NORTH GLASGOW UNIVERSITY HOSPITALS NHS DIVISION

GREATER GLASGOW NHS BOARD

RESEARCH ETHICS ANNUAL REPORT

2005/6

Incorporating: West Glasgow LRECs (1) & (2) East Glasgow LRECs (1) & (2) South Glasgow LREC Primary Care Division LRECs (1) & (2) Yorkhill LREC

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NORTH GLASGOW UNIVERSITY HOSPITALS NHS DIVISION

WEST LOCAL RESEARCH ETHICS COMMITTEES (1) & (2)

& GLASGOW ROYAL INFIRMARY ETHICS COMMITTEES (1) & (2)

ANNUAL REPORT 2005/6

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Chairman’s Report for West Ethics Committee 1 & 2. The standard of ethical review and operational aspects of West Ethics Committee 1 were subject to independent review in February. I am delighted to report that, despite being warned that we were unlikely to satisfy the standards they sought, we managed to do so without any subsequent points of clarification. At West Ethics Committee 1’s meeting in February we were observed throughout by our assessors and they reported satisfaction with the committee’s procedures. We continue to have a cohort of enthusiastic, thorough and careful committee members who have a pile of papers of approximately 4 cm thickness to read every month. Many are involved in providing advice between meetings as well. Without the commitment of EC members it would be impossible for research to proceed in the NHS. I am sure that others are not aware of the amount of work involved in being an Ethics Committee member. Those who are involved in NHS work almost always have to read the papers in their own time and lay members not only give up this time but also give up their time for the meetings, which are now substantially longer as more and more investigators attend when their projects are being assessed. I would like to take the opportunity to thank all our committee members. Finally, I am extremely grateful for the expertise, guidance and constant administrative support given by Mrs Andrea Torrie and Sharon Jenner. Without their efforts the committee simply could not operate. We have see a number of challenges in the past year with some difficult projects to assess but I hope we’ve given satisfactory guidance to researchers and I hope this guidance will see productive research being facilitated for the sake of patients and staff alike. J A Hunter Chairman.

NORTH GLASGOW UNIVERSITY HOSPITALS NHS DIVISION WEST LRECs (1) & (2) ADMINISTRATORS ANNUAL REPORT 2005/6 This report covers the period 1st April, 2005 to 31st March, 2006. General The national Application form and RED (Research Ethics Database) are now being well used and investigators seem to be getting used to the new application system which appears to be working well - although there are still some minor problems/additions with the database which Infonetica/COREC are working on. Despite a slow start in 2004 after the new application form and system came into being - submissions for this past year have picked up and both of our Committees have been busy over this 12 month period as can be seen from the attached project list. The Committees mainly have full agendas due to having received recognition by COREC as type II and type III committees. This means that they received allocated submissions – UK wide through the Central Allocation System (CAS) for each meeting. Administrators Update: The GRI committees are in the process of merging and intend to be one committee within the next month or two. Dr J B Neilly will act as Chairman and Dr Malcolm Booth will take on the role of Vice-Chair to the amalgamated committee. West Ethics Committee (1) were chosen to take part in the first group of committees (only 3 in Scotland) to go through the National Accreditation Review by external agencies (commissioned by COREC) during the month of February, 2006 and were delighted to achieve “full accreditation status” at first go. This committee has now been recognised to review multi-site Clinical Trials of Medicinal Products (CTIMPs) UK wide and is one of a small number of committees to have achieved this status at first review. It is anticipated that West EC(2) will require to undergo this process in the coming year. However, due to problems with the accreditation process in England, this programme of review has been suspended for the time being. Workload: Due to the enormous amount of documentation/administration now required by COREC (i.e. 43 standard letters, Standard Forms, etc ) together with numerous and regular changes to the RED database and associated documentation – our Administrators are finding this extra bureaucracy both time consuming and burdensome. Administrators are also having to support investigators through the new system to ensure that the documentation presented to the Committee members is "valid". Version 3 of the Standard Operating Procedures (SOPs) came into being in July, 2005 and these are being used by all Glasgow Administrators.

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Training GGNHS Board again took its responsibilities in regard to training extremely seriously and set up two separate training sessions for its LREC members. Induction training was held for all "new-starts" who have been recruited since the last session in 2004 and one for all members of Greater Glasgow LRECs. The Induction training session for the new members was undertaken by The Centre for Professional Ethics from Keele University (as in previous years) and was held locally in the Western Infirmary University Lecture Theatre. This took place on 25th April, 2005. A joint training session for all members of Greater Glasgow NHS Boards Ethics Committees was held in the Walton Conference Centre at the Southern General on 23rd May, 2005 - 75 members in total attended what was an extremely interesting and informative day. This training session covered some of the issues which trouble LRECs i.e. Qualitative Research, EU Directive/ICH/GCP, Tissue storage and retention, Data Protection/Freedom of Information. The speakers were both local and external. Separate sheets of attendees for both sessions for the West Committees is attached. COREC who have assumed responsibilities (via the National Patient Safety Agency - NPSA) for Research Ethics Committees nationally have held several training sessions for administrators on the database and EU Directive and both myself and Sharon Jenner (West Admin Assistant) have attended these . The forthcoming year 2006/7 will no doubt yet again provide an interesting challenge and hopefully a more settled administrative outlook for all LREC administrators. Andrea H Torrie Ethics Manager – West Ethics Committees June, 2006

ETHICS COMMITTEE - MEETING DATES FOR 2006 New submissions should be in the hands of the LREC Administrator at least one day before the deadline (see dates below). This is to ensure that the documents are valid* and to allow time for any changes/additions, since invalid submissions cannot be accepted on to an Agenda. The maximum number of new submissions each Committee will review is 10 and it should be noted that valid submissions will be placed on the Agenda on a first come first served basis. Once the Agenda is full, all other submissions will be held over to the next meeting.

Ethics Committee 1 Ethics Committee 2

Meeting Date

#Submission Deadline 4.00pm

Meeting Date #Submission Deadline 4.00pm

10 JANUARY

19 DECEMBER 2005

17 JANUARY

3 JANUARY

7 FEBRUARY

23 JANUARY

21 FEBRUARY 6 FEBRUARY

7 MARCH

20 FEBRUARY 21 MARCH 6 MARCH

4 APRIL 20 MARCH 18 APRIL 3 APRIL

2 MAY

17 APRIL 16 MAY 1 MAY

6 JUNE

22 MAY 20 JUNE 5 JUNE

4 JULY

19 JUNE 18 JULY 3 JULY

1 AUGUST

17 JULY 15 AUGUST 31 JULY

5 SEPTEMBER

21 AUGUST 19 SEPTEMBER 4 SEPTEMBER

3 OCTOBER 18 SEPTEMBER 17 OCTOBER 2 OCTOBER

7 NOVEMBER

23 OCTOBER 21 NOVEMBER 6 NOVEMBER

5 DECEMBER

20 NOVEMBER 19 DECEMBER 4 DECEMBER

*To ensure that an application is valid, it must be: • Fully completed in typescript and on the current application form. • Signed by all relevant personnel • Accompanied by all relevant attachments. (All documents to be given to patients (Information

Sheets, Questionnaires etc) must be dated and given a version number. Completed Applications/ Amendment Requests to be sent to: Mrs A H Torrie Ethics Manager West Ethics Committee Western Infirmary Dumbarton Road Glasgow #Applications will not under any circumstances be accepted after the above deadline.

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COMPOSITION: THE WEST ETHICS COMMITTEE

Your study will be considered by a quorum (6 or more) of the under noted Committee Members COMMITTEE 1 (Meets 1st Tuesday of each Month) NAME STATUS AFFILIATION APPOINTED Dr J Hunter Chairman Rheumatology 2003 Dr A Binning Vice Chairman Anaesthetics 2003 Mrs A H Torrie Administrator Ethics Office 2003 Ms J Doughty Trust Employee Consultant Surgeon 2004 (April) retired Dr K Hanretty Trust Employee Gynaecology 2003 Sister A McLinton Trust Employee Oncology 2001Retired Mr C Rodden Trust Employee Pharmacy 2003 (Nov) Dr C Weir Trust Employee Acute Medical 2003 (Sep) Prof D Stewart-Tull Expert Immunology (Retired) 2003 (June) Mr R Donald Lay Member Engineering (Retired) 2003 (June) Mrs A Lees Lay Member Housewife 2003 Mr R Sim Lay Member Investments (Retired) 2003 (June) Dr J Thorburn Lay Member Anaesthetics (Retired) 2003 Dr I Robertson Trust Employee Interventional Radiologist 2004 (Dec) Prof H Watson Expert Research 2004 (Dec) Dr G Robertson Trust Employee Oncology 2004 (Nov) Dr D Attwood Trust Employee Dentistry 2004 (Dec) Ms C Cowan Trust Employee Oncology 2006 (Jan) Dr L A McLintock Trust Employee Haematology 2006 (Apr) COMMITTEE 2 (Meets 3rd Tuesday of each month) NAME STATUS AFFILIATION APPOINTED Dr N Pace Chairman Anaesthetics 2003 Mrs A H Torrie Administrator Ethics Office 2003 Sister C Donald Trust Employee Renal 2003 Dr E Douglas Trust Employee Pharmacy 2004 (Oct) Dr R Soutar/ Dr N Lucie Trust Employees Haematology 2003 Dr S Humphries Expert Research 2003 (June) Dr S Langridge Expert General Practice 2003 (June) Professor B Parfitt Expert Research 2003 (June) Retired Prof C Robertson Expert Statistics/Modelling Science 2003 (Nov) Rev W Currie Lay Member Clergy (Retired) 2003 Mr J McHugh Lay Member Insurance 2003 Mrs H Miller Lay Member Teaching (Retired) 2003 Mr K Wallace Lay Member Surveying (Retired) 2003 (June) Retired Mrs J Wardlaw Lay Member Pharmacy (Retired) 2003 Dr R Lindsay Trust Employee Consultant Physician 2004 (Dec) Prof M Gilhooly Expert Research 2005 (Nov) Dr M T Hosey Trust Employee Dentistry 2006(Feb) Dr A Crighton Trust Employee Dentistry 2006 (Apr)

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Attendance Lists – West EC (1)

Name May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Dr J Hunter (Chair) Apr X √ √ √ X √ √ √ √ √ Dr A Binning √ X √ X √ √ X X √ √ √ X Mr R Donald √ √ √ √ √ √ √ √ √ √ √

Ms J Doughty √ X X X X X X Dr I Robertson √ √ √ √ X √ √ √ √ X √ X Dr K Hanretty √ X √ X X √ √ X X X √ √ Mrs A Lees √ √ √ X √ √ X X √ √ X X Sister A McClinton X √ √ √ √ √ X √ √ Mr C Rodden X √ √ √ √ √ √ √ √ √ √ √ Mrs Sandford X X √ Mr R Sim √ √ X √ √ √ √ √ √ √ √ √ Em Prof D Stewart-Tull X √ √ X √ √ X √ √ √ √ √

Dr J Thorburn √ X X X √ X X √ √ √ √ √ Dr C Weir X √ √ √ √ √ √ √ X √ √ √ Dr G Robertson √ X √ X √ √ √ X √ √ √ X Professor H Watson √ √ X √ √ X √ √ √ X √ √ Dr D Attwood √ √ X √ √ X √ √ √ √ √ √ Ms Chloe Cowan √ √ √ Mrs A H Torrie X √ √ √ √ √ X √ √ √ √ √ Total 12 12 12 9 14 13 9 12 14 13 15 12 Resigned from Committee Not current member of Committee

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Attendance Lists – West EC (2) Name Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Dr N Pace (Chairman) √ √ √ √ √ X X √ X √ √ √ Dr R Lindsay √ X √ √ √ X X √ √ √ X X

Dr R Soutar/Dr Lucie √ √ √ X √ √ √ √ √ √ √ √

rs H Millar X √ √ √ Comments √ X X X √ √ Rev R Currie √ √ √ √ √ √ √ X √ √ √ √ Professor B Parfitt

Dr S Langridge √ √ √ X √ √ X √ √ √ √ √

Professor C Robertson X √ X X X Comments X Comments Comments X Comments X Mrs J Wardlaw X √ √ √ √ X X √ √ √ X √ Dr E Douglas X √ √ √ √ √ √ √ √ X √ √ Sister Catriona Donald √ √ X √ √ √ √ √ √ √ √ X Mr J McHugh √ √ √ √ √ √ X √ √ √ X √ Dr S Humphreys √ √ √ X √ √ √ √ √ √ √ √ Mr K Wallace X √ √ √ √ √ √ √ √ √ √ √

Prof M Gilhooly √ √ √ X X

Dr M T Hosey √ X

Mrs A H Torrie X √ X √ √ √ √ √ √ √ √ √ Total 8 13 11 9 13 9 8 12 12 12 11 11 Resigned from Committee Not a current member of Committee

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GG NHS Board Local Research Ethics Committee Training Sessions – (All committees)

Initial Session

Monday 25th April 2005

Name Hospital Aktar Mr SGH Bell Dr G Yorkhill Brennand Dr J Yorkhill Bromby Mr M GRI1 Carmichael Ms C GGNHSB Cotton Dr P PTC 2 Curran Dr SGH Cuthbertson Ms L PCT1 Davies Mr P PCT2 Douglas Dr E WIG2 Jenner Miss S WIG Lindsay Dr R WIG2 McColl Dr I PCT2 McKelvie Ms F GRI McMillan Mr A Yorkhill Noble Dr S SGH Powls L Yorkhill Robertson Dr G WIG Robertson Dr I WIG Rodden Mr C WIG1 Watson Prof H WIG1

GG NHS Board Local Research Ethics Committee Training Sessions

23rd May, 2005

Dr Chris Weir West Ethics 1 Dr Derek Attwood West Ethics 1 Dr Elizabeth Douglas West Ethics 2 Dr Gerry Robertson West Ethics 1 Dr Iain Robertson West Ethics 1 Dr John Hunter West Ethics 1 Dr John Thorburn West Ethics 1 Dr Nick Pace West Ethics 2 Dr Norman Lucie West Ethics 2 Dr Richard Soutar West Ethics 2 Dr Robert Lindsay West Ethics 2 Dr Sue Humphries West Ethics 2 Dr Sue Langridge West Ethics 2 Miss Sharon Jenner West Ethics 1 & 2 Mr Colin Rodden West Ethics 1 Mr Jim McHugh West Ethics 2 Mr Ken Wallace West Ethics 2 Mr Robert Donald West Ethics 1 Mr Robert Sim West Ethics 1 Mrs Alison Lees West Ethics 1 Mrs Andrea Torrie West Ethics 1 & 2 Mrs Helen Millar West Ethics 2 Mrs Jackie Wardlaw West Ethics 2 Prof Duncan S Tull West Ethics 1 Prof Hazel Watson West Ethics 1 Rev Bob Currie West Ethics 2 Sister Ann McLinton West Ethics 1 Sister Catriona Donald West Ethics 2

North Glasgow Division Western Infirmary Ethics Committee 2005/06 Index of Protocols

(Committees 1 & 2) April 2005 to April 2006

Project No

Status

Brief Title

Chief Investigator

Date on Agenda

Date of Approval

05/S0703/35

EC1 Community care and mental health services for the sensory impaired (v.1)

Mrs K Skellington Orr 05.04.05 Not requiring NHS REC

05/S0703/36 EC1 STOPIT – study of public place intervention of tobacco exposure

Prof J Pell 05.04.05 05.04.05

05/S0703/37 EC1 Dexamethasone for prevention of propofol pain

Dr N B Scott 05.04.05 Not approved

05/S0703/38 EC1 An open label phase I dose escalation study of E7080

Dr T R J Evans 05.04.05 05.04.05

05/S0703/39 EC1 Education components and risk factor management with UK CR

Dr C Hankey 05.04.05 Not requiring NHS REC

05/S0703/40 EC1 The validation of druggable targets on COPD lung tissue V1

Prof J Westwick 05.04.05 05.04.05

05/S0703/41 EC1 Participation in clinical drug trials V2

Ms H Anderson 05.04.05 05.04.05

05/S0703/42 EC1 Rosiglitazone versus placebo in chronic stable angina

Prof S M Cobbe 05.04.05 05.04.05

05/S0703/43 EC1 Dental Submission – See separate sheet

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05/S0703/44 EC1 Hypophosphataemia after cardiac surgery

Dr A Campbell 05.04.05 05.04.05

05/S0703/45 SSA EC1

4/Q1907/68

BBC ONE Dr K G Oldroyd 05.04.05 05.04.05

05/S0703/46 SSA EC1

05/MRE03/4

Randomised controlled trial of adjuvant imatinib for GIST version 1

Dr J White 05.04.05 05.04.05

05/S0703/47 SSA EC1

05/Q1604/38

Feasibility and safety of 99m T c –NC100692 in late stage cancer patients

Dr C Featherstone 05.04.05 05.04.05

05/S0703/48SSA EC1 05/Q0104/3

Inflammatory control of asthma with Symbicort SIT (v 1.0) Prof N C Thomson 05.04.04 05.04.05

05/S0709/49 NUMBER NOT USED

05/S0709/37 EC2

See Dental Submissions – separate sheet

05/S0709/38 SSA EC2

05/Q1907/40

SWEET Study – Simplification with Easier Emtricitabine and Tenofovir

Dr R Fox 19.04.05 19.04.05

05/S0709/39 SSA EC2

05/MRE00/34

Evaluating treatment with Nesiritide in adHF Dr M C Petrie 19.04.05 19.04.05

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05/S0709/40 SSA EC2

05/MRE07/5

333369-EPY-2003 Refractory epilepsy study Prof M J Brodie 19.04.05 19.04.05

05/S0709/41 SSA EC2

04/Q2006/98

EaStER – final version 1.0 Mr K. McKenzie 19.04.05 19.04.05

05/S0709/42 SSA EC2

02/7/117 BTOG2 – version 3.1 : 1st July 2004

Dr D J Dunlop 19.04.05 19.04.05

05/S0709/43 EC2 WITHDRAWN BY INVESTIGATOR

05/S0709/44 EC2 WITHDRAWN BY INVESTIGATOR

05/S0709/45 EC2 Inhaled tiotropium vs nebulised ipratropium in stable COPD

Dr G W Chalmers 19.04.05 19.07.05

05/S0709/46 EC2 Teicoplanin use in OHPAT patients

Dr A Thomson 19.04.05 19.04.05

05/S0709/47 EC2 TICORA – 5 year follow up

Dr D Porter 19.04.05 19.04.05

05/S0709/48 EC2 Attitudes to fertility in young women with early breast cancer

Dr P Canney 19.04.05 19.07.05

05/S0709/49 EC2 LAPSIS trial

Mr P Modak 19.04.05 20.09.05

05/S0709/50 SSA EC2

GTAC102

A phase I trial of intra-peritoneal Ad-hTR-NTR and CB1954, adenovirus – delivered telomerase- directed enzyme-prodrug therapy in patients with advanced intra-abdominal cancer

Dr T R J Evans 19.04.05 19.04.05

19

05/S0709/51 SSA EC2

05/Q1702/12

SYNTAX study version 02 dated 01/12/04 Dr K Oldroyd 19.04.05 19.04.05

05/S0709/52 SSA EC2

05/MRE00/13

CHANT (Cerebral haemorrhage and NXY treatment) version 2 6 May 2004

Prof K R Lees 19.04.05 19.04.05

05/S0703/50 EC1 Efficacy of combination photodynamic laser therapy and

radiotherapy

Mr G Fullarton 03.05.05 07.06.05

05/S0703/51 SSA EC1

05/S0704/5 The reality of learning in the High Dependency Unit

Ms C Baxter 03.05.05 03.05.05

05/S0703/52 SSA EC1

05/MRE10/41

S-1 plus cisplatin in advanced gastric cancer Dr T R J Evans 03.05.05 03.05.05

05/S0703/53 SSA EC1

05/MRE09/17

Pse 3 study – Sorafenib in pats with advanced liver cancer Dr T R J Evans 03.05.05 03.05.05

05/S0703/54 SSA EC1

05/Q1702/22

GEM-TP version 1 Dr J White 03.05.05 03.05.05

05/S0703/55 SSA EC1

03/8/056 PET trial in Hodgkins disease

Dr N O’Rourke 03.05.05 06.09.05

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05/S0703/56 EC1 NUMBER NOT USED

05/S0703/57 SSA EC1

05/MRE07/12

RSR13 in the treatment of brain metastases from breast cancer v.2.2

Prof R Rampling 03.05.05 03.05.05

Project No

Status

Brief Title

Chief Investigator

Date on Agenda

Date of Approval

05/S0703/58

Dental Submission – see separate sheet

05/S0709/53 EC2

The development and impact of multi dimensional family therapy

Prof N McKeganey 17.05.05 16.08.05

05/S0709/54 SSA EC2

04/MRE07/35

STAMPEDE (Version 1.0) – PR08 Dr J Graham 17.05.05 17.05.05

05/S0709/55 SSA EC2

05/MRE/10/46 Extension study – bronchial thermoplasty in asthma

Prof N C Thomson 17.05.05 17.05.05

05/S0709/56 SSA EC2

05/Q2308/04

Ventavis observational study Prof A Peacock 17.05.05 17.05.05

05/S0709/57 SSA EC2

04/MRE01/Neo-tAnGo trial

Dr H Mackay 17.05.05 17.05.05

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60 05/S0709/58 SSA EC2

04/MRE02/10

Hyprofractional prostrate radiotherapy Dr J Graham 17.05.05 17.05.05

05/S0709/59 SSA EC2

05/MRE10/16

Study of trilostane in pre-menopausal women with breast cancer

Dr P Canney 17.05.05 17.05.05

05/S0709/60 SSA EC2

MREC03/9/31

EORTC 22991 three dimensional conformal radiotherapy Dr J Graham 17.05.05 17.05.05

05/S0709/61 SSA EC2

05/MRE05/06

Study of trilostane in post-menopausal women with breast cancerDr P Canney 17.05.05 17.05.05

05/S0709/62 SSA EC2

04/Q0801/111

Circulating tumour cells as a predictor of overall survival Dr J Graham 17.05.05 17.05.05

05/S0709/63 SSA EC2

MREC02/8/76

Alimta in mesothelioma Dr D Dunlop 17.05.05 17.05.05

05/S0709/64 SSA EC2

04/Q1407/170

FK506E (MR4) vs FK506 in de novo KTx Mr E Murio 17.05.05 17.05.05

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05/S0703/59 SSA

EC1 05/MRE11/23

Safety and efficacy of cofactor/5-FU in colorectal carcinoma patients

Prof J Cassidy 07.06.05 07.06.05

05/S0703/60 SSA EC1

05/Q1604/140

Safety and efficacy of Aliskiren in patients with stable heart failure V.1

Dr C Murphy 07.06.05 07.06.05

05/S0703/61 SSA EC1

05/MRE00/34

Evaluating treatment with Nesiritide in adHF Prof H Dargie 07.06.05 07.06.05

05/S0703/62 SSA EC1

05/S1401/20 Efficacy and safety of AER002 in cystic fibrosis

Dr D Bicknell 07.06.05 07.06.05

05/S0703/63 EC1 Supported employment for people with learning disabilities

Miss J Edgington 07.06.05 05.07.05

05/S0703/64 SSA

EC1 03/109(a)

4.12.03

Open label protocol of posaconazole in invasive fungal

Infections This submission has been approved at the EC2 and by the Chairman of EC1 due the nature of the patient’s condition

Dr E Fitzsimmons 07.06.05 17.05.05

05/S0703/65

EC1 Impact of emotional regulation on haemodialysis patients

Miss S Lewis 07.06.05 07.06.05

05/S0703/66 EC1 Long term effects of exercise intervention on breast cancer survivors

Prof N Mutrie 07.06.05 07.06.05

05/S0703/67 SSA

EC1 05/Q1604/16

Sirolimus vs ciclosporin in de novo renal transplant (original) Miss Laura Buist 07.06.05 07.06.05

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05/S0703/68 SSA

EC1 05/S0705/5

Fabry disease screening Prof H Dargie 07.06.05 07.06.05

05/S0703/69 SSA

EC1 05/MRE06/36

BO17706 phase III trial : Bevacizumab in metastatic pancreatic cancer

Dr T R J Evans 07.06.05 07.06.05

05/S0703/70 EC1 Withdrawn by COREC

05/S0709/65 EC2 The role of hair follicles in transdermal drug delivery

Dr V Meidan 21.06.05 21.06.05

05/S0709/66

EC2 Candida serology study Dr T Inkster

21.06.05 18.10.05

05/S0709/67 EC2 Cystic fibrosis sputum Version 3 Dr S Bicknell

21.06.05 19.07.05

05/S0709/68 SSA

EC2 03/0/036 ECASS III Dr M R Walters

21.06.05 21.06.05

05/S0709/69 SSA

EC2 05/MRE11/5

SCOTROC 5 Version 2 date 7th September 2004 Dr N S Reed 21.06.05 21.06.05

05/S0709/70 SSA

EC2 05/Q0505/44

GWCL0404 – Open label study of Sativex in subjects with neuropathetic pain

Dr M Serpell 21.06.05 21.06.05

05/S0709/71 SSA

EC2 05/MRE08/36

Registry of angiojet in thromboembolic occlusion Dr R Edwards 21.06.05 21.06.05

05/S0709/72 SSA

EC2 04/Q0505/01

Study of Sativex in subjects with painful diabetic neuropathy Dr M Serpell

21.06.05 21.06.05

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05/S0709/73 EC2 Drug and alcohol learning and development needs analysis Mrs J Barlow

21.06.05 Not requiring NHS REC

05/S0709/74 EC2 Acceptability of domestic abuse routine enquiry in maternity care Dr N Shields

21.06.05 16.08.05

05/S0703/71 EC1 Analysis of leukocytes in myometrium in labour Dr J Norman

05.07.05 05.07.05

05/S0703/72 EC1 Study to investigate new system to deliver medicines V1 Prof H NE Stevens

05.07.05 06.09.05

05/S0703/73 SSA

EC1 04/MRE00/92

Study of Sativex in subjects with peripheral neuropathic pain Dr M Serpell

05.07.05 05.07.05

05/S0703/74 SSA

EC1 05/Q1604/108

SON-8184-1073 phase 2 open label TOCOSOL of the Urothelium Dr J Graham

05.07.05 05.07.05

05/S0703/75 SSA

EC1 05/Q1205/123

Taxolog Inc – Procotol T05-10544 Dr T R J Evans 05.07.05 05.07.05

05/S0703/76 EC1 Study to investigate the break up in the gut of coated capsule V3 Prof C G Wilson

05.07.05 06.09.05

05/S0703/77 EC1 Study of a new delivery system in which stays in the stomach V1 Prof C G Wilson

05.07.05 06.09.05

05/S0703/78 EC1 Study to investigate the movement of particles through the gut V1

Prof C G Wilson 05.07.05 04.10.05

05/S0703/79 EC1 Study of the stomach emptying liquid meal (v.1) Prof C G Wilson

05.07.05 06.09.05

05/S0703/80 SSA

EC1 04/MRE08/05

DCIS II trial – Version 2 dated 20/03/04 Prof W D George 05.07.05 05.07.05

25

05/S0709/75 EC2 Dental submission – see separate sheet

05/S0709/76 EC2 Procalcitonin (PCT) and the diagnosis of deep infection Mr S. Ali

19.07.05 19.07.05

05/S0709/77 EC2 Cerebrovascular endothelial dysfunction in diabetes Dr M R Walters

19.07.05 19.07.05

05/S0709/78 EC2 Allopurinol and Cerebrovascular reactivity in stroke patients Dr M R Walters

19.07.05 19.07.05

05/S0709/79 EC2 Validity of CASSOS 2001

Dr B Khamby 19.07.05 19.07.05

05/S0709/80 EC2 Hox gene methylation in leukaemia

Dr G Strathdee 19.07.05 19.07.05

05/S0709/81 EC2 Dental submission – see separate page

05/S0709/82 SSA

EC2 04/MRE06/17

FAST version 1 Dr A Alhasso 19.07.05 19.07.05

05/S0709/83 SSA

EC2 05/MRE10/6

MRC TE23 study version 1 Dr J White 19.07.05 19.07.05

05/S0709/84 SSA

EC2 05/MRE06/37

Effect of changing to Myfortic on QOL in patients with GI symptoms

Dr A Jardine 19.07.05 19.07.05

05/S0709/85 SSA

EC2 03/0/041 Investigating the genetic basis of age-related maculopathy and

degeneration Dr M P Gavin

19.07.05 19.07.05

05/S0709/86 SSA

EC2 05/MRE10/ Phase II GW786034 in soft tissue sarcoma

Dr F Cowie 19.07.05 19.07.05

26

57 05/S0709/87 SSA

EC2 05/MRE05/43

NY-ESO-1 vaccine in melanoma Dr T R J Evans 19.07.05 19.07.05

05/S0709/88 SSA

EC2 04/MRE03/90

INCH – Induction chemotherapy and CHART in NSCLC Dr R Jones 19.07.05 19.07.05

05/S0709/89 SSA

EC2 05/MRE05/02

Macular hole and internal limiting membrane peeling study Mr J Murdoch 19.07.05 19.07.05

05/S0709/90 EC2 PM2734-A-002-05 Phase I study in malignant solid tumours

Dr T R J Evans 19.07.05 19.07.05

05/S0709/91 EC2 The long-term implications of becoming a living kidney donor

Dr C Geddes 19.07.05 19.07.05

05/S0703/81 EC1 Dental submission – see separate sheet

05/S0703/82 EC1 BEST – BioSTAR evaluation study v.1

Prof W S Hills 05.07.05 05.07.05

05/S0703/83 EC1

NUMBER NOT USED

05/S0703/84 EC1

NUMBER NOT USED

05/S0703/85 EC1

NUMBER NOT USED

05/S0703/86 EC1

NUMBER NOT USED

27

05/S0703/87 EC1

Prospective assessment of the treatment of alcoholic hepatitis Prof P C Hayes 02.08.05 06.09.05

05/S0703/88 EC1

Food intolerance in primary care Prof J Ogden 02.08.05 04.10.05

05/S0703/89 SSA

EC1 05/MRE00/43 Balloon-pump assisted coronary intervention study (BCIS 1)

Dr K Oldroyd 02.08.05 02.08.05

05/S0703/90 SSA

EC1 03/0/009 PACIFIC – Pegylated interferon alpha in liver cirrhosis

Dr P Mills 02.08.05 02.08.05

05/S0703/91 SSA

EC1 04/MRE08/59 Dose-ranging trial evaluating the efficacy and safety of ucb 34714

Prof M Brodie 02.08.05 02.08.05

05/S0703/92 SSA EC1

05/MRE07/51 Trastuzmabin HER2 positive advanced gastric cancer

Dr T R J Evans 02.08.05 02.08.05

05/S0703/93 SSA EC1

05/MRE12/46 Daptomycin versus Teicoplanin and Vancomycin in cSSTI DAP002

Dr R A Seaton 02.08.05 02.08.05

05/S0703/94 EC1 B-Type natriuretic peptide (BNP) levels during CPAP v.1

Dr A Binning 02.08.05 02.08.05

05/S0703/95 EC1 Fair blame culture

Dr B Stein 02.08.05 02.08.05

05/S0709/91 EC2 NUMBER NOT USED

05/S0709/92 EC2 Dental Submission – see separate sheet

05/S0709/93 EC2 Vitamin A and retinal function in low birth weight babies Version

1

Dr H McTier 16.08.05 16.08.05

05/S0709/94 EC2 Non face to face consultations in primary care

Dr K Fairhurst 16.08.05 16.08.05

28

05/S0709/95 EC2 European compliance study in Parkinson’s disease

Dr D Grosset 16.08.05 16.08.05

05/S0709/96 EC2 Asthma intervention research (AIR2) trial version 1

Dr R M Niven 16.08.05 16.08.05

05/S0709/97 EC2 Evaluation of wellness enchancement learning programme

(V1)

Dr D Reilly 16.08.05 16.08.05

05/S0709/98 SSA EC2

04/MRE03/91 Pregabalin time onset of pain relief in subjects with PHN

Dr M Serpell 16.08.05 16.08.05

05/S0709/99 SSA EC2

02/8/005 Immediate vs deferred chemotherapy after radical cystectomy (30994)

Dr J Graham 16.08.05 16.08.05

05/S0709/100 SSA EC2

05/MRE08/58

GW873140 in patients with drug resistant R5/X4- tropic HIV CCR104458

Dr R Fox 16.08.05 16.08.05

05/S0709/101 SSA EC2

05/MRE08/59 GW873140 in patients with drug resistant R5-tropic HIV RR104456

Dr R Fox 16.08.05 16.08.05

05/S0709/102 SSA EC2

05/MRE08/60 Screening study CCR104627 10-June-05

Dr R Fox 16.08.05 16.08.05

05/S0709/103 SSA EC2

05/MRE08/61 Observational study CCR104629 8-April-2005

Dr R Fox 16.08.05 16.08.05

05/S0703/96 EC1 An exploration of urban single-handed general practice

Dr C O’Donnell 06.09.05 06.09.05

05/S0703/97 EC1 Specialist GP training : Development of external workplace

assessment

Dr D Murphy 06.09.05 04.10.05

29

05/S0703/98 EC1 West of Scotland health inequalities pilot study

Ms L Lawson 06.09.05 06.09.05

05/S0703/99 EC1 Outcome of patients with multifocal/multicentric breast cancer

Dr M Mano 06.09.05 06.09.05

05/S0703/100 EC1 The experience of pain in mesothelioma

Dr L Ferguson 06.09.05 06.09.05

05/S0703/101 EC1 Post operative affective state in older adults

Ms L Whitnall-Pate 06.09.05 Not Approved

05/S0703/102 EC1 Resistance to antiplatelet therapy in patients undergoing PCI

Dr R I S Good 06.09.05 Withdrawn by REC

05/S0703/103 EC1 Pharmaceutical care of oral and IV treated colorectal cancer

Prof S Hudson 06.09.05 06.09.05

05/S0703/104 SSA EC1

05/Q1702/89 Extension study – Zoledronic acid in osteoporosis

Dr A McLellan 06.09.05 06.09.05

Project No

Status

Brief Title

Chief Investigator

Project No

Status

05/S0703/105 SSA EC1

04/5/016 Rituximab/watch and wait study

Dr R Soutar 06.09.05 06.09.05

05/S0703/106 SSA EC1

04/Q1104/27 R-CHOP 14 vs 21

Dr E Fitzsimmons 06.09.05 06.09.05

05/S0703/107 SSA EC1

05/Q702/135 Circulating tumour cells in CRC IMM06 amendment II, 31st January 2005

Prof J Cassidy 06.09.05 06.09.05

05/S0703/108 SSA EC1

E5873

Flomax Dr J Graham 06.09.05 06.09.05

30

05/S0703/109 SSA EC1

03/3/035

Extension study. A long term follow up study to evaluate the safety and efficacy in transplant recipients treated with modified release Tacrolimus, FK506E (MR4) based immunosuppressive regimen

Mr E Murio 06.09.05 06.09.05

05/S0703/110 SSA EC1

04/MRE10/10

Endosonography in cancer of the stomach and oesophagus Dr H Yousef 06.09.05 06.09.05

05/S0703/111 SSA EC1

05/Q0201/52 Efficacy and safety of M6G and morphine sulphate given IV over 24-48 hours

Dr A Binning 06.09.05 06.09.05

05/S0703/112 SSA EC1

05/MRE03/60 PK/PD response, safety and tolerability of SB424323 in NVAF patients

Prof H Dargie 06.09.05 06.09.05

05/S0703/113 SSA EC1

05/MRE08/63 Follow-up trial to evaluate long-term safety and efficacy of ucb 347

Prof M Brodie 06.09.05 06.09.05

05/S0703/114 SSA EC1

04/MRE08/59 Dose ranging trial evaluating the efficacy and safety of ucb 347

Prof M Brodie 06.09.05 06.09.05

05/S0703/115 SSA EC1

05/Q1702/89 Extension study – Zoledronic acid in osteoporosis

Dr H J Donnachie 06.09.05 06.09.05

05/S0703/116 SSA EC1

05/S0701/51 Factors affecting adherence to chronic pain medication

Miss L Ramsey 06.09.05 06.09.05

05/S0709/104 EC2

Lamellar bodies in the upper airway and oral cavity v.1 May 25 2005 Dr A G Robertson 20.09.09 20.09.05

05/S0709/105 EC2 Nutritional study of a yoghurt drink in subjects with evaluated BP

Dr L Sheil 20.09.05 20.12.05

05/S0709/106 EC2 The experiences of people affected by cancer in Scotland

Prof N Kearney 20.09.05 20.09.05

31

05/S0709/107 EC2 Research on the implementation of the GMC’s new doctors – are

we doing things right?

Prof T Van-Zwanenberg

20.09.05 20.09.05

05/S0709/108 EC2 Lamellar bodies in and around the larynx

Dr A G Robertson 20.09.05 20.09.05

05/S0709/109 EC2 Binding by AGP to anti-TB drugs (1)

Dr K D Smith 20.09.05 20.09.05


05/S0709/111 EC2 Surface air sampling of the airborne microbial density of a

student led podiatry clinic

Dr N McLarnon 20.09.05 20.09.05

05/S0709/112 EC2 Incidence/prevalence of foot problems and deformities in

Rheumatology

Mr G Burrow 20.09.05 20.09.05

05/S0709/113 EC2 To test the efficiency of the “Cobra ™” style insole

Mr R Campbell 20.09.05

20.09.05

05/S0709/114 EC2 Assessment of voice and swallowing following thyroid surgery

Mr K McKenzie 20.09.05 20.09.05

05/S0709/115 SSA EC2

05/MRE06/48 Roche Sample Repository Project B017706RG (Version 1)

Dr T R J Evans 20.09.05 20.09.05

05/S0703/117 EC1 Macmillan money advice project – cancer patients- Glasgow

Ms C Stanley 04.10.05 04.10.05

05/S0703/118 EC1 The role of prophylatic antibiotics in hallux valgus surgery : a

double-blinded randomised control trial

Mr A Arthur 04.10.05 Withdrawn by REC

05/S0703/119 EC1 Telomere dynamics in renal pathologies

Dr P Shiels 04.10.05 06.12.05

32

05/S0703/120 EC1 Isolation, characterisation and oxidative damage responses of

adult human stem cells

Dr P Shiels 04.10.05 04.10.05

05/S0703/121 SSA EC1

05/MRE00/83 SAINT-II

Prof K Lees 04.10.05 04.10.05


05/S0703/123 SSA EC1

04/MRE04/79 EURAMOS 1 treatment strategies in respectable osteosarcoma

Dr J White 04.10.05 04.10.05

05/S0703/124 SSA EC1

05/MRE12/67 Abatacept in patients with early erosive rheumatoid arthritis

Dr D Porter 04.10.05 04.10.05

05/S0703/125 SSA EC1

05/MRE02/48 Safety and efficacy Talampanel as adjunctive therapy in partial seizures

Prof M Brodie 04.10.05 04.10.05

05/S0703/126 SSA EC1

04/Q1407/256 SOCCAR – Sequential or Concurrent chemo and radiotherapy in NSCLC V1.0

Dr N O’Rourke 04.10.05 04.10.05

05/S0703/127 SSA EC1

04/MRE01/06 Neo-tAnGo trial

Dr J Fraser 04.10.05 04.10.05

05/S0703/128 SSA EC1

04/MRE06/48

Phase II efficacy and safety clinical trial – TRAPEZE Dr M Russell 04.10.05 04.10.05

05/S0709/116 EC2

An exploration of collective learning and change in primary care Dr D Kelly 18.10.05 18.10.05

05/S0709/117 EC2

Scottish Interstitial Lung Disease (SCILD) study Dr N Hirani 18.10.05 Not Approved

05/S0709/118 EC2

NUMBER NOT USED

33

05/S0709/119 EC2

Resistance to antiplatelet therapy in patients under going PCI Dr R Good 18.10.05 18.10.05

05/S0709/120 SSA EC2

05/MRE03/67

PKD response, safety and tolerability of SB424323 in NVAF patients Prof H Dargie 18.10.05 18.10.05

05/S0709/121 EC2

NUMBER WITHDRAWN

05/S0709/122 EC2

Use of digital recordings of modified Rankin Scale assessments

Prof K Lees 18.10.05 18.10.05

05/S0709/123 SSA EC2

05/S0709/96

Asthma Intervention Research (AIR2) trial version 1 Prof N C Thomson 18.10.05 18.10.05

05/S0709/124 EC2

Diastolic dysfunction following CABG : Isoflurance v Propofol version 2 Dr S Hickey 18.10.05 18.05.05

05/S0709/125 SSA EC2

05/S0501/50

A phase II SABER – Bupivacaine study in open hernia repair (02/02/05) Prof P O’Dwyer 18.10.05 18.10.05

05/S0709/126 SSA EC2

03/2/079

Penile carcinoma chemotherapy study – EORTC 30992 Dr J Graham 18.10.05 18.10.05

05/S0703/129 EC1

Recurrent paediatric epistaxis cautery & Naseptin v Naseptin (1.0) Mr H Kubba 01.11.05 07.03.06

05/S0703/130 EC1

Genomic analysis of Isosorbide induced labour Dr S M Nelson 01.11.05 01.11.05

05/S0703/131 EC1

NUMBER NOT USED

05/S0703/132 EC1

Extrapleural apical haematoma and brachial plexus injury Mr T E Hems 01.11.05 01.11.05

05/S0703/133 EC1

Dental submission – see separate sheet

34

05/S0703/134 EC1

Randomised study comparing standard version computer assisted TKR Mr F Picard 01.11.05 06.12.05

05/S0703/135 EC1

Assessing cardiac damage after treatment for lymphoma v1.0 Dr N O’Rourke 01.11.05 Not Approved

05/S0703/136 SSA EC1

05/Q0104/92

Epothilone in ovarian cancer study Dr N Reed 01.11.05 01.11.05

05/S0703/137 SSA EC1

05/MRE04/74

Phase 3 BAY 43-9006 (Sorafenib) protocol 1194 v 1.5 14 July 2005 Dr J Graham 01.11.05 01.11.05

05/S0703/138 EC1

Dental submission – see separate sheet

05/S0703/139 SSA EC1

GTAC113

G0029-CG1940&CG8711 vs docetaxel and prednisolone in HRPC pts 24Jun05

Dr J Graham 01.11.05 01.11.05

05/S0709/127 EC2

Assessment of c-kit and AP-2 alpha in ocular melanocyctic lesions Dr F Roberts 15.11.05 15.11.05

05/S0709/128 EC2

NUMBER NOT USED

05/S0709/129 EC2

HPV and SCC in organ transplant recipients Dr L J Mackintosh 15.11.05 15.11.05

05/S0709/130 EC2

Dyspnoea in acute heart failure: cause and objective measures? Dr A Murphy 15.11.05 15.11.05

05/S0709/131 EC2

Patient attitudes associated with stopping tamoxifen treatment Ms L Whitnall-Pate 15.11.05 15.11.05

05/S0709/132 EC2

Phase IIa VR040 in Parkinson’s disease Dr D Grosset 15.11.05 20.12.05

05/S0709/133 SSA EC2

05/MRE05/72

Calcipotriol/betamethasone gel in psoriasis 17 Aug 2005 Dr D Burden 15.11.05 15.11.05

05/S0703/140 EC1

Young fathers 1 Prof M Hill 06.12.05 Not approved

35

05/S0703/141 SSA EC1

05/MRE05/75

Gemcitabine/Cisplatin +/- PF3512676 in adv non small cell lung cancer Dr D Dunlop 06.12.05 06.12.05

05/S0703/142 SSA EC1

05/Q0301/52

Phase I study of Tarceva (Erlotinib) in patients with NSCLC who smoke Dr D Dunlop 06.12.05 06.12.05

05/S0703/143 EC1

A multi centre double blind randomised study to established the clinical benefit and safety of Vytorin (Ezetimibe/Simvastain tablet) vs Simvastatin monotherapy in high-risk subjects presenting with acute coronary syndrome (IMProved Reduction of Outcomes : Vytorin efficacy international trial – IMPROVE IT)

Dr A Brady 06.12.05 07.03.06

05/S0703/144 EC1

EFC5505 version EO3 10th August 2004 Prof J Cassidy 06.12.05 06.12.05

05/S0703/145 EC1

A comparison of myocardial protection using Sevoflurine or TEA Dr M McCormick 06.12.05 06.12.05

05/S0703/146 EC1

Co-stimulatory molecules in RA Dr G Sandilands 06.12.05 06.12.05

05/S0703/147 EC1

Vancomycin prohylaxis Dr A R Binning 06.12.05 06.12.05

05/S0703/148 SSA EC1

05/MRE0/86

Long term clinical follow up and MRI imaging in the REST trial Dr J Moss 06.12.05 06.12.05

05/S0703/149 SSA EC1

03/7/029

AZURE trial version 3 Dr D Ritchie 06.12.05 06.12.05

05/S0703/150 SSA EC1

02/2/094

Familial prostate cancer Dr M Russell 06.12.05 06.12.05

05/S0703/151 EC1

Testing “lamellosome” with sputum from cystic fibrosis subjects Dr S Bicknell 06.12.05 06.12.05

05/S0709/134 EC2

Patient maintained sedation with propofol in healthy volunteers Dr S Allan 20.12.05 20.12.05

05/S0709/135 EC2

Examining and understanding spiritual care in palliative care Mrs K F Nelson 20.12.05 20.12.05

36

05/S0709/136 EC2

See Dental Submission – see separate sheet

05/S0709/137 EC2

Aspirin resistance and mircoemboli Dr J Dawson 20.12.05 20.12.05

05/S0709/138 EC2

Oxidative stress and risk of coronary stent thrombosis Dr J Watt 20.12.05 20.12.05

05/S0709/139 SSA EC2

05/S0501/82

Bosentan effects in operable forms of CTEPH Prof A Peacock 20.12.05 20.12.05

05/S0709/140 SSA EC2

03/6/079

PARSPORT Dr G Robertson 20.12.05 20.12.05

05/S0709/141 SSA EC2

05/S0705/83

CALYPSO : Second line trial in platinum sensitive ovarian cancer V.1. Dr N Reed 20.12.05 20.12.05

05/S0709/142 SSA EC2

05/S0705/83

Perceptions of participants of a CBPP version 1 Miss L Gorman 20.12.05 20.12.05

05/S0709/143 EC2

Epstein Barr virus and multiple sclerosis version 1 Dr S Webb 20.12.05 20.12.05

05/S0709/144 EC2

Souble biomarker of endometriosis Dr D Howe 20.12.05 07.03.06

05/S0709/145 SSA EC2

05/MRE10/93

The PERFORM study – secondary prevention in stroke version 1 Prof K Lees 20.12.05 20.12.05

06/S0703/1 EC1

NUMBER NOT USED

06/S0703/2 EC1

Comparsion botox versus dysport pilot study

Dr N Lowe 10.01.06 07.03.06

37

06/S0703/3 EC1

Botox versus dysport in patients with severe glabella rhytidis

Dr N Lowe 10.01.06 07.03.06

06/S0703/4 EC1

Efficacy and safety of strontium ranelate versus placebo on knee OAEffic

Prof T Spector 10.01.06 07.03.06

06/S0703/5 EC1

MRI validation study (V1)

Prof T Spector 10.01.06 10.01.06

06/S0703/6 EC1

Breath ethane as measure of oxidant stress in renal failure patients Dr P G Shiels 10.01.06 10.01.06

06/S0703/7 EC1

Tight neckties and Cerebrovascular reactivity Dr C Harrow 10.01.06 10.01.06

06/S0703/8 EC1

Randomised trial of preoperative sildenafil in children – version 1 Mr T Vassalos 10.01.06 10.01.06

06/S0703/9 EC1

Genomic regulation of adrencortical function Prof J Connell 10.01.06 10.01.06

06/S0703/10 SSA EC1

05/Q1605/125

Pregabalin in subjects with post traumatic peripheral neuropathic pain Dr M Serpell 10.01.06 10.01.06

06/S0709/1 EC2

Patients attitudes to cannabis used for the treatment of chronic pain (1 Dr M Serpell 17.01.06 Withdrawn by Investigator

06/S0709/2 EC2

Accessing cardiac damage after treatment for lymphoma Dr N O’Rourke 17.01.06 17.01.06

06/S0709/3 EC2

Parental glutamine in alcoholic hepatitis tolerance study

Dr N Rajoriya 17.01.06 23.02.06

06/S0709/4 EC2

Incidence of osteoporosis following breast cancer treatment Miss J Doughty 17.01.06 17.01.06

06/S0709/5 SSA EC2

06/S1402/11

IL-6 and CFS patients version 1 Prof M Nimmo 17.01.06 Withdrawn by Investigator

06/S0709/6 SSA EC2

05/MRE05/70

Epleranone v placebo in NYHA class II chronic systolic heart failure

Dr M Barlow 17.01.06 17.01.06

38

06/S0709/7 EC2

Humour use in CNS-patients interactions and their respective peer group Ms M McCreaddie 17.01.06 17.01.06

06/S0709/8 EC2

New emerging pathogens discovery version 1

Dr W Carman 17.01.06 21.02.06

06/S0709/9 SSA EC2

03/5/076

UK National Acromegaly database Prof J Connell 17.01.06 17.01.06

06/S0709/10 SSA EC2

05/Q104/16

TRIUMPH 1 : Treprostinil inhalation used in the management of PAH Prof A Peacock 17.01.06 17.01.06

06/S0703/11 EC1

Hip study 1 Prof M Bassendine 07.02.06 04.07.06

06/S0703/12 EC1

High dose oral diurectics in heart failure Dr G Padfield 07.02.06 04.04.06

06/S0703/13 EC1

Circulating tumour cells in patients receiving neoadjuvant chemotherapy Dr J Graham 07.02.06 07.02.06

06/S0703/14 EC1

Does an educational programme improve patients understanding of steroid therapy in a clinic population

Dr K Hughes 07.02.06 07.02.06

06/S0703/15 EC1

Assessment of the effectiveness of PDT as a treatment for ARMD Dr S Parks 07.02.06 04.04.06

06/S0703/16 EC1

Telephone triage nursing and stress version 1.0 Mr H Szuster 07.02.06 07.02.06

06/S0703/17 SSA EC1

05/MRE03/87

Long term safety of tadalafil vs placebo for treatment in pulmonary arterial hypertension

Prof A Peacock 07.02.06 07.02.06

06/S0703/18 SSA EC1

05/MRE03/86

Tadalafil vs placebo for treatment in pulmonary arterial hypertension Prof A Peacock 07.02.06 07.02.06

06/S0703/19 SSA EC1

05/Q0501/205

A 3 arm randomised study in hormone resistant prostate cancer Dr J Graham 07.02.06 07.02.06

06/S0703/20 SSA EC1

OLYMPIA registry Dr K Oldroyd 07.02.06 Not approved by Main REC

39

06/Q0703/206 06/S0703/21 SSA EC1

06/Q1702/13

SYNTAX-LE-MANS Dr K Oldroyd 07.02.06 07.02.06

06/S0703/22 SSA EC1

05/S501/106

MRC SUPREMO TRIAL Dr P Canney 07.02.06 07.02.06

06/S0703/23 EC1

Cuffed v uncuffed tracheal tube in small children

Dr M Weiss 07.02.06 07.02.06

06/S0703/24 EC1

Survey of chronic pain following donor nephrectomy (Version 1, 16/1/06)

Dr M Serpell 07.02.06 07.02.06

Project No

Status

Brief Title Chief Investigator Date on Agenda

Date of Approval

06/S0709/11 EC2

Variation in response to antiplatelet therapy in PCI patients

Dr R I S Good 21.02.06 21.02.06

06/S0709/12 EC2

Rhythm and intonation in ataxic dysarthria version 1

Dr A Lowit 21.02.06 21.02.06

06/S0709/13 EC2

Dental Submission – see separate sheet

06/S0709/14 SSA EC2

05/Q2404/213

Phase II study to compare efficacy of ADZ2171 with Bevacizumab Prof J Cassidy 21.02.06 21.02.06

06/S0709/15 SSA EC2

05/Q0201/51

An open label study of Zonegran TM (Zonisamide) in patients with partial onset seizures

Prof M J Brodie 21.02.06 21.02.06

06/S0709/16 SSA EC2

05/MRE03/78

Study in refractory epilepsy 19th Aug 2005 Prof M J Brodie 21.02.06 21.02.06

06/S0709/17 SSA EC2

04/0/031

Superficial femoral artery stent versus angioplasty trial Dr J Moss 21.02.06 21.02.06

06/S0709/18 SSA EC2

A phase II study of E7389 in patients with metastatic breast cancer

Dr M Rizwanullah 21.02.06 21.02.06

40

06/MRE08/5 06/S0709/19 SSA EC2

05/S0501/49

XERES Dr A McDonald 21.02.06 21.02.06

06/S0709/20 EC2

NUMBER NOT USED

06/S0709/21 EC2

Propofol effect site concentration and sedation score (V2)

Dr A M R M Barakat 21.02.06 21.02.06

06/S0709/22 EC2

Epidural vs femoral/sciatic block TKR (V4) Dr A R Barakat 21.02.06 21.02.06

06/S0709/23 SSA EC2

06/MRE10/15

Protocol CR-1039797 – One Touch® Ultra® 2 outcome study 20th January 2006

Dr G M Crawford 21.02.06 21.02.06

Project No

Status

Brief Title Chief Investigator Date on Agenda

Date of Approval

06/S0709/24 SSA EC2

05/S0501/99

Pre-operative letrozole treatment in postmenopausal breast cancer

Miss J C Doughty 21.02.06 21.02.06

06/S0709/25 SSA EC2

05/Q0501/157

Infliximab vs methotrexate in psoriasis (06 May 2005) Dr D Burden 21.02.06 21.02.06

06/S0709/26 EC2

Gene expression and protein levels in human osteo-arthritis tissue Mr A W E Kinnonmonth 21.02.06 21.02.06

06/S0703/25 EC1

To evaluate the effect of roflumilast in COPD patients. Final version 8 Prof W MacNee 07.03.06

07.03.06

06/S0703/26 EC1

Allocated in error by CAS to this Committee for review. The submission has now been transferred to South West MREC

06/S0703/27 EC1

A phase IIa study of TA-5538 for the treatment of overactive bladder Mr C Chapple 07.03.06 06.06.06

06/S0703/28 EC1

Comparison of DCE-MRI and DCE-CT in bladder cancer Dr D Buckley 07.03.06 07.03.06

41

06/S0703/29 EC1

Number not used Withdrawn by investigator

06/S0703/30 EC1

RACE(s) – Radiation complications and epidemiology (supplement) version 1

Prof J Yarnold 07.03.06 07.03.06

06/S0703/31 SSA EC1

04/Q0603/1

The ASPECT trial Mr G Fullerton 07.03.06 07.03.06

06/S0703/32 SSA EC1

05/Q2803/137

Protocol No 01-04-TL-242-011 version :Incl Amdt Date 22 Jul 05 Dr A R Binning 07.03.06 07.03.06

06/S0703/33 SSA EC1

06/Q1205/45

GW679769 for prevention of post-operative nausea and vomiting Dr A R Binning 07.03.06 07.03.06

06/S0703/34 SSA EC1

05/Q0104/109

GERICO Dr N Mohammed 07.03.06 07.03.06

06/S0703/35 SSA EC1

05/Q1205/149

Ntegra study 100103-2 Dr R Fox 07.03.06 07.03.06

06/S0703/36 SSA EC1

06/Q2404/9

Food effects on single dose PK and repeat dose ADZ2171 phase II study

Prof T R J Evans 07.03.06 07.03.06

06/S0709/27 EC2

Seroma formation and management after breast cancer surgery version 1

Mrs M Sneddon 21.03.06 21.03.06

06/S0709/28 SSA EC2

06/Q1205/10

BTDS in elderly subjects with QA pain (BUP4004) version 1 0 22-Nov-05

Dr M Serpell 21.03.06 Not approved by Main REC

06/S0709/29 SSA EC2

06/MRE05/4

The MAX study version 5.0/10 August 2005 Prof J Cassidy 21.03.06 21.03.06

06/S0709/30 SSA EC2

05/MRE06/79

1160.26 RELY study Prof G McInnes 21.03.06 21.03.06

42

06/S0709/31 SSA EC2

06/MRE02/20

Study of aldesleukin with or without antiretroviral therapy

Dr R Fox 21.03.06 21.03.06

06/S0709/32 SSA EC2

05/MRE00/95

Generic consent for use of haematology data and residual tissue Dr R Soutar 21.03.06 21.03.06

06/S0709/33 SSA EC2

05/MRE08/82

Effect of sulodexide in patients with type 2 DM & microalbuminuria Dr A Jardine 21.03.06 21.03.06

06/S0709/34 SSA EC2

05/MRE08/88

Effect of sulodexide in overt type 2 diabetic nephropathy, Ukamend2 V9 Dr A Jardine 21.03.06 21.03.06

06/S0709/35 SSA EC2

06/MRE10/7

H6Q-MULTI-CENTRE-JCBF : Protocol version 01 November 2005 Dr A James 21.03.06 21.03.06

06/S0709/36 SSA EC2

05/MRE09/84

NCRI AML 16 trial Dr P McKay 21.03.06 21.03.06

06/S0709/37 SSA EC2

03/12/062

SHIELD STUDY : Original version 2.2 : Copied to version 4 Dr P McKay 21.03.06 21.03.06

06/S0709/38 EC2

PCEA in cardiac surgery v1 Dr A Barakat 21.03.06 21.03.06

06/S0709/39 EC2

Young fathers 2 Prof M Hill 21.03.06 21.03.06

06/S0709/40 SSA EC2

01/7/057

MRC CLL V Trial Dr P McKay 21.03.06 21.03.06

06/S0709/41 SSA EC2

Denosumalo AMG 162, 20050147 Dr D Dodds 21.03.06 21.03.06

43

06/MRE03/14 06/S0709/42 SSA

EC2 06/MRE08/22

Genetic screening for susceptibility to abacavir hypersensitivity v2 Dr R Fox 21.03.06 21.03.06

06/S0709/43 EC2

Study of investigate new insulin injection systems v1 Prof A T Elliot 21.03.06 21.03.06

06/S0709/44 SSA EC2

04/S0802/121

Outcome after transposed intestinal segment surgery in bladder cancer Mr I G Conn 21.03.06 21.03.06

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North Glasgow Division

Glasgow Dental School & Hospital 2005/06 Index of Protocols (Committees 1 & 2) April 2005 to April 2006

Project No

Status

Brief Title

Chief Investigator

Date on Agenda

Date of

Approval 05/S0703/43

EC1 Pets and human MRSA infection V1 Dr M Abu-Serriah 05.04.05 Not

approved 05/S0703/37 SSA EC2

04/Q1205/45

Dental trauma : the role of an internet based computer database part 2

Prof R Welbury 19.04.05 19.04.05

05/S0703/58 EC1

Bacteria involved in prosthetic hip joint infections Mr M P Riggio 03.05.05 03.05.05

05/S0709/75 SSA EC2

04/Q1206/144

Dental trauma :- the role of a internet based computer database part 1

Prof R Welbury 21.06.05 21.06.05

05/S0709/81 EC2

Assessment of residual deformities in cleft lip and palate patients

Prof A Ayoub 19.07.05 20.09.05

05/S0703/81 EC1

CleftNet UK Prof F Gibbon 02.08.05 04.10.05

05/S0709/92 EC2

Oral health risk assessment 01 Mr S Turner 16.08.05 16.08.05

46

05/S0709/110 EC2

Preventing oral cancer : Smoking cessation in a dental setting

Dr V Binnie 20.09.05 20.09.05

05/S0703/122 EC1

The use of rhBMP-7 for alveolar reconstruction Prof A Ayoub 04.10.05 01.11.05

05/S0703/133 EC1

The role of radiographs in orthodontics Mr C Lennox 01.11.05 01.11.05

05/S0703/138 SSA EC1

05/S0705/70

Oral complications in non-smokers with type 1 diabetes mellitus ver1

Dr P Hodge 01.11.05 01.11.05

Glasgow Royal Infirmary LREC 1

Annual Report

1 April 2005 – 31 March 2006

Name of REC: Glasgow Royal Infirmary LREC 1

Type of REC (E.g., Recognised, Type II) and Description of Type: Non-Recognised Chair: Dr Brian Neilly Vice-Chair: Dr Philip Owen Alternative Vice-Chair: Dr Ken James Co-ordinator: Mrs Sharon Macgregor Committee Address: 4th floor, Walton Building Glasgow Royal Infirmary 84 Castle Street GLASGOW G4 0SF Telephone: 0141 211 4020 Facsimile: 0141 232 0752 Email: �[email protected]

mailto:

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50

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Composition

Dates Name Occupation Expert or

Lay Appointed Resigned

Mr Antonio Aguila Assistant Researcher Expert Sept 2004 - Mr Michael Bromby Research Fellow Lay Apr 2003 - Dr Kenneth James Consultant Anaesthetist Expert Oct 2003 - Mrs Anne Lee Pharmacist Expert Dec 2000 June 2005Dr Grace Lindsay Reader in Nursing Research Expert May 2003 - Dr Una Macleod GP Expert Aug 2001 June 2005 Dr Claire McDougall Clinical Research Fellow Expert Feb 2003 Aug 2005 Mrs Cynthia Mendelsohn Retired Lay Aug 2002 - Dr David Moffat Consultant Pathologist Expert May 2002 Oct 2005 Mrs Jessica Murray Retired Teacher Lay Aug 2003 June 2005Dr Brian Neilly Consultant Physician Expert Mar 99 - Dr Philip Owen Consultant Obstetrician &

Gynaecologist Expert Nov 2002 -

Dr Jackie Riley Statistician Expert Mar 2002 - Dr Peter Thomson Research Fellow Expert Dec 2005 - Mr Kenneth Tomory Chartered Accountant Lay Aug 2003 Oct 2005 Mrs Janice Watt Principal Pharmacist Expert July 2005 - Mr Iain Wright Consultant Engineer Lay Aug 2003 -

Training 2005/6 Name of Member Date Event(s) attended Mr Antonio Aguila 25th April 2005 NHS Greater Glasgow (Keele) Induction Training 23rd May 2005 NHS Greater Glasgow Continuing Training Mr Michael Bromby 25th April 2005 NHS Greater Glasgow (Keele) Induction Training 23rd May 2005 NHS Greater Glasgow Continuing Training Mrs Cynthia Mendelsohn 25th April 2005 NHS Greater Glasgow (Keele) Induction Training 23rd May 2005 NHS Greater Glasgow Continuing Training Dr David Moffat 23rd May 2005 NHS Greater Glasgow Continuing Training Dr Brian Neilly 23rd May 2005 NHS Greater Glasgow Continuing Training Dr Jackie Riley 23rd May 2005 NHS Greater Glasgow Continuing Training Mr Kenneth Tomory 23rd May 2005 NHS Greater Glasgow Continuing Training Mr Iain Wright 23rd May 2005 NHS Greater Glasgow Continuing Training

M ti f F ll Ethi l R i 2005 2006

Month Date Number of Members Present at Meeting April 01/04/2005 9 June 03/06/2005 7 August 05/08/2005 8 September 02/09/2005 10 October 07/10/2005 9 November 04/11/2005 8 December 02/12/2005 9 January 13/01/2006 8 February 03/02/2006 9 March 03/03/2006 10 Meetings cancelled: Month Date May 06/05/2005 July 01/07/2005 Attendance of Members 2005/6 Name Number of Meetings

Attended Mr Iain Wright 10

53

Mrs Cynthia Mendelsohn 9 Dr Brian Neilly 8 Dr Kenneth James 8 Mrs Janice Watt 8 Dr Philip Owen 8 Mr Michael Bromby 7 Dr Jackie Riley 7 Dr Grace Lindsay 6 Dr David Moffat 4 Dr Peter Thomson 3 Mr Kenneth Tomory 3 Mr Antonio Aguila 1

Number of inquorate meetings held: none

54

P t T A li ti d lt ith i 2005 2006

S f W k T 2005 2006

S f D i i M d 2005 2006

Studies for Full Ethical Review – Type Number % Clinical Trial of Investigational Medicinal Product 0 0.00 Phase 1 0 0.00 Student Study 15 23.08 Other Types of Study 47 76.93 Total Studies Reviewed 65 100% Number of Studies Transferred in from other sites 1 Site Specific Assessment 39 All Studies for Full Ethical Review FavourableOpinion at initial meeting

Favourable Opinion following Provisional

Unfavourable Opinion

Unfavourable Opinion following Provisional

Withdrawn Other Total Number

9 38 4 0 9 5 65 13.85% 58.46% 6.15% 0.00% 13.85% 7.69% 100%

55

Average Number of Studies Reviewed per Full Meeting 2 Number of Studies for Full Ethical Review Over 60 Days 2 Number of Days Taken to Final Decision Mean Average 34 Number of Days Taken to Final Decision Mode 0 Number of SSAs Reviewed 39 Number of Studies for SSA Review Over 25 Days 4 Number of Studies for SSA Review Over 25 Days as % of all SSAs 10.26%

04/S0704/19

LGJ versus Endoscopic Stenting of Malignant Gastric Outlet Obstruction

Further Information Favourable Opinion

34

04/S0704/70

Comparison of hard bearing hybrid and surface hip replacement Further Information Favourable Opinion

19

05/S0704/4

Radiofrequency ablation in pancreatic cancer (version 2) Further Information Favourable Opinion

54

05/S0704/11

Understanding Suicidality: An Intergative Model Further Information Favourable Opinion

55

05/S0704/15

A pilot study to assess telomerase as a therapeutic target in CLL Further Information Favourable Opinion

31

05/S0704/22

Determinants of breastfeeding outcome Further Information Favourable Opinion

26

05/S0704/23

Injection Salvage of Collapsed Post-Mastectomy Nipple Reconstruction:1


120

05/S0704/24

Physical activity monitoring Further Information Favourable Opinion

38

05/S0704/25

Version 2- Spatio temporal imaging correlation of the foetal heart. Further Information Favourable Opinion

43

05/S0704/26

Cytokines in Giant Cell Arteritis Further Information Favourable Opinion

113

05/S0704/27

Stroke (Educational) Needs Analysis in Glasgow - version 1 Not requiring review by NHS REC 8

05/S0704/31

Reference ranges for red cell trace elements and serum ceruloplasmin


24

05/S0704/30

An audit of the use of the Glasgow screening tool by researchers Not requiring review by NHS REC 14

05/S0704/36

Performance of Oxygen Masks in Simulated Respiratory Failure Further Information Favourable Opinion

16

05/S0704/45

Measurement of plasma interleukin-6 in neonates. Version 1 Further Information Favourable Opinion

22

05/S0704/47

Evaluation of Antenatal HIV Screening Programme in NHSGG Further Information Favourable Opinion

26

Annual Report Page 57

05/S0704/50

Mature follicle metabolism: size and age Further Information Favourable Opinion

38

05/S0704/52

The use of service with young men with alcohol problems Withdrawn by REC

05/S0704/54

Fumarate hydratase mutations in uterine fibroids Further Information Favourable Opinion

34

05/S0704/55

Leukocyte activation in parturition Further Information Favourable Opinion

25

05/S0704/56

Multidisciplinary Teams Further Information Favourable Opinion

44

05/S0704/57

Acetabular bone grafting substitutes in revision hip surgery Withdrawn by Researcher 46

05/S0704/58

The Significance of Perineural Invasion in Rectal Adenocarcinoma Favourable Opinion 30

05/S0704/59

Genomic Analysis of Isosorbide Mononitrate Induced Labour Withdrawn by REC 30

05/S0704/60

in vitro bioactivity of a novel immunomodulator Further Information Favourable Opinion

34

05/S0704/66

Recruitment to Haemato-oncology Clinical Trials Further Information Favourable Opinion

40

05/S0704/67

Vernix and meconium screening in drug misuse Further Information Favourable Opinion

21

05/S0704/69

High resolution data acquisition and quantitative data analysis v1 Unfavourable Opinion 16

05/S0704/70

Measurement of toe joint angles in rheumatoid disease Further Information Favourable Opinion

22

05/S0704/71

Study of prevalence of occult adrenal suppression in primary care Invalid Application 10

05/S0704/72

Plasma bank from non-pregnant women Unfavourable Opinion 28

05/S0704/73

Binding by ajp to anti TB drugs Withdrawn by REC


05/S0704/79

To compare traditional method of wound assessment/wound recording

Not requiring review by NHS REC 11

05/S0704/80

Incidence and prevalence of foot problems in Psoriatic Arthritis Not requiring review by NHS REC 11

05/S0704/81

The prevalence of foot problems and deformities Further Information Favourable Opinion

22

05/S0704/82

Oesophageal Volume Research Further Information Favourable Opinion

43

05/S0704/83

Assessment of new disinfectant in reducing MRSA infection Further Information Favourable Opinion

42

05/S0704/84

Venous invasion in colorectal carcinoma. Favourable Opinion 20

05/S0704/85

High resolution data acquisition and quantitative data analysis v2 Favourable Opinion 27

05/S0704/89

Role of HER Family and Heregulin in Prostate Adenocarcinoma Further Information Favourable Opinion

56

05/S0704/90

RFA for AF in advanced CHF Further Information Favourable Opinion

42

05/S0704/91

Hyperprolactinaemia in patients taking risperidone depot (Consta) Unfavourable Opinion 27

05/S0704/92

Evaluation of ECG criteria for left ventricular hypertrophy Favourable Opinion 28

05/S0704/93

Perceptions of palliative care nurses of supporting bereaved children Withdrawn by REC

05/S0704/94

Expectation of patients in breast return clinic. Version 1.0 Further Information Favourable Opinion

32

05/S0704/95

Comparative Urinalysis: Women with SUI Vs women without Further Information Favourable Opinion

24

05/S0704/96

Coronary Care Nurses Perceptions Of Caring For Suddenly Bereaved Further Information Favourable Opinion

31

05/S0704/101

Social Deprivation In Patients Admitted For Induction Of Labour. Further Information Favourable Opinion

35


06/S0704/1

Perioperative fasting in adults Favourable Opinion 29

06/S0704/2

Magnetic Moment Imaging study of tablets taken with and without food


33

06/S0704/3

Human sweat gland function after botox injections Further Information Favourable Opinion

43

06/S0704/5

VEPs in methadone exposed babies Favourable Opinion 29

06/S0704/6

Molecular Epidemiology of Pneumococcal Carriage in Bolivia 1. Favourable Opinion 14

06/S0704/ 7

Molecular Epidemiology of Pneumococcal Carriage in Central Thailand 1.

Favourable Opinion 14

06/S0704/15

Stage of readiness and adherence to back class programme. Unfavourable Opinion 22

06/S0704/16

Compliance with advice after mild traumatic brain injury Further Information Favourable Opinion

23

Student Studies (already listed above) 05/S0704/25

Version 2- Spatio temporal imaging correlation of the foetal heart. Further Information Favourable Opinion

43

05/S0704/50

Mature follicle metabolism: size and age Further Information Favourable Opinion

38

05/S0704/56

Multidisciplinary Teams Further Information Favourable Opinion

44

05/S0704/69

High resolution data acquisition and quantitative data analysis v1 Unfavourable Opinion 16

05/S0704/70

Measurement of toe joint angles in rheumatoid disease Further Information Favourable Opinion

22

05/S0704/79

To compare traditional method of wound assessment/wound recording

Not requiring review by NHS REC 11

05/S0704/ Incidence and prevalence of foot problems in Psoriatic Arthritis Not requiring review by NHS REC 11


80 05/S0704/81

The prevalence of foot problems and deformities Further Information Favourable Opinion

22

05/S0704/85

High resolution data acquisition and quantitative data analysis v2 Favourable Opinion 27

05/S0704/92

Evaluation of ECG criteria for left ventricular hypertrophy Favourable Opinion 28

05/S0704/95

Comparative Urinalysis: Women with SUI Vs women without Further Information Favourable Opinion

24

05/S0704/96

Coronary Care Nurses Perceptions Of Caring For Suddenly Bereaved Further Information Favourable Opinion

31

05/S0704/101

Social Deprivation In Patients Admitted For Induction Of Labour. Further Information Favourable Opinion

35

06/S0704/1

Perioperative fasting in adults Favourable Opinion 29

06/S0704/15

Stage of readiness and adherence to back class programme. Unfavourable Opinion 22

SSAs over 25 day Timeline 05/S0702/62

Specific cytokine blockade: a role in the treatment of depression? No Objection 28

05/MRE01/93

Omalizumab in severe, allergic asthma - August 05 No Objection 28

05/MRE05/76

ARCHIPELAGO Revised protocol number 1 Oct 6th 2005 No Objection 30

06/S0709/3

Parenteral glutamine in alcoholic hepatitis tolerance study No Objection 30


Glasgow Royal Infirmary LREC 2

Annual Report

1 April 2005 - 31 March 2006


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Name of REC: Glasgow Royal Infirmary LREC (2)

Type of REC (E.g., Recognised, Type II) and Description of Type: Non-recognised Chair: Dr Malcolm Booth Vice-Chair: Dr Miles Fisher Alternative Vice-Chair: Mr Colin McKay Co-ordinator: Mrs Sharon Macgregor Committee Address: 4th floor, Walton Building Glasgow Royal Infirmary 84 Castle Street GLASGOW G4 0SF Telephone: 0141 211 4020 Facsimile: 0141 232 0752 Email: [email protected]

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REC M b hi

Dates Name Occupation Expert or

Lay Appointed Resigned

Dr Malcolm Booth Consultant in Anaesthesia & Intensive Care

Expert July 2000 -

Dr Miles Fisher Consultant Physician Expert Aug 2001 - Dr Helen Lyall Consultant Gynaecologist Expert Mar 2002 - Miss Fiona Mackelvie Helpline Advisor Lay Sept 2003 - Mr Julian May Company Director Lay Apr 2003 - Ms Margaret McDonald Administrative Officer Lay Apr 2003 - Mr Angus McFadyen Statistician Expert Apr 2003 - Mr Colin McKay Senior Lecturer in Surgery Expert Aug 2002 - Mrs Fiona McMillan Lead Pharmacist Clinical

Governance Expert Aug 2003 Sept 2005

Dr Anne Parker Consultant Haematologist Expert Oct 2003 - Dr Fatwui Poon Consultant Radiologist Expert Apr 2003 - Mrs Kathleen Tuck Retired Teacher Lay Oct 2005 - Mr Sandy Weatherhead Retired Lawyer Lay Mar 1999 -

T i i 2005 2006

Name of Member Date Event(s) attended Miss Fiona Mackelvie 25th April 2005 NHS Greater Glasgow (Keele) Induction Training Mr Julian May 23rd May 2005 NHS Greater Glasgow Continuing Training Ms Margaret McDonald 23rd May 2005 NHS Greater Glasgow Continuing Training Dr Anne Parker 25th April 2005 NHS Greater Glasgow (Keele) Induction Training 23rd May 2005 NHS Greater Glasgow Continuing Training Dr Fatwui Poon 23rd May 2005 NHS Greater Glasgow Continuing Training Mr Sandy Weatherhead 23rd May 2005 NHS Greater Glasgow Continuing Training


M ti f F ll Ethi l R i 2005 2006

Att d f M b 2005 2006

Month Date Number of Members Present at Meeting April 15/04/2005 8 May 20/05/2005 9 August 19/08/2005 7 October 21/10/2005 7 December 16/12/2005 10 February 17/02/2006 8 Meetings cancelled: June 17/06/2005 July 15/07/2005 September 16/09/2005 November 18/11/2005 January 27/01/2006 March 17/03/2006 Name Number of Meetings

Attended Mr Julian May 6 Dr Miles Fisher 5 Mr Angus McFadyen 5


Mr Sandy Weatherhead 5 Ms Margaret McDonald 5 Miss Fiona Mackelvie 5 Dr Anne Parker 5 Dr Malcolm Booth 4 Dr Fatwui Poon 3 Mrs Kathleen Tuck 2 Mr Colin McKay 1 Mrs Fiona McMillan 1 Dr Helen Lyall 0 (on Leave) Number of inquorate meetings held: none


P t T A li ti d lt ith i 2005 2006

S f W k T 2005 2006

S f D i i M d 2005 2006

Studies for Full Ethical Review – Type Number % Clinical Trial of Investigational Medicinal Product 0 0.00 Phase 1 0 0.00 Student Study 11 26.83 Other Types of Study 29 73.17 Total Studies Reviewed 41 100% Number of Studies Transferred in from other sites 5 Site Specific Assessment 32 All Studies for Full Ethical Review FavourableOpinion at initial meeting

Favourable Opinion following Provisional

Unfavourable Opinion

Unfavourable Opinion following Provisional

Withdrawn Other Total Number

3 22 6 0 7 3 41 7.32% 53.66% 14.63% 0.00% 17.07% 7.32% 100%


Oth M t I f ti 2005 2006

Average Number of Studies Reviewed per Full Meeting 1 Number of Studies for Full Ethical Review Over 60 Days 0 Number of Studies Over 60 Days as a % of Total 0.00% Number of Days Taken to Final Decision Mean Average 53 Number of Days Taken to Final Decision Mode 15 Number of SSAs Reviewed 32 Number of Studies for SSA Review Over 25 Days 4 Number of Studies for SSA Review Over 25 Days as % of all SSAs 12.50%


04/S0705/27

Assessment of laryngeal view by POGO (percentage of glotic opening) Further Information Favourable Opinion

60

04/S0705/33

Follow-up study of the role of a stroke nurse specialist Withdrawn by REC

04/S0705/53

Functional rehabilitation after treatment of oral cancer Withdrawn by REC 25

04/S0705/55

The natural history of chronic pancreatitis Withdrawn by REC

05/S0705/5 Fabry disease screening Unfavourable Opinion 15 05/S0705/6 Genomic Analysis of Spontaneous Labour Further Information Favourable

Opinion 52

05/S0705/9 Do multidisciplines have positive views on each other Withdrawn by REC 05/S0705/18

Toll-Like Receptors in Parturition Further Information Favourable Opinion

52

05/S0705/25

Activity, as a predictor of survival in gastro-oesophageal cancer. Further Information Favourable Opinion

37

05/S0705/26

Adrenal function after discharge from an Intensive Care Unit (1) Further Information Favourable Opinion

36

05/S0705/27

The Psychological and Biological Determinants of Disease (pSoBid1) Unfavourable Opinion 15

05/S0705/28

Incremental change in IOP when changing drug therapy Not requiring review by NHS REC 16

05/S0705/29

Frequency and reasons for changes in therapy in POAG & OH Not requiring review by NHS REC 16

05/S0705/30

Fumarate hydratase mutations in uterine fibroids Unfavourable Opinion 15

05/S0705/32

Does inflammation predict outcome in gastro-oesophageal cancer? Favourable Opinion 16

05/S0705/33

Do antibodies to CCP have a role in identifying early RA patients Further Information Favourable Opinion

35

05/S0705/34

Use of staphylococcal antibodies in human sera to detect antigens Favourable Opinion 15


05/S0705/37

A comparison of the Glasgow NST with formal dietetic assessment Withdrawn by REC 42

05/S0705/39

The clinical application of radiofrequency ablation in breast cancer Further Information Favourable Opinion

54

05/S0705/40

Psychological and Biological Determinants of Disease-pSoBid1 Further Information Favourable Opinion

28

05/S0705/42

Investigation into the effects of acupuncture on muscle performance 1 Further Information Favourable Opinion

26

05/S0705/43

Xanthelasma and Cholesterol Withdrawn by REC 26

05/S0705/50

Acceptability of domestic abuse routine enquiry in maternity care Withdrawn by REC 14

05/S0705/64

Mothers' attributions of intellectually disabled offsprings' SIB v1 Further Information Favourable Opinion

42

05/S0705/65

Staff's inter-personal attributions of individuals with severe ID & CB Further Information Favourable Opinion

42

05/S0705/66

Biological implications of core biopsy in malignant breast tumours Further Information Favourable Opinion

38

05/S0705/67

Fabry disease screening Further Information Favourable Opinion

32

05/S0705/68

The role of the D6 chemokine receptor in cutaneous inflammation. Further Information Favourable Opinion

35

05/S0705/70

Oral complications in non-smokers with type 1 diabetes mellitus Ver 1 Further Information Favourable Opinion

29

05/S0705/76

Angiotensin II Receptor Profile in Peripheral Blood Monocytes.V1. Further Information Favourable Opinion

26

05/S0705/78

Specialist Palliative Care Nurses and Supporting Bereaved Children Further Information Favourable Opinion

24

05/S0705/79

What are the needs of lung cancer patients who have had surgery? Unfavourable Opinion 19

05/S0705/80

MJC 1 2005 - Version 1 Further Information Favourable Opinion

26


05/S0705/81

Exploration of reductions in smoking during pregnancy in Glasgow Unfavourable Opinion 18

05/S0705/82

Nurses perceptions of place of death for cancer patients Further Information Favourable Opinion

28

05/S0705/83

Perceptions of Participants of a CBPP Version 1 Further Information Favourable Opinion

31

06/S0705/4 Hyperglycaemia and vessel function Further Information Favourable Opinion

31

06/S0705/5 Skin gland function in patients with Sjogren's syndrome Unfavourable Opinion 16 06/S0705/6 Correlation of validated and self reported smoking status Further Information Favourable

Opinion 35

06/S0705/9 The effect of Atrialvenous Fistula formation on exercise cap Invalid Application

Student Studies (also listed above) 05/S0705/42

Investigation into the effects of acupuncture on muscle performance 1 Further Information Favourable Opinion

26

05/S0705/64

Mothers' attributions of intellectually disabled offsprings' SIB v1 Further Information Favourable Opinion

42

05/S0705/65

Staff's inter-personal attributions of individuals with severe ID & CB Further Information Favourable Opinion

42

05/S0705/76

Angiotensin II Receptor Profile in Peripheral Blood Monocytes.V1. Further Information Favourable Opinion

26

05/S0705/78

Specialist Palliative Care Nurses and Supporting Bereaved Children Further Information Favourable Opinion

24

05/S0705/79

What are the needs of lung cancer patients who have had surgery? Unfavourable Opinion 19

05/S0705/80

MJC 1 2005 - Version 1 Further Information Favourable Opinion

26

05/S0705/81

Exploration of reductions in smoking during pregnancy in Glasgow Unfavourable Opinion 18

05/S0705/82

Nurses perceptions of place of death for cancer patients Further Information Favourable Opinion

28


05/S0705/83

Perceptions of Participants of a CBPP Version 1 Further Information Favourable Opinion

31

06/S0705/6 Correlation of validated and self reported smoking status Further Information Favourable Opinion

35

SSAs over 25 day Timeline LREC/2003/1/23

Risk factors for venous ulcers No Objection 59

05/MRE10/88 Antithrombin(AT)Alfa in hereditary AT deficient patients version 1 No Objection 30 04/Q1206/84 CRx-150 in Rheumatoid Arthritis No Objection 28 05/S0709/144 Soluble Biomarker of Endometriosis No Objection 27


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South Glasgow Research Ethics Committee

Membership List

Name

Designation Mr Naeem Akhtar

Consultant Urologist

Mr Brian Beacom MBE

Lay Member

Mr Gerald Belton OBE (Chairman)

Lay Member

Mr Graeme Boyle

Lay Member

Mr Robert Burleigh

Lay Member

Dr James Curran

GP

Mr John Devitt

Lay Member

Mr Con Gillespie

Acting Senior Nurse Manager

Professor Donald Hadley

Consultant Neuroradiologist

Mr Tim Hems (Vice Chairman)

Consultant Surgeon

Mrs Christine Hogg

Lay Member

Dr Stephen Noble

Consultant Anaesthetist

Dr Deepa Singh

Consultant Anaesthetist

Dr Alison Thomson

GP Principal

Mrs Fiona Walker

Pharmacy Manager


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South Glasgow REC - Record Of Attendance 2005-2006 Name

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Jan

Feb

Mar

Meetings Attended

Mr N Akhtar

A

A

R

R

R

R

A

A

A

A

R

6

Mr B Beacom MBE

A

R

R

A

A

R

A

A

R

R

R

5

Mr G Belton OBE (Chairman)

A

R

A

R

A

A

A

R

A

A

A

8

Mr G Boyle

R

R

R

R

R

R

R

R

R

X

R

0

Mr R Burleigh

A

A

A

A

R

A

A

R

A

A

A

9

Dr J Curran

R

A

A

A

R

R

A

A

A

R

A

7

Mr J Devitt

A

R

A

A

R

A

A

A

A

R

A

8

Mr C Gillespie

A

R

R

A

A

R

R

R

X

A

R

4

Professor D Hadley

A

A

R

A

R

A

A

A

A

A

A

9

Mr T Hems (Vice Chairman)

A

A

A

A

A

A

A

A

R

A

A

10

Mrs C Hogg

R

A

A

A

R

A

A

R

A

A

R

7

Dr S Noble

R

R

R

R

A

A

A

A

A

A

A

7

Dr D Singh

R

A

R

R

A

A

A

R

A

R

R

5

Dr A J Thomson

A

A

A

R

R

A

A

A

A

A

A

9

Mrs F Walker

A

A

A

A

A

R

A

A

A

A

R

9

A = Attended R = Apologies Received X = Absent


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Summary of Submissions 2005

Research Proposals

Site Specific Assessments

Protocol Amendments

Other Business Items

26 April

3

8

0

6

31 May

6

6

3

7

28 June

9

4

1

2

26 July

6

5

4

12

30 August

7

5

1

7

29 September

6

5

1

4

25 October

2

3

0

2

29 November

6

5

0

5

2006 17 January

3

4

2

8

28 February

4

10

5

28 March

0

6

0

6

Totals

52

61

12

64



PRIMARY CARE DIVISION Co-ordinators Report Overall it again was a busy year for the Research Ethics Committees, as can been seen from the attached list of proposals. Whilst the new national system gained some consistency and stability, nevertheless, the application form itself and also the administration process were the subject of continual ongoing change creating a challenge for both researchers and Research Ethics Committees alike. As in previous years membership of both Committees remained fairly static although due to other outside influences there were a few resignations. Several new members were also welcomed on to the Committee. As ever we very much value the expertise and time commitment that the members so freely give to the ethical review process – without this the process simply would not be able to progress – we continue to be very grateful to them. Again as in the previous year PCD1 Committee continued to meet on the second Thursday of every month and PCD2 on the last Thursday of the month thereby allowing a cross over of proposals should this be necessary. The two Sub Committees also continue to meet in the alternative fortnight to review changes and when appropriate Site Specific Assessments. Thanks must also be extended to the researchers who patiently navigated the research ethics process and we wish them well with their endeavours. The Committee continue to review to extremely high standards the many varied proposals that come before them and look forward with great interest to the year ahead. A W McMahon Co-ordinator



RECORD OF ATTENDANCE AT MEETINGS: April 2005 – March 2006 NAME DESIGNATION April

2005 May 2005

June 2005

July 2005

Aug 2005

Sept 2005

Oct 2005

Nov 2005

Dec 2005

Jan 2006

Feb 2006

Mar 2006

Total meetings attended

Dr P Fleming (Chairman)

Consultant Clinical Psychologist

x x x 9

Dr J Anderson Consultant Psychiatrist

x x x x 8

Dr J Baird Consultant Psychiatrist

x x x x x x x x 4

Dr S Carr Consultant in Family Planning & Sexual Health

x x x x 8

Miss I Cuthbertson Principal Pharmacist

x x x 5

Mr P Dolan (Vice Chairman)

Lay Member x x x x x x 6

Ms S Downie

Lay Member

x RESIGNED 1

Mr M Hattie

Clinical Nurse Specialist x X x x x 7

Rev C Langlands Lay Member

x x 10

Ms A Maclean

Lay Member x x x x x x x x x DECEASED

Ms M Matheson Senior Pharmacist

x RESIGNED

3

Dr Robert McNeill General Practitioner

x x x 9

Ms M Newton Head of Profession – PAM

x RESIGNED

2

Miss G Notman

AHP Head of Profession x 5

Dr D Watt Consultant Occupational x 11


Health Mr P Davies Principal Pharmacist

Seconded from PCD2 2

Mr L Reynolds Lay Member Chairman Seconded from PCD2

1

Mr J Leinster Lay Member Seconded from PCD2

1

Total

9 7 7 7 7 7 10 8 7 7 10 7



Chairman’s Foreword PCD1 As can be seen from the following pages the Committee has this year continued to review an extremely wide variety of proposals which ranged extensively in content, complexity and disciplinary input. With the new regulations and altered ethical review process which came into force in 2004 it has again been a highly exacting year for Committee members. I cannot praise too highly all of the Committee members who have so freely given their expertise and time, and also record my appreciation for their continued support to both myself and the ethical review process. I would also like to express a big thank you to Mrs Anne McMahon for her role in providing continued and highly efficient administrative support, particularly during these times of great administrative change. I would also like to express a big thank you to Ms Winifred McCartney who remains an essential and efficient additional administrative resource. As many of you will be aware, and may have indeed experienced directly, we have also been charged with implementing new meeting protocols. As ever implementing such changes has been arduous for us but some of the changes have also brought significant improvements – we have met with a record high number of researchers this year. I recognise that these meetings may sometimes be experienced as being difficult by the attending researchers but I am glad to say we have often managed to quickly gain greater definition in areas of ambiguity in applications and very often have found ourselves creatively resolving issues with researchers while maintaining the highest ethical standards for the research reviewed. Consequently, I think overall such exchanges have led to progressing research projects more quickly rather than incurring the inevitable delays sometimes brought about by engaging in correspondence. Such changes accord with my view that our role is one of facilitating research while maintaining the highest ethical standards. Finally, I would like to take the opportunity to thank all of the researchers with whom we have had correspondence this year – I would like to wish you well with your research. We look forward to collaborating with all of our existing and new researchers in the coming year. Dr Paul F J Fleming Chairman


Approved Approved after amendment Provisional opinion Declined Invalid Withdrawn

49 59 12 2 3 3


Figure 1


Figure 2

April May June July August September October November December January February March 8 14 9 12 8 11 11 6 9 16 5 17




Chairman’s Foreword PCD2 Sadly, the meeting on 30th March was the final meeting of the Committee. This follows the outcome of the Warner Report on rationalising LRECs and the decision by Greater Glasgow NHS Board's Research Ethics Governance Committee to merge both Primary Care LRECs due to the reduction in numbers of submissions last year. Each member of the Committee deserves mention particularly for their unstinting dedication both with expertise and time. Lawrence Reynolds as Chairman, until February 2006, provided excellent skill and leadership particularly throughout the period of change which the Committee experienced. Anne McMahon in her capacity of administrative support is quite exceptional, never failing to inform the Committee at each stage of the many changes to LREC guidelines. The changes have been varied and Anne has always managed to keep information to the Committee flowing as it was available. Winifred McCartney has provided excellent additional administrative support to both Anne and the Committee. i conclusion, I would like to thank all the researchers who have corresponded with the Committee this year and wish them well with their research. I look forward to working collaboratively with new and existing researchers in the coming year. Dr Carol McKinnon Vice Chairman and Acting Chairman



RECORD OF ATTENDANCE AT MEETINGS: April 2005 – March 2006 NAME DESIGNATION April

2005 May 2005

June 2005

July 2005

Aug 2005

Sept 2005

Oct 2005

Nov 2005

Dec 2005

Jan 2006

Feb 2006

Mar 2006

Total meetings attended

Mr L Reynolds (Chairman)

Lay Member x x x x x RESIGNED

6

Dr J Atkinson Senior Lecturer

x x x x 8

Dr P Cotton

General Practitioner x x x x x x 6

Mr P Davies

Principal Pharmacist x x x x 8

Mr J Leinster

Lay Member x x x x x 3

Dr I McColl

General Practitioner x x x RESIGNED 4

Dr C McKinnon (Vice Chairman)

General Practitioner x x x x x x 6

Ms F Roberts Senior Nurse

x x x x x x 6

Ms H Ross Lay Member

x x 10

Ms E Telfer

Lay Member

x x 10

Mr P Dolan Lay Member Seconded from PCD1

2

Total

8 6* 6* 7 8 7 8 5* X 7 X 7

* Committee was quorate according to the type of submissions reviewed




July August September October November December

12 8 11 11 6 9


April May June July August September October November December

8 14 9 12 8 11 11 6 9

0

5

10

15

20

April July October January

2005-2006Greater Glasgow Primary Care Division

Research Ethics Submissions PCD2


NORTH GLASGOW UNIVERSITY HOSPITALS NHS DIVISION

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