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HAMMERSMITH AND QUEEN CHARLOTTE’S & CHELSEA HOSPITALS research ethics committee annual report 2001/2002

Report for period 1 April 2001 – 31 March 2002

 INTRODUCTION

The Research Ethics Committee is responsible for protecting the rights of research participants and ensuring that all research involving human subjects carried out within the Imperial College School of Medicine (Hammersmith Campus), the Hammersmith Hospitals NHS Trust and its immediate geographical area conforms to the highest ethical standards.

All research projects involving human subjects at any of the hospitals of the Hammersmith Hospitals NHS Trust must be approved by a Research Ethics Committee. Currently, protocols undertaken at either Hammersmith, Queen Charlotte's and Chelsea or Acton hospitals are considered by the Hammersmith, Queen Charlotte's and Chelsea and Acton hospitals (HQC & AH) Research Ethics Committee. Applications for projects to be carried out at Charing Cross Hospital are considered by the Riverside Research Ethics Committee based at Chelsea and Westminster Hospital.

 Professor John Calam

The former Research Ethics Committee Chairman Professor John Calam died on 9 July 2001. The Chairman and the Secretary along with several members of the committee attended the memorial service celebrating John's life. The Committee’s sincere sympathies were forwarded to John's wife Joyce and his family.

 MEMBERSHIP

The Committee currently has 19 members (as of 31st March 2002), including the Chair and Vice Chair. The full membership is listed at annex 1. DEPARTURES:

May 2001:

Mr Jim Jeffs, Statistician, ICSM

August 2001:

Professor T R Rogers MSc, FRCPath, FRCPI, Infectious Diseases, ICSM

NEW MEMBERS:

The Committee welcomed the following new members during 2001/2002:

April 2001: Mr Jim Jeffs, Statistician, ICSM (resigned May 2001)

September 2001: Dr J Apperley, Reader in Haematology, ICSM; Dr Piers Benn, Lecturer in Medical ethics & Law, ICSM (lay member)

October 2001: Ms Alison Forrester, Trials Co-ordinator, ICRF Dept. of Viral & Gene Therapy, Hammersmith Hospital

December 2001: Ms D O'Dell-Athill, BSc Lecturer (lay member)

January 2002: Ms S Strickland, BSc, Clinical Nurse Specialist in Gestational Trophoblastic Disease, Charing X Hospital

OBSERVERS:

July 2001: Dr Piers Benn, Lecturer in Medical ethics & Law, ICSM (Prospective Lay Member)

September 2001: Ms A Forrester, BSc, Research Nurse/Trials Co-ordinator, Viral & Gene Therapy Dept., ICRF - (Prospective Lay Member)

November 2001: Dr S Coates, General Practitioner

March 2002: Dr Charles Mackworth-Young (Chair) and Ms Katherine Bolton (Administrator) from the Riverside Research Ethics Committee.

 REPORTS/GUIDELINES DISCUSSED

 Draft guidelines regarding student research produced by AREC for comment.

 The Nuffield Council of Bioethics consultation document “Genetics And Human Behaviour: The Ethical Context”

2 The committee felt that the Nuffield Council's should be contacted to indicate our general support for research into the genetic basis of human behaviour. The Chairman and the Secretary would compose a brief communication.

 MRC Human & Biological Samples: Use In Research – Final Guidelines

 The RCP Transitional Guidelines To Facilitate Changes In Procedures For Handling ‘Surplus’ And Archival Material From Human Biological Samples

It was noted that the general tone of the RCP's guidance was somewhat at variance with the MRC guidelines, specifically the recommendation by the MRC that tissue samples should be regarded as a "gift". It was also noted that the RCP guidelines did not address the use of paediatric samples.

However, the MRC guidelines were felt to be more likely to be those followed by the research community and were the guidelines that the committee expected all research using human tissue to be conducted by. It was felt that the Trust, ICSM and the MRC needed to disseminate the MRC guidelines to all research active staff. Dr Rodney Gale in the trust's R&D office would be approached to disseminate the document to Trust staff. Dr Charles Mackworth-Young would also be approached to ascertain whether the Riverside REC also require investigators to follow the MRC guidelines for research performed at Charing Cross. The Secretary would also disseminate the document to ICSM divisional heads informing them the committee required all research using human tissue to be conducted in accordance with the MRC guidelines.

 Governance Arrangements for NHS Research Ethics Committees (Draft) (New “Red Book”)

 AREC meeting: “Protecting Patients Better: Recent Advances in Research Regulation” - Information and application form.

 The draft national LREC application form from COREC for comments.

 COMMITTEE PROCEDURES

ICSM "no fault" scheme - standard paragraph in the information sheet:

The committee decided that the wording of the standard phrase regarding compensation through the Imperial College School of Medicine "no fault" scheme should be revised.

Old paragraph: “In the event of your suffering any adverse effects as a consequence of your participation in this study, you will be compensated through the Imperial College School of Medicine’s “No Fault” Compensation Scheme.”

Revised paragraph: “If you are harmed by taking part in this research project, you will be compensated through the Imperial College School of Medicine’s “No Fault” Compensation Scheme.”

 OTHER ISSUES DISCUSSED AND DECISIONS REACHED 3

REGISTER OF TISSUE SAMPLES:

It was felt that a letter should be written to the trust R&D department to encourage it to set up and maintain a register of all tissue samples taken from patients within the hospital. This register should be publicly available.

POLKINGHORNE GUIDELINES

The Committee discussed the relevance of the Polkinghorne guidelines to the provision of research information to women undergoing termination of pregnancy. It was felt that if the information regarding the research was given after the decision to terminate was made that this would not unduly influence or compromise the initial decision to undergo the termination.

 WORKLOAD

The Committee met on eleven occasions in 2001/2002.

No. of applications reviewed by Full Committee 124

No. of applications “approved” by Full Committee (as of 31-3-01) 96

No. of applications “approved” by Full Committee without amendment 1 No. of applications “approved” by Full Committee following amendment 95 (as of 31-3-01)

No. of applications “approved in principle” or “not approved” by Full Committee 28 awaiting final approval (at 31-3-01)

No. of applications reviewed by MREC Sub-Committee 29 No. of applications “noted” by MREC Sub-Committee (at 31-3-01) 27 No. of MREC applications pending (at 31-3-03) 2

No. of applications reviewed by Chairman’s action 85 No. of applications “approved” by Chairman’s action 85

Total new applications considered: 238

No. of applications for amendments reviewed by Chairman’s action 105

No. of applications “reviewed” in previous year finally given approval by Chairman’s action 23

A full list of protocols considered/approved during 2001/2002 is at annex 2.

 APPENDICES 4 1. Committee Membership 2(a). Studies “approved in principle” in previous financial year given final approval in 2001/2002 2(b). Studies approved by Full Committee without amendment 2(c). Studies approved by full committee after amendment 2(d). Studies approved by ‘Chairman's Action’ 2(e). Studies considered by Full Committee - Still pending (i.e. Approved in Principle/Not Approved) 2(f) MREC approved studies approved by sub-committee

Appendix 1 MEMBERSHIP OF HAMMERSMITH, QUEEN CHARLOTTE'S & CHELSEA AND ACTON HOSPITALS RESEARCH ETHICS COMMITTEE

5 Dr A George MA, PhD, MRCPath, Reader in Molecular Immunology, ICSM, (Chairman)

Dr J Apperley, Reader in Haematology, ICSM

Professor P Bennett BSc, Phd, MD, MRCOG, Professor in Obstetrics & Gynaecology, ICSM

Dr S Brett MB. MD, ChB, FRCA, Consultant in Intensive Care Medicine and Anaesthesia, HHT

Miss J Butler-Barnes, Imaging Research Nurse, Hammersmith Hospitals Trust

Dr S Coates, G.P.

Professor A D Edwards MA, MB, BS, FRCP, Weston Professor of Neonatal Medicine, ICSM

Dr D N F Harris MD, DA, FRCA, Senior Lecturer of Anaesthesia, ICSM

Ms A Jacklin Chief Pharmacist, Hammersmith Hospitals Trust

Mr P Jankowiak Head of Information, Hammersmith Hospitals Trust

Prof El-Nasir Lalani MBChB, B.Sc.(Hons), MRCPath, Ph.D. , Reader in Cellular and Molecular Pathology, ICSM

Dr M J Myers BSc, PhD, ARCS, FInstPSM, Honorary Lecturer Medical Physics and Radiation Protection Advisor, Hammersmith Hospitals Trust

Dr S Shaunak PhD, FRCP, FRCPE, Infectious diseases, ICSM

Ms S Strickland BSc, Clinical Nurse Specialist in Gestational Trophoblastic Disease, Charing X Hospital

Lay Representatives

Lady Riddell (Vice-Chair)

Dr P Benn

Ms F Freedland, BA

Mrs J Lundie BA

Ms D O'Dell-Athill, BSc

Secretary

Mr Clive Collett, BSc., PGDip., MA Appendix 2(a)

Studies “approved in principle/not approved” in previous year given final approval in 2001/2002

6 LREC Ref 2000/5942

Study Title Assessment of Ventilation-Perfusion abnormalities in patients with asthma and chronic obstructive pulmonary disease during acute exacerbations and recovery. Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2000/5973

Study Title Aortic Stentless Versus Stented Echocardiography Randomised Trial - A randomized comparison of the FreestyleTM valve and the MosaicTM valve in the Title Mr.

First Name J

Last Name Anderson

LREC Ref 2000/5974

Study Title The effect of cytokines on renal transplant outcome. Title Dr.

First Name Arlene

Last Name Rodrigues-Naim

LREC Ref 2000/5989

Study Title A study of the anti-leukaemic activity of cytotoxic T lymphocytes specific for haemopoietic antigens in acute and chronic myeloid leukaemia. Title Dr.

First Name Persis

Last Name Amrolia

LREC Ref 2001/6011

Study Title (BY9010 FK1 116 EXAC Trial) Comparative study of inhaled ciclesonide (800 µg bd) versus oral prednisolone (40 mg od) in patients with an asthma exacerbation. A randomized, double-blind, double dummy, parallel group study Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6012

Study Title Understanding pathophysiological mechanisms in sporadic and familial cases of motor neurone disease Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6027 7 Study Title In Vitro Studies of Endothelial Cells Derived from HHT Patients Title Dr.

First Name Claire

Last Name Shovlin

LREC Ref 2001/6028

Study Title Investigation of the genetic aetiology of intrauterine growth (blood and fetal tissues at termination) Title Dr.

First Name Gudrun

Last Name Moore

LREC Ref 2001/6029

Study Title Investigation of the genetic aetiology of intrauterine growth (blood and placenta at Title Dr.

First Name Gudrun

Last Name Moore

LREC Ref 2001/6032

Study Title Awareness of memory functioning in cognitive impairment: an empirical evaluation of the reformulated DICE model. Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6034

Study Title The effect of continuous combined oestrogen and progesteron on arterial compliance, left ventricular function and cognition in elderly women Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6037

Study Title Role of high-resolution ultrasound in the diagnosis and assessment of soft-tissue rheumatic complaints Title Dr

First Name Michael

Last Name Naughton

LREC Ref 2001/6042

Study Title Placental pathophysiology of intertwin transfusion syndromes in monochorionic multiple pregnancy 8 Title Prof.

First Name NM

Last Name Fisk

LREC Ref 2001/6053

Study Title Non-invasive determination of macrophage behaviour in scleroderma (SSc) patients at risk of fibrosing alveolitis (FA) Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6054

Study Title Bio-feedback for the active second stage of labour - does it facilitate spontaneous vaginal delivery? Title Dr.

First Name Sara

Last Name Paterson-Brown

LREC Ref 2001/6055

Study Title An open-label, single-center, pilot study to assess the ovarian response and technically correct injections using the needle-free J-Tip to administer Puregon to subjects undergoing controlled ovarian hyperstimulation for IVF or ICSI Title Mr.

First Name G

Last Name Trew

LREC Ref 2001/6056

Study Title A positron emission tomography study to investigate the effect of globus pallidum deep brain stimulation on patients with primary torsion dystonia. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6058

Study Title Expression of a novel human apical membrane calcium transporter and intestinal calcium absorption (Protocol B) Title Dr.

First Name Julian

Last Name Walters

LREC Ref 2001/6059

Study Title Expression of a novel human apical membrane calcium transporter and intestinal calcium absorption (Protocol C) Title Dr. 9 First Name Julian

Last Name Walters

LREC Ref 2001/6060

Study Title The relationship of cognitive measures of memory and personality traits to serotonin 1A receptor binding in the human brain Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6061

Study Title Brain 5-HT2A receptors in healthy volunteers and depressed patients: An [11C]MDL-100907 PET study Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6062

Study Title A Medium Term Follow-up Study of Women who took part in the Hammersmith Hospital Cervical Screening Study Title Dr.

First Name Anne

Last Name Szarewski

LREC Ref 2001/6063

Study Title Evaluation of the HemoCue for measuring haemoglobin in the peripartum population. Title Dr.

First Name Gary

Last Name Stocks

Appendix 2(b)

Studies Approved by Full Committee without Amendment

LREC Ref 2001/6082

Study Title Zinc in tuberculosis skin testing Title Dr.

First Name Carlton

Last Name Evans

10 Appendix 2(c)

Studies approved by full committee after amendment

LREC Ref 1993/3995

Study Title Clinical Evaluation of magnetic resonance imaging (MRI). (Extension of protocol

Title Prof.

First Name Graeme

Last Name Bydder

LREC Ref 1993/4047

Study Title Clinical evaluation of magnetic resonance spectroscopy (MRS). (Extension of protocol 93/4047)

Title Prof.

First Name Graeme

Last Name Bydder

LREC Ref 2001/6026

Study Title Protocol No CSTI571B2225. An open label, pilot phase 11 study of STI571 in patients with life threatening diseases known to be associated with one or more STI571-sensitive tyrosine

Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6035

Study Title Can a percentage change in the fractional retention of 2-(11C) thymidine at 1 hour be used to measure fractional cell kill and assess ultimate tumour response following anti cancer treatment ? (RREC 2761)

Title Prof.

First Name Charles

Last Name Coombes

11 LREC Ref 2001/6038

Study Title Glucose-Insulin-Potassium (GIK) Treatment In Non-Diabetic Females Undergoing Cardiac Surgery Trial

Title Prof.

First Name K

Last Name Taylor

LREC Ref 2001/6039

Study Title Androgens and endometrial receptivity

Title Mr.

First Name G

Last Name Trew

LREC Ref 2001/6052

Study Title A Phase 2, Multi-center, Double-blinded, Placebo-controlled, Dose-finding Study of ZYC101a in the Treatment of High-Grade Squamous Intra-epithelial Lesions of the Uterine Cervix.

Title Mr.

First Name Pat

Last Name Soutter

LREC Ref 2001/6057

Study Title Pharmacogenomics of Essential Hypertension

Title Prof.

First Name Martin

Last Name Wilkins

LREC Ref 2001/6076

Study Title Development of methods to assess sensory function in spinal cord injury

Title Prof.

First Name Praveen

Last Name Anand

12 LREC Ref 2001/6077

Study Title The Diagnostic Utility of Fluorescence Lifetime Imaging Microscopy (FLIM), Optical Coherence Tomography (OCT) and Magnetic Resonance Microscopy (MRM) in Human Female Breast Cancer

Title Dr.

First Name Paul

Last Name Tadrous

LREC Ref 2001/6078

Study Title In-vitro magnetic resonance spectroscopy of liver biopsies in viral hepatitis and steatohepatitis

Title Dr.

First Name Simon

Last Name Taylor-Robinson

LREC Ref 2001/6079

Study Title Microglial activation in patients taking neuroleptic therapy with/without tardive dyskinesia: A PET Study

Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6080

Study Title Investigation of the effects of repetitive Transcranial Magnetic Stimulation of the Anterior Cingulate on blood flow using Positron Emission Tomography

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6091

Study Title Investigation of the abnormal response to monosodium urate crystals in Behçet’s syndrome

Title Prof.

First Name Dorian

Last Name Haskard

13 LREC Ref 2001/6092

Study Title A study investigating whether progesterone suppositories (Cyclogest®) provide adequate luteal support / result in sufficient progesterone levels during IVF cycles

Title Mr.

First Name G

Last Name Trew

LREC Ref 2001/6093

Study Title A phase II, multi-centre, double-blind, placebo-controlled, parallel group study to assess the safety and efficacy of a single intravenous dose of the humanised anti-TNF PEG conjugate, CDP870 (1.25, 5 20mg/kg) in patients with active Crohn's

Title Dr.

First Name Julian

Last Name Walters

LREC Ref 2001/6094

Study Title Investigation Of The Effects Of Peptide YY On Appetite.

Title Prof.

First Name S

Last Name Bloom

LREC Ref 2001/6096

Study Title A novel human cell culture model of prion disease to study the pathophysiology of prion infection

Title Dr.

First Name Sarah

Last Name Tabrizi

LREC Ref 2001/6097

Study Title Anti-cytokine therapy with Infliximab for vasculitis

Title Prof.

First Name Charles

Last Name Pusey

14 LREC Ref 2001/6098

Study Title A study to measure the occupancy of ziprasidone at the 5-HT1A receptor using PET scanning

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6099

Study Title Genetic determinants of plasma factor VIII concentration

Title Dr.

First Name Mike

Last Name Laffan

LREC Ref 2001/6108

Study Title Brain receptor occupancy and pharmacokinetics of Ro 67-5930 after oral administration of multiple doses (MD PET Scan Study) version B dated 19th July

Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6111

Study Title The effect of low glycaemic diet on weight maintenance following a three-months weight reduction program using formula meal replacement in obese patients with late-onset diabetes mellitus (NIDDM).

Title Dr.

First Name Gary

Last Name Frost

LREC Ref 2001/6112

Study Title Evaluation of sexual satisfaction after dilator therapy for absent vagina in patients with Rokitansky syndrome

Title Dr.

First Name Sadhana

Last Name Nadarajah

15 LREC Ref 2001/6113

Study Title A multicentre, randomised, double-blind, placebo controlled, dose response study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina

Title Dr.

First Name Kevin

Last Name Beatt

LREC Ref 2001/6114

Study Title Myocardial Stunning in Type II Diabetes Mellitus

Title Prof.

First Name Roger

Last Name Hall

LREC Ref 2001/6115

Study Title A randomised prospective phase I/II study comparing HLA-A2+ autologous dendritic cells with HLA-A2+ haplotype mismatched dendritic cells pulsed with autologous tumour cells in CEA positive patients with advanced colorectal liver metastases.

Title Prof.

First Name Robert

Last Name Lechler

LREC Ref 2001/6116

Study Title Effects of delivery on the infant’s hypothalamic-pituitary-adrenal response

Title Prof.

First Name Vivette

Last Name Glover

LREC Ref 2001/6129

Study Title Treatment of leukaemic relapse after allogeneic stem cell transplantation by HSV-tk genetically modified donor lymphocyte transfusions

Title Dr.

First Name Jane

Last Name Apperley

16 LREC Ref 2001/6130

Study Title Informed consent (IC) for medicines – An exploratory trial

Title Dr.

First Name Bryony

Last Name Dean

LREC Ref 2001/6131

Study Title Differential occupancy of brain 5HT1A receptors by agonists: Positron Emission Tomography (PET) study using 11C-WAY 100635

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6132

Study Title Differential occupancy of 5-HT1A receptors by pindolol in depression: Positron Emission Tomography (PET) study using 11C-WAY 100635

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6133

Study Title PET measurement of the displaceability of [11C]FLB 457 from extra-striatal dopamine D2 receptors in man.

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6135

Study Title A positron emission tomography study to investigate the distribution of opioid receptors in patients with restless legs syndrome.

Title Prof.

First Name David

Last Name Brooks

17 LREC Ref 2001/6152

Study Title Pilot trial of Salbutamol in Minicore disease

Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6153

Study Title Pilot trial of Salbutamol in Nemaline Myopathy

Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6154

Study Title Pilot trial of Salbutamol in Central Core disease

Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6155

Study Title Pilot trial of Salbutamol in Myotubular Myopathy

Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6158

Study Title 15O PET investigations of tumour perfusion in patients with metastatic renal cell carcinoma receiving thalidomide and/or interferon-alpha

Title Prof.

First Name Charles

Last Name Coombes

18 LREC Ref 2001/6159

Study Title 15O PET investigations of tumour perfusion in patients with epithelial cell malignancies receiving platinum based chemotherapy

Title Prof.

First Name Charles

Last Name Coombes

LREC Ref 2001/6160

Study Title Euro Heart Survey on Coronary Revascularization

Title Prof.

First Name David

Last Name Wood

LREC Ref 2001/6161

Study Title An Open, Comparative, Within Patient, Controlled Phase III, Multicentre Study Of Hexvix Fluorescence Cystoscopy And Standard Cystoscopy In The Detection Of Carcinoma In Situ In Patients With Bladder Cancer

Title Mr.

First Name Gordon

Last Name Williams

LREC Ref 2001/6162

Study Title Use of bovine colostrum to reduce dyspepsia in patients taking non-steroidal anti-inflammatory drugs (NSAIDS).

Title Prof.

First Name Raymond

Last Name Playford

LREC Ref 2001/6163

Study Title Localization of brain regions involved in the processing of perceptual information obtained from observing human vs. robotic systems: A PET activation study.

Title Prof.

First Name David

Last Name Brooks

19 LREC Ref 2001/6164

Study Title Investigation of the Effect of Oxyntomodulin on Appetite

Title Prof.

First Name Stephen

Last Name Bloom

LREC Ref 2001/6165

Study Title The relationship between D2 receptor occupancy by sulpiride and neuropsychological function: an [11C] raclopride PET study

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6166

Study Title Significance of Serum Bactericidal Activity (SBA) test in ICU patients treated empirically for sepsis

Title Dr.

First Name Panagiotis

Last Name Kaltsas

LREC Ref 2001/6167

Study Title Investigation into the use of sucrose in the treatment of moderate

Title Dr.

First Name Audrey

Last Name Brynes

LREC Ref 2001/6168

Study Title The glycaemic index of malt containing products and their effects on cognitive

Title Dr.

First Name Gary

Last Name Frost

20 LREC Ref 2001/6169

Study Title The possible use of Human Chorionic Gonadotrophin in prevention of preterm

Title Prof.

First Name Phillip

Last Name Bennett

LREC Ref 2001/6170

Study Title To examine the effect that sexual activity may have on pregnancy outcome, in particular onset of natural labour

Title Dr.

First Name Philip

Last Name Rahmanou

LREC Ref 2001/6186

Study Title A clinical trial to assess the intracerebral transplantation of carotid body aggregates for Parkinson's Disease.

Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6187

Study Title Development of PET procedures for assessment of functional recovery following spinal cord injury in man

Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6188

Study Title Effects of the PPAR-gamma agonist Pioglitazone in the treatment of symptomatic peripheral arterial disease

Title Prof.

First Name Martin

Last Name Wilkins

21 LREC Ref 2001/6189

Study Title The use of flow cytometry to compare the dendritic cell population in induced sputum of normal healthy volunteers, atopic healthy volunteers and patients with mild

Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6192

Study Title A clinical and laboratory evaluation of topical micronutrient supplementation to improve the diagnosis of latent TB infection in haemodialysis patients.

Title Dr.

First Name Carlton

Last Name Evans

LREC Ref 2001/6193

Study Title Mirtazapine and 5-HT2A binding: The use of the cerebellum as a reference tissue to model the 5-HT2A PET ligand [11C] MDL 100907

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6194

Study Title Development of laboratory methods for non invasive prenatal genetic diagnosis in fetal cells in maternal blood.

Title Prof.

First Name Nicholas M

Last Name Fisk

LREC Ref 2001/6195

Study Title Study of a Red Clover Food Supplement (P-07) versus Placebo for Premenstrual Syndrome

Title Mr.

First Name Nicholas

Last Name Panay

22 LREC Ref 2001/6196

Study Title 11C-raclopride PET studies of endogenous dopamine release during performance of rewarded and unrewarded visual memory tasks by Parkinson’s disease patients and healthy volunteers

Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6197

Study Title Links between maternal and fetal stress hormone levels

Title Prof.

First Name Vivette

Last Name Glover

LREC Ref 2001/6198

Study Title Investigation of the efficacy in safety profile of the Nlite Laser for Treatment of Acne Vulgaris

Title Dr.

First Name Anthony

Last Name Chu

LREC Ref 2001/6214

Study Title The Effect of Medical Therapy on Cognitive Function and Cerebral Blood Flow in Patients Requiring Intensive Treatment for Heart Failure

Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6215

Study Title The effects of the D1-agonist prodrug DAS-431 on cognitive and language functions in healthy volunteers

Title Prof.

First Name Paul

Last Name Grasby

23 LREC Ref 2001/6216

Study Title Mannose Binding Lectin (MBL) mutations and their association with infections in the

Title Dr.

First Name Stephen

Last Name Brett

LREC Ref 2001/6217

Study Title A multi-centre, randomised, double-blind, parallel groups, placebo-controlled trial on efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven) in treatment of bleeding in patients following allogeneic stem cell transplantation (F7BMT1360)

Title Dr.

First Name M

Last Name Laffan

LREC Ref 2001/6218

Study Title 1. Validation of measurement of cerebrovascular compliance. 2. The association between cerebral vascular compliance and cognitive function in the elderly.

Title Dr.

First Name C

Last Name Rajkumar

LREC Ref 2001/6222

Study Title Comparison between early and late immunization with three doses of an heptavalant pneumococcal conjugate vaccine in allogeneic stem cell transplant recipients

Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6224

Study Title [11C]raclopride PET measurement of nicotine induced dopamine release

Title Prof.

First Name Paul

Last Name Grasby

24 LREC Ref 2001/6225

Study Title First Administration To Man Of An Oncolytic Herpesvirus-1 Vector Containing A Transgene For Granulocyte Macrophage Colony Stimulating Factor (Oncovex gm-csf) - A Study Of Its Safety, Biodistribution And Biological Activity

Title Prof.

First Name Charles

Last Name Coombes

LREC Ref 2001/6226

Study Title Cross-cultural study of early infant crying and parental care

Title Dr.

First Name Ian

Last Name St. James-Roberts

LREC Ref 2001/6227

Study Title Study of Arterial Compliance in Women With the Syndrome of Polycystic Ovaries

Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6228

Study Title Dynamic Spectral Imaging of the Cervix

Title Mr.

First Name Pat

Last Name Soutter

LREC Ref 2001/6229

Study Title Expectations and experiences of hospital-based postnatal care: a preliminary study of women’s and midwives’ perspectives.

Title Dr.

First Name Jane

Last Name Weaver

25 LREC Ref 2001/6230

Study Title Does improvement of coronary vasodilator reserve after aortic valve replacement reflect left ventricular decompression or regression of left ventricular hypertrophy?

Title Prof.

First Name DJ

Last Name Sheridan

LREC Ref 2001/6231

Study Title Fetal cystoscopy to evaluate lower urinary tract obstruction in utero

Title Dr.

First Name Sailesh

Last Name Kumar

LREC Ref 2001/6232

Study Title The development of a consumer friendly system to enable older people to express their health care wishes. (initial stage: interviews with elderly patients and design of proforma). (full study NOT APPROVED) first stage of the study alone approved i.e. the investigation of the opinions of elderly people as to the type of health care subjects they wish to discuss and their views on the type of language they understand. The use of this information to design a proforma along with "expert" input including the Trust's legal advisor. The use of this proforma will need to be submitted to the REC for review by the full committee before approval for the full

Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6233

Study Title Pilot study of allogeneic peripheral stem cell transplantation and donor lymphocyte infusion following non-myeloablative conditioning in patients with metastatic breast

Title Dr.

First Name DM

Last Name Vigushin

26 LREC Ref 2001/6234

Study Title Characterisation, differentiation, transduction, engraftment and reparative potential of fetal mesenchymal stem/progenitor cells.

Title Prof.

First Name NM

Last Name Fisk

LREC Ref 2001/6235

Study Title Can novel Ultrasound and CT methods show early responses to chemotherapy of liver metastases?

Title Dr.

First Name Thomas

Last Name Bryant

LREC Ref 2001/6242

Study Title In normal development, does the attainment of motor skills have an effect on the rate of development of cognitive skills? A comparison of intellectual development in children with type II and type III spinal muscular atrophy

Title Miss

First Name Emma

Last Name Sales

LREC Ref 2002/6254

Study Title Investigation of neutrophil abnormalities in Inflammatory Bowel Disease and Behçet’s Syndrome using a skin blister technique

Title Prof.

First Name Dorian

Last Name Haskard

LREC Ref 2002/6255

Study Title Monocyte intracellular interleukin-1Beta (IL-1 Beta) for the early detection of infections and necrotizing enterocolitis (NEC) in preterm infants

Title Dr.

First Name Neil

Last Name Murray

27 LREC Ref 2002/6256

Study Title Optimizing platelet transfusion therapy in preterm neonates with severe

Title Dr.

First Name Neil

Last Name Murray

LREC Ref 2002/6258

Study Title The effects of methylphenidate on cognitive and language functions in healthy elderly volunteers and patients suffering aphasic stroke

Title Dr.

First Name David

Last Name Sharp

LREC Ref 2002/6259

Study Title A randomized, double-blind, vehicle controlled phase I/II study to evaluate the safety, tolerability and efficacy of a histamine dihydrochloride-containing gel versus a gel vehicle in the treatment of radiotherapy-induced dermatitis in patients with head and neck squamous cell carcinoma

Title Dr.

First Name J Simon

Last Name Stewart

LREC Ref 2002/6260

Study Title Quantifying the 24 hour glycaemic response of a low glycaemic index diet in free living people with type 2 diabetes treated with insulin: A pilot study

Title Dr.

First Name Audrey

Last Name Brynes

LREC Ref 2002/6261

Study Title Investigation of The Effects Of Glucagon-Like-Peptide-1 and Peptide YY On Appetite

Title Prof.

First Name SR

Last Name Bloom

28 LREC Ref 2002/6262

Study Title Randomised double blind study to determine the effect of epidural volume extension on intrathecal dose requirements for Caesarean section

Title Dr.

First Name Gary

Last Name Stocks

LREC Ref 2002/6263

Study Title MRI Investigations of the Subgenual Prefrontal Cortex in Patients with Familial Bipolar Disorder

Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2002/6271

Study Title Comparison of hepatic vein transit times of Levovist and SonoVue in normal

Title Dr.

First Name Adrian

Last Name Lim

LREC Ref 2002/6273

Study Title A pilot study to determine the feasibility and reproducibility of kinetic 11C-choline PET imaging as an index of signal transduction in tumours and normal tissues

Title Prof.

First Name Charles

Last Name Coombes

LREC Ref 2002/6274

Study Title Investigation of the effects of the pancreatic polypeptide on appetite

Title Prof.

First Name SR

Last Name Bloom

29 LREC Ref 2002/6276

Study Title Investigation of the effect on tidal breathing of negative pressure applied at the mouth during normal expiration in normal volunteers and patients with chronic obstructive pulmonary disease (COPD)

Title Dr.

First Name PW

Last Name Ind

LREC Ref 2002/6277

Study Title A study to assess the inter- and intra-subject variability of lung 18FDG uptake by Positron Emission Tomography in stable COPD patients in comparison with normal

Title Dr.

First Name Philip

Last Name Ind

30 Appendix 2(d) Studies Approved by Chairman's Action

NB – These include studies that have been approved by other LRECs with whom we operate a reciprocal approval agreement as well as exten- sions to studies that have been previously reviewed by the full commit- tee.

LREC Ref 1998/5310

Study Title In vitro maturation of ovarian follicles and oocytes. (reapproval of study) Title Dr.

First Name Kate

Last Name Hardy Comments: reapproval of study - Co-investigator Dr S Buxani-Rice

LREC Ref 2001/6084

Study Title Musculoskeletal pain in patients with painful and with silent ischaemic heart disease. Title Dr.

First Name Jens Peder

Last Name Bagger Comments:

LREC Ref 2001/6086

Study Title Genetic Manipulation of Vascular Endothelium; modulation of adhesion molecule expression. Title Dr.

First Name Peng Hong

Last Name Tan Comments: Approved by Vice Chair - Sarah Riddell

LREC Ref 2001/6087

Study Title The release of VEGF and aggregation of platelets from patients with malignancy compared to controls upon endostatin treatment Title Mr.

First Name Guy

Last Name Nash Comments:

31 LREC Ref 2001/6088

Study Title Serum levels of Granulocyte Colony Stimulating Factor following abdominal and cardiothoracic surgery Title Dr.

First Name Mahdad

Last Name Noursadeghi Comments:

LREC Ref 2001/6089

Study Title Preventing medication administration errors - Bridging the knowledge gap Title Ms.

First Name Raliat

Last Name Onatade Comments:

LREC Ref 2001/6090

Study Title A Study of blood levels of markers for the prediction of Ovarian Hyperstimulation Syndrome in patients undergoing IVF treatment Title Dr.

First Name N

Last Name Reddy Comments:

LREC Ref 2001/6100

Study Title Familial Prostate Cancer Screening Study (MREC 00/1/72) Title Dr.

First Name DP

Last Name Dearnaley Comments: limited contact of local clininician within

LREC Ref 2001/6102

Study Title Study of the comparative incidences of pre-eclampsia in monochorionic and diochorionic twin pregnancies Title Prof.

First Name Nicholas M

Last Name Fisk Comments:

LREC Ref 2001/6103

Study Title Preliminary study on the presence of MUC-1 protein in bone marrow plasma cells and multiple myeloma Title Dr.

First Name IA

Last Name Lampert Comments:

32 LREC Ref 2001/6104

Study Title Study on the follicular dendritic cells in the germinal centres Title Dr.

First Name IA

Last Name Lampert Comments:

LREC Ref 2001/6105

Study Title Characterisation of two new antibodies to class II phosphatidylinositol 3 kinase enzymes C2 alpha and beta Title Dr.

First Name Soha

Last Name El-Sheikh Comments: tissue study

LREC Ref 2001/6106

Study Title Understanding the influences or variables which affect pain outcome in the immediate post-operative period Title Ms.

First Name Angela

Last Name Eccles Comments: BSc project

LREC Ref 2001/6118

Study Title Development of the Barnes Language Assessment Title Mrs.

First Name S

Last Name Stevens Comments:

LREC Ref 2001/6119

Study Title Analysis of genetic predisposition to brain injury in preterm infants by anonymous studies of umbilical cord blood Title Prof.

First Name David

Last Name Edwards Comments:

LREC Ref 2001/6120

Study Title Investigation of the effects of manual assist, cough in-exsufflation device and non-invasive ventilation on cough efficacy in adults and children with spinal muscular atrophy (SMA) and other neuromuscular disease Title Ms.

First Name Michelle

Last Name Chatwin Comments: Royal Brompton Registration No. 01-009

33 LREC Ref 2001/6121

Study Title Identification of genetic loci linked to systemic hypertension in the Kyrgyz Title Prof.

First Name Martin

Last Name Wilkins Comments: Study taking place in Kyrgyz

LREC Ref 2001/6122-M

Study Title The role of diet, environment and genotype in the development of breast cancer (MREC 01/1/07) Title Dr.

First Name Catherine

Last Name Duggan Comments:

LREC Ref 2001/6123

Study Title Clinical isolates of S. epidermidis from patients with a prosthesis/venous Title Dr.

First Name Robert

Last Name Feldman Comments: isolates from catheter lines only - no other patient involvement

LREC Ref 2001/6125

Study Title Assessment of cardiac sympathetic function in hibernating myocardium: correlation between CMR & PET in vivo and histopathological and molecular studies in vitro Title Prof.

First Name Paolo

Last Name Camici Comments: Brompton approval: 00-225;Co-investigators: Dr O Rimoldi; Dr M Khan and Dr A John

LREC Ref 2001/6126-M

Study Title Millenium Cohort Study (MREC /01/6/19) Title Prof.

First Name Heather

Last Name Joshi Comments:

LREC Ref 2001/6127

Study Title The role of nitric oxide in renal tubule cell injury Title Dr.

First Name Thomas John

Last Name Evans Comments:

34 LREC Ref 2001/6128-M

Study Title The genetic analysis of multiple sclerosis Title Prof.

First Name DAS

Last Name Compston Comments:

LREC Ref 2001/6138

Study Title The effects of immunosuppresive treatment - questionnaire study Title Dr.

First Name Jeremy

Last Name Levy Comments: MSc audit study

LREC Ref 2001/6139

Study Title Expression of CD80 in atherosclerotic plaques Title Dr.

First Name Joseph

Last Name Boyle Comments: archive tissue samples

LREC Ref 2001/6140-M

Study Title London Managed Clinical Networks: Evaluation (MREC/00/8/81) Title Prof.

First Name Ewan

Last Name Ferlie Comments:

LREC Ref 2001/6141

Study Title Evaluation of a bioelectrical impedance device (Bodystat 1500) Title Dr.

First Name Neena

Last Name Modi Comments:

LREC Ref 2001/6143

Study Title Testing the power and utility of SCI45 in selection and assessment of doctors in training Title Dr.

First Name Rodney

Last Name Gale Comments:

LREC Ref 2001/6146

35 Study Title Is the Wilms tumour antigen 1 a target for immunotherapy of malignancies? Title Dr.

First Name Hans

Last Name Stauss Comments:

LREC Ref 2001/6147

Study Title Measuring the amount of oxygen in leg muscles Title Dr.

First Name David

Last Name Harris Comments:

LREC Ref 2001/6148

Study Title Ex vivo testing of surgically resected tissue from cancer patients for efficacy of genetic treatments Title Dr.

First Name Nicholas R

Last Name Lemoine Comments: Dr D Kirn (Original PI) left IC 12-4- 2002

LREC Ref 2001/6149-M

Study Title Isolation of purified, sterile and viable islets from human pancreases (MREC/01/2/20) Title Dr.

First Name Vassilios

Last Name Papalois Comments:

LREC Ref 2001/6151

Study Title Are the needs of the physically disabled catered for in radiography Title Ms.

First Name Karen

Last Name Cole Comments: BSc study

LREC Ref 2001/6172

Study Title A phase I, double-blind, placebo-controlled, dose escalating study of recombinant human interleukin-11 (rhIL-11) in patients with ankylosing spondylitis (RREC 2608) Title Prof.

First Name RN

Last Name Maini Comments: RREC approved study - recruitment from HH

36 LREC Ref 2001/6173

Study Title A randomised, double-blind trial of anti-TNF alpha chimeric monoclonal antibody (infliximab) in combination with methotrexate compared with methotrexate alone, for the treatment of patients with early RA (Centocor - ASPIRE study) (RREC 2448) Title Prof.

First Name RN

Last Name Maini Comments: RREC approved study - recruitment from HH

LREC Ref 2001/6174-M

Study Title A double-blind, randomised, parallel group, controlled, dose ranging study of the safety, tolerability, pharmocokinetics and efficacy of repeat doses of MRA given alone or in combination with methotrexate in patients with rheumatoid arthritis (RREC 2724) Title Prof.

First Name RN

Last Name Maini Comments: RREC approved study - recruitment from HH

LREC Ref 2001/6175-M

Study Title Morbidity of pneumococcal meningitis in UK 1996-1999 (MREC/01/2/12) Title Dr.

First Name M

Last Name Hussain Comments: no local researcher

LREC Ref 2001/6176

Study Title Randomised, placebo-controlled study of the effect of sildenafil on hypoxia induced pulmonary hypertension Title Prof.

First Name Martin

Last Name Wilkins Comments: Study taking place in Kyrgyz

LREC Ref 2001/6177

Study Title Study to compare the results of different questionnaires in pregnancy Title Prof.

First Name Vivette

Last Name Glover Comments:

LREC Ref 2001/6178

Study Title The effect of vascular disease on the intravertebral disc and low back pain (RREC 1928) Title Prof.

First Name SPF

Last Name Hughes Comments: reciprocal approval

37 LREC Ref 2001/6179

Study Title The measurement of soluble DAF in order to assess of cellular cryoprotection and predict relative risk of long-term vascular injury Title Prof.

First Name Dorian

Last Name Haskard Comments: Uses plasma from blood obtained under 99/5625

LREC Ref 2001/6180-M

Study Title National comparative subarachnoid haemorrhage Audit (MREC/00/0/59) Title Mr.

First Name Julia

Last Name Langham Comments: no local researcher

LREC Ref 2001/6181

Study Title Cardiac resynchronization in heart failure Title Prof.

First Name Paulo

Last Name Camici Comments: St Marys Rec approved;Co-investigators: Dr O Rimoldi; Dr M Khan and Dr A John

LREC Ref 2001/6183

Study Title Household Survey to assess the impact of Single Regeneration Budget (SRB) expenditure on the Edward Woods Estate, Hammersmith and Fulham Title Dr.

First Name Gordana

Last Name Djuric Comments:

LREC Ref 2001/6184-M

Study Title Randomised controlled trial of the effects of antioxidant and folinic acid supplementation on the mental development, growth and health of children with Down's syndrome Title Prof.

First Name Sally

Last Name Grantham-McGregor Comments:

LREC Ref 2001/6200

Study Title A prospective analysis of the cost benefit implications of introducing an orally active anti-gram positive agent at a London Hospital Trust Title Dr.

First Name Kathleen

Last Name Bamford Comments: 38 LREC Ref 2001/6201

Study Title Reducing the risk of overdose from take home methadone study of impact of community pharmacy leaflets Title Dr.

First Name Vince

Last Name Naik Comments: previously approved by maudsley LREC

LREC Ref 2001/6202

Study Title Pregnacy test result questionnaire Title Sister

First Name Cathy

Last Name Turner Comments:

LREC Ref 2001/6203

Study Title Audit of provision of vaccinations for asplenic patients Title Dr.

First Name Alison

Last Name Holmes Comments:

LREC Ref 2001/6204-M

Study Title Prospective collaborative study of the aetiopathogenesis of Kawasaki disease (MREC 01/2/45) Title Dr.

First Name Anuradha

Last Name Bose Comments:

LREC Ref 2001/6206

Study Title Should health professionals who perform 1st trimester ultrasound scans be involved in informing patients about those scans? Title Ms.

First Name Angela

Last Name Smith Comments: MSc project - Questionnaire

LREC Ref 2001/6207

Study Title Research Investigation of Perceptions, Management and Control of Type-2 Diabetes Title Dr.

First Name Timothy

Last Name Moor Comments:

LREC Ref 2001/6209-M 39 Study Title A multicentre, randomised controlled trial of Pentacol - a new enteric copated tablet form of Mesalazine - in comparison to Asacol - Lagap study EC 2444 (MREC/1/3/26) (RREC 2738) Title Dr.

First Name Andrew

Last Name Thillainayagam Comments: Reciprocal approval

LREC Ref 2001/6210-M

Study Title children, families and services in communities (MREC/01/6/65) Title Prof.

First Name Edward

Last Name Melhuish Comments:

LREC Ref 2001/6212

Study Title The distribution of gastrointestinal peptide receptors in human tissue Title Dr.

First Name Tom

Last Name Evans Comments:

LREC Ref 2001/6213

Study Title Zinc cream in tuberculosis skin testing in Peru - a follow-up study to extend the positive results from the similar project 'zinc in TB skin testing' (Hammersmith Ethical approval #2001/6082). Title Dr.

First Name Carlton

Last Name Evans Comments: THIS PROJECT HAS LOCAL ETHICAL APPROVAL IN PERU - This document includes the results of study #2001/6082. The current protocol is the same as study #2001/6082 except that individuals are now asked to have unilateral single rather than simultaneous bilateral skin tests. This change is necessary to confirm and extend the results of study #2001/6082

LREC Ref 2001/6219

Study Title Epidural questionnaire Title Ms.

First Name Sarah

Last Name Beake Comments: Audit/questionnaire

LREC Ref 2001/6220

Study Title Induced sputum as a surrogate for broncho-alveolar lavage in patients with fibrosing alveolitis secondary to systemic sclerosis Title Prof.

40 First Name R

Last Name du Bois Comments: Brompton approved 01-221 - reciprocal action

LREC Ref 2001/6221

Study Title Hiatus hernia as a cause of gastrointestinal bleeding diagnosis on Title Dr.

First Name Vaishali

Last Name Gada Comments:

LREC Ref 2001/6236

Study Title Long term glial changes in the thalamus following limb amputation, brachial plexus injury and paraplegia (using material from the tissue collection of the German Spinal Cord Injury Foundation) Title Dr.

First Name Richard

Last Name Banati Comments: Tissue coming form Germany

LREC Ref 2001/6237

Study Title Fluorescent in situ hybridisation to detect Helicobacter pylori in gastric antral biopsies Title Dr.

First Name Julian

Last Name Walters Comments:

LREC Ref 2001/6238

Study Title Study to establish whether variations in cortisol binding globulin (CBG) in normal volunteers affects their results to a short synacthen test (SST) (RREC Title Dr.

First Name WS

Last Name Dillo Comments: reciprocal action with RREC

LREC Ref 2001/6239

Study Title Components of spatial neglect following stroke (RREC 2677) Title Dr.

First Name Masud

Last Name Husain Comments:

LREC Ref 2001/6240

Study Title To develop a quality of life measure for Behçet’s disease Title Prof. 41 First Name Dorian

Last Name Haskard Comments: other investigator: Mrs G Gilworth

LREC Ref 2001/6241

Study Title Determining tensile strength of human cardiac tissue Title Dr.

First Name Maria-Benedicta

Last Name Edwards Comments:

LREC Ref 2001/6243-M

Study Title Waiting for drug treatment - effects on uptake and immediate outcome a.k.a. the outcome of waiting lists (OWL) project Title Ms.

First Name AJ

Last Name Watson Comments:

LREC Ref 2001/6244

Study Title In vitro studies into the role of monocytes and platelets in inflammation and thrombosis Title Dr.

First Name RC

Last Name Landis Comments:

LREC Ref 2002/6248

Study Title Outcome data in diabetic patients with coronary disease. A retrospective Title Dr.

First Name Julian

Last Name Strange Comments:

LREC Ref 2002/6249-M

Study Title Genetic factors in the development of insulin-dependant (type 1) diabetes: A study in UK patients diagnosed before age two (MREC/01/6/09) Title Dr.

First Name Paul

Last Name Lambert Comments: no local researcher

LREC Ref 2002/6250

Study Title Attitudes of sub-fertile women on the use of acupuncture to aid fertility - Questionnaire Title Ms.

First Name Lyndsey 42 Last Name Taylor Comments: BSc Study

LREC Ref 2002/6251

Study Title UK prevalence of patients with refractory angina pectoris study Title Dr.

First Name JP

Last Name Bagger Comments:

LREC Ref 2002/6252

Study Title Recording of heart sounds from patients - MSc project Title Dr.

First Name Terry

Last Name Gourlay Comments: MSc Study

LREC Ref 2002/6253

Study Title An operational assessment of strategies to prevent airbourne TB transmission and to improve TB diagnosis and treatment Title Dr.

First Name Carlton

Last Name Evans Comments: Study taking place in Peru - has Peruvian REC approval

LREC Ref 2002/6270-M

Study Title Links between statutory and non-statutory agencies providing support and facilities for teenagers in sexual health promotion Title Dr.

First Name Mary

Last Name Cooke Comments: no local researcher

LREC Ref 2002/6281

Study Title Quantifying glomerular cytokine expression in glomerulonephritis using paraffin sections Title Prof.

First Name HT

Last Name Cook Comments: tissue study

LREC Ref 2002/6282

Study Title Are epitope spread and the Th1 cytokine response essential for relapsing-remitting experimental allergic encephalomyelitis Title Miss

First Name Selina

43 Last Name Davies Comments: 30mls blood from HV's

LREC Ref 2002/6283

Study Title The biochemistry of term human placenta and membranes Title Prof.

First Name PR

Last Name Bennett Comments: Dr Cath Williamson

LREC Ref 2002/6284

Study Title Histological analyses and in vitro studies of endothelial cells derived from HHT patients Title Dr.

First Name Claire

Last Name Shovlin Comments:

LREC Ref 2002/6286

Study Title In vivo hepatocyte transplant model for research into hepatitis viruses Title Mr.

First Name Nagy

Last Name Habib Comments:

LREC Ref 2002/6289

Study Title Investigation of coagulation parameters in hereditary hemorrhagic telangiectasia - DNA Analysis (amendment to 00/5908) Title Dr.

First Name Claire

Last Name Shovlin Comments:

LREC Ref 2002/6290

Study Title A prospective, randomised, controlled study of a rapid protocol for the prevention of contrast induced renal dysfunction (RAPPID) (ELCHA REC No. Title Dr.

First Name Sanjay

Last Name Kumar Comments: Approved by St Bart's REC (study reviewed by Dr David Harris & Chairman)

LREC Ref 2002/6291

Study Title A prospective, randomised, controlled study of a rapid protocol for the prevention of contrast induced renal dysfunction Title Dr.

First Name Sanjay

44 Last Name Kumar Comments: Study approved by ELCHA REC

LREC Ref 2002/6295

Study Title Effect of preformed antibodies on renal transplant outcome Title Dr.

First Name Anthony

Last Name Warrens Comments: Archived tissue study

LREC Ref 2002/6308

Study Title Studies of white blood cells derived from HHT Patients Title Dr.

First Name Claire

Last Name Shovlin Comments: extra blood sample taken at time of clinical

LREC Ref 2002/6309

Study Title Does 67gallium scanning still have a role in the diagnosis and management of pulmonary sarcoidosis Title Dr.

First Name Robina

Last Name Coker Comments: Retrospective survey of case notes

Appendix 2(e) Studies considered by Full Committee - Still Pending (i.e. Approved in Principle/Not approved)

LREC Ref 1993/3995

Study Title Clinical Evaluation of magnetic resonance imaging (MRI). (Extension of protocol Title Prof.

First Name Graeme

Last Name Bydder

LREC Ref 1993/4047

Study Title Clinical evaluation of magnetic resonance spectroscopy (MRS). (Extension of protocol 93/4047) Title Prof.

First Name Graeme

Last Name Bydder

LREC Ref 2001/6026

Study Title Protocol No CSTI571B2225. 45 An open label, pilot phase 11 study of STI571 in patients with life threatening diseases known to be associated with one or more STI571-sensitive tyrosine Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6035

Study Title Can a percentage change in the fractional retention of 2-(11C) thymidine at 1 hour be used to measure fractional cell kill and assess ultimate tumour response following anti cancer treatment ? (RREC 2761) Title Prof.

First Name Charles

Last Name Coombes

46 LREC Ref 2001/6038

Study Title Glucose-Insulin-Potassium (GIK) Treatment In Non-Diabetic Females Undergoing Cardiac Surgery Trial Title Prof.

First Name K

Last Name Taylor

LREC Ref 2001/6039

Study Title Androgens and endometrial receptivity Title Mr.

First Name G

Last Name Trew

LREC Ref 2001/6052

Study Title A Phase 2, Multi-center, Double-blinded, Placebo-controlled, Dose-finding Study of ZYC101a in the Treatment of High-Grade Squamous Intra-epithelial Lesions of the Uterine Cervix. Title Mr.

First Name Pat

Last Name Soutter

LREC Ref 2001/6057

Study Title Pharmacogenomics of Essential Hypertension Title Prof.

First Name Martin

Last Name Wilkins

LREC Ref 2001/6075

Study Title A personal cervical sampler - assesment of the adequacy of cytology samples Title Mr.

First Name Pat

Last Name Soutter

47 LREC Ref 2001/6076

Study Title Development of methods to assess sensory function in spinal cord injury Title Prof.

First Name Praveen

Last Name Anand

LREC Ref 2001/6077

Study Title The Diagnostic Utility of Fluorescence Lifetime Imaging Microscopy (FLIM), Optical Coherence Tomography (OCT) and Magnetic Resonance Microscopy (MRM) in Human Female Breast Cancer Title Dr.

First Name Paul

Last Name Tadrous

LREC Ref 2001/6078

Study Title In-vitro magnetic resonance spectroscopy of liver biopsies in viral hepatitis and steatohepatitis Title Dr.

First Name Simon

Last Name Taylor-Robinson

LREC Ref 2001/6079

Study Title Microglial activation in patients taking neuroleptic therapy with/without tardive dyskinesia: A PET Study Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6080

Study Title Investigation of the effects of repetitive Transcranial Magnetic Stimulation of the Anterior Cingulate on blood flow using Positron Emission Tomography Title Prof.

First Name Paul

Last Name Grasby

48 LREC Ref 2001/6081

Study Title A study of platelet reactivity, its relationship to glycoprotein polymorphisms and its predictive value for major cardiovascular events Title Dr.

First Name Graham

Last Name Davies

LREC Ref 2001/6082

Study Title Zinc in tuberculosis skin testing Title Dr.

First Name Carlton

Last Name Evans

LREC Ref 2001/6091

Study Title Investigation of the abnormal response to monosodium urate crystals in Behçet’s syndrome Title Prof.

First Name Dorian

Last Name Haskard

LREC Ref 2001/6092

Study Title A study investigating whether progesterone suppositories (Cyclogest®) provide adequate luteal support / result in sufficient progesterone levels during IVF cycles Title Mr.

First Name G

Last Name Trew

LREC Ref 2001/6093

Study Title A phase II, multi-centre, double-blind, placebo-controlled, parallel group study to assess the safety and efficacy of a single intravenous dose of the humanised anti-TNF PEG conjugate, CDP870 (1.25, 5 20mg/kg) in patients with active Crohn's Title Dr.

First Name Julian

Last Name Walters

49 LREC Ref 2001/6094

Study Title Investigation Of The Effects Of Peptide YY On Appetite. Title Prof.

First Name S

Last Name Bloom

LREC Ref 2001/6095

Study Title Xenon as a neuroprotective agent during cardiopulmonary bypass – Pilot Feasibility and Safety Study Title Prof.

First Name Mervyn

Last Name Maze

LREC Ref 2001/6096

Study Title A novel human cell culture model of prion disease to study the pathophysiology of prion infection Title Dr.

First Name Sarah

Last Name Tabrizi

LREC Ref 2001/6097

Study Title Anti-cytokine therapy with Infliximab for vasculitis Title Prof.

First Name Charles

Last Name Pusey

LREC Ref 2001/6098

Study Title A study to measure the occupancy of ziprasidone at the 5-HT1A receptor using PET scanning Title Prof.

First Name Paul

Last Name Grasby

50 LREC Ref 2001/6099

Study Title Genetic determinants of plasma factor VIII concentration Title Dr.

First Name Mike

Last Name Laffan

LREC Ref 2001/6108

Study Title Brain receptor occupancy and pharmacokinetics of Ro 67-5930 after oral administration of multiple doses (MD PET Scan Study) version B dated 19th July Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6109

Study Title Investigation of the biochemistry, cell and molecular biology of haematological Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6110

Study Title Cellular and molecular biology of haematological disorders and their treatment Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6111

Study Title The effect of low glycaemic diet on weight maintenance following a three-months weight reduction program using formula meal replacement in obese patients with late-onset diabetes mellitus (NIDDM). Title Dr.

First Name Gary

Last Name Frost

51 LREC Ref 2001/6112

Study Title Evaluation of sexual satisfaction after dilator therapy for absent vagina in patients with Rokitansky syndrome Title Dr.

First Name Sadhana

Last Name Nadarajah

LREC Ref 2001/6113

Study Title A multicentre, randomised, double-blind, placebo controlled, dose response study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina Title Dr.

First Name Kevin

Last Name Beatt

LREC Ref 2001/6114

Study Title Myocardial Stunning in Type II Diabetes Mellitus Title Prof.

First Name Roger

Last Name Hall

LREC Ref 2001/6115

Study Title A randomised prospective phase I/II study comparing HLA-A2+ autologous dendritic cells with HLA-A2+ haplotype mismatched dendritic cells pulsed with autologous tumour cells in CEA positive patients with advanced colorectal liver metastases. Title Prof.

First Name Robert

Last Name Lechler

LREC Ref 2001/6116

Study Title Effects of delivery on the infant’s hypothalamic-pituitary-adrenal response Title Prof.

First Name Vivette

Last Name Glover

52 LREC Ref 2001/6129

Study Title Treatment of leukaemic relapse after allogeneic stem cell transplantation by HSV-tk genetically modified donor lymphocyte transfusions Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6130

Study Title Informed consent (IC) for medicines – An exploratory trial Title Dr.

First Name Bryony

Last Name Dean

LREC Ref 2001/6131

Study Title Differential occupancy of brain 5HT1A receptors by agonists: Positron Emission Tomography (PET) study using 11C-WAY 100635 Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6132

Study Title Differential occupancy of 5-HT1A receptors by pindolol in depression: Positron Emission Tomography (PET) study using 11C-WAY 100635 Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6133

Study Title PET measurement of the displaceability of [11C]FLB 457 from extra-striatal dopamine D2 receptors in man. Title Prof.

First Name Paul

Last Name Grasby

53 LREC Ref 2001/6134

Study Title Identification of cell populations and mediators in patients undergoing clinical bronchoscopy for diagnostic purposes Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6135

Study Title A positron emission tomography study to investigate the distribution of opioid receptors in patients with restless legs syndrome. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6152

Study Title Pilot trial of Salbutamol in Minicore disease Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6153

Study Title Pilot trial of Salbutamol in Nemaline Myopathy Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6154

Study Title Pilot trial of Salbutamol in Central Core disease Title Dr.

First Name Eugenio

Last Name Mercuri

54 LREC Ref 2001/6155

Study Title Pilot trial of Salbutamol in Myotubular Myopathy Title Dr.

First Name Eugenio

Last Name Mercuri

LREC Ref 2001/6156

Study Title An Action Research Project to develop and evaluate an evidence-based model for HIV antenatal testing in primary care Title Dr.

First Name Chris

Last Name McCourt

LREC Ref 2001/6157

Study Title Analysis of genetic mutations in pulmonary hypertension: a gene bank Title Prof.

First Name Martin

Last Name Wilkins

LREC Ref 2001/6158

Study Title 15O PET investigations of tumour perfusion in patients with metastatic renal cell carcinoma receiving thalidomide and/or interferon-alpha Title Prof.

First Name Charles

Last Name Coombes

LREC Ref 2001/6159

Study Title 15O PET investigations of tumour perfusion in patients with epithelial cell malignancies receiving platinum based chemotherapy Title Prof.

First Name Charles

Last Name Coombes

55 LREC Ref 2001/6160

Study Title Euro Heart Survey on Coronary Revascularization Title Prof.

First Name David

Last Name Wood

LREC Ref 2001/6161

Study Title An Open, Comparative, Within Patient, Controlled Phase III, Multicentre Study Of Hexvix Fluorescence Cystoscopy And Standard Cystoscopy In The Detection Of Carcinoma In Situ In Patients With Bladder Cancer Title Mr.

First Name Gordon

Last Name Williams

LREC Ref 2001/6162

Study Title Use of bovine colostrum to reduce dyspepsia in patients taking non-steroidal anti-inflammatory drugs (NSAIDS). Title Prof.

First Name Raymond

Last Name Playford

LREC Ref 2001/6163

Study Title Localization of brain regions involved in the processing of perceptual information obtained from observing human vs. robotic systems: A PET activation study. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6164

Study Title Investigation of the Effect of Oxyntomodulin on Appetite Title Prof.

First Name Stephen

Last Name Bloom

56 LREC Ref 2001/6165

Study Title The relationship between D2 receptor occupancy by sulpiride and neuropsychological function: an [11C] raclopride PET study Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6166

Study Title Significance of Serum Bactericidal Activity (SBA) test in ICU patients treated empirically for sepsis Title Dr.

First Name Panagiotis

Last Name Kaltsas

LREC Ref 2001/6167

Study Title Investigation into the use of sucrose in the treatment of moderate Title Dr.

First Name Audrey

Last Name Brynes

LREC Ref 2001/6168

Study Title The glycaemic index of malt containing products and their effects on cognitive Title Dr.

First Name Gary

Last Name Frost

LREC Ref 2001/6169

Study Title The possible use of Human Chorionic Gonadotrophin in prevention of preterm Title Prof.

First Name Phillip

Last Name Bennett

57 LREC Ref 2001/6170

Study Title To examine the effect that sexual activity may have on pregnancy outcome, in particular onset of natural labour Title Dr.

First Name Philip

Last Name Rahmanou

LREC Ref 2001/6186

Study Title A clinical trial to assess the intracerebral transplantation of carotid body aggregates for Parkinson's Disease. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6187

Study Title Development of PET procedures for assessment of functional recovery following spinal cord injury in man Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6188

Study Title Effects of the PPAR-gamma agonist Pioglitazone in the treatment of symptomatic peripheral arterial disease Title Prof.

First Name Martin

Last Name Wilkins

LREC Ref 2001/6189

Study Title The use of flow cytometry to compare the dendritic cell population in induced sputum of normal healthy volunteers, atopic healthy volunteers and patients with mild Title Dr.

First Name Philip

Last Name Ind

58 LREC Ref 2001/6190

Study Title Will new imaging techniques improve assessment and treatment of sarcoidosis? Title Dr

First Name Robina

Last Name Coker

LREC Ref 2001/6191

Study Title Does HLA polymorphism influence the incidence and severity of sarcoidosis? Title Dr

First Name Robina

Last Name Coker

LREC Ref 2001/6192

Study Title A clinical and laboratory evaluation of topical micronutrient supplementation to improve the diagnosis of latent TB infection in haemodialysis patients. Title Dr.

First Name Carlton

Last Name Evans

LREC Ref 2001/6193

Study Title Mirtazapine and 5-HT2A binding: The use of the cerebellum as a reference tissue to model the 5-HT2A PET ligand [11C] MDL 100907 Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6194

Study Title Development of laboratory methods for non invasive prenatal genetic diagnosis in fetal cells in maternal blood. Title Prof.

First Name Nicholas M

Last Name Fisk

59 LREC Ref 2001/6195

Study Title Study of a Red Clover Food Supplement (P-07) versus Placebo for Premenstrual Syndrome Title Mr.

First Name Nicholas

Last Name Panay

LREC Ref 2001/6196

Study Title 11C-raclopride PET studies of endogenous dopamine release during performance of rewarded and unrewarded visual memory tasks by Parkinson’s disease patients and healthy volunteers Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6197

Study Title Links between maternal and fetal stress hormone levels Title Prof.

First Name Vivette

Last Name Glover

LREC Ref 2001/6198

Study Title Investigation of the efficacy in safety profile of the Nlite Laser for Treatment of Acne Vulgaris Title Dr.

First Name Anthony

Last Name Chu

LREC Ref 2001/6199

Study Title VTP-1/01: A Phase I/II Trial of Intravenous vs. Hepatic Arterial Infusion of an E1A-CR2 Deleted Adenovirus (VTP-1) Alone and in Combination with Intravenous 5FU/Leucovorin for Patients with Inoperable, Metastatic Colorectal Carcinoma - Title Dr.

First Name David

Last Name Kirn

60 LREC Ref 2001/6214

Study Title The Effect of Medical Therapy on Cognitive Function and Cerebral Blood Flow in Patients Requiring Intensive Treatment for Heart Failure Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6215

Study Title The effects of the D1-agonist prodrug DAS-431 on cognitive and language functions in healthy volunteers Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6216

Study Title Mannose Binding Lectin (MBL) mutations and their association with infections in the Title Dr.

First Name Stephen

Last Name Brett

LREC Ref 2001/6217

Study Title A multi-centre, randomised, double-blind, parallel groups, placebo-controlled trial on efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven) in treatment of bleeding in patients following allogeneic stem cell transplantation (F7BMT1360) Title Dr.

First Name M

Last Name Laffan

LREC Ref 2001/6218

Study Title 1. Validation of measurement of cerebrovascular compliance. 2. The association between cerebral vascular compliance and cognitive function in the elderly. Title Dr.

First Name C

Last Name Rajkumar

61 LREC Ref 2001/6222

Study Title Comparison between early and late immunization with three doses of an heptavalant pneumococcal conjugate vaccine in allogeneic stem cell transplant recipients Title Dr.

First Name Jane

Last Name Apperley

LREC Ref 2001/6223

Study Title An experimental therapeutic intervention in Huntington’s disease: pre-operative characterization and post-operative follow-up with PET of patients receiving foetal striatal cell implant. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2001/6224

Study Title [11C]raclopride PET measurement of nicotine induced dopamine release Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2001/6225

Study Title First Administration To Man Of An Oncolytic Herpesvirus-1 Vector Containing A Transgene For Granulocyte Macrophage Colony Stimulating Factor (Oncovex gm-csf) - A Study Of Its Safety, Biodistribution And Biological Activity Title Prof.

First Name Charles

Last Name Coombes

LREC Ref 2001/6226

Study Title Cross-cultural study of early infant crying and parental care Title Dr.

First Name Ian

Last Name St. James-Roberts

62 LREC Ref 2001/6227

Study Title Study of Arterial Compliance in Women With the Syndrome of Polycystic Ovaries Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6228

Study Title Dynamic Spectral Imaging of the Cervix Title Mr.

First Name Pat

Last Name Soutter

LREC Ref 2001/6229

Study Title Expectations and experiences of hospital-based postnatal care: a preliminary study of women’s and midwives’ perspectives. Title Dr.

First Name Jane

Last Name Weaver

LREC Ref 2001/6230

Study Title Does improvement of coronary vasodilator reserve after aortic valve replacement reflect left ventricular decompression or regression of left ventricular hypertrophy? Title Prof.

First Name DJ

Last Name Sheridan

LREC Ref 2001/6231

Study Title Fetal cystoscopy to evaluate lower urinary tract obstruction in utero Title Dr.

First Name Sailesh

Last Name Kumar

63 LREC Ref 2001/6232

Study Title The development of a consumer friendly system to enable older people to express their health care wishes. (initial stage: interviews with elderly patients and design of proforma). (full study NOT APPROVED) first stage of the study alone approved i.e. the investigation of the opinions of elderly people as to the type of health care subjects they wish to discuss and their views on the type of language they understand. The use of this information to design a proforma along with "expert" input including the Trust's legal advisor. The use of this proforma will need to be submitted to the REC for review by the full committee before approval for the full Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6233

Study Title Pilot study of allogeneic peripheral stem cell transplantation and donor lymphocyte infusion following non-myeloablative conditioning in patients with metastatic breast Title Dr.

First Name DM

Last Name Vigushin

LREC Ref 2001/6234

Study Title Characterisation, differentiation, transduction, engraftment and reparative potential of fetal mesenchymal stem/progenitor cells. Title Prof.

First Name NM

Last Name Fisk

LREC Ref 2001/6235

Study Title Can novel Ultrasound and CT methods show early responses to chemotherapy of liver metastases? Title Dr.

First Name Thomas

Last Name Bryant

64 LREC Ref 2001/6242

Study Title In normal development, does the attainment of motor skills have an effect on the rate of development of cognitive skills? A comparison of intellectual development in children with type II and type III spinal muscular atrophy Title Miss

First Name Emma

Last Name Sales

LREC Ref 2001/6247

Study Title High-resolution computed tomographic features of aging lung Title Dr.

First Name S

Last Name Copley

LREC Ref 2002/6254

Study Title Investigation of neutrophil abnormalities in Inflammatory Bowel Disease and Behçet’s Syndrome using a skin blister technique Title Prof.

First Name Dorian

Last Name Haskard

LREC Ref 2002/6255

Study Title Monocyte intracellular interleukin-1Beta (IL-1 Beta) for the early detection of infections and necrotizing enterocolitis (NEC) in preterm infants Title Dr.

First Name Neil

Last Name Murray

LREC Ref 2002/6256

Study Title Optimizing platelet transfusion therapy in preterm neonates with severe Title Dr.

First Name Neil

Last Name Murray

65 LREC Ref 2002/6257

Study Title Assessment of changes in ventilation following induced broncho-constriction with inhaled histamine in normal subjects using 81Krypton ventilation scintigraphy Title Dr.

First Name Philip W

Last Name Ind

LREC Ref 2002/6258

Study Title The effects of methylphenidate on cognitive and language functions in healthy elderly volunteers and patients suffering aphasic stroke Title Dr.

First Name David

Last Name Sharp

LREC Ref 2002/6259

Study Title A randomized, double-blind, vehicle controlled phase I/II study to evaluate the safety, tolerability and efficacy of a histamine dihydrochloride-containing gel versus a gel vehicle in the treatment of radiotherapy-induced dermatitis in patients with head and neck squamous cell carcinoma Title Dr.

First Name J Simon

Last Name Stewart

LREC Ref 2002/6260

Study Title Quantifying the 24 hour glycaemic response of a low glycaemic index diet in free living people with type 2 diabetes treated with insulin: A pilot study Title Dr.

First Name Audrey

Last Name Brynes

LREC Ref 2002/6261

Study Title Investigation of The Effects Of Glucagon-Like-Peptide-1 and Peptide YY On Appetite Title Prof.

First Name SR

Last Name Bloom

66 LREC Ref 2002/6262

Study Title Randomised double blind study to determine the effect of epidural volume extension on intrathecal dose requirements for Caesarean section Title Dr.

First Name Gary

Last Name Stocks

LREC Ref 2002/6263

Study Title MRI Investigations of the Subgenual Prefrontal Cortex in Patients with Familial Bipolar Disorder Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2002/6271

Study Title Comparison of hepatic vein transit times of Levovist and SonoVue in normal Title Dr.

First Name Adrian

Last Name Lim

LREC Ref 2002/6272

Study Title Phase 1/2 Study Of The Adjunctive Use Of Glivec (STI-571) In Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation For Chronic Myeloid Title Dr.

First Name Eduardo

Last Name Olavarria

LREC Ref 2002/6273

Study Title A pilot study to determine the feasibility and reproducibility of kinetic 11C-choline PET imaging as an index of signal transduction in tumours and normal tissues Title Prof.

First Name Charles

Last Name Coombes

67 LREC Ref 2002/6274

Study Title Investigation of the effects of the pancreatic polypeptide on appetite Title Prof.

First Name SR

Last Name Bloom

LREC Ref 2002/6275

Study Title A multinational, multicentre, randomised, double-blind, parallel group, active controlled, comparative trial, to assess the endometrial histological profile following treatment with tibolone (Org OD 14) versus conjugated oestrogen (CE) plus medroxyprogesterone acetate (MPA) in postmenopausal women. Title Mr.

First Name N

Last Name Panay

LREC Ref 2002/6276

Study Title Investigation of the effect on tidal breathing of negative pressure applied at the mouth during normal expiration in normal volunteers and patients with chronic obstructive pulmonary disease (COPD) Title Dr.

First Name PW

Last Name Ind

LREC Ref 2002/6277

Study Title A study to assess the inter- and intra-subject variability of lung 18FDG uptake by Positron Emission Tomography in stable COPD patients in comparison with normal Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2002/6278

Study Title A randomized placebo-controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy Title Mr.

First Name Nicholas

Last Name Panay

68 LREC Ref 2002/6279

Study Title Distribution of Opioid Receptors Measured with Positron Emission Tomography in Parkinsonian Patients Experiencing Pain Title Prof.

First Name DJ

Last Name Brooks

LREC Ref 2002/6280

Study Title An investigation in to the use of hospital services by refugees and asylum seekers in West London Title Dr.

First Name Philip

Last Name Gothard

LREC Ref 2002/6296

Study Title Contribution of PET imaging with [F-18] FLT to the evaluation of patients with non-small cell lung cancer Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2002/6297

Study Title To evaluate the feasibility and reproducibility of the combination of an automatic border delineation technique for assessment of systolic cardiac function with an algorithm for qualitative and quantitative assessment of myocardial perfusion during SonoVue®-enhanced echocardiography. Title Dr.

First Name Petros

Last Name Nihoyannopoulos

LREC Ref 2002/6298

Study Title A multicentre, Double blind, Randomised, Placebo controlled study to evaluate the effects of Simvastatin on clinical endpoints in patients with degenerative aortic Title Dr.

First Name Petros

Last Name Nihoyannopoulos

69 LREC Ref 2002/6299

Study Title Autologous stem cell transplant followed by imatinib mesylate as therapy for patients cytogenetically resistant to imatinib mesylate Title Dr.

First Name David

Last Name Marin

LREC Ref 2002/6300

Study Title Calcium blockade and Pulmonary AVMs Title Dr.

First Name Claire

Last Name Shovlin

LREC Ref 2002/6301

Study Title A prospective randomised pilot study to compare the absorption of Adept versus ringers lactate solution from the pelvis following laparoscopic gynaecological surgery using a semi-quantitative ultrasound scoring system. Title Mr.

First Name G

Last Name Trew

LREC Ref 2002/6302

Study Title Effects of dapsone on microglia activation in early Alzheimer’s disease: A positron emission tomography study. Title Prof.

First Name David

Last Name Brooks

LREC Ref 2002/6303

Study Title Longitudinal changes of microglial activation and dopaminergic function in patients with idiopathic and atypical parkinson's disease: a pet study Title Prof.

First Name David

Last Name Brooks

70 LREC Ref 2002/6305

Study Title The effects of methylphenidate on acute stress-responsivity and working memory Title Prof.

First Name Paul

Last Name Grasby

LREC Ref 2002/6306

Study Title The effects of withdrawal from dopamine medication on cognitive function in Parkinson’s disease Title Prof.

First Name David

Last Name Brooks

LREC Ref 2002/6307

Study Title Assessing the dopaminergic function of the globus pallidus internus in Parkinson's disease complicated by motor fluctuations. Title Prof.

First Name David

Last Name Brooks

Appendix 2(f) 71 MREC approved studies approved by sub-committee

LREC Ref 2001/6047-M

Study Title A study comparing the costs and efficacy of on demand treatment with esomeprazole 20mg and continuous treatment with esomeprazole 20mg in long term management of patients with symptomatic gastro-oesophageal reflux disease (GORD). A six month, open, randomised multi centre study - Title Dr.

First Name Navin A

Last Name Thakrar

LREC Ref 2001/6066-M

Study Title European Heart Survey for Valvular Heart Disease Title Prof.

First Name David

Last Name Wood

LREC Ref 2001/6074-M

Study Title A national DNA Bank for Glomerulonephritis (MREC00/5/42) Title Prof.

First Name Charles

Last Name Pusey

LREC Ref 2001/6083-M

Study Title A study of the time lag between a move of address and subsequent GP registration (MREC/1/3/5) Title Mr.

First Name Christopher

Last Name Millett

72 LREC Ref 2001/6085-M

Study Title An open label study of recombinant human activated protein C in severe sepsis A phase 3b clinical trial Title Dr.

First Name Stephen

Last Name Brett

LREC Ref 2001/6107-M

Study Title Phase II study of low intensity non-myeloablative allografts following high-dose melphalan with autologous stem cell support in myeloma patients with sibling donors (MREC 01/8/4) Title Dr.

First Name Diana

Last Name Samson

LREC Ref 2001/6117-M

Study Title DNA Repository for characterisation of the inherited abnormalities in combined hyperlipidaemia Title Prof.

First Name James

Last Name Scott

LREC Ref 2001/6136-M

Study Title Non-neutropenic candida infection treatment study (MREC(1) 99/46) Title Dr.

First Name Stephen

Last Name Brett

LREC Ref 2001/6137-M

Study Title Risk factors for group B streptococcal (GBS) disease in infants <90 days of Title Dr.

First Name Neena

Last Name Modi

73 LREC Ref 2001/6142-M

Study Title Randomised trial evaluating Elotaxin (Oxaliplatin) combined with two different 5-Fluorouracil regimens in patients with previously untreated advanced colorectal cancer. Title Dr.

First Name Harpreet

Last Name Wasan

LREC Ref 2001/6144-M

Study Title A randomised double blind, placebo controlled, parallel group, multi-centre, phase II study to assess the efficacy and tolerability of ME3301 in patients with moderate asthma Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6145-M

Study Title Omalizumab in patients with co-morbid allergic asthma and perennial allergic rhinitis (MREC 01/1/42) Title Dr.

First Name Philip

Last Name Ind

LREC Ref 2001/6150-M

Study Title Five year follow up of children who suffered from meningitis during neonatal Title Prof.

First Name David

Last Name Harvey

LREC Ref 2001/6171-M

Study Title The coronary artery revascularisation in diabetics (CARDia) trial Title Dr.

First Name Akhil

Last Name Kapur

74 LREC Ref 2001/6182-M

Study Title Heart failure revascularisation trial - UK Title Dr.

First Name Petros

Last Name Nihoyannopoulos

LREC Ref 2001/6185-M

Study Title Optimising the use of Azathioprine in inflammatory bowel disease: a study to investigate the influence of Thiopurine methyl transferase genotype and phenotype and the role of 6-thioguanine nucleotides (Azathioprine in inflammatory bowel disease: the role of measuring TPMT and 6-TGN) Title Dr.

First Name Andrew

Last Name Thillainayagam

LREC Ref 2001/6205-M

Study Title Carriage of hypervirulent meningococci before and after the introduction of serogroup C conjugate polysaccharide vaccine in the UK (MREC/99/4/036) Title Dr.

First Name Yuen kai

Last Name Lau

LREC Ref 2001/6208-M

Study Title Diabetes in the very elderly pilot trial (DIVET) Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2001/6245-M

Study Title Efficacy of Probiotics in the prevention of Antibiotic-associated Diarrhoea Title Prof.

First Name CJ

Last Name Bulpitt

75 LREC Ref 2001/6246-M

Study Title A randomised trial of hormone therapy alone versus hormone therapy plus radical radiotherapy in non-metastatic prostate cancer (PRO7) Title Dr.

First Name Simon

Last Name Stewart

LREC Ref 2002/6265-M

Study Title Genetic study of multiple leiomyomas of the skin (amendment #1 - 8-11-01) (MREC 99/2/13) Title Dr.

First Name Ian

Last Name Tomlinson

LREC Ref 2002/6268-M

Study Title Thalidomide maintainance following high dose therapy in multiple myeloma: phase 2 study (MREC/01/7/19) Title Dr.

First Name Amin

Last Name Rahemtulla

LREC Ref 2002/6269-M

Study Title MREC/99/2/4 An international, multi-centre observational registry of patients with haemoglobinopathies Title Dr.

First Name DM

Last Name Layton

LREC Ref 2002/6285-M

Study Title Whole body hypothermia for the treatment of perinatal asphyxia encephalopathy (MREC 00/2/73) Title Dr.

First Name Denis

Last Name Azzopardi

76 LREC Ref 2002/6288-M

Study Title A randomized, double-blind study of GT160-246 versus vancomycin in patients with c.difficile associated diarrhoea Title Prof.

First Name CJ

Last Name Bulpitt

LREC Ref 2002/6292-M

Study Title A multi-centre randomised double-blind placebo-controlled parallel-group study to evaluate the safety and efficacy of CDC-501 in the treatment of adults with moderately severe Crohn's disease (MREC 01/4/075) Title Prof.

First Name Subrata

Last Name Ghosh

LREC Ref 2002/6293-M

Study Title A multicentre, double blind, randomised, placebo controlled, phase 2 study of prophylactic administration of recombinant human lactoferrin in patients receiving autologous peripheral stem cell transplants (MREC/01/9/50) Title Dr.

First Name Jane

Last Name Apperley

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