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MULTI CENTRE REASEARCH COMMITTEE ANNUAL REPORT

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MULTI CENTRE REASEARCH COMMITTEE ANNUAL REPORT Powered By Docstoc
					Norfolk Research Ethics Committee

          Annual Report

     01 April 2008 – 31 March 2009
Part 1 – Committee Membership and Training

Name of REC:                    Norfolk Research Ethics Committee

Type of REC:                    Authorised

Type of Flag:                   Adults lacking capacity (Paediatric Member available)

Chair:                          Dr Michael Sheldon

Vice-Chair:                     Dr Robert Stone

Alternate Vice-Chair:           Dr Elizabeth Lund

Co-ordinator:                   Mrs Janette Guymer [on secondment to Cambridgeshire 4 REC for
                                period October 2007 to November 2008]

Assistant Co-ordinators:        Miss Katherine Norton [Acting Norfolk REC Co-ordinator for period
                                October 2007 to November 2008] [Resigned from National
                                Research Ethics Service February 2009]

                                Mrs Samantha Podmore [also Acting Cambridgeshire 4 REC
                                Assistant Co-ordinator from October 2007 to May 2008] [Resigned
                                from National Research Ethics Service May 2008]

Committee Address:              c/o The Norfolk & Norwich University Hospitals NHS Foundation
                                Trust
                                East of England REC Office [2]
                                Room 2.08 First Floor
                                Aldwych House
                                57 Bethel Street
                                NORWICH
                                Norfolk
                                NR2 1NR

Telephone:                      01603 289813
Fax:                            01603 286573
Email:                          janette.guymer@nnuh.nhs.uk




Norfolk Research Ethics Committee Annual Report 2008-2009                      Page 2
 Chair’s overview of the past year:

After what seemed an unnecessarily prolonged interregnum, the appointment of a new Chair was
confirmed in July. The new Chair has valued the support of two Vice-Chairs and a cooperative
and experienced Committee. The whole Committee has received outstanding service throughout
the year from its Co-ordinator (now back after a period of secondment) and from the Assistant Co-
ordinator who covered that period. Both have been unfailingly friendly and knowledgeable in their
dealings with the Committee and with researchers.


A committee probably benefits from a balance between stability (allowing expertise and co-
operation to develop) and some degree of change (avoiding ways of working that are too firmly
set). Two Members have needed to take temporary absence because of other commitments, and
we have been fortunate to recruit a new Member with extensive experience elsewhere.            There
have been occasions when unavoidable absences took us uncomfortably close to quorum
requirements and we have appreciated the readiness of one Member of a neighbouring REC to
help us out at one such meeting.


The Norfolk REC is one of those that volunteered to take part in a Shared Ethical Debate. On
reflection we were not persuaded of the value of the exercise and were able to present our views
to NRES.     We also continue to struggle intermittently over our relationship to scientific review,
finding some lack of clarity in GAfREC’s instruction that a committee should ‘satisfy itself that the
review already undertaken is adequate’. That could be taken to mean that our responsibility is
limited to satisfying ourselves that the review has face validity (that it was carried out by properly
qualified people), or it could mean that we are to satisfy ourselves about the conclusions of the
review.   The distinction is of some importance, particularly to Members who are not used to
accepting the conclusions of authority in matters of science without question.        It has been a
particular concern recently that the local multidisciplinary committee that reviews many of the
proposals we see has decided no longer to consider any kind of student proposal.           We are not
satisfied that review by educational supervisors is always sufficient.



Michael Sheldon MA PhD
Chair




Norfolk Research Ethics Committee Annual Report 2008-2009                         Page 3
Norfolk Research Ethics Committee Membership:

Name                           Occupation                   Expert or            Dates
                                                              Lay         Appointed Resigned

The Reverend William (Bill)    Senior Hospital Chaplain       Lay +       01/08/2005
Bazely

Miss Kim Clipsham              Senior Research Nurse          Expert      01/07/2007

Mr Ron Driver                  University Lecturer            Expert      01/12/2008

Dr Michael Flowerdew           Acupuncture Practitioner        Lay        01/08/2005
                               and Writer

Miss Sheila Ginty              Senior Sister - Surgery        Expert      01/08/2005

Mrs Belinda Hoste              Senior Housing Law              Lay        01/08/2005
                               Adviser

Miss Rosemary Jackson          Midwife                        Expert      01/08/2005

Mrs Pamela Keeley              East Anglian Eye Bank          Expert      01/08/2005
                               Nurse Manager

Dr Peter E Langdon             Clinical Lecturer and          Expert      01/05/2007
                               Clinical Psychologist
Dr Elizabeth Lund              Principal Research              Lay /      01/08/2005
                               Scientist                    Alternate
                                                            Vice-Chair

Mr Azad B Mathur               Consultant Paediatric          Expert      01/08/2005
                               Surgeon

Dr Michael Sheldon             Retired - Clinical           Lay / Chair   01/08/2005
                               Psychologist                    from
                                                            01/09/2008

Dr Robert Stone                General Practitioner          Expert /     01/08/2005
                                                            Vice-Chair


Co-opted Members

Name                            Occupation                  Expert or     Meeting date attended
                                                              Lay
Mr Colin Green                  Drugs & Therapeutics        Expert /       08 September 2008
                                Pharmaceutical Advisor      Cambs 4
                                                              REC



Norfolk Research Ethics Committee Annual Report 2008-2009                     Page 4
Meetings for Full Ethical Review 01 April 2008- 31 March 2009:


            Month                                Date               Number of Members Present
                                                                           at Meeting
April                                        14/04/2008                         9
May                                          12/05/2008                        11
June                                         09/06/2008                         8
July                                         14/07/2008                         9
August                                       11/08/2008                         9
September                                    08/09/2008                         8
October                                      13/10/2008                         7
January                                      12/01/2009                        11
February                                     09/02/2009                         7
March                                        09/03/2009                         8

10 main committee meetings were held during the reporting period.




Norfolk Research Ethics Committee Annual Report 2008-2009                    Page 5
Attendance of Members: 01 April 2008 – 31 March 2009:



Name                                                            Number of
                                                                Meetings
                                                                Attended
The Reverend Bill Bazely                                           10

Dr Michael Sheldon                                                   9

Miss Sheila Ginty                                                    9

Mrs Belinda Hoste                                                    8

Mrs Pamela Keeley                                                    8

Dr Michael Flowerdew                                                 7

Miss Kim Clipsham                                                    7

Dr Elizabeth Lund                                                    7

Dr Robert Stone                                                      7

Mr Azad B Mathur                                                     5

Miss Rosemary Jackson                                                4
[On Sabbatical for 12 month period from 01/09/2008]

Dr Peter E Langdon                                                   3
[On Sabbatical for 12 month period from 01/08/2008]

Mr Ron Driver                                                        2
[Attendance at meetings commenced in January 2009]

Mr Colin Green                                                       1
[Co-opted for September 2008 meeting only]




Number of inquorate meetings held: Zero




Norfolk Research Ethics Committee Annual Report 2008-2009   Page 6
Training 01 April 2008 – 31 March 2009:

Name of Member                       Date         Event(s) attended

Miss Kim Clipsham               28 & 30/09/08     Ethical Review of Clinical Research, Robinson
                                                  College Cambridge (convened by the Clinical
                                                  Contract Research Association)
                                   03/12/08       NRES Adults Lacking Capacity (Mental Capacity
                                                  Act) Workshop, Reading
Dr Michael Flowerdew            17 & 18/02/09     NRES Advanced Ethics Training, London

Miss Sheila Ginty                 July 2008       Awarded MSc by Research

Dr Peter Langdon                  June – July     Child Mental Health and the Law: Expert Witness
                                     2008         Course, Royal Society of Medicine

Dr Michael Sheldon              10/09/08          NRES Publication of Lay Summaries Workshop,
                                                  Cambridge

                                22/09/08          NRES Raising Awareness workshop, London:
                                                  learning points for NRES, RECs and applicants to
                                                  RECs

                                28 & 30/09/08     Ethical Review of Clinical Research, Robinson
                                                  College, Cambridge (convened by the Clinical
                                                  Contract Research Association)
                                04/12/08          NRES Shared Ethical Debate, London

                                March 2009        National Programme for Prison Service Diversity
                                                  Training, HMP Norwich
                                17 & 18/03/09     NRES Chairing Skills workshops, London

Dr Robert Stone                 02/12/2008        NRES Conference

                                17 & 18/02/09     NRES Advanced Ethics Training, London
                                17 & 18/03/09     NRES Chairing Skills workshops, London




Norfolk Research Ethics Committee Annual Report 2008-2009                       Page 7
Part 2: REC workload and activity Locally by the Co-ordinator:
List of Training Events Organised during the reporting period.



Table 1: Applications assigned to a full committee meeting held within the reporting
period:

Applications for full ethical review – Type                 Number                  %
Clinical Trial of Investigational Medicinal Product            0                   0.00
Phase 1                                                        0                   0.00
Gene Therapy                                                   0                   0.00
Research Tissue Bank                                           0                   0.00
Research Database                                              0                   0.00
Others                                                        57                  100.00
Total Applications Reviewed                                   57                  100.0



 Table 2: Other REC activity during the reporting period:

Number of applications made invalid by co-ordinator                            2
Number of studies withdrawn prior to the meeting                               6
Site Specific Assessment                                                      154
Number of student applications reviewed                                        30
Number of substantial amendments reviewed                                      30
Number of Section 30 applications reviewed                                     0



Table 3: Decisions given at meetings held within the reporting period:

Decisions taken at meetings following review of             Number                  %
applications
Favourable Opinion with Standard Conditions                   10                  17.54
Favourable Opinion with Additional Conditions                  4                   7.02
Unfavourable Opinion                                           0                   0.00
Provisional Opinion                                           43                  75.44
Invalid                                                        0                   0.00
No Opinion Pending Consultation with Referee                   0                   0.00
Not Requiring Review by NHS REC                                0                   0.00
Total                                                         57                  100%
Number of studies sent back to full committee meeting          1
for final opinion




Norfolk Research Ethics Committee Annual Report 2008-2009                Page 8
Table 4: Summary of current status of applications reviewed during the reporting
period:

Status of applications at date of generation of report        Number           %
Further Information Favourable Opinion with Standard            37          64.91%
Conditions
Further Information Favourable Opinion with Additional          4               7.02%
Conditions
Further Information Unfavourable Opinion                         0           0.00%
Favourable Opinion with Standard Conditions                     10          17.54%
Favourable Opinion with Additional Conditions                    4           7.02%
Unfavourable Opinion                                             0           0.00%
Provisional Opinion                                              0           0.00%
Invalid                                                          0           0.00%
No Opinion Pending Consultation with Referee                     0           0.00%
Further Information response not complete                        0           0.00%
Not Requiring Review by NHS REC                                  0           0.00%
No decision entered on RED                                       0           0.00%
Number of studies withdrawn after the meeting                    2           3.51%
Total                                                           57           100%



 Table 5: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting                  5.7
Number of applications for full ethical review over 60 days                0
Number of applications over 60 days as a % of total                     0.00%
Number of days taken to final decision - average                          41
Number of days taken to final decision - mode                             29

Number of SSAs reviewed                                                  154
Number of applications for SSA review over 25 days                        4
Number of applications for SSA review over 25 days as % of               2.6%
all SSAs

Number of substantial amendments over 35 days                             2
Number of substantial amendments over 35 days as a % of                  6.7%
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




Norfolk Research Ethics Committee Annual Report 2008-2009              Page 9
Table 6: Breakdown of current status of applications reviewed within the reporting period:

Further Information Favourable Opinion with Standard Conditions
REC Reference     Application Short Title                                                    Number of Days on Clock
08/H0310/32       F1 doctors’ preparedness to practice. Version 3                                       31
08/H0310/36       An ethnographic study of the culture in an imaging department                         56
08/H0310/37       Ultrasound of rotator cuff disease in inflammatory arthritis                          36
08/H0310/34       Development of a gel to aid tablet administration (version 1)                         50
08/H0310/46       Quality and continuity of heart failure care in the UK and Canada                     47
08/H0310/44       Band 5 Nurses: post mobility and professional development version 1                   59
08/H0310/51       Pilot Study on Diabetes HbA1c Management using reinforcement Version 1                39
08/H0310/53       Inflammatory biomarkers in chronic ordinary urticaria                                 51
08/H0310/49       "Classical" vs. "non-classical" adult coeliac disease.                                35
08/H0310/55       D-dimer levels in pregnancy and post-operative patients                               44
08/H0310/69       Exploratory study comparing strength of gag reflex & severity of GORD                 45
08/H0310/72       CBT in young people with OCD                                                          41
08/H0310/83       SUUDS: Substance Users Use of Dental Services                                         43
08/H0310/91       Evaluating arterial anomalies of the brachial plexus with ultrasound                  56
08/H0310/96       Biomarkers in severe asthma                                                           58
08/H0310/97       Nitric oxide in bronchiectasis after antibiotics                                      58
08/H0310/98       Alveolar nitric oxide and bronchodilation                                             58
08/H0310/93       confidentiality in the GP waiting room                                                53
08/H0310/95       Measuring Moral Distress and Burnout on Paediatric Intensive Care                     46
08/H0310/115      The experience of living with hepatitis C.                                            56
08/H0310/119      Feasibility study of usefulness of EBC in post stroke pneumonia-V5                    45
08/H0310/118      Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies                  58
08/H0310/120      Clinical practice and perceived barriers in resuscitation decisions v3                44
08/H0310/127      An Evaluation of Rheumatology Practitioner Clinics in Primary Care                    58
08/H0310/128      Visual Estimation of Weight in Stroke Patients (Version 1.0)                          46
08/H0310/131      An exploration of mental health beliefs with Congolese refugees                       42
08/H0310/138      LCP impact on care delivery in isolated, rural community, Version 2                   32
08/H0310/152      Longitudinal study into childhood dysfluency (stuttering)                             55
08/H0310/154      FOLCAN study                                                                          37
08/H0310/156      Primary Eye Care Study Version 1.0                                                    37

Norfolk Research Ethics Committee Annual Report                                                                        Page 10
08/H0310/157         Short term costs and outcomes of total hip/knee replacement surgery             50
09/H0310/1           Image Guided Brachytherapy for Cervix Cancer: A Dosimetry Study                 42
09/H0310/3           Physiological MR imaging of small bowel                                         41
09/H0310/9           Innovating practice project version 1                                           52
09/H0310/16          Exploring the Interpretation of Stroke Imaging through Eye-Tracking             33
09/H0310/29          Sputum MMP mRNA and montelukast                                                 42
09/H0310/30          HOPS - Health literacy in older patients                                        50

Further Information Favourable Opinion with Additional Conditions
REC Reference     Application Short Title                                                  Number of Days on Clock
08/H0310/187      The relationship between heart rate variability and physical activity               38
09/H0310/4        CBT for social anxiety in psychosis                                                 38
09/H0310/6        The Role of Blood Ketone Monitoring in Diabetes in Pregnancy                        39
09/H0310/12       Optimising service delivery through workforce redesign                              48


Further Information Unfavourable Opinion
REC Reference     Application Short Title                                                  Number of Days on Clock


Favourable Opinion with Standard Conditions
REC Reference    Application Short Title                                                   Number of Days on Clock
08/H0310/52      An exploratory study using Forn's index to assess liver fibrosis                     25
08/H0310/99      Survey of Neurophysiology in patients with Carpal Tunnel Syndrome v1.1               29
08/H0310/101     Individual's experiences of computerised and therapist-delivered CBT                 29
08/H0310/137     Risk of Obstructive Sleep Apnoea in Patients with Rheumatoid Arthritis               21
08/H0310/139     Narratives of Resilience amongst Adolescent Refugees Version One                     27
08/H0310/149     The Parent/Child Game with a Child with Asperger's Syndrome                          29
08/H0310/153     FolGene study                                                                        29
09/H0310/2       Sensory & motor impairment after carpal tunnel surgery (version 1)                   18
09/H0310/13      Travalert Pilot Study - Version 1                                                    29
09/H0310/31      Echo Strain Imaging of sub clinical LV dysfunction in aortic stenosis                30



Norfolk Research Ethics Committee Annual Report                                                                      Page 11
Favourable Opinion with Additional Conditions
REC Reference    Application Short Title                                               Number of Days on Clock
08/H0310/201     Surgeons' management of early breast cancer in the UK and Sweden.                25
09/H0310/18      Chocolate meal study                                                             29
09/H0310/26      Safeguarding Vulnerable Adults: An Evaluative Case study                         30
09/H0310/27      Reduction of Stroke Risks with Lifestyle Modifications                           30

Unfavourable Opinion
REC Reference    Application Short Title                                               Number of Days on Clock

Provisional Opinion
REC Reference     Application Short Title                                              Number of Days on Clock

Further information response not complete
REC Reference     Application Short Title                                              Number of Days on Clock

Withdrawn after the meeting
REC Reference     Application Short Title                                              Number of Days on Clock
08/H0310/35       Feasibility study of usefulness of EBC in post stroke pneumonia-V5              31
08/H0310/116      An investigation and critical analysis of benchmarking in the NHS               30


Invalid Application
REC Reference      Application Short Title                                             Number of Days on Clock

No Opinion Pending Consultation with Referee
REC Reference    Application Short Title                                               Number of Days on Clock

Not Requiring Review by NHS REC
REC Reference    Application Short Title                                               Number of Days on Clock




Norfolk Research Ethics Committee Annual Report                                                                  Page 12
Table 7: Items exceeding timelines:

Full applications for ethical review over 60 day timeline
REC Reference       Application Short Title                                                                                    Number of Days on Clock

SSAs over 25 days timeline
REC Reference    Application Short Title                                                                                       Number of Days on Clock
08/H0310/176     Feasibility study of usefulness of EBC in post stroke pneumonia-V5                                                      100 1
08/H0310/185     An RCT to compare prednisolone and doxycycline in bullous pemphigoid                                                      32
08/H0310/188     Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC Trial                                                     26
08/H0310/191     VenUS III (Venous Ulcer Studies III) Ultrasound for venous leg ulcers                                                    30 2

Substantial Amendments over 35 day timeline
Amendment Reference     Application Short Title                                     Amendment Title                               Number of Days on
                                                                                                                                  Clock
                                                                                                                                              3
08/H0310/98/AM01                   Alveolar nitric oxide and                        Amendment 1, 02 December 2008                          36
                                   bronchodilation
                                                                                                                                                     4
06/Q0101/37/AM03                   Family Carers and Learning                       Substantial Amendment No 1,                                 45
                                   Disabilities                                     dated 12 January 2009

Section 30 application over 60 day timeline
Amendment Reference       Application Short Title                                   Amendment Title                               Number of Days on
                                                                                                                                  Clock


1
  This SSA was reviewed together with the main application 08/H0310/119 therefore a separate SSA reference should not have been generated. In error the clock was
not stopped on the SSA until the final opinion was given on the main application, therefore the RED clock for the SSA includes the time taken for the applicant to make a
response to the provisional opinion.
2
  Affected by Christmas / New Year break
3
  The amendment clock was stopped after 31 days. However, in error, the clock was stopped again when generating the minutes of the meeting. RED has recognised
the later date.
4
  Arose due to an error of judgement in the validation process.

Norfolk Research Ethics Committee Annual Report                                                                                                                             Page 13

				
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