

01/07/2014 8

12/LO/1962/AM06 Self-management education for adults with epilepsy (SMILE) Three 21/08/2014 21

13/LO/0026/AM05 Genetic determinants of Kawasaki disease version 1 Two 17/06/2014 22

13/LO/0073/AM06 Protocol 20120231 - Extension Study -AMG 416 in Chronic Kidney Disease

Three 26/01/2015 6

13/LO/0112/AM01 Defining Immune Tolerance in ANCA-associated Vasculitis One 05/06/2014 27

13/LO/0126/AM02 Risk of preterm labour after treatment for cervical precancer 2 04/03/2014 20

13/LO/0126/AM03 Risk of preterm labour after treatment for cervical precancer 3 08/06/2014 25

13/LO/0161/AM04 MAESTRO: Macitentan in Eisenmenger Syndrome AC-055-305

Amendment 2 15/04/2014 12

13/LO/0161/AM05 MAESTRO: Macitentan in Eisenmenger Syndrome AC-055- Four 21/07/2014 11


305


Six 30/07/2014 21


Seven 15/12/2014 30

13/LO/0378/AM01 Brain PET imaging of the PDE10A enzyme (Ver 2.2) 1 14/04/2014 15

13/LO/0383/AM09 Odyssey - Alternative 4 22/04/2014 21

13/LO/0383/AM11 Odyssey - Alternative Six 03/07/2014 8

13/LO/0419/AM06 B3281004 - Pfizer Extension Study 21/05/2014 19

13/LO/0419/AM07 B3281004 - Pfizer Extension Study 20/11/2014 12

13/LO/0535/AM04 A Phase 3 Study of Pacritinib in Patients with Myelofibrosis 29/09/2014 13

13/LO/0535/AM06 A Phase 3 Study of Pacritinib in Patients with Myelofibrosis Seven 04/12/2014 18

13/LO/0671/AM03 Long-term extension study to evaluate safety and efficacy of DAC HYP

1 29/04/2014 26

13/LO/1277/AM08 Study of ARN-509 in Prostate Cancer Substantial Protocol

Amendment

15/04/2014 12

13/LO/1277/AM11 Study of ARN-509 in Prostate Cancer 01/07/2014 10

13/LO/1277/AM20 Study of ARN-509 in Prostate Cancer Eleven 18/02/2015 29

13/LO/1283/AM03 TAMIGA - Bevacizumab GBM Study Investigator's Brochure for Av

27/03/2014 18

13/LO/1283/AM04 TAMIGA - Bevacizumab GBM Study Protcol Version 5.0 25/07/2014 21

13/LO/1283/AM06 TAMIGA - Bevacizumab GBM Study Five 14/11/2014 19

13/LO/1305/AM01 Wave intensity analysis in the pulmonary artery One 27/06/2014 23

13/LO/1479/AM05 ASPRE (Version 1) AM03 08/05/2014 18

13/LO/1479/AM07 ASPRE (Version 1) Four 02/07/2014 13

13/LO/1479/AM08 ASPRE (Version 1) Eight 22/10/2014 22

13/LO/1502/AM02 DIPSS: Development of a high blood pressure management website

01/05/2014 21

13/LO/1517/AM03 Dolomites 1.0 28/03/2014 5

13/LO/1517/AM05 Dolomites 1.0 12/05/2014 16

13/LO/1517/AM06 Dolomites 13/06/2014 12

13/LO/1517/AM08 Dolomites Five 14/08/2013 21

13/LO/1577/AM01 Assessment of the severity of personality disorder 1 24/02/2014 13

13/LO/1673/AM01 The relationship between BMI and CSF opening pressure One 30/01/2015 20

13/LO/1687/AM02 ARCADIA. Association of ncRNAs with CAD and type 2 Two 22/09/2014 18


diabetes

14/LO/0036/AM01 Phase 3 Blinatumomab in Philadelphia negative B-precursor ALL

Amendment 1 - Main PIS&ICF upd

02/04/2014 11

14/LO/0036/AM02 Phase 3 Blinatumomab in Philadelphia negative B-precursor ALL

Two 10/11/2014 21

14/LO/0037/AM01 Blinatumomab in adult patients with Acute Lymphoblastic Leukaemia

Amendment 1 - Main PIS&ICF Upd

02/04/2014 11

14/LO/0037/AM02 Blinatumomab in adult patients with Acute Lymphoblastic Leukaemia

Two 10/11/2014 21

14/LO/0059/AM01 Developmental Coordination Disorder: A brain imaging study v1

One 12/01/2015 8

14/LO/0072/AM01 GENPROS 14/05/2014 12

14/LO/0072/AM02 GENPROS 1a 23/06/2014 20

14/LO/0099/AM01 Impulsive Behaviours; Causal Attributions, Guilt and Shame in BPD.

Substantial Amendment 2,

3/4/1

06/05/2014 21

14/LO/0108/AM01 Southall And Brent REvisited (SABRE) - SABRE V3 1 10/03/2014 19

14/LO/0108/AM02 Southall And Brent REvisited (SABRE) - SABRE V3 Two 02/07/2014 6

14/LO/0135/AM04 Radium-223 in subjects with bone predominant metastatic CRPC.

Four 02/10/2014 16


Five 16/10/2014 29


Six 02/12/2014 19

14/LO/0212/AM02 Influenza A/Wisconsin/67/2005 (H3N2) Characterisation Study 1 14/05/2014 24

14/LO/0258/AM02 Ambulatory oxygen and health status in patients with lung fibrosis

One 02/12/2014 33

14/LO/0345/AM01 Generation of human induced pluripotent stem cell-lines by CGaP (WTSI)

2.0 06/03/2014 16

14/LO/0359/AM01 Extension study of EVP6124 in patients with Schizophrenia 1 07/07/2014 14

14/LO/0362/AM03 MERIT-1 Two 15/12/2014 30

14/LO/0369/AM01 RIPPLE MAPPING IDENTIFIES ARRHYTHMOGENIC CONDUCTION CHANNELS

2 17/08/2014 12

14/LO/0385/AM01 Development of a tool to assess OHQoL in CCU One 20/10/2014 12

14/LO/0675/AM03 SOCRATES REDUCED One 29/07/2014 23

14/LO/0676/AM03 SOCRATES-PRESERVED One 29/07/2014 23


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

14/LO/0732/AM01 Experiences of Adherence Assessment in Asthma V1 One 10/07/2014 22

14/LO/0851/AM01 Open Label, Phase IIa of ALXN1007 for Antiphospholipid Syndrome

1 31/07/2014 21

14/LO/0861/AM01 STAND UP - Cut-point validation study 22/05/2014 22

14/LO/0865/AM01 Phase 2 Study of Fostamatinib for Subjects with IgA Nephropathy

One 29/08/2014 26

14/LO/0871/AM01 EndoBarrier TM Gastrointestinal Liner Diabetes Trial Version 2 23/09/2014 32

14/LO/1179/AM02 A PK Study of Serelaxin in Paediatric Heart Failure Patients Two 07/01/2015 14

14/LO/1196/AM02 A study of LEE011 in ER+ HER2- breast cancer patients Two 06/03/2015 18

14/LO/1230/AM01 Ketogenic diet treatment of epilepsy in infants One 26/08/2014 10

14/LO/1291/AM02 PALLET One 28/01/2015 5

14/LO/1330/AM01 Modelling retinal disease mechanisms and ocular cell development

1 12/11/2014 21

14/LO/1370/AM02 MERIT-2 Two 15/12/2014 30

14/LO/1561/AM01 VITAL One 22/10/2014 12

14/LO/1711/AM01 MicroRNA Expression and Function in Psoriasis II One 04/11/2014 24

14/LO/1812/AM01 PROSPECT-R One 17/11/2014 19

14/LO/2060/AM01 EFFECTIVENESS OF RIPPLE MAPPING FOR ATRIAL TACHYCARDIA ABLATION

One 13/02/2015 20

Unfavourable opinion



14/LO/0108/AM03 Southall And Brent REvisited (SABRE) - SABRE V3 Three 01/10/2014 9

Favourable opinion timeline



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


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



res committee london - fulham annual report 01 april 2014 ... · res committee london - fulham...

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