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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - Download Now DOC

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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - Download Now DOC Powered By Docstoc
					Joint RNOH/IOMS Research Ethics Committee Annual Report
1 April 2007 - 31 March 2008

Part 1 – Committee Membership and Training
Name of REC: Type of REC: Type of Flag: Chair: Vice-Chair: Co-ordinator: Committee Address: Joint RNOH/IOMS Research Ethics Committee Authorised Devices Mrs Rosemary Hill Mrs Gill Thurlow Ms Uzma Chaudhry R&D Office/ACDS Brockley Hill Stanmore Middlesex HA7 4LP 020 8909 5752 020 385 7151 uzma.chaudhry@rnoh.nhs.uk

Telephone: Fax: Email:

Chair’s overview of the past year:

The Royal National Orthopaedic Hospital and the Institute of Orthopaedics and Musculoskeletal Sciences conduct pioneering research into a wide range of challenging orthopaedic conditions in the UK and overseas. The committee has an in-depth knowledge of this type of research, including that using specially built equipment and equipment used in a novel way. The applications coming before the Research Ethics Committee cover many different areas and have included several applications for research in the use of medical devices. The Committee have gained considerable experience in a wide variety of these trials. Both the Chair and the Co-ordinator received a large number of requests for advice on possible applications. We have received much thanks and praise for the responses we have given, though one person was very aggrieved that they were advised to apply for research ethics approval. As well as including specialists with knowledge of the type of research conducted at the Royal National Orthopaedic Hospital, the Committee has enthusiastic lay members and members with expertise in other areas such as statistics and the law. Quite a few members have conducted research themselves and have been in a position to help and advise applicants in their research. Many of the members of the Committee have taken part in training events this year. Unfortunately there were no evening training meetings this year, some Committee members find it difficult to

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take time off work for training. In the future, training events out of working hours would make it very much easier for these members to get more training. The new recruits have all settled in well and have proved to be very useful, wise and knowledgeable members of the Committee. We had two resignations in the year. Both people had moved away from the area to new jobs and though both had hoped to continue on the Committee this proved too difficult. There were ten meetings and all were quorate, though it was necessary to co-opt one person for one of the meeting to ensure this would be the case. One member of our Committee has been co-opted to other RECs from time to time for the same reason. All decisions were taken by the Committee within the required time frame. There were only a few poor projects presented to the committee, nearly all the student research was of a very high quality. It is very helpful to the Committee when the researcher attends the meeting, particularly when the application is poor. Much of the research to come to the committee was of a very high quality. It is a privilege to be asked to assess the ethics and contribute to such projects. As a Committee we are very keen to promote good ethical research. Rosemary Hill August 6th 2008

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Joint RNOH/IOMS Research Ethics Committee Membership:

Name Ms Margaret Byers Mrs Marion Cumbers Dr Geraldine Edge Dr Anthony Gilbert Mrs Diana Harvey Dr Mike Hetreed Mrs Rosemary Hill Mr Jonathan Isaacs Mr Steve Mckerral Mrs Elayne Nasr Dr Brian Seaton Miss Sally Tennant Ms Gill Thurlow Ms Kaye Walls Mr Nicholas Yeo

Occupation Senior Biomedical Scientist School Librarian Consultant Anaesthetist Medical Doctor/Research Physician Solicitor Consultant Anaesthetist Freelance Statistician Retired Research Nurse Retired Director / Business Consultant Consultant Paediatric Orthopaedic Surgeon Ward Manager/Lead Nurse-Rehabilitation Physiotherapist Compliance Manager

Expert or Lay Expert Lay Expert Expert Lay Expert Expert Lay Expert Lay Lay Expert Expert Expert Lay

Dates Appointed Resigned November 2003 September 2006 March 2007 May 2007 August 2003 1989 April 2002 June 2006 November 2003 August 2003 November 2003 March 2007 1998 June 2005 June 2006 November 2007

December 2007

Deputy Members None. Co-opted Members Name Mr Stephen Humphries Occupation GP surgery Practice Manager Expert or Lay Lay Meeting date attended Thursday 6th March 2008

Member Bank None

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Meetings for Full Ethical Review 1 April 2007- 31 March 2008:
Month April May June July September October November December January March Date 05/04/2007 03/05/2007 07/06/2007 11/07/2007 06/09/2007 04/10/2007 01/11/2007 06/12/2007 03/01/2008 06/03/2008 Number of Members Present at Meeting 7 14 12 12 11 8 10 7 10 8

Attendance of Members: 1 April 2007 – 31 March 2008:
Name Number of Meetings Attended 9 9 7 5 5 8 9 6 8 8 3 4 7 6 6

Ms Margaret Byers Mrs Marion Cumbers Dr Geraldine Edge Dr Anthony Gilbert Mrs Diana Harvey Dr Mike Hetreed Mrs Rosemary Hill Mr Jonathan Isaacs Mr Steve Mckerral Mrs Elayne Nasr * Dr Brian Seaton Miss Sally Tennant Ms Gill Thurlow Ms Kaye Walls Mr Nicholas Yeo

* 2 of the meetings attended by Elayne Nasr were as a co-opted Member: Brent and Harrow REC;
East London REC. Number of inquorate meetings held: None.

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Training 1 April 2007 – 31 March 2008:
Name of Member Rosemary Hill Rosemary Hill Rosemary Hill Date 18th February 2008 22nd February 2008 31st October 2007 17th September 2007 28th February 2008 27th and 28th September 2007 22nd-23rd November 2007 5th February 2008 8th February 2008 5th February 2008 th 8 February 2008 Event(s) attended NRES: Quality Assurance Audit Workshop NRES: Quality Assurance Scheme Workshop NRES: Ethics behind closed doors, workshop.

Margaret Byers Margaret Byers

NRES Road show NRES: Human Tissue and Ethical review Workshop University of Kent: Goodenough College, Issues for RECs

Kaye Walls

Steve McKerral Anthony Gilbert Anthony Gilbert Sally Tennant Sally Tennant

NRES: Chairs and Coordinators conference. NRES: Induction for New members NRES: Complex ethics NRES: Induction for New members NRES: Complex ethics

List of Training Events Organised Locally by the Co-ordinator:
None.

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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 Clinical Trial of Investigational Medicinal Product Phase 1 Gene Therapy Research Tissue Bank Research Database Others Total Applications Reviewed Number of applications transferred in from other RECs Number of applications transferred out to other RECs Number of invalid applications received Number of studies withdrawn prior to the meeting Number of studies withdrawn after the meeting Site Specific Assessment Number of student applications reviewed Number of substantial amendments reviewed Number of Section 30 applications reviewed Number 0 0 0 0 0 34 34 1 0 0 0 2 15 13 10 1 % 0.0 0.0 0.0 0.0 0.0 100.0 100.0

Summary of Decisions Made 1 April 2007 – 31 March 2008:
Decisions taken at meetings following review of applications Favourable Opinion Unfavourable Opinion Provisional Opinion Other Total Number of studies sent back to full committee meeting for final opinion Status of applications at date of generation of report Further Information Favourable Opinion Further Information Unfavourable Opinion Favourable Opinion Unfavourable Opinion Provisional Opinion Other Total Number 5 3 26 0 34 0 % 14.7% 8.8% 76.5% 0.0% 100%

Number 26 0 4 3 0 0 33

% 78.8% 0.0% 12.1% 9.1% 0.0% 0.0% 100%

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Other Management Information 1 April 2007 – 31 March 2008:
Average number of applications reviewed per full meeting Number of applications for full ethical review over 60 days Number of applications over 60 days as a % of total Number of days taken to final decision - average Number of days taken to final decision - mode Number of SSAs reviewed Number of applications for SSA review over 25 days Number of applications for SSA review over 25 days as % of all SSAs Number of substantial amendments over 35 days Number of substantial amendments over 35 days as a % of total substantial amendments Number of Section 30 applications over 60 days Number of Section 30 applications over 60 days as a % of total Section 30 applications 3.4 0 0.0% 32 21 15 0 0.0%

0 0%

0 0%

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Joint RNOH/IOMS Research Ethics Committee Annual Report 2007/08 Proposals Considered between 1 April 2007 and 31 March 2008
Further Information Favourable Opinion 07/H0724/35 Attendant Wheelchair Propulsion 07/H0724/37 Bone disease in Noonan syndrome 07/H0724/38 Ultrasound guided cervical nerve root injection- version 1 07/H0724/39 Treatment of tendinopathies using autologous skin-derived tenocytes 07/H0724/45 Factors in nerve pain & regeneration 07/H0724/46 Role of SPECT in prognosis of response to spinal facet joint injection 07/H0724/48 Ward nurses' perception of critical care outreach effectiveness 07/H0724/50 A survey to assess ulnar nerve function in prone surgical patients 07/H0724/53 Human Papilloma virus (HPV) detection in urine and genital swabs 07/H0724/58 Titan one touch release clinical trial version 1 07/H0724/60 TIA Project 07/H0724/62 Effect of Posterior Neck Muscle Vibration on Imaginal Neglect 07/Q0506/13 Differences in energy expenditure during UL exercise following SCI 07/Q0506/16 wheelchair propulsion in children with spinal cord injury version 1 07/Q0506/17 Comparison Of Local Injections For Treatment Of Morton Neuroma. 07/Q0506/18 Disabled Children’s experiences of Hip Surgery 07/Q0506/19 The effects of electrical stimulation of the pudendal nerve V1 07/Q0506/22 Titan Zircon dental implants: A Pilot Study, Protocol Version 1.0 07/Q0506/23 Whole body MRI and bone scans; metastatic detection in bone tumours 07/Q0506/24 How important is excision of the biopsy tract during tumour surgery. 07/Q0506/28 Bone and joint disease in Noonan syndrome 07/Q0506/29 Assessment of form and function in bilateral amputee gait 07/Q0506/31 Non-invasive methods for assessing upper limb contractions associated 07/Q0506/5 Long Term Follow Up of Metal on Metal Hip prostheses (1) 08/H0724/1 Vibration Therapy in Distraction Osteogenesis of the Tibia 08/H0724/3 Efficacy of computer based therapy in adolescents with cleft palate Favourable Opinion 07/H0724/40 07/H0724/59

60 32 37 25 45 38 29 42 46 42 32 26 30 35 31 28 31 37 36 38 28 55 26 30 24 24

An Investigation Into The Pathomechanics Of Proximal Humeral Fractures Retrieval study investigating wear in total knee replacements

21 21
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Joint RNOH/IOMS Research Ethics Committee Annual Report

Joint RNOH/IOMS Research Ethics Committee Annual Report 2007/08 Proposals Considered between 1 April 2007 and 31 March 2008
07/H0724/61 08/H0724/2 Analysis of failed Hip Resurfacing Implant A pilot study of CCBT in the management of SCI pain 25 21

Further Information Unfavourable Opinion Unfavourable Opinion 07/H0724/56 07/Q0506/21 07/Q0506/25 Provisional Opinion None Other Decisions None Full applications for ethical review over 60 day timelines None SSAs over 25 day timeline None Substantial amendments over 35 day timeline None Section 30 applications over 60 day timeline None
Joint RNOH/IOMS Research Ethics Committee Annual Report Page 10

Questionnaire Survey on Sexual Function in Spinal Cord Injury Obstetric brachial plexus injuries and scoliosis 30 year follow up of open reduction of DDH hips V.1

16 15 27


				
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