Grampian Research

GRAMPIAN RESEARCH

ETHICS COMMITTEES

ANNUAL REPORT

1 APRIL 2006 – 31 MARCH 2007

Table of Contents

1. CHAIRS’ OVERVIEW OF THE PAST YEAR......

2.0COMMITTEE MEMBERSHIP, ATTENDANCE AND TRAINING......

2.1COMMITTEE ONE – Membership List......

2.2COMMITTEE ONE – Meeting Attendance......

2.3COMMITTEE ONE - Training Record......

2.4COMMITTEE TWO – Membership List......

2.5COMMITTEE TWO – Meeting Attendance......

2.6COMMITTEE TWO – Training Record......

3APPLICATION STATISTICS......

3.1Graph 1 Application Decisions per month (Total 280)......

3.2Table 1 1 April 2006 – 31 March 2007 - Application Decisions per Month......

3.3Graph 2 Decisions Given to Full Applications at Meetings......

3.4Table 2 Decisions Given to Full Applications at Meetings......

3.5Graph 2 Reasons for Withdrawn Projects - 1April 2006 – 31March 2006......

3.6Table 3 Reasons for Withdrawn Projects – 1 April 2006 – 31 March 2007......

4APPLICATION SUBMISSIONS......

4.1COMMITTEE ONE – APPLICATION SUBMISSIONS......

APPENDIX AGRAMPIAN RESEARCH ETHICS COMMITTEES TRAINING EVENT......

1. CHAIRS’ OVERVIEW OF THE PAST YEAR

INTRODUCTION

All research conducted within the NHS on human subjects must be reviewed and receive a favourable opinion from a Research Ethics Committee. Each NHS Board has a responsibility to constitute and support a Research Ethics Committee to look at research done on NHS patients, NHS staff or using NHS premises.

Because of the workload in Grampian, we have two Committees, both supported by the same secretariat.

April 2006 to March 2007 has been dominated by changes in the service and preparation for becoming ‘The North of Scotland Research Ethics Service’

WORKLOAD

A total of 250 applications were received in 2006-7 of which 153 were considered at a Committee meeting. 97 were applications for consideration of local research as part of a multi centre study. We have delegated consideration of these ‘Site Specific Applications’ to the Research and Development Department (R&D) but our office has to process the paperwork.

More details of the applications are given in sections three and four.

OFFICE BEARERS

Committee 1 was chaired by Dr W Melvin Morrison, with Dr Angus Thompson as vice chair.

Committee 2 was chaired by Dr Sheila Simpson with Ms Judith Pearson as vice chair.

MEMBERSHIP

There have, as always, been a number of members leaving the Committees, for work or personal reasons. Recruitment is undertaken using ‘Nolan’ rules, so vacancies are advertised, and then potential members are interviewed. Currently we have 15 members on Committee 1 with 6 being lay members and on Committee 2 we have 14 members with 5 of them being lay members. When the Grampian Research Ethics Service merges to form the North of Scotland Research Ethics Service, members who were on Ethics Committees have beeninvited to join our Committee. At present we know of 3 members from the Highland Ethics Committee will be joining us. After the merger has occurred we will review Committee Membership again and advertise as required.

Details of membership are provided in section two.

STAFF

Dr Julie Kelly was appointed as Scientific Advisor/Manager in May 2006. That left the Co-ordinator's post vacant and this was filled by the appointment of Dr Rachel Venables in December 2006. Unfortunately Dr Kelly has been on sick leave and now, more happily, is on maternity leave. Dr Rachel Venables is acting Scientific Advisor/Manager and Mrs Carol Irvineis acting Co-ordinator. Both are fulfilling these roles excellently, but office staffing remains a problem, all the more so because of the expansion to cover the North of Scotland.

ACCREDITATION

As reported in last year’s Annual Report, Committee 1 is fully accredited, and we anticipate that Committee 2 will have an accreditation visit in due course.

REVIEW OF RESEARCH ETHIC COMMITTEES

As mentioned in last year’s report, the Scottish Executive has reviewed the operation of RECs in Scotland. Dr Sheila Simpson was a member of the review group. The number of RECs has been reduced and as of 1st April 2007 we have become the North of Scotland Research Ethics Service, covering Grampian, Highland, Orkney, Shetland and Western Isles. NHS Grampian now has the responsibility for constituting and supporting this service on behalf of the North of Scotland Boards.

The administrative and Committee work will increase and be detailed in next year’s report.

We are pleased that three members of Highland’s Committee have opted to continue their involvement and will join Committee 2, using video-conferencing facilities.

ETHICAL ISSUES

As in previous years, we mention a few issues to give a flavour of our work.

The Human Tissue Act

The implementation of the Human tissue act in Scotland is underway, although this is a much more straightforward process than in England where the law is different. We await further instruction from the Scottish executive on some aspects of practice. The act does however cause great concern to researchers, and guidance is offered on a regular basis.

Links with R&D

The Committee chairs have maintained regular meetings with the senior staff at the Grampian R&D department, and the office copies relevant correspondence to themeach week. The whole process of gaining approval for research projects is inevitably bureaucratic, but both we and R&D strive to help researchers as much as possible.

Training

We arrange one annual training day locally and encourage members to attend external training when possible. NRES is meant to provide training, but that aspiration has not been realised. External training therefore represents a financial burden, but there is an obligation on members to attend training and on the Board to support it.

SUMMARY

As of 1 April 2007, Grampian Research Ethics Committeeswill become the North of Scotland Research Ethics Service.

The workload continues to be heavy, and low staffing levels are a source of continuing concern.

The Board is asked to receive the annual report, to note its contents and to continue to support the Committees as fully as possible.

W Melvin Morrison Sheila A Simpson Rachel Venables

Chair Chair Acting Manager &

Committee 1 Committee 2 Scientific Advisor

2.0COMMITTEE MEMBERSHIP, ATTENDANCE AND TRAINING

2.1COMMITTEE ONE – Membership List

Name / Designation / Term of Office
Dr Melvin Morrison
(Chair) / General Practitioner / 01/08/03 – 31/07/07
(Second Term)
Dr Angus J Thompson / Consultant Radiologist / 01/07/06 – 30/06/10
(Second Term)
Dr John S Callander / Associate Medical Director / 24/11/05 – 23/11/09
(First Term)
Ms Susan Campbell
(Resigned June 2006) / Nurse & Research Specialist / 01/07/02 – 30/06/06
(First Term)
Ms Jane Drury / Health Visitor / 01/07/06 – 30/06/10
(Second Term)
Dr Helen Galley / Senior Lecturer in Anaesthesia &Intensive Care / 01/11/04 – 31/10/08
(First Term)
Dr Paul Haggarty / Senior Research Scientists / 01/11/04 – 31/10/08
(First Term
Dr Morley Hutchinson / Lay Member – Retired Research Fellow / 01/11/04 – 31/10/08
(First Term)
Dr Alex Johnstone / Non-Medical Research Specialist / 01/07/06 – 30/06/10
(Second Term)
Mr Albert McLean-Bullen / Lay Member – Farmer / 01/07/06 – 30/06/10
(Second Term)
Mr Leslie E F Moffat / Consultant Urologist / 30.11.06 – 29.11.10
(First Term)
Rev Mark Rodgers / Lay Member – Hospital Chaplain/Minister / 01/11/04 – 31/10/08
(First Term)
Mrs Shirley A Shay / Lay Member – Associate Solicitor / 01/11/04 – 31/03/10
(First Term)
Mr Peter Sim
(Resigned August 2006) / Pharmacist / 27/11/03 – 26/11/07
(First Term)
Mrs Mary Simpson / Research Nurse / 01/11/04 – 31/10/08
(First Term)
Mr John Thompson / Lay Member – Retired Oceanographer/Meteorologist / 01/09/03 – 01/08/07
(First Term)
Mr David Wood / Lay Member – Retired Marine Supervisor / 01.04.06 – 31.03.10
(First Term)
Prof George G Youngson / Consultant Surgeon / 01/07/06 – 30/06/10
(Second Term)

Officers in attendance

Mrs Carol Irvine / Administrator
NHS Grampian
Dr Julie Kelly / Scientific Advisor & Manager
NHS Grampian
Dr Rachel Venables / Ethics Co-ordinator
NHS Grampian

Observers

Dr Sarah Ross / SpR in Clinical Pharmacology

2.2COMMITTEE ONE – Meeting Attendance

COMMITTEE ONE – Meeting Attendance

MEMBER /

April 27th

May 25th

June 29th

July 27th

August 31st

Sept 28th

/ Oct 26th** / Nov 30th / Dec / Jan 25th / Feb 22nd / Mar 29th / Total meetings attended / Comments
Dr W Melvin Morrison / √ / x / √ / √ / √ / x / √ / √ / √ / x / √ / 8
Dr A J Thompson / √ / √ / x / X / √ / √ / √ / √ / √ / √ / √ / 9
Dr J Callender / x / x / x / X / √ / √ / √ / x / √ / √ / x / 5

Ms S Campbell

/ x / √ / √ / Resigned / Resigned July 2006

Ms J Drury

/ x / √ / x / √ / √ / √ / √ / x / √ / x / x / 6
Dr H F Galley / √ / √ / x / √ / X / X / √ / √ / √ / x / x / 6
Dr P Haggarty / √ / √ / x / X / √ / √ / √ / x / √ / x / √ / 7
Dr M Hutchinson / √ / √ / √ / X / √ / √ / √ / √ / √ / √ / √ / 10
Dr A Johnstone / √ / √ / x / √ / √ / √ / X / x / √ / √ / √ / 8
Mr L Moffat / √ / x / x / √ / 2
Mr Albert McLean-Bullen / √ / √ / x / X / √ / √ / √ / √ / x / √ / √ / 8
Rev M Rodgers / √ / √ / √ / X / X / √ / √ / √ / x / √ / √ / 8
Mrs S Shay / √ / √ / √ / √ / √ / √ / √ / √ / x / √ / x / 9
Mr P Sim / √ / x / √ / X / X / Resigned / Resigned August 2006
Mrs M Simpson / x / √ / x / √ / √ / √ / X / √ / x / x / x / 5
Mr J Thomson / x / √ / √ / x / √ / √ / √ / √ / x / √ / √ / 8
Mr D Wood / √ / √ / x / √ / √ / X / √ / √ / x / x / √ / 7
Prof G G Youngson / x / x / √ / √ / √ / X / X / x / √ / x / √ / 5
Dr S Ross / √ / x / √ / √ / √ / √ / x / x / 5
Dr C McDougall / √ / Resigned / Resigned May 2006
IN ATTENDANCE
Dr J Kelly / x / x / x / √ / √ / x / √ / x / √ / x / x / 4
Ms C Bain / √ / √ / √ / √ / √ / √ / x / x / x / √ / √ / 8
Dr R Venables / √ / x / √ / 2

Stuart Bale, Judith Pearson & Berwyn Williams - Attended Meeting on 29 June 06

2.3COMMITTEE ONE - Training Record

Name of Member / Date / Event(s) attended
Melvin Morrison
Chair / 18/11/05 / Local LREC Training Day (Summerfield House)
Angus Thompson / 18/11/05
11/12/05 / Local LREC Training Day (Summerfield House)
Ethical Review of Clinical Research, Training Conference, Cambridge
David St Clair / None
David Lloyd / None
Albert Mclean-Bullen / 18/11/05 / Local LREC Training Day (Summerfield House)
John S Callender / None
Susan Campbell / 18/11/05 / Local LREC Training Day (Summerfield House)
Jane Drury / None
Helen Galley / 18/11/05 / Local LREC Training Day (Summerfield House)
Paul Haggarty / 18/11/05 / Local LREC Training Day (Summerfield House)
Morley Hutchinson / None
Alex Johnstone / 18/11/05 / Local LREC Training Day (Summerfield House)
Mark Rodgers / 18/11/05 / Local LREC Training Day (Summerfield House)
Shirley Shay / 13/03/06 / Mock Training Day (Summerfield House)
Mr Peter Sim / None
Mary Simpson / 18/11/05 / Local LREC Training Day (Summerfield House)
John Thomson / 18/11/05 / Local LREC Training Day (Summerfield House)
David Wood / 13/03/06 / Mock Training Meeting (Summerfield House)
George G Youngson / None

2.4COMMITTEE TWO – Membership List

Name / Designation / Term of Office
Dr Sheila Simpson
(Chair) / Clinical Geneticist / 01/07/06 – 30/06/10
(First Term)
Ms Judith Pearson
(Vice-chair) / Honorary Senior Lecturer in Law / 01/07/04 – 30/06/08
(Second Term)
Mr Stuart Bale / Lay Member - Retired Health Safety Manager / 01/06/06 – 31/05/10
(First Term)
Prof S Bhattacharya / Consultant in Obstetrics & Gynaecology / 01/07/06 – 30/06/10
(Second Term)
Dr Gillian Bruce / General Practitioner / 01/08/03 – 31/08/07
(Second Term)
Dr Willem J van Ijperen / Consultant Paediatrician / 01/11/04 – 31/10/08
(First Term)
Prof Graeme I Murray / Professor of Pathology / 01/07/04 – 30/06/08
(Second Term)
Mr John McKinnon / Service Manager
NHS Grampian / 01/11/04 – 31/10/08
(First Term)
Dr Liesl M Osman / Senior Research Fellow / 01/07/06 – 30/06/10
(Second Term)
Mr Alistair Ritchie / Lay Member
Retired Police Officer Grampian Police / 01/11/04 – 31/10/08
(First Term)
Mr Craig Rore
(Resigned December 2006) / Pharmacist / 01/07/06 – 30/06/10
(SecondTerm)
Dr Andy Schofield / Lecturer in Surgery and Molecular Cell Biology / 01/11/04 – 31/10/08
(First Term)
Dr Pat Smith
(Resigned June 2006) / Associate Specialist / 01/07/02 – 30/06/06
(First Term)
Dr Ruth Stephenson / Consultant in Anaesthesia / 11/09/06 – 10/09/10
(First Term)
Mrs Tilly Thomas
(Resigned December 2006) / Retired – Sister Accident and Emergency Dept / 31/01/06 – 30/01/10
(First Term)
Mrs Juliette Watson / Senior Operational Support Manager / 01/11/04 – 31/10/08
(First Term)
Dr Berwyn L Williams / Lay Member –
Retired Principal Scientific Officer / 01/07/06 – 30/06/10
(Second Term)

Officers in attendance

Mrs Carol Irvine / Administrator
NHS Grampian
Dr Julie Kelly / Scientific Advisor & Manager
NHS Grampian
Dr Rachel Venables / Ethics Co-ordinator
NHS Grampian

Observers

Dr John Dean / Consultant Geneticist

2.5COMMITTEE TWO – Meeting Attendance

COMMITTEE TWO – Meeting Attendance

MEMBER /

April 13th

/ May 11th / June 8th / July 13th /

August 10th

Sept 14th

Oct 12th

/ Nov 9th / Dec 14th / Jan 11th * / Feb 8th / Mar 8th / Total Meetings attcnded / Comments
Dr S Simpson / √ / √ / √ / √ / x / x / √ / √ / √ / - / x / √ / 8
Ms J Pearson / √ / X / √ / √ / √ / √ / √ / √ / √ / - / √ / √ / 10
Mr S Bale / - / - / √ / √ / √ / x / √ / √ / √ / - / √ / √ / 8
Dr S Bhattacharya / X / √ / x / √ / x / √ / x / X / x / - / x / x / 3
Dr G Bruce / √ / √ / √ / x / √ / x / √ / √ / x / - / √ / √ / 8
Prof G I Murray / X / √ / x / √ / x / √ / √ / √ / √ / - / √ / x / 7
Mr J McKinnon / X / √ / √ / x / x / √ / x / √ / √ / - / √ / √ / 7
Dr L Osman / √ / X / x / √ / √ / x / x / √ / √ / - / x / x / 5
Mr A Ritchie / √ / √ / √ / √ / √ / √ / x / √ / x / - / x / √ / 8
Mr C Rore / √ / X / x / x / √ / √ / x / √ / x / Resigned December 06
Dr A Schofield / √ / √ / √ / x / X / √ / √ / X / x / - / √ / √ / 7
Dr P Smith / X / X / √ / Resigned June 06
Dr R Stephenson / √ / √ / - / √ / √ / 4
Mrs T Thomas / √ / √ / √ / √ / √ / √ / √ / X / √ / Resigned December 06
Dr W van Ijperen / X / X / √ / √ / √ / √ / X / X / x / - / x / √ / 5
Mrs J Watson / X / √ / x / x / √ / x / √ / √ / √ / - / x / x / 5
Dr B L Williams / √ / X / √ / √ / √ / √ / √ / √ / √ / - / √ / x / 9
Dr J Dean / X / X / x / x / X / x / X / X / x / - / x / x / 0
IN ATTENDANCE
Dr J Kelly / X / √ / √ / x / √ / x / X / √ / x / - / √ / x / 5
Ms C Bain / √ / √ / √ / √ / x / √ / √ / √ / √ / - / x / √ / 9
Dr R Venables / √ / - / √ / √ / 3

* Insufficient applicants, therefore no meeting was held

2.6COMMITTEE TWO – Training Record

Sheila Simpson –
Chair (2) / 18/11/05 / Local LREC Training Day (Summerfield House)
Judith Pearson
Vice Chair (2) / 24/11/05 / NHS REC Chairs 4th Annual Conference
Vijay Anandavijayan / None
Siladitya Bhattacharya / 18/11/05 / Local LREC Training Day (Summerfield House)
Gillian Bruce / 18/11/05 / Local LREC Training Day (Summerfield House)
John Dean / None
John McKinnon / 18/11/05 / Local LREC Training Day (Summerfield House)
Geraldine McNeil / None
Graeme Murray / 18/11/05 / Local LREC Training Day (Summerfield House)
Liesl Osman / 18/11/05 / Local LREC Training Day (Summerfield House)
Alistair Ritchie / 23/09/05
18/11/05
11/12/05 / KeeleUniversity Training Day
Local LREC Training Day (Summerfield House)
Ethical Review of Clinical Research, Training Conference, Cambridge
Craig Rore / 18/11/05 / Local LREC Training Day (Summerfield House)
Andy Schofield / None
Pat Smith / None
Tilly Thomas / 23/03/06 / Mock Training Meeting (Summerfield House)
Willem van Ijperen / 18/11/05 / Local LREC Training Day (Summerfield House)
Juliette Watson / None
Berwyn Williams / 18/11/05 / Local LREC Training Day (Summerfield House)

3APPLICATION STATISTICS

From 1 April 2006 to 31 March 2007 a total of 280 applications were reviewed by the Grampian Research Ethics Committees. There were 153 full applications, 97 site-specific applications and 30 applications were withdrawn.

The total number of applications received throughout the year was fairly consistent, an average of 21 applications per month. There was a maximum of 28 in April and a minimum of 17 in November (Graph 1, Table 1).

3.1Graph 1Application Decisions per month (Total 280)

April 2006-March 2007

3.2Table 11 April 2006 – 31 March 2007 - Application Decisions per Month

Month / Number of Decisions Made
April / 28
May / 21
June / 23
July / 23
August / 18
September / 22
October / 19
November / 17
December / 25
January / 18
February / 19
March / 17
Total Number of Decisions / 250

All 97 site-specific applications over the period reviewed received a decision of ‘No Objection’. The breakdown of decisions awarded to full application is given in Table 2 and Graph 2.

3.3Graph 2Decisions Given to Full Applications at Meetings

1 April 2006 – 31 March 2007

3.4Table 2Decisions Given to Full Applications at Meetings

1 April 2006 – 31 March 2007

Month / Provisional Opinion / Favourable Opinion / Further Info Required / Ethical Approval Not Required / Rejected
April / 18 / 3
May / 6 / 4
June / 15 / 1
July / 13
August / 11 / 1 / 1
September / 12 / 1
October / 12 / 1 / 1
November / 10 / 1
December / 10
January / 10
February / 10 / 1
March / 10 / 1
Total / 137 / 4 / 0 / 1 / 11
Percentage / 89.55% / 2.61% / 0% / 0.70% / 7.14%

Examination of the 30 withdrawn applications (Graph 3, Table 3), indicated that 46.67% were withdrawn by the office as a result of further information requested from the researcher not being received. 40% were entered in error, mostly a result of the projects being assigned to the wrong committee as they involved either multi centre drugs trials or adults unable to consent for themselves, areas which neither Grampian Committee is authorised to give a decision on. Researchers withdrew three applications.

3.5Graph 2Reasons for Withdrawn Projects - 1April 2006 – 31March 2006

3.6Table 3Reasons for Withdrawn Projects –1 April 2006 – 31 March 2007

Month / Withdrawn by REC* / Transferred to Other Committee / Entered in Error / Withdrawn by Researcher / Total
April / 1 / 1
May / 2 / 1 / 2 / 5
June / 3 / 3 / 1 / 7
July / 1 / 1 / 1 / 3
August / 2 / 3 / 5
September
October / 3 / 3
November
December
January
February / 1 / 2 / 3
March / 1 / 2 / 3
Total / 14 / 1 / 12 / 3 / 30
Percentage / 46.67% / 3.33% / 40% / 10%

4APPLICATION SUBMISSIONS

4.1COMMITTEE ONE – APPLICATION SUBMISSIONS

Local Ref / Title / Decisions / Principle Investigator / Time from application submission to Final Decision
06/S0801/45 / Investigation of chronic pain after breast cancer surgery: a qualitative study / Further Information
Favourable Opinion / Miss Carina Ebdy / 27
06/S0801/46 / Components of energy balance in free-living individuals / Further Information
Favourable Opinion / Dr Stephen Whybrow / 39
06/S0801/47 / A longitudinal study of exhaled nitric oxide in children with asthma and inflammatory bowel disease / Unfavourable Opinion / Dr Ibrahim A M Abuzayan / 21
06/S0801/48 / A phase II multicentre, open label, two-stage design study evaluating E7389 in patients with hormone refractory prostate cancer with advanced and/ or metastatic disease stratified by prior chemotherapy / No Objection / Dr A Graham Macdonald / 7
06/S0801/49 / A pilot study to evaluate the appropriateness of antibiotic prescribing in primary care:linking prescription to diagnosis / Further Information
Favourable Opinion / Prof Christine Bond / 27
06/S0801/50 / Study of Migrant Workers in Grampian / Further Information
Favourable Opinion / Ms Philomena de Lima / 32
06/S0801/51 / Non-invasive measurement of augmentation index in determining the presence of coronary artery disease at coronary angiography: a prospective diagnostic accuracy study / Further Information
Favourable Opinion / Dr Michael A Crilly / 29
Local Ref / Title / Decisions / Principle Investigator / Time from application submission to Final Decision
06/S0801/52 / Evaluating pelvic organ prolapse in women: objective clinical assessment compared with MRI and subjective symptom assessment. / Further Information
Favourable Opinion / Dr Cathryn Glazener / 29
06/S0801/53 / A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituxmab Alone in Subjects with Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma / No Objection / Dr Dominic Culligan / 2
06/S0801/54 / Effect of a 12 week exercise programme on weight loss, physiological variables, and quality of life in obese adults / Unfavourable Opinion / Miss Stephanie Valentin / 20
06/S0801/55 / The role of retroactive interference in the memory problems encountered by patients following unilateral temporal lobectomy / Unfavourable Opinion / Prof Sergio Della Sala / 14
06/S0801/56 / Proteolytic activities in amniotic fluid as an index of infant lung function / Unfavourable Opinion / Dr Steve Turner / 21
Local Ref / Title / Decisions / Principle Investigator / Time from application submission to Final Decision
06/S0801/57 / The biology of anterior cruciate reconstruction / Withdrawn by Researcher / Mr Alasdair Sutherland / N/A
06/S0801/58 / ACL analgesia / Withdrawn by Researcher / Mr Alasdair Sutherland / N/A
06/S0801/59 / Selection of Pacing Sites to optimise left ventricular contraction / Unfavourable Opinion / Dr Paul A Broadhurst / 20
06/S0801/60 / A Survey of the attitudes of GP's, including trainers and registrars, in Scotland towards obesity prevention. / Further Information
Favourable Opinion / Dr Rebecca Riddell / 35
06/S0801/61 / An 8 week extension to a randomized, double-blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipine treatment strategy in achieving blood pressure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy / No Objection – Then withdrawn as main application not give favourable opinion / Dr John Webster / 14
06/S0801/62 / Effect of inhaled versus nebulised salbutamol on augmentation index / Further Information
Favourable Opinion / Dr Roy L Soiza / 30

Local Ref / Title / Decisions / Principle Investigator / Time from application submission to Final Decision
06/S0801/63 / Effect of a 12 week exercise programme on weight loss, physiological variables, and quality of life in obese adults
(Resubmission of 06/S0801/54) / Unfavourable Opinion / Miss Stephanie Valentin / 20
06/S0801/64 / An investigation of whether the existing finding of excess left/mixed handedness in male combat veterans with PTSD extends to civilian populations with PTSD and to women / Further Information
Favourable Opinion / Ms Carolyn J Choudhary / 30
06/S0801/65 / Posture and loading in the human spine / Further Information
Favourable Opinion / Prof Richard M Aspden / 27
06/S0801/66 / Adjuvant treatment of fully resected stage III colon cancer with folfox-4 versus folfox-4 plus cetuximab / No Objection / Dr Leslie Samuel / 7
06/S0801/67 / Airway epithelial cell inflammatory phenotype in atopic asthma and COPD / Further Information
Favourable Opinion / Dr Catherine McDougall / 33
06/S0801/68 / Impact of action-perception on motor-preparative capacities in autism / Further Information
Favourable Opinion / Dr Justin H G Williams / 34
06/S0801/69 / PELPP Study / Withdrawn by Researcher / Prof Gary Macfarlane / N/A
06/S0801/70 / 'Filling the Gap' An exploratory study of how secondments affect the team / Further Information
Favourable Opinion / Mrs Una Lyon / 28
Local Ref / Title / Decisions / Principle Investigator / Time from application submission to Final Decision
06/S0801/71 / A Phase III, Multicenter, Randomised, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nauseaa and Vomiting Induced by Moderately Emetogenic Chemotherapy / Further Information
Favourable Opinion / Prof I C Reid / 33
06/S0801/72 / Assessment of microbial diversity in subjects with reconstructed urinary bladder using intestine / Further Information
Favourable Opinion / Mr Ghulam Nabi / 35
06/S0801/73 / Habitual physical activity and osteoarthritis: how can we best investigate whether there is a link between them? / Further Information
Favourable Opinion / Mr Suren Sivakumar / 32
06/S0801/74 / An exploration of midwives' experiences of maternal transport.-what are the impacts of these experiences on the future practice?- / Further Information
Favourable Opinion / Ms Rie Inomata / 28