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MULTI CENTRE REASEARCH COMMITTEE ANNUAL REPORT (DOC)

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MULTI CENTRE REASEARCH COMMITTEE ANNUAL REPORT (DOC) Powered By Docstoc
					The Joint UCL/UCLH Committees on
  the Ethics of Human Research
           (Committee A)

          Annual Report

      1 April 2007 - 31 March 2008
Part 1 – Committee Membership and Training

Name of REC:                   The Joint UCL/UCLH Committees on the Ethics of Human Research
                               (Committee A)

Type of REC:                   Recognised type 3

Type of Flag:                  Paediatrics

Chair:                         Dr Geoff Scott

Vice-Chair:                    Dr Robert Urquhart

Co-ordinator:                  Miss A. Mittu

Committee Address:             ICH Research & Development Directorate Office
                               1st Floor, 3 Long Yard
                               London WC1N 1EH
                               POSTAL ADDRESS
                               R&D Department, Institute of Child Health,
                               30 Guilford Street, London
                               WC1N 1EH

Telephone:                     0207 599 4144
Fax:                           0207 599 4138
Email:                         a.mittu@ich.ucl.ac.uk



 Chair’s overview of the past year:




 The Committee is functioning well. We were sad to have lost some valuable members: Mr Andrew
 Green, Professor Renata Whurr, Dr Elizabeth Pruvulovich and Dr Adrian Naftalin. However, we are
 pleased to welcome several new members: Miss Marion Koebner, Ms Vivien Yule,
 Dr Stuart Adams, Dr John Phelan, Ms Stephanie Williams. Committee members work hard in
 preparation for meetings. The amount of paperwork to read has been increasing not decreasing.

 There is lively debate and wide discussion which leads to well-considered consensus of opinions.
 Our impression is that the quality of applications has been steadily improving over the last few
 years. We give advice on dealing with ethical concerns raised in the committee.

 Where the committee has not given a favourable opinion or requested changes, this has invariably
 led to clarification and improvement in the ethical approach and quality of the research applications.
 As a result, we have, in most cases, been pleased to be able subsequently to approve the
 applications. We have dealt with applications within the required time limits and the review process
 has not been significantly delayed, particularly if applicants respond quickly to our comments.



The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 2
The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A)
Membership:

Name                           Occupation                     Expert or              Dates
                                                                Lay         Appointed     Resigned
Ms. Sally Davis                Lay - Barrister                   Lay         Nov 2005
Ms Sarah Corker                Nurse                           Expert       April 2003    June 2007
Mr Andrew Green                Planning Analyst                 Lay          Jan 2004      Feb 2008
Miss Mina Karamshi                                             Expert        Feb 2005
Dr Raymond MacAllister         Clinical Pharmacologist         Expert          2001
Ms Wendy Matthews              Legal Member (Lay)               Lay          Dec 2004
Dr Judith Meek                 NNU Consultant                  Expert       March 2005
Dr Adrian Naftalin             General Practitioner            Expert        Dec 1997      Feb 2008
Dr Raymond Noble               Sub-Dean Medical School         Expert        Feb 2003
Dr Elizabeth Prvulovich        Consultant Physician in         Expert        July 2002
                               Medicine/Honorary Senior
                               Lecturer
Dr Geoff Scott                 Microbiologist                   Expert       April 2001
Mr Jonathan Simons             Investment Banker                 Lay         Jan 2004
Dr. Anne Marie Swart           Clinical Epidemiologist          Expert      August 2005
Dr Robert Urquhart             Head of Pharmacy                 Expert       Sept 2004
Professor Renata Whurr         Specialist Speech and            Expert        Feb 2003        Feb
                               Language Therapist                                            2008
Miss Marion Koebner            Retired Lawyer                    Lay       January 2007
Ms Vivien Yule                 Director of Executives            Lay         July 2007
                               Consultancy
Dr Stuart Adams                Clinical Scientist               Expert       February
                                                                               2008
Dr John Phelan                 Research                         Expert      March 2008
                               Scientist/Molecular
                               Biologist
Ms Stephanie Williams          Writer                            Lay          February
                                                                                2008

Deputy Members

Name                           Occupation                     Expert or      Meeting date attended
                                                                Lay
Not Applicable

Co-opted Members

Name                           Occupation                     Expert or      Meeting date attended
                                                                Lay
Dr Elizabeth Carrey            Programme Director, MSc          Lay               28 June 2007
Moorfields & Whittington       Programme in Clinical                             31 January 2008
Ethics Committee               Paediatrics and Senior
                               Lecturer in Medical
                               Education


The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 3
Member Bank

Name                           Occupation                     Expert or      Meeting date attended
                                                                Lay
Not Applicable


Meetings for Full Ethical Review 1 April 2007- 31 March 2008:

            Month                               Date                  Number of Members Present
                                                                             at Meeting
April                                        26/04/2007                           8
May                                          31/05/2007                           8
June                                         28/06/2007                           9
July                                         26/07/2007                           9
September                                    20/09/2007                          13
October                                      25/10/2007                          10
December                                     06/12/2007                          10
January                                      31/01/2008                           7
February                                     28/02/2008                          11
March                                        27/03/2008                          14

Attendance of Members: 1 April 2007 – 31 March 2008:


Name                                                                                   Number of
                                                                                       Meetings
                                                                                       Attended
Dr Geoff Scott                                                                             8
Dr Robert Urquhart                                                                         8
Prof Raymond McAllister                                                                    7
Dr Adrian Naftalin                                                                         6
Dr Elizabeth Pruvulovich                                                                   2
Professor Renata Whurr                                                                     2
Dr Anne Marie Swart (five for our committee and 1 co-option for Camden                     6
Committee)
Dr Raymond Noble                                                                            9
Dr Judith Meek                                                                              5
Mr Jonathan Simons                                                                          9
Ms Wendy Matthews                                                                           7
Mr Andrew Green                                                                             3
Ms Mina Karamshi                                                                            6
Ms Sally Davis                                                                              7
Miss Marion Koebner                                                                         5
Ms Vivien Yule                                                                              3
Dr Stuart Adams                                                                             2
Ms Stephanie Williams                                                                       2
Dr John Phelan                                                                              1

Number of inquorate meetings held: 0


The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 4
 Training 1 April 2007 – 31 March 2008:

Name of Member                      Date         Event(s) attended
Dr Anne Marie Swart               May 2007       Clinical Research and the Provision of New
                                                 Medicines – A Crisis of Confidence
                                                 Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection
Dr Judith Meek                    May 2007       Good Clinical Practice Course
                                                 Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection
Miss Marion Koebner                27-29         The Ethics of Research on Humans
                               February 2008
Ms Vivien Yule                   November        Induction
                                   2007
                                   27-29         The Ethics of Research on Humans
                               February 2008
Prof Raymond McAllister        Continuous to     Self Directed Learning
                                    date
                                                 Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection
Dr Raymond Noble                Continuous to    Self Directed Learning
                                    date

Dr Robert Urquhart                               Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection

                                                 Continuous Pharmacy courses/refreshers
Dr Geoff Scott                                   Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection
Dr John Phelan                                   Annual Updates/Refreshers/Equality & Diversity
                                                 Training and Data Protection



List of Training Events Organised Locally by the Co-ordinator:

None.




The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 5
Part Two: REC Workload 1 April 2007 – 31 March 2008:


Summary of Work Types 1 April 2007 – 31 March 2008:


Applications for full ethical review – Type                        Number                     %
Clinical Trial of Investigational Medicinal Product                  17                      22.7
Phase 1                                                               0                      0.0
Gene Therapy                                                          0                      0.0
Research Tissue Bank                                                  0                      0.0
Research Database                                                     0                      0.0
Others                                                               58                      77.3
Total Applications Reviewed                                          75                     100.0

Number of applications transferred in from other RECs                  3
Number of applications transferred out to other RECs                   0
Number of invalid applications received                                0
Number of studies withdrawn prior to the meeting                       0
Number of studies withdrawn after the meeting                          0
Site Specific Assessment                                              37
Number of student applications reviewed                               24
Number of substantial amendments reviewed                             91
Number of Section 30 applications reviewed                             0



Summary of Decisions Made 1 April 2007 – 31 March 2008:

Decisions taken at meetings following review of                    Number                    %
applications
Favourable Opinion                                                    25                    33.8%
Unfavourable Opinion                                                   7                     9.5%
Provisional Opinion                                                   40                    54.1%
Other                                                                  2                     2.7%
Total                                                                 74                    100%
Number of studies sent back to full committee meeting                  5
for final opinion

Status of applications at date of generation of report             Number                     %
Further Information Favourable Opinion                               40                     53.3%
Further Information Unfavourable Opinion                              0                      0.0%
Favourable Opinion                                                   25                     33.4%
Unfavourable Opinion                                                  7                      9.3%
Provisional Opinion                                                   2                      2.7%
Other                                                                 1                      1.3%
Total                                                                75                     100%



The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 6
 Other Management Information 1 April 2007 – 31 March 2008:

Average number of applications reviewed per full meeting                             4.9
Number of applications for full ethical review over 60 days                           2
Number of applications over 60 days as a % of total                                  2.5%
Number of days taken to final decision - average                                     37
Number of days taken to final decision - mode                                        23

Number of SSAs reviewed                                                              37
Number of applications for SSA review over 25 days                                    0
Number of applications for SSA review over 25 days as % of                           0.0%
all SSAs

Number of substantial amendments over 35 days                                         0
Number of substantial amendments over 35 days as a % of                              0%
total substantial amendments

Number of Section 30 applications over 60 days                                        0
Number of Section 30 applications over 60 days as a % of                             0%
total Section 30 applications




The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report
Page 7
 The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


Further Information Favourable Opinion
07/H0714/100             Prostate angiography trial v1                                                 44
07/H0714/103             Study to compare Tiotropium & Salmeterol on COPD exacerbations                33
07/H0714/104             Measurement of in vivo cellular immune responses to M tuberculosis            34
07/H0714/107             Biomechanical Breast Model Investigation, version 1                           25
07/H0714/110             Prevention of Pulmonary Hypertension in Interstitial Lung Disease             50
07/H0714/111             Biomarkers for predicting breast radiotherapy induced side-effects            55
07/H0714/114             Learning and decision making in Parkinson's Disease                           76
07/H0714/116             Gemini - health and development in twins                                      40
07/H0714/118             Mechanisms of assessing ambiguity and risk                                    47
07/H0714/125             Bosentan in Interstitial Lung Disease and Pulmonary Hypertension              45
07/H0714/131             IV immunoglobulin in the treatment of refractory trigeminal neuralgia.        44
07/H0714/133             Non-rigid registration of CT colonography and colonoscopy                     40
07/H0714/77              GWSP0702 Sativex Randomised Withdrawal study: Spasticity due to MS            40
07/H0714/79              Recall of lifestyle and medication recommendations.                           36
07/H0714/82              MRI evaluation of colonic IBD version 1                                       50
07/H0714/84              Efficacy and Safety of BOTOX in Treating Benign Prostatic Hyperplasia         56
07/H0714/85              Childrens' experiences of stimulant drug medication for ADHD Version 1        34
07/H0714/89              Elevated Factor VIII and Thrombin Generation in Thrombosis                    47
07/H0714/91              European Database of 123I FP-CIT SPET scans of healthy controls               23
07/H0714/94              Constituents of a beautiful smile perceived by child & adult group            21
07/H0714/96              EFC 6546: VENICE - Study of Aflibercept in prostate cancer                    23
07/H0714/97              Treatment of Periodontitis and Type 2 Diabetes Mellitus                       31
07/Q0505/11              Can endoanal sono-elastography help characterise sphincter function?          65
07/Q0505/49              Patient centred outcomes: prolapse and urinary incontinence surgery           43
07/Q0505/52              vestibular hypofunction in migraine related vertigo- version 1                40
07/Q0505/54              laboratory reference range                                                    48
07/Q0505/58              Gene Expression profiling                                                     47
07/Q0505/59              Prevalence of swallowing difficulties after laryngectomy - version 1          51
07/Q0505/60              Developing a simple molecular assay for malaria                               39
07/Q0505/62              Coping styles, fear of hypoglycaemia and frequency of SMBG                    46
The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A)                          Page 8
Annual Report
 The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/Q0505/68                 Young people's experience of stimulant medication for ADHD                 42
07/Q0505/69                 Innovative technology in cancer care                                       35
07/Q0505/72                 Stem cells from dental pulp - version 1                                    46
07/Q0505/73                 Retrospective survival of adhesive gold onlays and gold backings           37
07/Q0505/8                  Yakult in maintenance of ulcerative colitis                                52
08/H0714/15                 Sorafenib vs combination low dose interferon in advanced RCC patients.     58
08/H0714/19                 Inhaled liposomal ciprofloxacin in patients with bronchiectasis v1         40
08/H0714/20                 Phase I study of rhuMAb Beta7 in patients with ulcertive colitis           56
08/H0714/7                  Lower lip numbness following lower jaw surgery                             56
08/H0714/8                  Predictive utility of DASIMAR as prognostic Biomarker in ACLF              41

Favourable Opinion
07/H0714/102                Recognising Fathers version1                                               29
07/H0714/112                A Structured Competencies Approach to Diabetes Education                   32
07/H0714/113                CWS - version 1                                                            36
07/H0714/121                Urinary symptoms following vaginal lengthening procedures                  41
07/H0714/122                Are stepping adjustments delayed in chronic stroke patients?               33
07/H0714/126                A genomewide association study of refractive error.                        23
07/H0714/128                Prenatal determination of fetal rhesus D status using free fetal DNA       43
07/H0714/134                Recovery following anaesthesia score                                       24
07/H0714/76                 M30 antibody for differential diagnosis of graft-versus-host disease       21
07/H0714/78                 COU-AA-004 19th April 2007                                                 26
07/H0714/81                 Case-control study of biomarkers in endometrial cancer                     34
07/H0714/99                 Beckman Coulter Haematology Sample Supply Procedure                        39
07/Q0505/41                 Orthodontic extraction patterns and tooth size discrepencies.              35
07/Q0505/50                 Neurophysiological markers of antisocial behaviour in adolescents          31
07/Q0505/53                 Functional changes of the anorectum after treatment for rectal cancer      31
07/Q0505/56                 Older People's Exercise in Residential & nursing Accommodation (OPERA)     27
07/Q0505/57                 TNF inhibitors against combination intensive therapy (TACIT)               25
07/Q0505/65                 HIV Elite Controller                                                       40
07/Q0505/71                 A Study to Determine the Dental Features in Aperts Syndrome                27
The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A)                          Page 9
Annual Report
 The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/Q0505/74                 A Therapeutic approach to Freezing in Parkinson's disease                                                     19
08/H0714/1                  Atripla treatment of HIV-infected adults, GS-UK-177-0109, Final                                               23
08/H0714/12                 Role of incisal embrasure space & connector areas on smile aesthetics                                         35
08/H0714/13                 Influence of Gingival Margin Positioning on Perceived Smile Aesthetics                                        34
08/H0714/21                 MRI after prostate biopsy v1                                                                                  27
08/H0714/6                  Understanding the biology of CLL                                                                              41

Further Information Unfavourable Opinion

Unfavourable Opinion
07/H0714/109                Bosentan in Interstitial Lung Disease and Pulmonary Hypertension                                              39
07/H0714/115                MEG imaging of a Ketamine model of schizophrenia                                                              34
07/H0714/132                An fMRI study of spider imminence                                                                             23
07/H0714/88                 GWSP0604 Study of Sativex® in subjects with spasticity due to MS                                             31
08/H0714/14                 Eurohead Headache Diary Evaluation Study                                                                      33
08/H0714/18                 Topical vs Oral Antiobiotic in Diabetic Mild Leg Ulcer Infections (V1)                                        25
08/H0714/4                  B-PHIT Extension Study                                                                                        56

Provisional Opinion
08/H0714/17                 Randomised Trial of a Steerable Sheath in AF Ablation
08/H0714/22                 MAP-PAF study version 1.3 - 4 Oct 2007

Other Decisions
07/Q0505/63                 A Study of Adult Orthodontic Patients and Treatment Outcomes             43       Not requiring review by NHS REC

Full applications for ethical review over 60 day timelines
Further Information Favourable Opinion 07/Q0505/11       Can endoanal sono-elastography help characterise sphincter function?             65
Further Information Favourable Opinion 07/H0714/114 Learning and decision making in Parkinson's Disease                                   76



The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A)                                                            Page 10
Annual Report
 The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A) Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


SSAs over 25 day timeline

Substantial amendments over 35 day timeline

Section 30 applications over 60 day timeline




The Joint UCL/UCLH Committees on the Ethics of Human Research (Committee A)                          Page 11
Annual Report

				
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