MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 1997/1998 - DOC

Document Sample
MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 1997/1998 - DOC Powered By Docstoc
					Bromley Local Research Ethics
         Committee

        Annual Report

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

Name of REC:                   Bromley Local Research Ethics Committee

Type of REC:                   Authorised

Type of Flag:                  Mental Capacity Act

Chair:                         Ms Carol Jones

Vice-Chair:                    Dr Ian Jessiman (until July 2007 –post vacant thereafter)
Co-ordinator:                  Mrs Janine Peters

Assistant Co-ordinator:        None

Committee Address:             Bromley PCT, Bassetts House,
                               Broadwater Gardens
                               Farnborough
                               Kent
                               BR6 7UA

Telephone:                     01689 880592
Fax:                           01689 855662
Email:                         janine.peters@bromleypct.nhs.uk




Bromley Local Research Ethics Committee Annual Report                                      Page 2
Chair’s overview of the past year:


The appointment of Bromley REC as a flagged committee for Mental Capacity Act issues has
brought a different experience to our committee work, which continues to be a very rewarding
and interesting experience. The committee, as you will see from this report, has had an extremely
busy and productive year reviewing a wide variety of research proposals. We continue to enjoy
meeting the researchers and their supervisors at the committee meetings. This in turn provides
the committee with invaluable information in helping the committee come to an informed and
considered opinion and reduces the number of proposals that have required to be returned to
researchers for clarification.

We have commenced a system of performance review for all new committee members this year.
This is a prelude to the introduction of appraisal for chairs, which is being introduced next year.

This year for our local training event, we looked at how we may be perceived as a committee by
the researchers attending our meetings. We looked at our values, culture, and what we see as
our prime role. It was a very productive half day facilitated for us by Dr Sarah Edwards, Senior
Lecturer in Research Governance from University College Hospital, London. We are looking
forward to undertaking further work on this topic through the coming year.

Accreditation of our committee has not yet taken place. However, our Co-ordinator, Janine,
continues to ensure that all of our evidence for the accreditation process is available and that
committee members are prepared for the process.

Time to attend meetings continues to be a challenge for members this year particularly as the
meetings are now longer to deal with the increase in business. Clearly, it is an issue that we need
to continue to monitor in the coming year.

This year saw our Vice Chair retire. Dr Ian Jessiman served on this committee for over ten years
and his experience, attention to detail, linked to his humour and understanding of ethical issues in
research made him a most valuable colleague. I know that I speak for all of the committee when I
say how much we will miss him.

As previously reported at the end of last year we were in the process of recruiting a number of
new members to the Committee. We have been pleased to welcome Mrs Susan Beer, Mrs
Angela Clayton-Turner, Dr Josephine Hammond, Mrs Fran McMillan and Dr David Osoba to the
Committee this year and look forward to continuing to work with them. We were also pleased that
several of our longstanding and very experienced members, Mr Munir Ahmed, Nr Niall McCrae,
Mr Walter Million and Mrs Pauline Pierce were reappointed for further 5 year terms of office on
the REC.

Dr Hamza Zeytinoglu also left the committee this year after a brief spell as a committee member.
Dr Zeytinoglu has moved overseas we wish him well in his new life.

As we end 2007/08 we are looking to the recruitment of a new Vice Chair and hope to make an
appointment by the summer.

Once again I should like to record our thanks to Janine, our diligent and helpful co-ordinator who
makes REC life so straightforward.




Bromley Local Research Ethics Committee Annual Report                                         Page 3
Bromley Local Research Ethics Committee Membership:


Name                           Occupation                  Expert or           Dates
                                                             Lay       Appointed    Resigned
Mr Munir Ahmed                 Consultant Urologist         Expert      12/02/08
                                                                         nd
                                                                       (2 term)
Mrs Susan Beer            Retired Project Manager            Lay        17/05/07
Mrs Angela Clayton-Turner Retired NHS Therapy                Lay        15/06/07
                          Manager
Dr Josephine Hammond      Consultant                        Expert      10/04/07
                          Paediatrician/Senior
                          Lecturer (Retd)
Dr Ian Jessiman           Retired GP                        Expert     Extended     20/07/07
                                                                       10/08/05
Ms Carol Jones (Chair)         Management Consultant         Lay        25/05/04
Mr Niall McCrae                Health Services              Expert     12/02/08
                                                                         nd
                               Researcher                              (2 term)
Mrs Fran McMillan              Bookseller                    Lay        10/04/07
Rev Tim Mercer                 Hospital Chaplain             Lay        13/08/04
Mr Walter Million              Retired Solicitor             Lay        12/02/08
                                                                       (2nd term)
Dr Angela Orunta               Consultant Anaesthetist      Expert      12/08/04
Dr David Osoba                 Staff Community              Expert      10/04/07
                               Paediatrician
Ms Pauline Pierce              Musician/Magistrate           Lay        12/02/08
                                                                         nd
                                                                       (2 term)
Mr C.V. Praveen                Staff Grade/ENT              Expert      14/03/06
Dr Mukesh Sahi                 General Practitioner         Expert      24/10/06
Ms Jayne Steadman              Consultant                   Expert      13/08/04
                               Physiotherapist
Miss Nathalie Walsh            Research Infrastructure      Expert      13/08/04
                               Programme Manager
Dr Hamza Zeytinoglu            Information Lead/Practice    Expert      31/01/07    13/12/07
                               Based Commissioning


Deputy Members - None


Co-opted Members - None


Member Bank - None




Bromley Local Research Ethics Committee Annual Report                                 Page 4
Meetings for Full Ethical Review 1 April 2007- 31 March 2008:

            Month                                Date       Number of Members Present
                                                                   at Meeting
April                                        19/04/2007                11
May                                          17/05/2007                10
June                                         21/06/2007                12
July                                         19/07/2007                15
October                                      18/10/2007                10
November                                     15/11/2007                11
December                                     13/12/2007                11
January                                      17/01/2008                13
February                                     21/02/2008                11




Bromley Local Research Ethics Committee Annual Report                          Page 5
Attendance of Members: 1 April 2007 – 31 March 2008:


Name                                                                     Number of
                                                                         Meetings
                                                                         Attended
Dr Josephine Hammond                                                         9
Dr Mukesh Sahi                                                               9
Ms Carol Jones                                                               8
Ms Jayne Steadman                                                            7
Ms Pauline Pierce                                                            7
Mrs Angela Clayton-Turner                                                    7
Mrs Fran McMillan                                                            7
Mr Niall McCrae                                                              6
Mr Walter Million                                                            6
Rev Tim Mercer                                                               6
Mr C.V. Praveen                                                              5
Dr Angela Orunta                                                             5
Dr David Osoba                                                               5
Mr Munir Ahmed                                                               4
Mrs Susan Beer (Dec, Jan & Feb – unable to attend due to illness)            4
Dr Hamza Zeytinoglu (Left Committee Dec 2007)                                4
Miss Nathalie Walsh (Maternity leave from September 2007)                    3
Dr Ian Jessiman (Left Committee July 2007)                                   3



Number of inquorate meetings held: None but no meeting held in September 2007 as
insufficient studies for review.




Bromley Local Research Ethics Committee Annual Report                              Page 6
Training 1 April 2007 – 31 March 2008:

Name of Member                       Date         Event(s) attended
Mr Munir Ahmed                   25/04/2007       NRES Workshop: Quantitative Research and
                                                  the Ethics Committee
                                 05/11/2007       NRES Workshop: Social Science Methodology

                                 09/11/2007       AREC Conference: Social Care and Social
                                                  Research – Different Ethics
                                 27/02/2008       Southern England REC Conference

Mrs Susan Beer                 07/06/07           NRES Workshop: Mental Capacity Act
                               26/09/07-          KCL Course: Introduction to the Ethics of
                               28/9/07            Research in Humans
                               31/10/07           NRES Workshop: Social Science Methodology

                               20/03/08           Bromley REC Training Event: (i) the vision, values
                                                  and role of the REC, and (ii) the experience of the
                                                  researcher
Mrs Angela Clayton-Turner      07/06/07           NRES Workshop: Mental Capacity Act
                               19/06/07           NRES Workshop: Social Science Methodology

                               26/09/07-          KCL Introduction to the ethics of research in
                               28/09/07           humans
                               27/02/08           NRES Southern England REC Conference

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Dr Josephine Hammond           28/03/07           NRES Mental Capacity Act Workshop

                               09/05/07           KCL Advanced Study Day: Ethical Issues in
                                                  the retention of human tissue and the
                                                  collection of genetic material

                               26/04/07           Bromley R&D Event
                               26/09/07-          KCL Introduction to the Ethics of Research in
                               28/09/07           Humans

                               14/09/07           KCL Advanced Ethics: No Consent, no
                                                  research

                               31/10/07           NRES Workshop: Ethics behind closed doors
                               05/02/08           NRES New members induction
                               08/02/08           NRES Workshop: Complex Ethics

                               20/03/08           Bromley REC Training Event: (i) the vision,



Bromley Local Research Ethics Committee Annual Report                                          Page 7
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Ms Carol Jones                 15/03/07           REC Training Event: Mental Capacity Act

                               07/06/07           Mental Capacity Act Workshop

                               23/11/07           NRES Chairs and Co-ordinators Conference

Mr Niall McCrae                20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Mrs Fran McMillan              05/02/08           NRES New Members Induction
                               08/02/08           NRES Complex Ethics

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Rev Tim Mercer                 20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Mr Walter Million              20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Dr Angela Orunta               27/02/08           Southern England REC Conference

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Dr David Osoba                 27/06/07           NRES Induction Training

                               26/09/07-          KCL Introduction to the ethics of research in
                               28/09/07           humans
                               27/02/08           Southern England REC Conference

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Mrs Pauline Pierce             08/02/08           NRES Workshop: Complex Ethics

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Dr Mukesh Sahi                 07/06/07           NRES Workshop: Mental Capacity Act

                               31/10/07           NRES Workshop: Ethics behind closed doors
                               05/02/08           NRES REC Members Induction




Bromley Local Research Ethics Committee Annual Report                                      Page 8
                               08/02/08           NRES Complex Ethics
                               27/02/08           Southern England REC Conference

                               20/03/08           Bromley REC Training Event: (i) the vision,
                                                  values and role of the REC, and (ii) the
                                                  experience of the researcher
Ms Jayne Steadman              11/10/07           NRES Mental Capacity Act Workshop

                               20/03/08           Bromley REC Local Training Event: (i)The
                                                  vision, values and purpose of the REC, and (ii)
                                                  the experience of REC review
Dr Hamza Zeytinoglu            26-28/09/07        KCL Introduction to the ethics of research in
                                                  humans



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

Event                                                                                 Date
Bromley REC Local Training Event: (i)The vision, values and purpose                 20/03/08
of the REC, and (ii) the experience of REC review (led by Sarah
Edwards, Senior Lecturer, UCLH) – included in members’ individual
training records above




Bromley Local Research Ethics Committee Annual Report                                     Page 9
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                                                     40     100.0
Total Applications Reviewed                                40     100.0

Number of applications transferred in from other RECs       1
Number of applications transferred out to other RECs        1
Number of invalid applications received                     1
Number of studies withdrawn prior to the meeting            0
Number of studies withdrawn after the meeting               1
Site Specific Assessment                                    4
Number of student applications reviewed                    24
Number of substantial amendments reviewed                   8
Number of Section 30 applications reviewed                  1



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

Decisions taken at meetings following review of          Number    %
applications
Favourable Opinion                                         14     35.9%
Unfavourable Opinion                                        2      5.1%
Provisional Opinion                                        23     59.0%
Other                                                       0      0.0%
Total                                                      39     100%
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                     22     57.9%
Further Information Unfavourable Opinion                    0      0.0%
Favourable Opinion                                         14     36.8%
Unfavourable Opinion                                        2      5.3%
Provisional Opinion                                         0      0.0%
Other                                                       0      0.0%
Total                                                      38     100%


Bromley Local Research Ethics Committee Annual Report                     Page
10
 Other Management Information 1 April 2007 – 31 March 2008:

Average number of applications reviewed per full meeting       4.4
Number of applications for full ethical review over 60 days    0
Number of applications over 60 days as a % of total           0.0%
Number of days taken to final decision - average              31
Number of days taken to final decision - mode                 21

Number of SSAs reviewed                                        4
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




Bromley Local Research Ethics Committee Annual Report                Page
11
 Bromley Local Research Ethics Committee Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


Further Information Favourable Opinion
07/H0805/21              Mannose-binding lectin and invasive aspergillosis                            32
07/H0805/22              Mannose-binding lectin and Chronic Hepatitis C infection                     31
07/H0805/24              Air Polishing Powders for Treating Dental Stain                              29
07/H0805/26              Investigation into the psychometric properties of the STORI                  35
07/H0805/27              Telephone intervention for fatigue during chemotherapy (version1)            44
07/H0805/28              EULAR Classification of fibromyalgia; patient interviews - Version 1         26
07/H0805/32              Emergency Care of Young People who Self-Harm                                 27
07/H0805/33              Medically Unexplained Symptoms & Life Events v1                              32
07/H0805/39              Attachment style in Psychosis and Bipolar Disorder                           34
07/H0805/43              Illness Perceptions in Cardiac Valve Patients                                28
07/H0805/43              Illness Perceptions in Cardiac Valve Patients                                28
07/H0805/45              An exploration of how the Clubhouse model promotes recovery(Version 1)       50
07/H0805/46              Gut Microbiota in Patients with Crohn's disease and Their Relatives          60
07/Q0705/10              Patients' Perception of Need in Cardiac Rehabilitation                       45
07/Q0705/11              Factors controlling folliculogenesis in the human ovary 1                    40
07/Q0705/13              An exploration of clinical supervision within physiotherapy version 1        34
07/Q0705/15              What are the palliative care needs of patients with advanced dementia        47
07/Q0705/16              Is Mycoplasma genitalium in women "the new chlamydia"?                       33
07/Q0705/17              Pre-assessment patients perceptions of MRSA Version 1                        39
07/Q0705/19              Alexithymia and treatment outcome in opiate detoxification (01)              36
07/Q0705/20              Survey of physical health problems among opiate dependent patients           29
08/H0805/6               The molecular role of zinc and complement Factor H in AMD                    56

Favourable Opinion
07/H0805/35                  Service Users Experiences of a Psychiatric Intensive Care Unit           20
07/H0805/36                  Proteomic Fingerprinting for Respiratory Syncytial Virus Infection       23
07/H0805/37                  Factors affecting the Performance of Thromboplastin Reagents             21
07/H0805/38                  Oral Biology of Bifidobacteria and related species: version 1.0          19
07/H0805/42                  HLA Antibody and Transplantation v1                                      21
07/H0805/44                  Quality of Care for Psychosis - the development of a new instrument      21

Bromley Local Research Ethics Committee Annual Report                                              Page 13
 Bromley Local Research Ethics Committee Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/H0805/47                  Probiotic and prebiotic use by patients with IBD                           32
07/H0805/48                  Treatment decision-making capacity in patients with chronic psychosis      32
07/H0805/49                  Portfolio Study                                                            22
08/H0805/1                   OT programme to increase independence in Padl following TBI.               25
08/H0805/2                   Omega-3 index trial                                                        31
08/H0805/3                   Inhibitory Effect on Plaque Formation                                      21
08/H0805/4                   Diabetes, depression and illness perceptions, version 1                    31
08/H0805/5                   Stroke and self-identity among people of advanced older age                31


Further Information Unfavourable Opinion

Unfavourable Opinion
07/H0805/40                  Prevalence of sexually abusive behaviour in adults with I.D.               15
07/Q0705/12                  The role of additional therapeutic contact                                 27

Provisional Opinion

Other Decisions

Full applications for ethical review over 60 day timelines

SSAs over 25 day timeline

Substantial amendments over 35 day timeline

Section 30 applications over 60 day timeline




Bromley Local Research Ethics Committee Annual Report                                                Page 14

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:10
posted:2/17/2012
language:
pages:14