National Research Ethics Service
NRES Committee East Midlands - Northampton
Annual Report
01 April 2012 – 31 March 2013
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Part 1 – Committee Membership and Training
Name of REC: NRES Committee East Midlands - Northampton
Type of REC: Recognised to review CTIMPS in patients - type iii
Type of Flag: None
Chair: Mr Ken Willis/Mr John Aldridge
Vice-Chair: Mr Mike Newman
Alternate Vice-Chair: n/a
Co-ordinator: Miss Jessica Parfrement
PRSC Co-ordinator: n/a
Assistant Co-ordinator: Miss Georgia Copeland
Committee Address: The Old Chapel Royal Standard Place Nottingham NG1 6FS
Telephone: 0115 8839425 Fax: 0115 8839294 Email: [email protected]
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Chair’s overview of the past year:
Ken Willis comments:
The annual report for this year is essentially split into two periods, namely April – July, and August – March. This is due the chair taking a break in service. I would express my thanks to a proficient committee who effectively and efficiently “carried on regardless”. During the first period many of the applications could not receive approval because of common themes emerging from disparity between the IRAS form and the PIS and ICF. A cross check of information could have eradicated the majority of these errors, permitting the application to proceed unhindered. Other stumbling blocks that arose in several applications was the lack of consideration to the consequences of actions such as stress and possible parental conflict, such consequences should be anticipated and either avoided or mechanisms instituted to allay concerns. If the IRAS guide lines for the formulation of PIS and ICF sheets were adhered to a lot of time could be saved by the researchers, the attendance of academic supervisors could also have increased the application success rates. In general there have been many novel, interesting and worthwhile applications that in the fullness of time have gained approval, and I hope that the future will continue to bring numerous research projects to conclusion bringing an overall benefit to society
John Aldridge comments:
The committee has undergone a number of changes and challenges over the past year, including a change of Coordinator and Assistant Coordinator. We have lost a number of members due to retirement or transfer but have recently gained a number of new recruits and our numbers are again buoyant. These new members will require some training but, in view of their backgrounds and skills, I am confident that they will quickly be able to make a significant contribution to the committee and, indeed, have already done so. In the interim we have needed to co-opt a number of members and I would like to thank them for giving up their free time to support us. Sudden break in service of our chairman in September required that a replacement be found very quickly. I have been happy to step temporarily into the breach and have experienced a steep learning curve. I am pleased that the chairman has returned and that I will be able to hand back in May. We have been able to recruit a replacement expert pharmacist member and are able to resume scrutiny of CTIMPs. Overall, in spite of the difficulties, the committee has been able to function well and applications have been resolved effectively and within the time limits. I believe that the majority of researchers have been satisfied with the review process. My thanks go out to my colleagues on the committee and the extremely efficient support of our administrators and coordinators.
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NRES Committee East Midlands - Northampton Membership:
Name Occupation Expert or Dates Lay Appointed Resigned Mr John Aldridge Senior Lecturer in Expert 24/04/2008 Nursing Dr Timothy Bedford Consultant Anaesthetist Expert 05/09/2008 01/04/2012 Ms Elaine Blackshaw Clinical Trial Manager Expert 29/02/2008 Mr Alan Caswell Lay Member Lay 01/12/2011 Dr Belinda Cupid Head of Research -MND Expert 20/12/2012 Association Mr James Simon Deery Student Lay 20/12/2012 Dr Geoff Dickens Research Manager Expert 15/04/2002 30/04/2012 Mrs Lorenza Francescut Research Technician Lay 15/04/2008 Ms Elizabeth Gibbons Senior Research Officer Expert 13/07/2011 Mr Mike Newman Consultant Gynaecologist Expert 08/04/2005 Mrs Yael Vinciguerra Lay Member Lay 16/08/2011 01/08/2012 Mr Stuart Campbell Retired Senior Lecturer in 20/12/2012 Watson Education Mrs Sarah Elizabeth Lecturer Expert 20/12/2012 Westwater-Wood Mr Clive Wilkinson Lay Member Lay Plus 08/02/2010 27/09/2012 Mr Ken Willis Medical Devices Lay 17/01/2005 Manager Mr Derek Butters Pharmacist Expert 01/02/2012
Co-opted Members
Name Occupation Expert or Meeting date attended Lay Mr Chris Foy Medical Statistician Expert 16/08/2012 19/07/2012 Dr Ian Ross Consultant Physician Expert 15/11/2012 Mrs Theresa Hyde Retired Head Teacher Lay 18/10/2012 Mrs Janet Mallet Lay Member Lay 17/05/2012 Mr Mike Wakeman Pharmacist Expert 16/08/2013 Ms Margaret Vince Lay Member Lay 21/03/2013 15/11/2012 Mr John Baker Radiation Protection Lay 18/10/2012 Advisor and Senior Lecturer (retired) Mr Paul Hamilton Retired Local Government Lay 16/08/2013 Officer 19/07/2012
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NRES Committee East Midlands - Northampton: Members’ Declarations of Interest:
Name Declaration of Interest Date Mr Mike Newman None 19/04/2012 Mrs Lorenza Francescut None 28/11/2012 Mr Alan Caswell None 28/11/2012 Mr John Aldridge None 29/11/2012 Ms Elaine Blackshaw None 28/11/2012 Mr Stuart Campbell Watson None 17/12/2012 Ms Elizabeth Gibbons None 20/12/2012 Mr James Simon Deery None 19/12/2012 Mrs Sarah Elizabeth Chair of Undergraduate Ethics Committee 20/12/2012 Westwater-Wood Dr Belinda Cupid Head of Research Motor Neurone Disease 17/01/2013 Association Mr Ken Willis None 01/12/2012
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Meetings for Full Ethical Review 01 April 2012 - 31 March 2013:
Month Date Number of Members Present at Meeting April 19/04/2012 7 May 17/05/2012 7 June 21/06/2012 8 July 19/07/2012 7 August 16/08/2012 7 October 18/10/2012 8 November 15/11/2012 8 December 20/12/2012 9 January 17/01/2013 9 February 21/02/2013 8 March 21/03/2013 7
11 full committee meetings were held during the reporting period.
Proportionate Review Sub Committee Meetings held during 01 April 2012 - 31 March 2013 :
Month Date Number of Members Present at Meeting April 19/04/2012 3 May 17/05/2012 4 June 21/06/2012 3 July 19/07/2012 3 August 16/08/2012 3 October 18/10/2012 3 November 15/11/2012 3 December 20/12/2012 4 January 17/01/2013 3 February 21/02/2013 3 March 21/03/2013 3
11 proportionate review sub-committee meetings were held during the reporting period.
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Attendance of Members: 01 April 2012 – 31 March 2013:
Name Number of Meetings Attended Mr Alan Caswell 10 Mr John Aldridge 10 Ms Elizabeth Gibbons 9 Ms Elaine Blackshaw 8 Mrs Lorenza Francescut 7 Mr Mike Newman 6 Mr Ken Willis 5 Mr Clive Wilkinson 4 Dr Belinda Cupid 4 Mr James Simon Deery 3 Mr Stuart Campbell Watson 3 Mrs Sarah Elizabeth Westwater-Wood 3 Mrs Yael Vinciguerra 2 Mr Derek Butters 7
Number of inquorate meetings held: None
Attendance of Members at proportionate review sub-committee meetings: 01 April 2012 – 31 March 2013:
Name Number of Meetings Attended Mr John Aldridge 6 Ms ElizabethGibbons 6 Mrs Lorenza Francescut 5 Ms Elaine Blackshaw 4 Mr Alan Caswell 3 Mr Ken Willis 3 Mr Mike Newman 3 Mr Clive Wilkinson 2 Mrs Yael Vinciguerra 2
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Training 01 April 2012 – 31 March 2013:
Name of Member Date Event(s) attended Mr Mike Newman 16/10/2012 - 16/10/2012 East Midlands Local Training Event , NRES Mr Alan Caswell 24/10/2012 - 24/10/2012 HRA National Members Training Day Mr John Aldridge 18/10/2012 - 18/10/2012 SED Report Mr John Aldridge 18/10/2012 - 18/10/2012 SID Report Mr Alan Caswell 18/10/2012 - 18/10/2012 SED report Mr Alan Caswell 18/10/2012 - 18/10/2012 SID report Mrs Lorenza Francescut 18/10/2012 - 18/10/2012 SED report Mrs Lorenza Francescut 18/10/2012 - 18/10/2012 SID report Ms Elizabeth Gibbons 18/10/2012 - 18/10/2012 SED Report Ms Elizabeth Gibbons 18/10/2012 - 18/10/2012 SID report Mr Mike Newman 18/10/2012 - 18/10/2012 SED Report Mr Mike Newman 18/10/2012 - 18/10/2012 SID Report Ms Elizabeth Gibbons 07/11/2012 - 07/11/2012 Equality & Diversity, HRA Ms Belinda Cupid 23/04/2013 – 23/04/2013 HRA Induction Training Mr Stuart Watson 23/04/2013 – 23/04/2013 HRA Induction Training Mrs Sarah Westwater-Wood 23/07/2012-26/07/2012 Qualitative research skills EdD module Mrs Sarah Westwater-Wood 25/05/2012 – 25/05/2012 Chair the Division of physiotherapy education internal ethical review committee Mrs Sarah Westwater-Wood 23/04/2013 – 23/04/2013 HRA Induction Training Ms Elaine Blackshaw 14/03/2013 – 14/032013 Personal data in research: workshop
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ListPart of2: TrainingREC workload Events and Organised activity duringLocally the by reportingthe Co-ordinator: period.
Table 1: Applications assigned to a full committee meeting held within the reporting period:
Applications for full ethical review – Study Type Number % Clinical Trial of Investigational Medicinal Product 8 15.69 Phase 1 0 0.00 Gene Therapy 0 0.00 Research Tissue Bank 0 0.00 Research Database 0 0.00 Others 43 84.31 Total Applications Reviewed 51 100
Table 2: Other REC activity during the reporting period:
Number of applications made invalid by co-ordinator 0 Number of studies withdrawn prior to the meeting 7 Number of student applications reviewed 24 Number of paediatric applications reviewed 3 Number of device applications reviewed 0 Number of prisoner applications reviewed 0 Number of applications involving adults unable consent reviewed 6 Number of applications reviewed funded by the US DHHS 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 1 1.96 Favourable Opinion with Additional Conditions 6 11.76 Unfavourable Opinion 6 11.76 Provisional Opinion 38 74.51 Invalid 0 0.00 No Opinion Pending Consultation with Referee 0 0.00 Provisional Opinion Pending Consultation with Referee 0 0.00 Not Requiring Review by NHS REC 0 0.00 Total 51 100 Number of studies sent back to full committee meeting 0 for final opinion
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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 35 68.63 Conditions Further Information Favourable Opinion with Additional 1 1.96 Conditions Further Information Unfavourable Opinion 0 0.00 Favourable Opinion with Standard Conditions 1 1.96 Favourable Opinion with Additional Conditions 6 11.76 Unfavourable Opinion 6 11.76 Provisional Opinion 2 3.92 Provisional Opinion Pending Consultation with Referee 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 0 0.00 Total 51 100
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Table 5: Applications assigned to a proportionate review sub-committee within the reporting period:
Total Applications Reviewed 26
Table 6: Decisions given at proportionate review sub-committee meetings held within the reporting period:
Decisions taken at proportionate review sub- Number % committee meetings Favourable Opinion with Standard Conditions 11 42.31 Favourable Opinion with Additional Conditions 6 23.08 No Opinion transfer to full committee for review 4 15.38 Provisional Opinion 5 19.23 Unfavourable Opinion 0 0.00 Total 26 100
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Table 7: Other Management Information for the reporting period:
Average number of applications reviewed per full meeting 4.64 Number of applications for full ethical review over 60 days 1 Number of applications over 60 days as a % of total 1.96% Number of days taken to final decision - average 38 Number of days taken to final decision - mode 30
Number of SSAs (non-Phase 1) reviewed 1 Number of applications for SSA review over 25 days 0 Number of applications for SSA review over 25 days as % of 0.0% all non-Phase 1 (SSAs)
Number of SSAs (Phase 1) reviewed 0 Number of applications for SSA review over 14 days 0 Number of applications for SSA review over 14 days as % of 0% all Phase 1 (SSAs)
Number of substantial amendments reviewed 92 Number of substantial amendments over 35 days 2 Number of substantial amendments over 35 days as a % of 2.2% total substantial amendments
Number of Section 30 applications reviewed 0 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
Number of modified amendments reviewed 2 Number of modified amendments over 14 days 1 Number of modified amendments over 14 days as a % of total 50.0% modified amendments
Number of proportionate review applications for ethical 1 review over 14 days* Number of proportionate review applications over 14 days as 4.55% a % of total
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Further Information Favourable Opinion with Standard Conditions REC Reference Application Short Title Number of Days on Clock 12/EM/0132 PRESTIGE study 63 12/EM/0135 Intraocular Pressure change during Laparoscopic Colorectal Surgery 53 12/EM/0152 The HOOP Study 28 12/EM/0161 How do men experience problematic anger version 1 (1/12/11) 54 12/EM/0183 Genotype dependent changes in bone phenotypes assessed via pQCT 42 12/EM/0184 Physical Activity Opinions in Kidney Patients (QCKD) 47 12/EM/0185 Low Back Pain and chiropractic awareness in opioid dependent clients 60 12/EM/0238 Alcohol use in diabetic Type 2 population and Brief Interventions 42 12/EM/0262 Genetics of Rare Inherited Disorders 41 12/EM/0263 Characterization of mesenchymal stem cells in multiple sclerosis 52 12/EM/0265 Gaviscon® Double Action Acid Pocket Investigation 59 12/EM/0289 Impact of depth of anaesthesia on post operative pain 21 12/EM/0304 DREAM Study (Daily Remote Ischaemic Conditioning following AMI) 31 12/EM/0313 The Impact of an Unknown Release Date on Psychological Wellbeing 23 12/EM/0317 Clinical and genetic characterisation of Gordon syndrome 35 12/EM/0331 28 year follow-up of patients with neurotic disorder 32 12/EM/0351 A feasibility study for web based PR (full data set) 30 12/EM/0377 Hydronephrosis after ALIF 32 12/EM/0381 The Impact of Polypharmacy Interventions on Patient Outcomes 30 12/EM/0431 Transition to a care home, identity and mental health in older people 22 12/EM/0432 Investigation of biological pathways following thermal injury 39 12/EM/0440 Inflammation in South Asian and White European Men (INFLAME) 13 12/EM/0444 ILLUMINATE-X 24 12/EM/0470 Dietary Correlates of the Maximal Capacity for Fat Oxidation. 1.0 38 12/EM/0475 Red Cell Washing in Cardiac Surgery 30 12/EM/0477 Maintenance Therapy with Tasquinimod in patients with mCRPC 31 12/EM/0484 The ASSESS study 10 13/EM/0002 Parental Experiences of Hospice Care through Reflective Diaries. 45 13/EM/0009 The lived experience of women with Alzheimer's disease v1 41 13/EM/0020 The role of anger in inpatient aggression and violence (Version 1.0) 44 NRES Committee East Midlands - Northampton Annual Report Page 13
13/EM/0049 The Impact of Ethnicity on the High Density Lipoprotein (HDL) proteome 56 13/EM/0071 Nottingham Carotid Occlusion Study 47 13/EM/0087 Body image disturbances in colorectal resection patients 40 13/EM/0094 Sedentary time and glucose regulation in women with IGT: ACUTE Study 38 13/EM/0095 (duplicate) Long term safety study of secukinumab in pts with Psoriati 32 13/EM/0108 Development of a health instrument to identify anxiety in pregnancy 45 13/EM/0109 Oral Health Related Quality of Life in Primary Care Dentistry: v1 11 13/EM/0119 PCOS AND ENDOMETRIAL CANCER RISK. 38 13/EM/0139 Creating Integrated Care Pathways for Safer Medicines Management 18
Further Information Favourable Opinion with Additional Conditions REC Reference Application Short Title Number of Days on Clock 12/EM/0211 Microarrays expression in Twin pregnancies 9 12/EM/0267 Managing Weight In Pregnancy 60
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 12/EM/0175 Prognostic relevance of small cell lung cancer biopsy IHC profiles 8 12/EM/0247 Lateral extra articular augmentation for ACL injuries 6 12/EM/0248 Investigating keratinocyte gene expression in genodermatosis 8 12/EM/0249 Interside SSEP latency differences in Scoliosis Patients v1 9 12/EM/0294 Routine Data Pilot – Dementia (RDP Dem) 8 12/EM/0355 Understanding the pathogenesis of abdominal aortic aneurysms v1 55 12/EM/0485 Sleep disordered breathing(SDB) in cardiac surgery 7 12/EM/0488 Epidemiology of Hepatitis C in pregnant women in North Thames 4 13/EM/0056 reticulated platelet analysis utilising the beckman coulter fc500 6 13/EM/0105 Exploring Parent Experiences of Receiving Screen Positive Results 7 13/EM/0138 Cadaveric testing of a novel unicondylar knee replacement 9 13/EM/0140 Insula ischaemia and angioedema in stroke thrombolysis 3
Favourable Opinion with Additional Conditions
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REC Reference Application Short Title Number of Days on Clock 12/EM/0143 Normothermic perfusion of disused human kidneys 41 12/EM/0159 metabolomics and novel biomarkers for pancreatic cancer 8 12/EM/0197 1199.33 - Extension trial of long term safety of BIBF 1120 in IPF 26 12/EM/0209 Living with Rheumatoid Arthritis and Fibromyalgia 7 12/EM/0212 PIVOT: Patient Information Videos on Operations Trial 8 12/EM/0269 Macular abnormality in both eyes of children who have strabismus. 30 12/EM/0336 Patient factors related to outcome after Total Knee Replacement V1.2 3 12/EM/0391 TAK375 as treatment for depression associated with Bipolar 1 Disorder 25 12/EM/0403 IOP and corneal viscoelastic properties determined by CORVIS NCT 3 12/EM/0404 Non-Contact Ultra Wide Field Imaging of Retinopathy of Prematurity 3 12/EM/0467 Micronutrient loss in acute renal replacement therapy 36 13/EM/0036 New methods to measure the immune response to Hepatitis B vaccines 29
Unfavourable Opinion REC Reference Application Short Title Number of Days on Clock 12/EM/0153 Mechanisms of change in the treatment of personality disorder 33 12/EM/0219 The development and validation of The Myeloma pain assessment tool. 32 12/EM/0306 The development and validation of The Myeloma pain assessment tool . 17 12/EM/0419 A reveiw of a family and professionals experience of being in BFT 22 12/EM/0469 Diagnostic potential of low frequency cardiac & skeletal muscle sound 37 13/EM/0022 Long term safety study of secukinumab in pts with Psoriatic Arthritis 39
Provisional Opinion REC Reference Application Short Title Number of Days on Clock 13/EM/0110 Experiences of Parkinson’s disease and psychological outcomes N/A 13/EM/0112 AKT inhibitor in breast cancer (STAKT study) N/A
Provisional Opinion Pending Consultation with Referee 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
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Withdrawn after the meeting REC Reference Application Short Title Number of Days on Clock
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
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Table 9: Items exceeding timelines:
Full applications for ethical review over 60 day timeline REC Reference Application Short Title Number of Days on Clock 12/EM/0132 PRESTIGE study 63
Proportionate review applications for ethical review over 14 days timeline REC Reference Application Short Title Number of Days on Clock 13/EM/0139 Creating Integrated Care Pathways for Safer Medicines Management 18
SSAs (non Phase 1) over 25 days timeline REC Reference Application Short Title Number of Days on Clock
SSAs (Phase 1) over 14 days timeline REC Reference Application Short Title Number of Days on Clock
Substantial Amendments over 35 day timeline Amendment Reference Application Short Title Amendment Title Number of Days on Clock 11/EM/0415/AM02 The role of peripheral and central Substantial Amendment 2 36 vision in postural stability. 09/H0402/74/AM10 IMCL CP12-0606/TRIO-012 version Substantial Amendment 38 4.0 18 July 2008 12.11.2012
Modified Amendments over 14 day timeline Amendment Reference Application Short Title Amendment Title Number of Days on Clock 09/H0402/92/AM13/1 20080763 Panitumumab vs Modified Amendment 12 20 Cetuximab in Colorectal Cancer
Section 30 application over 60 day timeline Amendment Reference Application Short Title Amendment Title Number of Days on Clock
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