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