MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - DOC 2

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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 - DOC 2 Powered By Docstoc
					Ealing & West London Research
       Ethics Committee

        Annual Report

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

Name of REC:                     Ealing & West London Mental Health Trust Research Ethics
                                 Committee

Type of REC:                     Authorised

Type of Flag:                    Prison, Mental Health

Chair:                           Mr Colin Standfield

Vice-Chair:                      Ms Trudi Hilton

Co-ordinator:                    Mrs Alene Pointon

Assistant Co-ordinator:          Not applicable

Committee Address:               Room 4W/12, 4th Floor West
                                 Charing Cross Hospital
                                 Fulham Palace Road
                                 London
                                 W6 8RF

Telephone:                       020 8846 7255
Fax:                             020 8846 7280
Email:                           Alene.Pointon@imperial.nhs.uk



 Chair’s overview of the past year:

 The workload for the Committee has remained reasonably constant during the year and we are noticing the
 implications of the Mental Capacity Act in a number of Applications, as people are becoming used to it.

 We were audited in February, and the resulting 13 Action Plans were dealt with accordingly, the June
 Meeting being suspended to allow for the points to be clarified. Chief among these were those to do with
 timing: both the 60-day schedule and the length of Meetings. We now have arrangements for the Chair
 and Co-ordinator to meet more regularly, despite their working from distant premises. The new location for
 the Meetings means that there is a deadline for finishing in good time.

 Another Action Plan point concerned a non-attending Member, who has now formally left. We are actively
 recruiting and have taken on our first new Member in April. We are now fully accredited for the next three
 years.

 There has been some improvement in the quality of submissions, but we are still mindful of the need,
 especially for educational Proposals, for some better guidance from superiors or academic supervisors.

 Colin Standfield
 Chair




Ealing & West London Research Ethics Committee Annual Report                                         Page 2
Ealing & West London Research Ethics Committee Membership:


Name                            Occupation                     Expert or           Dates
                                                                 Lay       Appointed    Resigned
Mrs Marian Cohen                Retired                          Lay        Feb 2003
Ms Kathleen Dolan               Research Nurse                  Expert      Apr 2007
Dr Mary Hill                    Clinical Psychologist            Lay        Apr 2001
Ms Trudi Hilton                 Chief Pharmacist                Expert      Feb 2005
Dr Mary Leung                   Clinical Psychologist            Lay       Sep 2003
Dr Michael Maier                Consultant Psychiatrist         Expert     Sep 2003
Dr Rajat Mathur                 Consultant Medical              Expert      Feb 2003     Jun 2008
                                Directorate
Prof Sandra Oliver              Retired                          Lay       Dec 2003
Mr Tom Rosenbaum                Consultant Urologist            Expert     Feb 2003
Dr Paramjit Sandhu              GP                              Expert     Feb 2003
Mrs Gillian Sichau              Occupational Therapist          Expert     Sep 2003
Mr Colin Standfield             Chair                            Lay       Sep 2003
Dr David Taylor                 Consultant Psychiatrist         Expert     Sep 2003
Dr Ian H Treasaden              Consultant Forensic             Expert     Feb 2003
                                Psychiatrist


Co-opted Members

Name                            Occupation                     Expert or   Meeting date attended
                                                                 Lay
Dr David Evans                  General Practitioner            Expert           Sep 2007




Ealing & West London 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
April                                         10/04/2007                  10
May                                           08/05/2007                  10
June                                          12/06/2007                   9
July                                          10/07/2007                  12
September                                     11/09/2007                  10
October                                       09/10/2007                   8
November                                      13/11/2007                  13
December                                      11/12/2007                   8
January                                       08/01/2008                  10
February                                      12/02/2008                   9
March                                         11/03/2008                   9




Ealing & West London Research Ethics Committee Annual Report                      Page 4
Attendance of Members: 1 April 2007 – 31 March 2008:


Name                                                           Number of
                                                               Meetings
                                                               Attended
Mr Colin Standfield                                               11
Dr Mary Hill                                                      10
Dr Mary Leung                                                     10
Ms Trudi Hilton                                                    9
Prof Sandra Oliver                                                 8
Ms Kathleen Dolan                                                  8
Mr Tom Rosenbaum                                                   8
Mrs Gillian Sichau                                                 8
Mrs Marian Cohen                                                   7
Dr David Taylor                                                    7
Dr Ian H Treasaden                                                 7
Dr Michael Maier                                                   6
Dr Paramjit Sandhu                                                 6
Dr Rajat Mathur                                                    2
Dr David Evans                                                     1



Number of inquorate meetings held: 0




Ealing & West London Research Ethics Committee Annual Report         Page 5
Training 1 April 2007 – 31 March 2008:

Name of Member                       Date          Event(s) attended
Mrs Alene Pointon                 06/06/2007       MCA Training, Bristol, NRES
Mrs Gillian Sichau                07/06/2007       MCA Training, London, NRES
Miss Kate Dolan                   07/06/2007       MCA Training, London, NRES
Miss Kate Dolan                   17/09/2007       NRES Roadshow, London, NRES
Ms Trudi Hilton                   17/09/2007       NRES Roadshow, London, NRES
Dr Michael Maier                  11/10/2007       MCA Training, London, NRES
Mr Colin Standfield               11/10/2007       MCA Training, London, NRES
Miss Kate Dolan                   31/10/2007       Evening Seminar, London, NRES
Mrs Gillian Sichau                31/10/2007       Evening Seminar, London, NRES
Mrs Gillian Sichau                05/11/2007       Social Sciences, London, NRES
Mrs Alene Pointon                 05/11/2007       Social Sciences, London, NRES
Mr Colin Standfield               05/11/2007       Social Sciences, London, NRES
Dr Mary Leung                     05/11/2007       Social Sciences, London, NRES
Dr David Taylor                   14/11/2007       New members Induction, London, NRES
Ms Trudi Hilton                   23/11/2007       Social Sciences, Bristol, NRES
Dr Mary Leung                     28/11/2007       Evening Seminar, London, NRES
Dr Mary Hill                      28/11/2007       Evening Seminar, London, NRES
Mrs Alene Pointon                 17/12/2007       PHRN Workshop, London, PHRN
Mrs Alene Pointon                 07/01/2008       Quality Assurance, London, NRES
Mr Tom Rosenbaum                  08/02/2008       Advanced Ethics, London, NRES
Mrs Alene Pointon                 21/02/2008       Ethics behind open doors, London, NRES
Mrs Gillian Sichau                27/02/2008       South London Conference, London, NRES
Dr Mary Hill                      27/02/2008       South London Conference, London, NRES
Dr Mary Leung                     27/02/2008       South London Conference, London, NRES
Miss Kate Dolan                   13/03/2008       Quality Assurance Conference, London, NRES




Ealing & West London Research Ethics Committee Annual Report                              Page 6
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              0        0.0
Phase 1                                                          0        0.0
Gene Therapy                                                     0        0.0
Research Tissue Bank                                             0        0.0
Research Database                                                0       0.0
Others                                                           60     100.0
Total Applications Reviewed                                      60     100.0

Number of applications transferred in from other RECs            2
Number of applications transferred out to other RECs             0
Number of invalid applications received                          6
Number of studies withdrawn prior to the meeting                 0
Number of studies withdrawn after the meeting                    0
Site Specific Assessment                                         20
Number of student applications reviewed                          39
Number of substantial amendments reviewed                        9
Number of Section 30 applications reviewed                       3



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

Decisions taken at meetings following review of                Number    %
applications
Favourable Opinion                                               6      10.0%
Unfavourable Opinion                                             20     33.3%
Provisional Opinion                                              33     55.0%
Other                                                            1       1.7%
Total                                                            60     100%
Number of studies sent back to full committee meeting            0
for final opinion

Status of applications at date of generation of report         Number     %
Further Information Favourable Opinion                           33     55.0%
Further Information Unfavourable Opinion                         0       0.0%
Favourable Opinion                                               6      10.0%
Unfavourable Opinion                                             20     33.3%
Provisional Opinion                                              0       0.0%
Other                                                            1       1.7%
Total                                                            60     100%



Ealing & West London Research Ethics Committee Annual Report                 Page 7
 Other Management Information 1 April 2007 – 31 March 2008:

Average number of applications reviewed per full meeting        5.5
Number of applications for full ethical review over 60 days     7
Number of applications over 60 days as a % of total            9.1%
Number of days taken to final decision - average               36
Number of days taken to final decision - mode                  24

Number of SSAs reviewed                                         20
Number of applications for SSA review over 25 days               2
Number of applications for SSA review over 25 days as % of     10.0%
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




Ealing & West London Research Ethics Committee Annual Report           Page 8
 Ealing & West London Research Ethics Committee Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


Further Information Favourable Opinion
07/H0710/50              Emotion Recognition in Borderline Personality Disorder                    24
07/H0710/52              The effects of yoga and meditation on inmates at HMYOI Castington         81
07/H0710/53              Risk factors for self-harm in men within a high secure hospital (V.1)     24
07/H0710/54              Controlled trial of a home based intervention for people with CHD         33
07/H0710/55              Caseload midwifery in a multi-ethnic population                           32
07/H0710/59              A Comparative Study on Boredom in Personality Disordered Patients         74
07/H0710/60              The influence of malnutrition on outcome after acute stroke               49
07/H0710/67              An exploration of the motivational structures of DSPD patients V.2        31
07/H0710/68              Pathology of hallucinations and sleep problems in Parkinson's disease     28
07/H0710/69              Characterization of lung carbohydrate receptors for influenza virus       57
07/H0710/70              Parental attitudes and stigma in relation to attending CAMHS              23
07/H0710/73              Use of the DSQ with offender patients.                                    67
07/H0710/81              Study of ICU patients at risk of acute kidney injury                      33
07/H0710/87              Evaluation of Groupwork Interventions with Violent Offenders              32
07/H0710/88              Gene brain interactions                                                   43
07/H0710/91              Non-contrast SSFP MRA for the assessment of renal arteries v1.0           53
07/H0710/92              Direct Payments and Me                                                    60
07/Q0410/21              Domestic Violence Screening In Midwifery Practice                         44
07/Q0410/23              Patients' experiences of nurses' attitudes around self-harm.              58
07/Q0410/25              Evaluating Evelina                                                        26
07/Q0410/31              cortical control of sympathetic nervous system                            61
07/Q0410/32              A study of Service Users understanding of mental distress                 31
07/Q0410/37              Brain imaging the serotonin system in disorders of impulse control        37
07/Q0410/42              Life journeys and pathways of BME offenders in forensic settings 1        56
07/Q0410/43              Existential Needs/Religious/Spiritual Attitudes of Surgery Patients       36
07/Q0410/44              1. ADHD: Children's experiences, beliefs, self-esteem & coping styles     50
08/H0710/1               Attitudes towards self-harming service users                              45
08/H0710/11              Vitrification after biopsy at different stages of embryo development      32
08/H0710/14              Effect of breathing limit and breathing pattern on breathlessness         28


Ealing & West London Research Ethics Committee Annual Report                                     Page 9
 Ealing & West London Research Ethics Committee Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


08/H0710/15                  The validation of novel targets in neuropathic pain conditions              38
08/H0710/2                   The experience of caring for people with dementia                           49
08/H0710/6                   Factors underlying parental decisions about MMR vaccination: v1             42

Favourable Opinion
07/H0710/61                  Biomechanical study of the effects of osteotomy on knee function            20
07/H0710/65                  The impact of the Mental Capacity Act 2005                                  57
07/Q0410/26                  Barriers to phosphate binding medication adherence Vesion1                  29
07/Q0410/29                  Cardiac Iron Load Imaging v1.0                                              23
08/H0710/10                  Bullying & Harassment among staff at WLMHT v.2                              26
08/H0710/7                   Therapeutic engagement for eating difficulties - (version 1)                27

Further Information Unfavourable Opinion

Unfavourable Opinion
07/H0710/47                  Students And Mentors Perspectives Of Mentorship- Version One                21
07/H0710/63                  Negative Emotions, the Eating Disorders and Silencing the Self              16
07/H0710/66                  Chelsea and Westminster HIV-1 Cohort Data Review:Treatment Patterns         20
07/H0710/74                  Mind the Gap - Investigation of a Transitional Music Therapy Group (1)      27
07/H0710/75                  The Construction and Negotiation of Social Roles and Identities             17
07/H0710/79                  The process of change in forensic mental health settings                    49
07/H0710/84                  To identify the value of the ventilatory efficiency index in patients       16
07/H0710/89                  Bullying & Harassment among staff at WLMHT v.1                              28
07/Q0410/13                  Lesbian, Gay Men, and Bisexual Mental Health Service Users                  22
07/Q0410/20                  CVD risk factor profile in a forensic mental health setting (V1)            21
07/Q0410/22                  Service user involvement impact on psychological well-being Version 1       24
07/Q0410/24                  How does the expert witness arrive at an opinion for court. Version 1       17
07/Q0410/27                  Existential Needs/Religious/Spiritual Attitudes of Surgery Patients         24
07/Q0410/30                  SIPS-CJS Version 1                                                          23
07/Q0410/34                  Evaluating healthcare assistants' knowledge on diabetes.                    29

Ealing & West London Research Ethics Committee Annual Report                                          Page 10
 Ealing & West London Research Ethics Committee Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/Q0410/39                  Evaluation of the EMIS implementation into HMP Pentonville                                                         44
07/Q0410/41                  Attitudes towards self-harming service users                                                                       21
07/Q0410/45                  Self-referral following self-diagnosis of labour: SERENE STUDY - Ver 1                                             22
07/Q0410/46                  Women sexual offenders version 1                                                                                   21
08/H0710/13                  M-PACT Prison Version 1                                                                                            21

Provisional Opinion

Other Decisions
07/H0710/51                  Treatment options and compliance for women in Broadmoor                  24            Not requiring review by NHS REC
                             Hospital, v.1

Full applications for ethical review over 60 day timelines
Further Information Favourable Opinion 06/Q0410/72 Nurses' Contribution to Promote Social Inclusion                                             70
Further Information Favourable Opinion 07/Q0410/7        Understanding wound healing and scar formation                                         61
Further Information Favourable Opinion 07/Q0410/18 Coping, social support, satisfaction and the caring role.                                    62
Further Information Favourable Opinion 07/Q0410/31 cortical control of sympathetic nervous system                                               61
Further Information Favourable Opinion 07/H0710/52 The effects of yoga and meditation on inmates at HMYOI Castington                            81
Further Information Favourable Opinion 07/H0710/59 A Comparative Study on Boredom in Personality Disordered Patients                            74
Further Information Favourable Opinion 07/H0710/73 Use of the DSQ with offender patients.                                                       67

SSAs over 25 day timeline
No Objection                                 07/H0710/62       RECORDAF C_01264                                                                 27
No Objection                                 08/H0710/8        After Diagnosis Diabetes REsearch Support System, version 2                      27

Substantial amendments over 35 day timeline

Section 30 applications over 60 day timeline




Ealing & West London Research Ethics Committee Annual Report                                                                                 Page 11

				
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