Royal Postgraduate Medical School/Hammersmith, Queen Charlotte S & Chelsea and Acton Hospitals

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”

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

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

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

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

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

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

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.

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

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

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