HAMMERSMITH, QUEEN CHARLOTTE’S & CHELSEA AND ACTON HOSPITALS
research ethics committee
annual report 2000/2001
Report for period 1 January 2000 – 31 March 2001 (report timeframe adjusted to come into step with financial year)
· 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.
· MEMBERSHIP
The Committee currently has 16 members (as of 31st March 2001), including the Chair and Vice Chair. The full membership is listed at annex 1.
DEPARTURES:
September 2000:
Katie Scales resigned from the committee to take up a new position as a Nurse Consultant.
Dr Dolores Iorizzo resigned from the committee for personal reasons.
NEW MEMBERS:
The Committee welcomed the following new members:
Dr Columba Quigley - Palliative Care, Medical Oncology, Charing Cross Hospital (joined September 2000)
Ms Fiona Freedland - Lawyer (joined November 2000)
Dr Sunil Shaunak – Infectious Diseases (joined February 2001)
OBSERVERS:
September 2000:
Ms Kam Datta – Human Biomaterials Resource Centre Manager
Dr Bryony Dean - Principal Pharmacist Clinical Pharmacy Services and Director of the Academic Pharmacy Unit (APU).
· REPORTS/GUIDELINES DISCUSSED
· “Report of A Review of The Research Framework in The North Staffordshire Hospital NHS Trust"
The committee received the report of the review of the research framework in the North Staffordshire Hospital NHS Trust which was instigated following allegations made against Professor Southall by parents of children recruited into the CNEP ventilator trial.
It was noted that many of the issues raised in the report were beyond the immediate remit of the research ethics committee and would be taken up by the "research management working party" chaired by Dr Andrew George. The research ethics committee would be kept informed of any recommendations that were made by the working party.
· "Draft report of the research management working party", of which The Chairman, Vice-Chair and the Secretary were members.
· Draft guidelines on informal collection of blood samples from colleagues within Imperial College - from Dr Alan Swann of the Occupational Health Service.
It was felt that the committee could not approve or licence these guidelines. The committee took the view that the approval of a research ethics committee should be sought for all research involving blood taken from human donors. The removal of this step from the research appraisal process was considered to be an erosion of the protection afforded to all research participants by ethical review. It was requested that the committee's view that REC permission should be obtained in all cases of blood collection for research at the Hammersmith and Queen Charlotte's hospitals should be indicated in the final guidelines.
· Supplementary operational guidelines for REC’s : “Ethical review of multi-centre research in the NHS where there is no local researcher”
· MRC Guidelines – Personal information in research (Executive Summary)
· Human Genetics Commission consultation document (www.hgc.gov.uk) regarding storage, protection and use of personal genetic information.
· COMMITTEE PROCEDURES
APPLICATION FORM:
following confusion concerning studies carried out in different countries by one investigator the following wording was introduced in the application form to elucidate in which countries the research would be taking place:
(vi) The site(s) where the research will take place (e.g. which hospital(s), medical school(s), GP clinic(s) etc. - include all UK multi-centre sites and all overseas sites (if greater than 5 overseas sites please give co-ordinating centre only):
POTENTIAL FOR ABNORMAL FINDINGS DURING RESEARCH INVESTIGATIONS.
During the committee's deliberations the issue of how investigators should deal with abnormal results derived from research investigations e.g. MRI, PET scans etc. was discussed. The committee decided that participants should be made aware in the information sheet of the possibility of abnormalities being discovered and the procedure that would be followed in such an event.
The following paragraph was added to the information sheet template for studies where the possibility exists that information might be discovered which could have implications for the participants’ health (e.g. MRI/PET studies):
“You should be aware that there is a possibility that the methods used in this study may produce an unexpected result that may have relevance for your health. In the unlikely event of this happening, we will discuss this with you and, if necessary, provide any support that you may require, such as arranging follow-up tests and/or treatment.”
SERIOUS ADVERSE EVENTS
A covering letter was produced which is to be submitted by the principal investigator with all SAE notifications, which asks them to confirm that they have assessed the adverse event(s) and are happy for the study to continue.
TISSUE SAMPLES
The table “Definitions of Types of Tissue Sample" included in the HGC document was incorporated into the committee's guidance notes in order to help researchers explain to participants the relative "anonymity" of data obtained from them.
Question 4(5)(e) "if samples are to be taken for genetic studies, will the samples be rendered anonymous?" Was expanded to indicate the type of anonymisation:
“Please indicate method used (refer to REC guidance notes for definitions):
Anonymous (unidentified):
Anonymised (unlinked):
Coded (‘linked’ or ‘identifiable’):
Identified:”
· OTHER ISSUES DISCUSSED AND DECISIONS REACHED
TISSUE COLLECTIONS:
The committee decided that in future it could not give its approval for any collection of human tissue that was unconnected to any specific research proposal. It was felt that approval of such collections would be entirely outside of its current remit. However, specific research proposals using tissue collections would only be approved by the committee if those tissues were collected, stored and distributed according to the MRC guidelines.
The committee recommended that the Trust needed to take responsibility for approving all such collections involving tissue from patients of Hammersmith Hospitals NHS Trust. The Chairman reiterated the committee's position that we are unable to ‘approve’ tissue banks, which should be governed by their relevant institution, but that we would provide the custodian with advice regarding the activities of any tissue collections within their remit if approached to do so. This ‘advice’ would not constitute ‘approval’.
GENETIC TESTING IN RESEARCH PROJECTS
The committee also discussed the implications of genetic testing for research participants. If genetic testing was not anonymised in the course of performing a study and a result found which might indicate that further clinical genetic testing would be appropriate, then it was felt that this result (i.e. one which indicated a need for further investigation) should be fed back to the participants with appropriate counselling. The participants should then be urged to seek clinical genetic testing to confirm the tentative research result.
POLKINGHORNE GUIDELINES
The committee felt that the Polkinghorne consent sheet should be modified to give participants the opportunity to find out about the research being proposed if they so wished. It was aware that thisdecision went against the Polkinghorne guidelines and it took this decision because it believed that a prohibition on informing patients (who wished to know) about the nature of the research went against the important principle of facilitating patient autonomy and the principle of ‘informed’ consent.
· WORKLOAD
The Committee met on eleven occasions in 2000/2001.
No. of applications reviewed by Full Committee 145
No. of applications “approved” by Full Committee (as of 31-3-01) 100
No. of applications “approved” by Full Committee without amendment 1
No. of applications “approved” by Full Committee following amendment 99
(as of 31-3-01)
No. of applications “approved in principle” or “not approved” by Full Committee 45 awaiting final approval (at 31-3-01)
No. of applications “not approved” and awaiting resubmission to Full Committee 4
(at 31-3-01)
No. of applications “withdrawn” 1
No. of applications reviewed by MREC Sub-Committee 52
No. of applications “approved” by MREC Sub-Committee (at 31-3-01) 46
No. of applications pending (at 31-3-03) 6
No. of applications reviewed by Chairman’s action 115
No. of applications “approved” by Chairman’s action 115
Total new applications considered: 312
No. of applications for amendments reviewed by Chairman’s action 228
No. of applications “reviewed” in previous year finally given approval by Chairman’s action 23
A full list of protocols considered/approved during 2000/2001 is at annex 2.
· APPENDICES
1. Committee Membership
2(a). Studies “approved in principle” in previous year given final
approval in 2000/2001
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
2(g) Withdrawn studies
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)
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
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
Professor T R Rogers MSc, FRCPath, FRCPI, Infectious Diseases, ICSM
Dr S Shaunak PhD, FRCP, FRCPE, Infectious diseases, ICSM
Lay Representatives
Lady Riddell (Vice-Chair)
Ms F Freedland, BA
Mrs J Lundie BA
Statistics Advisor
Mr P Bassett
Secretary
Mr Clive Collett, BSc., PGDip. (Healthcare Ethics)
Appendix 2(a)
Studies “approved in principle/not approved” in previous year given final approval in 2000/2001
Studies "approved in principle" in previous year given final approval
LREC Ref 1999/5547-M
Study Title A study to compare the use of conventional Oral
Melphalan (M7) with intravenous intermediate
dose Melphalan and Dexamethasone in patients
aged 65 years or older (MREC (1) 98/16)
Title Dr.
First Name Jane
Last Name Apperley
LREC Ref 1999/5558
Study Title Occult Form of Infiltrative and Hypertrophic
Cardiomyopathies Characterised by a Novel
Echocardiographic Approach - Myocardial
Velocity Gradient
Title Dr.
First Name Petros
Last Name Nihoyannopoulos
LREC Ref 1999/5632
Study Title Quantification of Sympathetic Innervation of the
Myocardium of Patients Suffering from
Brugada-Syndrome and Idiopathic Left Ventricular
Fibrillation using Positron Emission Tomography
Title Prof.
First Name Paolo
Last Name Camici
LREC Ref 1999/5635
Study Title Dopamine D2 receptor function in depressed
patients and normal volunteers before and after
antidepressant treatment, assessed with positron
emission tomography and 11C-raclopride
Title Dr.
First Name Paul
Last Name Grasby
LREC Ref 1999/5647
Study Title Magnetic resonance monitored focussed
ultrasound ablation of prostate carcinomas:
correlation of magnetic resonance changes with
histopathology at varying energy doses.
Title Mr.
First Name P
Last Name Abel
LREC Ref 1999/5649
Study Title Experimental therapeutic intervention in
Huntington’s Disease: the effects of foetal striatal
cell implants.
Title Prof.
First Name David
Last Name Brooks
LREC Ref 1999/5685
Study Title The role of lung water in the development of
respiratory disease in the neonate.
Title Prof.
First Name David
Last Name Edwards
LREC Ref 1999/5702
Study Title Assessment of myocardial alpha 1-adrenoceptors
using 11GB67, a new radioligand for positron
emission tomography
Title Prof.
First Name Paolo
Last Name Camici
LREC Ref 1999/5705
Study Title DMP 115-203 - A phase II open label,
non-randomised, multi-centre trial to determine the
ability of DMP 115 to improve the detection of
prostate cancer in subjects referred for
transrectal ultrasound of the prostate
Title Prof.
First Name David
Last Name Cosgrove
LREC Ref 1999/5706
Study Title A non randomised, open labelled, phase II study
investigating the tolerability and efficacy of
CAELYX (tm) in patients with advanced
carcinoma of the bladder
Title Prof.
First Name Jonathan
Last Name Waxman
LREC Ref 1999/5718
Study Title The effect of glyceryl trinitrate (GTN) in the
healing of venous ulcers
Title Mr.
First Name NJ
Last Name Standfield
LREC Ref 1999/5720
Study Title Investigation of the pharmacokinetics of prolactin
releasing peptide (PRP) and its effect on pituitary
hormone secretion
Title Prof.
First Name SR
Last Name Bloom
LREC Ref 1999/5721
Study Title Extension to clinical protocol study No: 99103 -
Open label study to assess the safety and
efficacy of daily doses of 400mg cizolirtine citrate
in patients suffering from neuropathic pain
syndromes during a 6 month period following a
clinical phase II study
Title Prof.
First Name Praveen
Last Name Anand
LREC Ref 1999/5724
Study Title A study to investigate the mechanisms of
recovery of speech comprehension following
stroke, using positron emission tomography and
behavioral measures
Title Ms.
First Name Jennifer
Last Name Crinion
LREC Ref 1999/5727
Study Title Evaluation of the safety, tolerability,
pharmacokinetics and effect of GI181771, a
CCK-A agonist, administered orally on gallbladder
contractility
Title Dr.
First Name W
Last Name Svensson
LREC Ref 1999/5735