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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998

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MULTI-CENTRE REASEARCH COMMITTEE ANNUAL REPORT 19971998 Powered By Docstoc
					      HSC REC 2

    Annual Report

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

Name of REC:                         HSC REC 2

Type of REC:                         Type II

Type of Flag:                        N/a

Chair:                               Dr Theresa Donaldson

Vice-Chair:                          Dr Ronald Atkinson

Alternate Vice Chair:                Dr Donna Fitzsimons

Co-ordinator:                        Miss Katrina Walls

Committee Address:                   ORECNI
                                     Office Suite 3
                                     1-4 Haslems Lane
                                     Lisburn
                                     Co. Antrim
                                     BT28 1TW

Telephone:                           028 9260 3107
Fax:                                 028 9260 3619
Email:                               wallsk@orec.n-i.nhs.uk



 Chair’s overview of the past year:


 It is my pleasure to provide a foreword to the annual report of HSC REC2 for reporting year 07/08. It is clear to those
 reading these reports year on year and to those of us contributing, that a standard format is used. This is helpful in
 facilitating comparison between reporting periods and indeed assists reflection on the operation of the Research Ethics
 system as a whole. The activity of the Committee is evidenced in the number of applications that continue to be
 reviewed and ethical opinion provided within the 60 day period. All those involved in the review process are conscious
 of the clock ticking and are committed to turning applications around as quickly as possible to avoid delay for those
 undertaking research. It is pleasing to note that all applications were turned around within 60 days maintaining the
 achievement from last year. The number of unfavourable opinions reduced again from 7(8.3% of decisions) in 06/07 to
 5 (7.8% of decisions) in 07/08. These achievements can only be attained when a system is managed appropriately and
 all those involved are committed to common goals. The work of the Committee is challenging but also very rewarding.
 Thanks are due to all members of the Committee providing as ever their time and expertise for no financial reward, to
 the staff in OREC particularly Katrina Walls Administrator for this Committee, and to Dr Ronnie Atkinson and Dr.
 Donna Fitzsimmons for their support and commitment.




HSC REC 2 Annual Report                                                                          Page 2
HSC REC 2 Membership:


Name                      Occupation                     Expert                Dates
                                                         or Lay      Appointed       Resigned
Dr Ronald Atkinson        Retired Oncologist             Expert      17th Feb 04
                                                                     Re-apt 14th
                                                                       Feb 07
Mr Alan Cecil             Retired Industry Manager        Lay        10th Dec 04
Professor Wallace         Consultant Physician           Expert      1st March 07
Dinsmore
Dr Theresa Donaldson      Director of Policy and          Lay        17th Feb 04
                          Service Delivery                           Re-apt 14th
                                                                       Feb 07
Dr Donna Fitzsimons       Senior Manager of Nursing      Expert      17th Feb 04
                          Research & Development                     Re-apt 14th
                                                                       Feb 07
Dr Clodagh Loughrey       Consultant Chemical            Expert      17th Feb 04
                          Pathologist
Prof Tanya McCance        Co- Director Nursing R & D     Expert      17th Feb 04
***Mr Aidan McDonnell     Executive Officer               Lay        12th Sept 07
Ms Mary McMahon           Social Policy Researcher        Lay        10th Dec 04
Professor Patrick         Advisor on Political, Social    Lay         1st Dec 05
Murphy                    & Economic Policy
Dr Andrew Percy           Research Statistician           Lay        17th Feb 04
Dr Marian Traynor         Lecturer in Nursing            Expert      17th Feb 04
Ms Kathryn Turner         Head of Professional           Expert      17th Feb 04
                          Pharmacy Services                          Re-apt 14th
                                                                       Feb 07
Prof Robert Welch         Professor of Food Science      Expert      17th Feb 04
                          & Nutrition
Mr Roger Woodward         Senior Lecturer in              Lay        17th Feb 04
                          Psychology                                 Re-apt 14th
                                                                       Feb 07
Mr Victor Robinson        Nurse Lecturer                 Expert      17th Feb 04
Dr Andrew Jackson         General Practitioner           Expert                       10th Jan 08
Mr Robert Marshall        Retired                         Lay                         29th Oct 07
***Ms Lynn Keenan         Pharmacist                     Expert      1st Dec 05

***Lynn Keenan co-opted to REC 3 (March 07 - June 07) Lynn moved to REC 3 as of 12th Sept 07
***Aidan McDonnell co-opted from REC 3 to REC 2 as of 12th Sept 07.
Deputy Members

Name                         Occupation                  Expert or     Meeting date attended
                                                           Lay




HSC REC 2 Annual Report                                                      Page 3
Co-opted Members

Name                      Occupation               Expert or   Meeting date attended
                                                     Lay
Dr Mary Hannon-Fletcher   Lecturer in Biomedical    Expert        9th August 2007
(HSC REC 1)               Sciences
Mr Michael Stevenson      Statistician              Expert        9th August 2007
(HSC REC 1)

Member Bank

Name                      Occupation               Expert or   Meeting date attended
                                                     Lay




HSC REC 2 Annual Report                                            Page 4
Meetings for Full Ethical Review 1 April 2007- 31 March 2008:

            Month                        Date              Number of Members Present
                                                                  at Meeting
May                                   10/05/2007                      16
June                                  14/06/2007                      11
July                                  05/07/2007                      12
August                                09/08/2007                       8
September                             13/09/2007                      13
October                               11/10/2007                      14
November                              08/11/2007                      15
December                              13/12/2007                      13
January                               10/01/2008                      14
February                              07/02/2008                      10
March                                 06/03/2008                      12




HSC REC 2 Annual Report                                             Page 5
Attendance of Members: 1 April 2007 – 31 March 2008:


Name                                                                            Number of
                                                                                Meetings
                                                                                Attended
Professor Patrick Murphy                                                           11
Prof Robert Welch                                                                  10
Mr Roger Woodward                                                                  10
Dr Donna Fitzsimons                                                                 9
Dr Clodagh Loughrey                                                                 7
Dr Theresa Donaldson                                                                7
Mr Alan Cecil                                                                       8
Ms Mary McMahon                                                                     8
Prof Tanya McCance                                                                  8
Ms Kathryn Turner                                                                   7
Mr Aidan McDonnell                                                                  7
Dr Andrew Percy                                                                     7
Dr Ronald Atkinson                                                                  7
Professor Wilbert Wallace Dinsmore                                                  7
***Dr Marian Traynor                                                                5
Mr Victor Robinson                                                                  8
Dr Andrew Jackson                                                                   8
Mr Robert Marshall                                                                  4
***Ms Lynn Keenan                                                                   0

***10.01.08 Meeting. Dr Marian Traynor car broke down - unable to attend (Written comments
provided).

***Lynn Keenan co-opted to REC 3 (March 07 - June 07) Lynn moved to REC 3 as of 12th Sept
07. Lynn gave apologies for July and August meetings.

Number of inquorate meetings held:

All meetings were quorate between 01/04/07 – 31/03/08




HSC REC 2 Annual Report                                                     Page 6
 Training 1 April 2007 – 31 March 2008:

Name of Member                    Date         Event(s) attended
                               nd
Dr Theresa Donaldson         22 June 07        Local Chairs Meeting
                              13th Nov 07      Advanced Chairs Skills (Paul Gapper)
                              22nd Jan 08      ORECNI Members Conference
                              12th Feb 08      Local Chairs Training
Dr Ronald Atkinson          th
                           7 – 8th June 07     AREC ‘To Serve & Protect’
                           8th – 9th Nov 07    AREC ‘Social Care & Social Work Research’
                              24th May 07      BCH – Human Tissue Seminar
                              13th Nov 07      Advanced Chairs Skills (Paul Gapper)
                              22nd Jan 08      ORECNI Members Conference
                              12th Feb 08      Local Chairs Training
Dr Donna Fitzsimons           24th May 07      BCH – Human Tissue Seminar
                              22nd Jan 08      ORECNI Members Conference
Mr Alan Cecil                 22nd Jan 08      ORECNI Members Conference
Dr Tanya McCance              22nd Jan 08      ORECNI Members Conference
Dr Andrew Percy               22nd Jan 08      ORECNI Members Conference
Mr Victor Robinson            22nd Jan 08      ORECNI Members Conference
Dr Marian Traynor             22nd Jan 08      ORECNI Members Conference
Ms Kathryn Turner             22nd Jan 08      ORECNI Members Conference
Mr Roger Woodward            th
                           8 – 9th Nov 07      AREC ‘Social Care & Social Work Research’
                              22nd Jan 08      ORECNI Members Conference
Prof Patrick Murphy          nd
                          22 – 23rd Nov 07     NRES – REC Chairs & Co-ordinators Conference
                              22nd Jan 08      ORECNI Members Conference
                              12th Nov 07      NRES Advisory Group (NHS Service Users & Ethical
                                               Review)
                             14th Jan 08       NRES Advisory Group (NHS Service Users & Ethical
                                               Review)
                             19th Feb 08       NRES Advisory Group (NHS Service Users & Ethical
                                               Review)
                            26 March 08        NRES Advisory Group (NHS Service Users & Ethical
                                               Review)
Mr Aidan McDonnell        22nd – 24th Oct 07   Introduction to Ethics (Keele University)




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

Event                                                                                 Date




HSC REC 2 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        3                 4.7
Phase 1                                                    0                 0.0
Gene Therapy                                               0                 0.0
Research Tissue Bank                                       0                 0.0
Research Database                                          0                0.0
Others                                                     61               95.3
Total Applications Reviewed                                64              100.0

Number of applications transferred in from other RECs      2
Number of applications transferred out to other RECs       5
Number of invalid applications received                    0
Number of studies withdrawn prior to the meeting           1
Number of studies withdrawn after the meeting              0
Site Specific Assessment                                   69
Number of student applications reviewed                    39
Number of substantial amendments reviewed                  26
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                                         8               12.5%
Unfavourable Opinion                                       5                7.8%
Provisional Opinion                                        49              76.6%
Other                                                      2                3.1%
Total                                                      64              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                     46              71.9%
Further Information Unfavourable Opinion                   3                4.7%
Favourable Opinion                                         8               12.5%
Unfavourable Opinion                                       5                7.8%
Provisional Opinion                                        0                0.0%
Other                                                      2                3.1%
Total                                                      64              100%



HSC REC 2 Annual Report                                           Page 8
 Other Management Information 1 April 2007 – 31 March 2008:

Average number of applications reviewed per full meeting        5.8
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                42
Number of days taken to final decision - mode                   44

Number of SSAs reviewed                                         69
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




HSC REC 2 Annual Report                                       Page 9
 HSC REC 2 Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


Further Information Favourable Opinion
07/NIR02/100             Comparison of the ROBD and the Ventimask method of flight assessment.       47
07/NIR02/102             Mechanisms of action of PARP inhibitors                                     44
07/NIR02/103             Work-related stress in community pharmacy: a qualitative study              56
07/NIR02/104             Two Virtual Reality Platforms for Children with Cerebral Palsy              36
07/NIR02/112             Managing stress in ICU patients: effects of pre-admission information       39
07/NIR02/113             Strepsils original efficacy study                                           29
07/NIR02/114             Realistic Evaluation of H4L Health Promotion Programme.                     54
07/NIR02/115             Generation of a genetic signature of severe RSV disease                     59
07/NIR02/116             Inter hospital transfer of the critically ill: the family experience        54
07/NIR02/117             Development of an interactive CD-ROM for people with Type 2 diabetes        38
07/NIR02/130             Staff attitudes towards learning disabled patient aggression (v:1)          43
07/NIR02/131             Information Processing and Dissociation in PTSD                             59
07/NIR02/136             Evaluation of archival material for biomarkers of pre-eclampsia             37
07/NIR02/137             Patient perspective on an intermediate care discharge option Vers No:1      37
07/NIR02/140             Women with diabetes: your views about pregnancy version 1.1                 44
07/NIR02/141             Effects of IL-13 on Paediatric Airway Epithelial Cells                      49
07/NIR02/144             Placental and cord blood PCR in preterm babies                              50
07/NIR02/146             PAVR Study. ver09/11/2007                                                   34
07/NIR02/148             Carer-young person relationships                                            33
07/NIR02/150             Evaluation of wound residence properties of PVA-borax hydrogels             45
07/NIR02/56              Patient controlled lumbar plexus block                                      55
07/NIR02/58              O2 supplementation during Remifentanil PCA in labour.VERSION 1              40
07/NIR02/68              Diagnostic Role of Haematopoiesis Markers in Patients with Cytopenia 1      59
07/NIR02/69              Children's Home Ventilation                                                 48
07/NIR02/72              Palliative And Terminal care for Children (PATCH Study) version 1           43
07/NIR02/73              The Epidemiology of Diabetic Kidney Disease in Northern Ireland             41
07/NIR02/78              Northern Ireland Chldhood Diabetes Register                                 44
07/NIR02/83              Acute lung injury post one lung ventilation: effects of simvastatin         30
07/NIR02/85              V1 Muscle Activity of Able-Bodied Children in Tilted Seating Positions      40


HSC REC 2 Annual Report                                                                           Page 10
 HSC REC 2 Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/NIR02/87               Memory, Depression, and Trauma in Bipolar Disorder v1.0                     50
07/NIR02/88               Raman spectroscopic evaluation of protein modification.                     54
07/NIR02/96               Identifying Intrauterine Growth Restriction in a Low Risk Population        40
07/NIR02/97               Psychometric Properties of the Test of Everyday Attention for Children      42
07/NIR02/98               Stress and well-being in healthcare staff Version 1                         50
08/NIR02/1                Does "Breathing Space" clinic improve quality of life?                      55
08/NIR02/14               Making sense of illness, coping and emotional well-being among women        49
08/NIR02/15               Care for Individuals with Alzheimer's Disease, Version 1                    46
08/NIR02/17               Parents experiences of caring for their child being sutured                 52
08/NIR02/18               Can certain genotypes predispose to poor asthma control?                    48
08/NIR02/20               Investigation of Endothelial Progenitor Cells                               43
08/NIR02/22               Premature Adult Lung Study (PALS)                                           46
08/NIR02/24               Youth Development Study; Leaving Care                                       47
08/NIR02/3                Natural History of Geographic Atrophy Progression Ver 1.0 - 30-Oct-07       50
08/NIR02/4                Occupational stress in nurses providing palliative care for children        40
08/NIR02/6                Auditory processing disorders and the effects of remediation                43
08/NIR02/7                Follow-up observational bone study on coeliac disease patients              44

Favourable Opinion
07/NIR02/109              Biomarker qualification in Barrett's oesophagus (Version 1.0)               31
07/NIR02/110              Continuous exhalation transfer factor in respiratory disease                35
07/NIR02/132              Predicting chemotherapy response from colorectal primary tumour             39
07/NIR02/47               Pathways to Permanency                                                      34
07/NIR02/70               Health professional perspective of palliative care in advanced COPD         34
07/NIR02/95               Development of the Belfast Pulmonary Rehabilitation Questionnaire           38
07/NIR02/99               Unified Modelling for Stroke Patients (RIGHT)                               29
08/NIR02/2                Biomarker Development to Risk Stratify Barrett's Oesophagus (V 1.0)         35

Further Information Unfavourable Opinion
07/NIR02/120             Validation of SCORE (systemic clinical outcome routine evaluation)           45


HSC REC 2 Annual Report                                                                            Page 11
 HSC REC 2 Annual Report 2007/08
 Proposals Considered between 1 April 2007 and 31 March 2008


07/NIR02/60               The Piloting of a Single Assessment Tool for Older People                                           49
07/NIR02/86               The OMeGA Supraglottic Airway Device                                                                46

Unfavourable Opinion
07/NIR02/105              A Genetic Study of Alcohol Dependence in Northern Ireland                                           37
07/NIR02/118              Evaluation of wound residence properties of PVA-borax hydrogels                                     37
07/NIR02/51               Study of Phenotypic Methods to Find ESBL-Producing Enterobacteriaceae                               42
07/NIR02/53               Assessment criteria for sedation in a primary care dental setting                                   35
07/NIR02/93               Comparison of 15% vs 5% sucrose intakes as part of eucaloric diet                                   29

Provisional Opinion

Other Decisions
07/NIR02/59               PERCEPTIONS OF PALLIATIVE CARE SERVICES IN                        29    Not requiring review by NHS REC
                          THE WESTERN BOARD AREA
07/NIR02/71               Feeding of the Head and Neck Cancer Patient during                38    Not requiring review by NHS REC
                          Chemoradiation

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




HSC REC 2 Annual Report                                                                                                    Page 12

				
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