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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998

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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 ...

Part 1 Committee Membership and Training

    Guy's Research Ethics Committee Name of REC:

    Type 1 and Type 3. Able to review CTIMPs, Multi-site and Phase 1 Type of REC:

    studies

    Professor Steven Sacks Chair:

    Dr Shane Tibby Vice-Chair:

    Stephanie Hill Co-ordinator:

    Maureen Fisher Assistant Co-ordinator:

    (South London REC Office 3) Committee Address:

    Governor's Hall Suite

    St Thomas' Hospital

    SE1 7EH

    020 7188 2260 Telephone:

    020 7188 2258 Fax:

    stephanie.hill@gstt.nhs.uk Email:

Chair’s overview of the past year:

     Guy's REC has continued to keep up to date with new processes from NRES and guidance on the implementation of current legislation such as the Human Tissue Act. The Committee took part in the “Ethical Debate Exercise” at the March meeting and will be part of the SSA Network for Phase 1 trials in healthy volunteers when it is implemented in June 2008. The Committee has maintained a good attendance record (an average of 9 members attended each meeting , no meetings were inquorate) and continues to review an average of 7 studies per meeting. The percentage of Phase 1 and CTIMP applications reviewed has increased on 2006-7, from 22.9 % to 25.7 % Phase 1s and from 11.4% to 13.5% CTIMPs. There has been an increased uptake of training by members with 80% of members taking part in training.

     There was a successful joint Annual training event held with St Thomas' REC which many members

     attended.

The Guy's REC office moved to a shared office with the St Thomas' REC situated on the St Thomas' site

    in October 2007. The move went well however the necessary change in working practices has adversely

    affected the review time-lines for studies and SSIs. It was decided in March 2008 that Maureen Fisher

    should be the REC assistant for both REC's and it is expected that the time-lines will improve in the

    coming year.

We continue to have a good relationship with the Trust R & D department and work closely to ensure

    researchers within the Trust are aware of the sponsorship requirements and new developments such as the introduction of IRAS in January which encompasses, amongst others, the NRES application form and the

    R & D form.

Over the past year there have been a number of resignations from the Committee: Ruth Sanderson after Guy's Research Ethics Committee Annual Report Page 2 almost 7 years service, Dr Elizabeth Grunfeld, Dr Jacques Mizan and Val Jones.

Guy's Research Ethics Committee Membership:

    Name Occupation Expert or Dates

    Lay Appointed Resigned Ms Sarah Allen Consultant Physicist Expert 01/09/2000 Professor David Bartlett Senior Lecturer/Honorary Expert 22/03/2007

    Consultant

    Dr Michelle Frost Lecturer in Imaging Expert 11/07/2005

    Sciences

    Dr Elizabeth Grunfeld Senior Lecturer Expert 01/1/2005 28/09/2007 Ms Val Jones Lay Member Lay 26/04/2004 13/12/2007 Dr Bruce Kirkham Consultant Expert 01/12/2006

    Rheumatologist

    Dr Jacques Mizan GP Member Expert 02/07/2004 31/10/2007 Dr Franco Moscuzza Consultant Anaesthetist Expert 06/09/2005 Mr Brady Pohle Legal Services Advisor Lay 01/01/2007 Professor Steven Sacks Consultant in Nephrology Expert 24/06/1997

    & Transplantation

    Ms Karen Sanders Lay Member Lay 06/06/2006 Mrs Ruth Sanderson Teacher/Lay but Guy's Lay 01/08/2001 27/03/2008

    affiliated

    Ms Lorna Sutcliffe Research Fellow Lay 01/12/2004 Dr Shane Tibby Paediatric ITU Expert 11/12/2001

    Consultant/Expert

    Mr Paul Tunstell Pharmacist Expert 28/03/2006

Deputy Members

    Name Occupation Expert or Meeting date attended

    Lay

    Mr William Thornhill Senior Pharmacist, Expert 29/08/2007

    Paediatric Renal Services

Co-opted Members

    Name Occupation Expert or Meeting date attended

    Lay

Member Bank

    Name Occupation Expert or Meeting date attended

    Lay

    Guy's Research Ethics Committee Annual Report Page 3

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

    Month Date Number of Members Present

    at Meeting May 02/05/2007 10 May 30/05/2007 10 June 27/06/2007 9 August 29/08/2007 10 September 26/09/2007 11 October 31/10/2007 8 December 12/12/2007 10 January 30/01/2008 11 February 27/02/2008 9 March 26/03/2008 9

    Guy's Research Ethics Committee Annual Report Page 4

     Attendance of Members: 1 April 2007 31 March 2008:

    Name Number of

    Meetings

    Attended Dr Bruce Kirkham 9 Mrs Ruth Sanderson 9 Mr Paul Tunstell 9 Professor Steven Sacks 9 Mr Brady Pohle 8 Ms Karen Sanders 7 Ms Lorna Sutcliffe 7 Ms Sarah Allen 7 Dr Michelle Frost 6 Dr Shane Tibby 6 Professor David Bartlett 6 Dr Franco Moscuzza 5 Ms Val Jones 5 Dr Jacques Mizan 3 Mr William Thornhill 1

Number of inquorate meetings held: None

    Guy's Research Ethics Committee Annual Report Page 5

Training 1 April 2007 31 March 2008:

    Name of Member Date Event(s) attended Allen, Sarah 25/04/2007 Statistics and the Research Ethics Committee

    Bartlett, David 01/10/2007 NRES Roadshow Jones, Val 09/11/2007 AREC London Conference Pohle, Brady 27/06/2007 New Members Induction Course Sanders, Karen 09/05/2007 Waste not, Want not: ethical issues in the

    retention of human tissue and the collection of

    genetic material Sanders, Karen 14/09/2007 No consent, no research? Sanders, Karen 15/02/2007 The Human Tissue Act and Ethical Review

    Workshop

    Sutcliffe, Lorna 14/09/2007 No consent, no research? Sutcliffe, Lorna 28/09/2007 Issues for Research Ethics Committees: theory to

    practice (day 1) genetics, human tissue, vulnerable

    groups and fraud (day 2) Sutcliffe, Lorna 24/10/2007 Active public involvement in research: the

    implications for RECs Oct Workshops Tibby, Shane 28/02/2008 The Human Tissue Act and Ethical Review

    Workshop

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

    Event Date

    31/01/2008 Joint Annual Training Event:

    Attended by: Val Jones, Steve Sacks, Karen Sanders, Bruce Kirkham, Ruth Sanderson, Shane Tibby, Paul Tunstell

    29/09/2007 Human Tissue Act 2004: Storing Tissue for Research:

    Attended by: Jacques Mizan, Steve Sacks, Karen Sanders, Lorna Sutcliffe, Sarah Allen, David Bartlett, Michelle Frost, Bruce Kirkham, Shane Tibby, Paul Tunstell, Stephanie Hill

    Guy's Research Ethics Committee Annual Report Page 6

     List of Training attended by the Co-ordinator:

Name Date Event(s) attended

    Hill, Stephanie 18/02/2007 Quality Assurance Audit Workshop Hill, Stephanie 07/06/2007 AREC Conference

    Hill, Stephanie 01/10/2007 NRES Roadshow

    Hill, Stephanie 22/11/2007 NRES Annual Conference Guy's Research Ethics Committee Annual Report Page 7

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 10 13.5 Phase 1 19 25.7 Gene Therapy 0 0.0 Research Tissue Bank 3 4.1 Research Database 0 0.0 Others 42 56.8 Total Applications Reviewed 74 100.0

Number of applications transferred in from other RECs 1

    Number of applications transferred out to other RECs 4

    Number of invalid applications received 7

    Number of studies withdrawn prior to the meeting 0

    Number of studies withdrawn after the meeting 0

    Site Specific Assessment 80

    Number of student applications reviewed 11

    Number of substantial amendments reviewed 54

    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 5 6.8% Unfavourable Opinion 0 0.0% Provisional Opinion 68 91.9% Other 1 1.4%

    100% Total 74

    Number of studies sent back to full committee meeting 1 for final opinion

    Status of applications at date of generation of report Number % Further Information Favourable Opinion 64 86.5% Further Information Unfavourable Opinion 0 0.0% Favourable Opinion 5 6.8% Unfavourable Opinion 0 0.0% Provisional Opinion 4 5.4% Other 1 1.4% Total 74 100% Guy's Research Ethics Committee Annual Report Page 8

     Other Management Information 1 April 2007 31 March 2008:

     7.4 Average number of applications reviewed per full meeting

    2 Number of applications for full ethical review over 60 days

     2.7% Number of applications over 60 days as a % of total

    41 Number of days taken to final decision - average

    40 Number of days taken to final decision - mode

    80 Number of SSAs reviewed

    33 Number of applications for SSA review over 25 days

     41.2% Number of applications for SSA review over 25 days as % of

    all SSAs

    0 Number of substantial amendments over 35 days

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

    total substantial amendments

    0 Number of Section 30 applications over 60 days

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

    total Section 30 applications

Guy's Research Ethics Committee Annual Report Page 9

     Guy's Research Ethics Committee Annual Report 2007/08

     Proposals Considered between 1 April 2007 and 31 March 2008

Further Information Favourable Opinion

    07/H0804/105 ADSORB - Version 27JULY06 48 07/H0804/114 Study of lung epithelial and immune cell interactions 38 07/H0804/118 AS1409 with RCC or Metastatic Malignant Melanoma,Version 06JUL07 42 07/H0804/123 Effect of HIV and Candida infection on mucosal epithelium 35 07/H0804/125 A study to investigate ONO-8539 in healthy elderly subjects. 45 07/H0804/126 A study of single and multiple doses of R932348 in healthy subjects 48 07/H0804/127 A study of the safety, tolerability and pharmacokinetics of GPD-1116 54 07/H0804/131 Guy's & St Thomas' Breast Tissue & Data Bank 54 07/H0804/135 Sativex? Drug Interaction Study 27 07/H0804/140 Ventilatory Strategies To Treat Obesity Hypoventilation Syndrome 38 07/H0804/144 Multiple dose inhaled TPI ASM8 in mild asthmatics 35 07/H0804/145 Study in healthy volunteers to investigate effects of TAK-683 40 07/H0804/146 A study to assess the effects of food on Sativex? 41 07/H0804/148 Reference range for 5-methyltetrahydrofolate, version 1 62 07/H0804/75 Effect of Omacor? on lipid profile in HIV subjects treated with HAART 43 07/H0804/76 Eosinophils & Th2 memory cells in allergic inflammation (skin) 34 07/H0804/77 Eosinophils & Th2 memory cells in allergic inflammation (lung) 44 07/H0804/78 Persistence of bacteria in macrophages in Crohn's Disease 39 07/H0804/79 A study to investigate Fenofibrate/Simvastain in healthy subjects 52 07/H0804/80 A study to investigate SLV334 in healthy volunteers 28 07/H0804/81 The effect of CI on the resonant frequency of the middle ear 29 07/H0804/82 Fractal analysis of sway before and after vest. schwannoma surgery 23 07/H0804/91 Thoracic Tissue Bank 40 07/H0804/93 Growth of human teeth and cells 37 07/H0804/94 Improving adherence to oral hygiene instruction 42 07/H0804/96 Effects of AZD1386 administered orally to Healthy Japanese Volunteers 45 07/H0804/97 Qualitative Study Exploring TB Clinicians' Decisions when Choosing IGT 52 07/Q0704/43 11702 VTE Rivaroxaban for acute symptomatic DVT or Pulmonary Embolism 35 07/Q0704/44 11899 EXT Rivaroxaban for acute symptomatic DVT or Pulmonary Embolism 35 Guy's Research Ethics Committee Annual Report Page 10

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